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0 | LLY | 2015 | Eli Lilly and Company (the “company” or “registrant” or "Lilly") was incorporated in 1901 in Indiana to succeed to the drug manufacturing business founded in Indianapolis, Indiana, in 1876 by Colonel Eli Lilly. We discover, develop, manufacture, and market products in two business segments—human pharmaceutical products... | [-0.008280634880065918, -0.007574935909360647, -0.01596563495695591, -0.007736793719232082, -0.007121734786778688, 0.01565486751496792, -0.017195751890540123, 0.01394565124064684, -0.0024019668344408274, 0.010663178749382496, -0.008753259666264057, 0.010902728885412216, 0.021701868623495102, 0.0048524909652769566, 0.00... |
1 | LLY | 2015 | The mission of our human pharmaceutical business is to make medicines that help people live longer, healthier, more active lives. Our vision is to make a significant contribution to humanity by improving global health in the 21st century. Most of the products we sell today were discovered or developed by our own scient... | [0.005879111588001251, -0.009281421080231667, 0.002430691383779049, -0.006791444029659033, 0.005480583291500807, 0.008800552226603031, 0.0016525737009942532, 0.025611188262701035, -0.004933842457830906, 0.011046800762414932, -0.024899765849113464, 0.017666976898908615, -0.012640913017094135, -0.011554018594324589, -0.0... |
2 | LLY | 2015 | Our animal health business, operating through our Elanco division, develops, manufactures, and markets products for both food animals and companion animals. Elanco food animal products help the food industry produce an abundant supply of safe, nutritious and affordable food. Elanco companion animal products help pets l... | [0.008651016280055046, -0.010181127116084099, -0.007238605059683323, -0.016791993752121925, -0.0038775906432420015, 0.0072124493308365345, -0.008991040289402008, -0.004711305256932974, -0.01989145204424858, 0.002283724257722497, -0.014241808094084263, 0.018008237704634666, -0.014712612144649029, -0.0248479675501585, -0... |
3 | LLY | 2015 | We manufacture and distribute our products through facilities in the United States (U.S.), Puerto Rico, and 14 other countries. Our products are sold in approximately 125 countries. | [-0.008739529177546501, -0.01351007167249918, -0.00806079339236021, -0.013548856601119041, -0.001387367956340313, 0.014660689979791641, 0.0001015578382066451, 0.023723427206277847, 0.009276053868234158, 0.005000018980354071, -0.01304465252906084, 0.012146135792136192, -0.030329786241054535, -0.025223109871149063, -0.00... |
4 | LLY | 2015 | •Jardiance®, for the treatment of type 2 diabetes (approved in the U.S., Europe, and Japan in 2014) | [-0.011450473219156265, -0.027455970644950867, 0.01676047407090664, -0.0074050589464604855, 0.007902084849774837, 0.022863198071718216, -0.008436859585344791, -0.007348435930907726, -0.017792275175452232, 0.0008383382228203118, 0.012142535299062729, 0.014747203327715397, -0.012658435851335526, -0.014306800439953804, -0... |
5 | LLY | 2015 | •Trulicity®, for the treatment of type 2 diabetes (approved in the U.S. and Europe in 2014 and Japan in 2015) | [-0.0018952175742015243, -0.031124867498874664, 0.00890574511140585, -0.004268682561814785, 0.009028538130223751, 0.0206292737275362, -0.016661111265420914, -0.016234565526247025, -0.0061073508113622665, -0.0010534372413530946, 0.01995714195072651, 0.020435389131307602, -0.014567161910235882, -0.019737405702471733, -0.... |
6 | LLY | 2015 | •Glyxambi®, a combination tablet of linagliptin and empagliflozin (Jardiance) for the treatment of type 2 diabetes (approved in the U.S. in 2015) | [-0.014703057706356049, -0.0235917828977108, 0.016671184450387955, -0.01203386764973402, -0.011692983098328114, 0.014986056834459305, -0.018870854750275612, -0.011397121474146843, -0.009943538345396519, -0.012008140794932842, 0.023205876350402832, -0.002564673777669668, -0.009544767439365387, -0.008039729669690132, -0.... |
7 | LLY | 2015 | •Synjardy®, a combination tablet of empagliflozin and metformin hydrochloride for the treatment of type 2 diabetes (approved in the U.S. and Europe in 2015)[DATA_TABLE_REMOVED] | [-0.00901094265282154, -0.020253658294677734, -0.00013313636009115726, -0.024665601551532745, -0.017402665689587593, 0.031064210459589958, -0.019660240039229393, -0.01787998154759407, -0.01607392355799675, -0.0012916545383632183, 0.031399622559547424, 0.0026445859111845493, -0.014242063276469707, -0.007372589781880379,... |
8 | LLY | 2015 | ◦approved in 2014 in the U.S. and the European Union (EU), and in Japan in 2015, both as a single agent and in combination with another agent as a second-line treatment of advanced or metastatic gastric cancer | [-0.00635975506156683, -0.005094227846711874, 0.01088867150247097, -0.027366219088435173, -0.004805148113518953, 0.017447570338845253, -0.01703643426299095, -0.006706650834530592, -0.0134389977902174, 0.00047376961447298527, 0.010875822976231575, -0.0008162488811649382, -0.00036315646138973534, -0.007715217769145966, -... |
9 | LLY | 2015 | ◦approved in 2014 in the U.S., and in the EU in 2016, in combination with another agent as a second-line treatment of metastatic NSCLC | [-0.011375345289707184, -0.013853772543370724, 0.0014679915038868785, -0.04023949056863785, -0.00874439999461174, 0.011972709558904171, -0.025928162038326263, 0.0008356748148798943, -0.027072051540017128, 0.019840126857161522, 0.0005890236352570355, 0.008274134248495102, 0.007905547507107258, 0.003301392076537013, -0.0... |
10 | LLY | 2015 | ◦approved in 2015 in the U.S., and in the EU in 2016, as a second-line treatment of metastatic colorectal cancer | [-0.008754134178161621, -0.008076843805611134, -0.0073679047636687756, -0.023952020332217216, -0.015849856659770012, 0.005855078808963299, -0.024952130392193794, -0.012893833220005035, -0.008830091916024685, 0.032915037125349045, 0.010798664763569832, -0.004557466600090265, 0.010115044191479683, -0.009671957232058048, ... |
11 | LLY | 2015 | •Portrazza™, approved in 2015 in the U.S. for use in combination with other agents as a first-line treatment of metastatic squamous NSCLC, and approved in 2016 in the EU for use in combination with other agents as a first-line treatment for epidermal growth factor receptor expressing squamous NSCLC | [-0.022488387301564217, -0.006631616968661547, 0.018490158021450043, -0.02916981652379036, 0.008328540250658989, 0.00542617030441761, -0.018197927623987198, -0.012326771393418312, -0.03421741724014282, 0.008029669523239136, 0.004393404815346003, 0.0012959381565451622, -0.02571619488298893, 0.007923404686152935, -0.0073... |
12 | LLY | 2015 | On January 1, 2015, we completed our acquisition of Novartis Animal Health (Novartis AH) in an all-cash transaction for $5.28 billion. Novartis AH operates in approximately 40 countries. The combined organization has added several hundred products to our animal health product portfolio, expanded our global commercial p... | [-0.007876128889620304, -0.010703456588089466, 0.010820719413459301, -0.020742425695061684, -0.018071448430418968, 0.015700140967965126, -0.008736053481698036, -0.010755573399364948, -0.02250136248767376, 0.006120448932051659, 0.007153009995818138, 0.011113875545561314, -0.0017524223076179624, -0.013420036993920803, 0.... |
13 | LLY | 2015 | •Sentinel® (outside the U.S.), a monthly tablet for the prevention of flea populations, the concurrent prevention of heartworm disease and the treatment of roundworms, hookworms, and whipworms in dogs | [-0.004040185362100601, -0.0035463478416204453, -0.008922213688492775, -0.010141892358660698, -0.00906804483383894, 0.01487477496266365, -0.021344374865293503, -0.008836041204631329, 0.0036656642332673073, -0.015405070036649704, 0.015577415935695171, 0.04181376099586487, -0.015869079157710075, 0.013204346410930157, 0.0... |
14 | LLY | 2015 | We sell most of our products worldwide. We adapt our marketing methods and product emphasis in various countries to meet local customer needs. | [-0.02065546251833439, -0.007061642128974199, 0.0051160226576030254, -0.020757528021931648, -0.007284909952431917, 0.018193136900663376, 0.002057253383100033, 0.01134838443249464, 0.018869319930672646, -0.015386342070996761, -0.01852484978735447, 0.028246568515896797, -0.015182211063802242, -0.018971385434269905, -0.00... |
15 | LLY | 2015 | In the U.S., we distribute human pharmaceutical products principally through independent wholesale distributors, with some sales directly to pharmacies. In 2015, 2014, and 2013, three wholesale distributors in the U.S.—AmerisourceBergen Corporation, McKesson Corporation, and Cardinal Health, Inc.—each accounted for bet... | [-0.004985287319868803, -0.006349404342472553, 0.004672265611588955, -0.015341374091804028, 0.00416154507547617, 0.027414139360189438, 0.004451502580195665, 0.010655928403139114, -0.002705169143155217, -0.0017908153822645545, 0.010431870818138123, 0.02931204065680504, -0.003977027256041765, 0.01053730957210064, -0.0011... |
16 | LLY | 2015 | We promote our major human pharmaceutical products in the U.S. through sales representatives who call upon physicians and other health care professionals. We advertise in medical journals, distribute literature and samples of certain products to physicians, and exhibit at medical meetings. In addition, we advertise cer... | [-0.007708063814789057, 0.004710113164037466, 0.0024683126248419285, -0.01770789362490177, 0.007048514671623707, 0.025715753436088562, 0.003357704496011138, 0.03091219998896122, 0.009573454968631268, 0.0038040659856051207, 0.004726768471300602, 0.014936455525457859, -0.009773318655788898, 0.0081810737028718, -0.0190269... |
17 | LLY | 2015 | We maintain special business groups to service wholesalers, pharmacy benefit managers, managed care organizations, government and long-term care institutions, hospitals, and certain retail pharmacies. We enter into arrangements with these organizations providing for discounts or rebates on our products. | [-0.0013540616491809487, -0.015715396031737328, -0.0010600604582577944, -0.01637793518602848, -0.030158720910549164, 0.032146334648132324, 0.024315137416124344, 0.021174708381295204, 0.004233616404235363, 0.0012936050770804286, 0.0023039751686155796, 0.027985597029328346, 0.006863891612738371, 0.0016960968496277928, -0... |
18 | LLY | 2015 | Outside the U.S, we promote our human pharmaceutical products primarily through sales representatives. While the products marketed vary from country to country, endocrinology products constitute the largest single group in total revenue. Distribution patterns vary from country to country. In most countries in which we ... | [-0.0005862158141098917, -0.007588532753288746, 0.006699609104543924, -0.016837261617183685, 0.02444540336728096, 0.012013543397188187, -0.006127691362053156, 0.006941448897123337, 0.0011503718560561538, 0.013013582676649094, -0.004375988617539406, 0.012608337216079235, 2.948951441794634e-05, -0.004124344792217016, -0.... |
19 | LLY | 2015 | •We and Boehringer Ingelheim have a diabetes alliance under which we jointly develop and commercialize Trajenta, Jentadueto, Jardiance, Glyxambi, Synjardy, and Basaglar in major markets. | [-0.01687890850007534, -0.032205432653427124, 0.021786026656627655, -0.014037253335118294, -0.0021197304595261812, 0.02836393378674984, -0.015879066661000252, -0.0009348849998787045, 0.00023701020109001547, -0.00791322160512209, 0.011050883680582047, 0.004446664825081825, -0.009584009647369385, -0.010603585280478, 0.00... |
20 | LLY | 2015 | •We co-promote Cymbalta in Japan with Shionogi & Co. Ltd. | [0.0020768707618117332, -0.010652497410774231, 0.016388457268476486, -0.0020868636202067137, -0.02431620843708515, 0.029605817049741745, -0.001268273452296853, -7.80700211180374e-05, 0.014429837465286255, -0.0034442408941686153, -0.005206333473324776, 0.049431852996349335, 0.01982603780925274, -0.022770630195736885, -0... |
21 | LLY | 2015 | •Through September 30, 2015, Erbitux was marketed in the U.S. and Canada by Bristol-Myers Squibb (BMS). Effective October 1, 2015, BMS transferred to us all commercialization rights for Erbitux in those two countries. Outside the U.S. and Canada, Erbitux is commercialized by Merck KGaA, and we receive royalties from Me... | [-0.018319670110940933, -0.00839272327721119, -0.008451231755316257, -0.0386156290769577, -0.022480275481939316, 0.020126933231949806, -0.01594032347202301, -0.011526179499924183, 0.008646260015666485, 0.000514387444127351, 0.016915464773774147, 0.007060028612613678, -0.017773590981960297, 0.0004530347650870681, -0.017... |
22 | LLY | 2015 | •Effient is co-promoted with us by Daiichi Sankyo Co., Ltd. (Daiichi Sankyo) in the U.S., Brazil, Mexico, and certain other countries. Through the end of 2015, we also co-promoted Effient with Daiichi Sankyo in major European markets. Effective January 2016, Daiichi Sankyo is exclusively promoting Effient in major Euro... | [-0.027845775708556175, 0.01218753308057785, 0.002586346585303545, -0.027552101761102676, -0.01057899184525013, 0.031716953963041306, 0.0011905537685379386, 0.0015017497353255749, -0.017620529979467392, -0.01616550050675869, 0.005826788954436779, 0.01744699478149414, 0.00018187856767326593, -0.007275143172591925, -0.01... |
23 | LLY | 2015 | For additional information, see Item 8, "Financial Statements and Supplementary Data—Note 4, Collaborations and Other Arrangements." | [-0.018397772684693336, -0.012333132326602936, -0.009593851864337921, -0.0539192296564579, -0.02443693019449711, 0.01073415670543909, -0.018410513177514076, -0.004128031898289919, 0.004589887335896492, -0.01996489427983761, 0.019493484869599342, 0.023519588634371758, -0.009224367327988148, 0.009460072964429855, -0.0064... |
24 | LLY | 2015 | Our Elanco animal health business unit employs field salespeople throughout the U.S. and has an extensive sales force outside the U.S. Elanco sells its products primarily to wholesale distributors. Elanco promotes its products primarily to producers and veterinarians for food animal products and to veterinarians for co... | [-0.016964025795459747, -0.018380945548415184, -0.013077249750494957, -0.0014209809014573693, -0.003334308508783579, 0.022306719794869423, -0.009255468845367432, 0.003025576239451766, -0.01611907407641411, -0.002962204860523343, -0.009235969744622707, 0.010503397323191166, -0.016782036051154137, -0.01670404151082039, 0... |
25 | LLY | 2015 | Our human pharmaceutical products compete globally with products of many other companies in highly competitive markets. Our animal health products compete globally with products of animal health care companies as well as pharmaceutical, chemical, and other companies that operate animal health businesses. | [-0.0021501844748854637, -0.004658185876905918, -7.63746356824413e-05, 0.00035207218024879694, -0.0032695934642106295, 0.022611405700445175, 0.0016265899175778031, 0.018435779958963394, -0.020050879567861557, -0.0024439883418381214, -0.02501435950398445, 0.02674763835966587, -0.015218709595501423, -0.018081245943903923... |
26 | LLY | 2015 | Important competitive factors for both human pharmaceutical and animal health products include effectiveness, safety, and ease of use; price and demonstrated cost-effectiveness; marketing effectiveness; and research and development of new products, processes, and uses. Most new products that we introduce must compete w... | [-0.0002840037923306227, -0.0013371673412621021, -0.004590226802974939, -0.003670202801004052, 0.004441835917532444, 0.022146524861454964, 0.002400635741651058, -0.0055597140453755856, -0.026446564123034477, -0.018123481422662735, -0.010585220530629158, 0.01663297601044178, -0.008824314922094345, -0.007379976566880941,... |
27 | LLY | 2015 | We believe our long-term competitive success depends upon discovering and developing (either alone or in collaboration with others) or acquiring innovative, cost-effective human pharmaceutical and animal health products that provide improved outcomes and deliver value to payers, and continuously improving the productiv... | [-0.016178537160158157, -0.0068228342570364475, 0.0023256647400557995, -0.015104388818144798, -0.011305084452033043, 0.03140227496623993, -0.003912023268640041, 0.018432924523949623, -0.025143038481473923, 0.015130911022424698, -0.004843615461140871, 0.02356496825814247, 0.004323117434978485, -0.014680033549666405, -0.... |
28 | LLY | 2015 | One of the biggest competitive challenges we face is from generic pharmaceuticals. In the U.S. and the EU, the regulatory approval process for human pharmaceuticals (other than biological products (biologics)) exempts generics from costly and time-consuming clinical trials to demonstrate their safety and efficacy, allo... | [0.013457770459353924, -0.015759669244289398, -0.01068214699625969, -0.006985764019191265, 0.01395818404853344, 0.03296053037047386, 0.019122444093227386, 0.012930668890476227, -0.02542097494006157, -0.021270884200930595, 0.0023702890612185, -0.013731329701840878, -0.002967448439449072, -0.019082412123680115, -0.005698... |
29 | LLY | 2015 | with generic or counterfeit versions of our products. Many of our animal health products also compete with generics. | [-0.015832850709557533, -0.010775508359074593, -0.011031746864318848, -0.00910995714366436, -0.01896165870130062, 0.03309524059295654, -0.0035805976949632168, 0.0026685905177146196, -0.020310282707214355, -0.01039115060120821, 0.0026719619054347277, 0.015536152757704258, -0.005246148910373449, -0.011153123341500759, -0... |
30 | LLY | 2015 | Several of our current products, including Cyramza, Erbitux, Trulicity, and Portrazza, and many of the new molecular entities (NMEs) in our research pipeline are biologics. Competition for Lilly’s biologics may be affected by the approval of follow-on biologics, also known as biosimilars. A biosimilar is a subsequent v... | [-0.015477749519050121, -0.012101276777684689, -0.008177815936505795, -0.00403488427400589, -0.005922332406044006, 0.022892482578754425, -0.013053442351520061, -0.011682594195008278, -0.02117723412811756, -0.017679208889603615, 0.01719299703836441, -0.008191321976482868, -0.016017984598875046, -0.014289231039583683, 0.... |
31 | LLY | 2015 | Biosimilars may present both competitive challenges and opportunities. For example, with our partner Boehringer Ingelheim we have developed Basaglar, a new insulin glargine product which has the same amino acid sequence as the product currently marketed by a competitor. Our product has launched in the EU and Japan, and... | [-0.0127042131498456, -0.03491809219121933, -0.0018545192433521152, -0.004529532976448536, 0.006399183999747038, 0.018185384571552277, -0.011769387871026993, -0.002920489525422454, -0.03997556492686272, -0.01914038695394993, -0.006150345783680677, 0.01339692622423172, -0.007182689383625984, -0.012784917838871479, -0.00... |
32 | LLY | 2015 | U.S. Private Sector Payer Consolidation | [-0.00621248921379447, -0.00539216585457325, 0.019371982663869858, -0.03558623790740967, -0.0068955197930336, 0.017683284357190132, -0.018342288210988045, 0.005268602631986141, -0.020085904747247696, -0.0189326461404562, 0.019879965111613274, 0.018795354291796684, 0.037178829312324524, 0.011354096233844757, 0.003672576... |
33 | LLY | 2015 | In the U.S. private sector, consolidation and integration among healthcare providers is also a major factor in the competitive marketplace for human pharmaceuticals. Health plans and pharmaceutical benefit managers have been consolidating into fewer, larger entities, thus enhancing their purchasing strength and importa... | [0.0054802973754704, -0.010785069316625595, 0.020464977249503136, -0.018319666385650635, -0.013125410303473473, 0.026809900999069214, 0.0013465085066854954, 0.01503018755465746, -0.018098633736371994, -0.023481417447328568, 0.010804572142660618, 0.021908188238739967, 0.013977034017443657, 0.006500945892184973, -0.00964... |
34 | LLY | 2015 | Payers typically maintain formularies which specify coverage (the conditions under which drugs are included on a plan's formulary) and reimbursement (the associated out-of-pocket cost to the consumer). Formulary placement can lead to reduced usage of a drug for the relevant patient population due to coverage restrictio... | [0.012625440955162048, -0.004165582824498415, 0.0043721687979996204, -0.020347008481621742, -0.033080823719501495, 0.026212692260742188, 0.0033121462911367416, -0.00682410504668951, -0.03373106196522713, 0.005117231979966164, 0.024722564965486526, 0.006790238432586193, -0.0004893713048659265, 0.016513317823410034, -0.0... |
35 | LLY | 2015 | Intellectual property protection is critical to our ability to successfully commercialize our life sciences innovations and invest in the search for new medicines. We own, have applied for, or are licensed under, a large number of patents in the U.S. and many other countries relating to products, product uses, formulat... | [0.004318978637456894, 0.00442312890663743, 0.012211611494421959, -0.047336265444755554, 0.0065028783865273, 0.023954546079039574, 0.0007184736896306276, 0.01908552460372448, 0.010154644958674908, -0.0119707640260458, 0.005318169482052326, 0.013227075338363647, -0.0004446725361049175, -0.0006419883575290442, -0.0082083... |
36 | LLY | 2015 | The patent protection anticipated to be of most relevance to human pharmaceuticals is provided by national patents claiming the active ingredient (the compound patent), particularly those in major markets such as the U.S., various European countries, and Japan. These patents may be issued based upon the filing of inter... | [0.015745924785733223, -0.0033540260046720505, 0.0276437196880579, -0.0354708693921566, 0.0032558594830334187, 0.006168135907500982, -0.007663540542125702, 0.0023249126970767975, -0.02806256338953972, 0.010091528296470642, 0.00992137286812067, 0.02054954506456852, -0.015012947842478752, 0.0201307013630867, -0.013651704... |
37 | LLY | 2015 | •Patent term adjustment is a statutory right available to all U.S. patent applicants to provide relief in the event that a patent is delayed during examination by the United States Patent and Trademark Office (USPTO). | [-0.010507497936487198, -0.015111161395907402, 0.018786132335662842, -0.030010050162672997, -0.019369881600141525, 0.005230531562119722, -0.004683265928179026, 0.004995041526854038, -0.02272644266486168, -0.0032487669959664345, 0.02579113095998764, 0.013187440112233162, -0.02019243873655796, 0.005797697696834803, -0.01... |
38 | LLY | 2015 | •Patent term restoration is a statutory right provided to U.S. patents that claim inventions subject to review by the U.S. Food and Drug Administration (FDA). A single patent for a human pharmaceutical product may be eligible for patent term restoration to make up for a portion of the time invested in clinical trials a... | [0.01341790147125721, -0.01264791190624237, 0.012219395488500595, -0.012413566932082176, -0.006923208478838205, -0.00039378259680233896, 0.000971693079918623, 0.0013617094373330474, -0.029406897723674774, 0.006862948182970285, 0.005192406475543976, 0.022014999762177467, -0.03650419041514397, 0.003990553319454193, -0.01... |
39 | LLY | 2015 | Loss of effective patent protection for human pharmaceuticals typically results in the loss of effective market exclusivity for the product, which can result in severe and rapid decline in sales of the product. However, in some cases the innovator company may be protected from approval of generic or other follow-on ver... | [-0.006381271872669458, -0.01131179928779602, 0.01072347816079855, -0.029148608446121216, -0.011880063451826572, 0.02389383502304554, 0.0026925692800432444, -0.011238259263336658, -0.023960690945386887, -0.014119692146778107, 0.017181633040308952, 0.027704548090696335, -0.006585178431123495, 0.01438711117953062, -0.009... |
40 | LLY | 2015 | •Regulatory authorities in major markets generally grant data package protection for a period of years following new drug approvals in recognition of the substantial investment required to complete clinical trials. Data package protection prohibits other manufacturers from submitting regulatory applications for marketi... | [0.005279149394482374, -0.015259730629622936, -0.0005644373595714569, -0.016229234635829926, -0.020425992086529732, 0.012470745481550694, -0.00416023563593626, 0.009535671211779118, -0.010970006696879864, -0.0012533830013126135, 0.008818503469228745, 0.019695544615387917, -0.0059265922755002975, -0.0059996373020112514,... |
41 | LLY | 2015 | •Under the Biologics Price Competition and Innovation Act of 2010, the FDA has the authority to approve biosimilars. A competitor seeking approval of a biosimilar must file an application to show its molecule is highly similar to an approved innovator biologic and include a certain amount of safety and efficacy data wh... | [-0.009747253730893135, -0.016306892037391663, -0.023788567632436752, -0.0033983667381107807, -0.015266306698322296, 0.01604345254600048, -0.02937348000705242, 0.002461510943248868, -0.03698687627911568, 0.0082324780523777, 0.01932327263057232, -0.00016001878248061985, 0.010471711866557598, -0.02335389330983162, -0.004... |
42 | LLY | 2015 | •In the U.S., the FDA has the authority to grant additional data protection for approved drugs where the sponsor conducts specified testing in pediatric or adolescent populations. If granted, this “pediatric exclusivity” provides an additional six months, which are added to the term of data protection as well as to the... | [0.0031515266746282578, 0.001097770407795906, -0.0054574389941990376, -0.04615899920463562, -0.01798543706536293, 0.010079451836645603, -0.013387195765972137, -0.0020664914045482874, -0.017713753506541252, -0.008714242838323116, 0.03192279115319252, 0.00942741148173809, -0.005121230613440275, -0.005752894561737776, -0.... |
43 | LLY | 2015 | •Under the U.S. orphan drug law, a specific use of a drug or biological product can receive "orphan" designation if it is intended to treat a disease or condition affecting fewer than 200,000 people in the U.S., or affecting more than 200,000 people but not reasonably expected to recover its development and marketing c... | [0.0005307144019752741, -0.01123060192912817, 0.0003119147731922567, -0.029877008870244026, -0.005688790697604418, 0.0029228960629552603, -0.014230328612029552, -0.002857757266610861, -0.030732164159417152, 0.01623460091650486, 0.016929414123296738, 0.013936368748545647, -0.005120913963764906, -0.0043693119660019875, -... |
44 | LLY | 2015 | Outside the major markets, the adequacy and effectiveness of intellectual property protection for human pharmaceuticals varies widely. Under the Trade-Related Aspects of Intellectual Property Agreement (TRIPs) administered by the World Trade Organization, more than 140 countries have agreed to provide non-discriminator... | [0.0024837744422256947, -0.017737090587615967, 0.017788803204894066, -0.030509864911437035, 0.000352487521013245, 0.02233942598104477, 0.0022042084019631147, 0.0003498615405987948, -0.00721377320587635, -0.009372733533382416, 0.0027875802479684353, 0.007504650857299566, -0.0045700157061219215, -0.006402547005563974, -0... |
45 | LLY | 2015 | countries, with many developing countries limiting protection for biopharmaceutical products under their interpretation of “flexibilities” allowed under the agreement. Thus, certain types of patents, such as those on new uses of compounds or new forms of molecules, are not available in many developing countries. Furthe... | [-0.009438508190214634, -0.006460370495915413, 0.01248960755765438, -0.03401312232017517, 0.008058881387114525, 0.03281921520829201, -0.009935970418155193, -0.0017444327240809798, -0.0026746862567961216, -0.02198117971420288, 0.017245342954993248, 0.0127615537494421, -0.003916682675480843, -0.016237152740359306, 0.0034... |
46 | LLY | 2015 | Certain of our Elanco animal health products are covered by patents or other forms of intellectual property protection. Historically, upon loss of effective market exclusivity for our animal health products, we have not generally experienced the rapid and severe declines in revenues that are common in the human pharmac... | [-0.003569117747247219, -0.02404387854039669, 0.010710697621107101, -0.03872174769639969, -0.002512096893042326, 0.010336058214306831, -0.0016574487090110779, -0.0021274215541779995, -0.02049817517399788, 0.0006401498685590923, 0.006231739651411772, 0.017608093097805977, 0.004301673267036676, -0.002520459471270442, -0.... |
47 | LLY | 2015 | There is no assurance that the patents we are seeking will be granted or that the patents we hold will be found valid and enforceable if challenged. Moreover, patents relating to particular products, uses, formulations, or processes do not preclude other manufacturers from employing alternative processes or marketing a... | [-0.010942116379737854, -0.013755066320300102, -0.002200036309659481, -0.026890767738223076, -0.007167860399931669, 0.03254247456789017, -0.007238829508423805, 0.010167909786105156, -0.016026072204113007, -0.01361312810331583, 0.0016088975826278329, 0.012187298387289047, 0.002662947168573737, -0.009329186752438545, -0.... |
48 | LLY | 2015 | We consider intellectual property protection for certain products, processes, uses, and formulations—particularly with respect to those products discussed below—to be important to our operations. For many of our products, in addition to the compound patent, we hold other patents on manufacturing processes, formulations... | [-0.00840731617063284, 0.0246488768607378, 0.015830297023057938, -0.04403896629810333, -0.007631982676684856, 0.02907165139913559, 0.00579477846622467, 0.004695826675742865, 0.006526289042085409, -0.03157968819141388, 0.012061499059200287, 0.031363941729068756, -0.0022400408051908016, 0.008899484761059284, -0.012304211... |
49 | LLY | 2015 | The most relevant U.S. patent protection or data protection for our top-selling or recently launched patent-protected marketed products is as follows: | [-0.022575905546545982, -0.001870252308435738, 0.014071738347411156, -0.03484050929546356, -0.0016227677697315812, 0.009048964828252792, -0.015493528917431831, 0.004275336861610413, -0.011952340602874756, -0.015148047357797623, 0.01457667350769043, 0.016078190878033638, -0.012789469212293625, -0.014098313637077808, -0.... |
50 | LLY | 2015 | •Alimta is protected by a compound patent (July 2016) plus pediatric exclusivity (January 2017), and a vitamin regimen patent (2021) plus pediatric exclusivity (2022). | [-0.0006803542491979897, -0.008755721151828766, 0.002162715420126915, -0.04220572113990784, -0.014313244260847569, 0.03227033466100693, -0.01160657312721014, -0.01460160594433546, -0.025677330791950226, -0.003086784854531288, 0.03276841714978218, 0.019936304539442062, 0.002046387642621994, -0.009876400232315063, -0.008... |
51 | LLY | 2015 | •Cialis is protected by compound and use patents (November 2017). | [-0.010926537215709686, -0.009061984717845917, 0.02779877930879593, -0.017537223175168037, 0.010398464277386665, 0.023704586550593376, -0.013899389654397964, -0.0015613995492458344, -0.016624504700303078, -0.02190522849559784, 0.019779900088906288, 0.03609147295355797, 0.0050232079811394215, -0.004860222805291414, 0.00... |
52 | LLY | 2015 | •Cyramza is protected by biologics data package protection (2026). | [-0.029293300583958626, -0.017690803855657578, -0.0030074366368353367, -0.02014748938381672, -0.002621910534799099, 0.024433337152004242, -0.027557598426938057, -0.0020644834730774164, -0.023111533373594284, 0.009452897123992443, 0.01528752502053976, 0.012056449428200722, 0.003765137167647481, -0.031189220026135445, -0... |
53 | LLY | 2015 | •Effient is protected by a compound patent (April 2017) and patents covering methods of using Effient with aspirin (2023). | [-0.02959052287042141, 0.0074043371714651585, 0.0033953313250094652, -0.03283662721514702, 0.01028156653046608, 0.02249469794332981, 0.0017060491954907775, -0.005321867298334837, -0.017223132774233818, -0.006881204899400473, 0.022373976185917854, 0.02678706869482994, -0.0010772841051220894, 0.003584799123927951, -0.000... |
54 | LLY | 2015 | •Forteo is protected by patents primarily covering its formulation and related processes (2018) and use patents (2019). | [-0.012338644824922085, -0.007850654423236847, -0.012904638424515724, -0.031109632924199104, -0.003104637609794736, 0.0071648042649030685, -0.018711060285568237, 0.00879619549959898, -0.01562140416353941, 0.0034758623223751783, 0.022293461486697197, 0.012684899382293224, -0.006132699549198151, -0.0007278835400938988, 0... |
55 | LLY | 2015 | •Jardiance, and the related combination products Glyxambi and Synjardy, are protected by a compound patent (2025 not including possible patent extension). | [-0.01688362844288349, -0.010461634024977684, 0.017479216679930687, -0.013918634504079819, -9.280775702791288e-05, 0.021221062168478966, -0.010785323567688465, -0.01173049584031105, -0.02760421298444271, -0.0004976721247658134, 0.02294308878481388, 0.0019421350443735719, -0.009115087799727917, -0.007101740688085556, 0.... |
56 | LLY | 2015 | •Portrazza is protected by a compound patent (2025 not including possible patent extension), and by biologics data package protection (2027). | [-0.026363924145698547, -0.009059208445250988, 0.02211911603808403, -0.013426072895526886, 0.0006717274081893265, 0.00987969059497118, -0.010571337305009365, 0.0003337447124067694, -0.023787204176187515, -0.0076420120894908905, 0.002907287096604705, 0.014673748053610325, -0.02114267461001873, -0.01369052566587925, 0.01... |
57 | LLY | 2015 | •Strattera is protected by a patent covering its use in treating attention deficit-hyperactivity disorder (2016) plus pediatric exclusivity (May 2017). | [-0.02216179110109806, 0.017305467277765274, 0.021211082115769386, -0.035818591713905334, -0.011427775025367737, 0.02158365584909916, -0.024422936141490936, -0.015455439686775208, -0.010303626768290997, -0.0007997515494935215, 0.010843218304216862, 0.0159179475158453, -0.00785619392991066, 0.012127959169447422, 0.01131... |
58 | LLY | 2015 | •Trajenta and Jentadueto are protected by a compound patent (2023), and Boehringer Ingelheim has applied for a patent extension to 2025 under the patent restoration laws. | [-0.02727198228240013, -0.02482709474861622, 0.024935156106948853, -0.013440129347145557, 0.01142748724669218, 0.020342547446489334, -0.011184348724782467, -0.008813753724098206, -0.022746913135051727, -0.0043325843289494514, 0.0057441359385848045, 0.02041008695960045, 0.0021713576279580593, 0.0017323584761470556, 0.00... |
59 | LLY | 2015 | •Trulicity is protected by a compound patent (2024 not including possible patent extension) and by biologics data package protection (2026). | [-0.012067776173353195, -0.023057015612721443, 0.01640165224671364, -0.004060954786837101, 0.011791565455496311, 0.01782216504216194, -0.026621447876095772, -0.00853622518479824, -0.015415186062455177, 0.001620271592400968, 0.014494484290480614, 0.033092670142650604, -0.006395592354238033, -0.009838361293077469, 0.0151... |
60 | LLY | 2015 | Outside the U.S., important patent protection or data protection includes: | [0.0028089494444429874, -0.009628770872950554, 0.02346259541809559, -0.04009532555937767, 0.011778169311583042, 0.020730648189783096, -0.002758729737251997, 0.009454675950109959, 0.012816040776669979, -0.02429289184510708, 0.01611044630408287, 0.01399452704936266, -0.0008210903615690768, -0.004332276992499828, -0.00019... |
61 | LLY | 2015 | •Cymbalta in Japan (data package protection 2018). In major European countries, our Cymbalta data package protection expired in 2014, and we experienced the entry of generic competitors in 2015 in these markets. | [-0.0157333817332983, -0.021475011482834816, 0.025989118963479996, -0.021791789680719376, -0.03252269700169563, 0.03320905193686485, -0.01360831968486309, 0.0007280153804458678, 0.010961891151964664, -0.015469399280846119, 0.01185943279415369, 0.026754669845104218, 0.00043639677460305393, -0.00636858819052577, -0.01314... |
62 | LLY | 2015 | •Forteo in Japan (data package protection 2018; patent covering its formulation and related process 2019). | [-0.01675795018672943, -0.0059670512564480305, -0.013229960575699806, -0.01413909625262022, -0.0050782691687345505, 0.011072458699345589, -0.01981101743876934, 0.0066251568496227264, 0.005061307922005653, 0.00013060345372650772, 0.020421631634235382, 0.019431080669164658, -0.0066726491786539555, -0.010251522995531559, ... |
63 | LLY | 2015 | •Zyprexa in Japan (patent for schizophrenia expired December 2015; patent for bipolar mania will expire April 2016). | [-0.012660271488130093, -0.0025012395344674587, 0.027772611007094383, -0.021255619823932648, -0.010122972540557384, 0.01598433032631874, -0.028375793248414993, 0.005392580758780241, -0.007965940050780773, -0.016548175364732742, 0.005238506942987442, 0.03304389864206314, 0.00022844709747005254, 0.004612377379089594, 0.0... |
64 | LLY | 2015 | U.S. patent protection or data protection for our new molecular entities that have been submitted for regulatory review is as follows (additional information about these molecules is provided in Item 7, "Management’s Discussion and Analysis—Late-Stage Pipeline”): | [-0.013883903622627258, -0.015285391360521317, 0.004492621403187513, -0.03976559266448021, -0.008834615349769592, 0.018730171024799347, -0.013530256226658821, 0.008022538386285305, -0.004430405795574188, 0.00596287427470088, 0.003824622370302677, 0.001707654562778771, 0.0035888580605387688, 0.005412757396697998, 0.0053... |
65 | LLY | 2015 | 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... | [-0.00739061227068305, -0.01836765743792057, 0.014345729723572731, -0.0348140113055706, 0.0005071439663879573, 0.005257965996861458, -0.008870015852153301, 0.010067627765238285, 0.013820572756230831, -0.016254223883152008, -0.00830002874135971, 0.0232093408703804, -0.005209933500736952, -0.002723447047173977, -0.000224... |
66 | LLY | 2015 | Most of our major products were discovered in our own laboratories and are not subject to significant license agreements. Two of our largest products, Cialis and Alimta, are subject to patent assignments or licenses granted to us by others. | [0.013245978392660618, -0.006410399451851845, 0.01671936735510826, -0.03602905943989754, -0.009295078925788403, 0.029304681345820427, -0.015057897195219994, 0.015895172953605652, -0.023836219683289528, -0.013553415425121784, 0.0037448506336659193, 0.025772420689463615, 0.0027178784366697073, -0.006161832716315985, -0.0... |
67 | LLY | 2015 | •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 agreement is not subject to termination by Glaxo for any reason other than a ma... | [-0.002587131457403302, 0.0017921187682077289, 0.025119727477431297, -0.034793492406606674, -0.01163791585713625, 0.023649955168366432, -0.01648816093802452, -0.00023487111320719123, -0.02669639140367508, -0.025026196613907814, 0.02701706811785698, 0.04200873523950577, 0.0013829211238771677, 0.01696917787194252, 0.0078... |
68 | LLY | 2015 | •The compound patent for Alimta is the subject of a license agreement with Princeton University, granting us an irrevocable exclusive worldwide license to the compound patents for the lives of the patents in the respective territories. The agreement calls for royalties of a single-digit percentage of net sales. The agr... | [-0.0028459220193326473, -0.007328123785555363, 0.018109500408172607, -0.03905655816197395, -0.009476368315517902, 0.029446342960000038, -0.026381246745586395, -0.006451426073908806, -0.0244136955589056, -0.01829688623547554, 0.026769403368234634, 0.02888418547809124, 0.009723985567688942, 0.0036807928700000048, 0.0061... |
69 | LLY | 2015 | In the U.S., the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, made a complex set of changes to both patent and new-drug-approval laws for human pharmaceuticals. Before the Hatch-Waxman Act, no drug could be approved without providing the FDA complete safety and... | [-0.003425495931878686, -0.0009343786514364183, 0.006622849032282829, -0.00276623060926795, -0.027913933619856834, 0.0050124297849833965, -0.011796320788562298, -0.005780734121799469, -0.030705327168107033, -0.006176628638058901, 0.016493376344442368, -0.003195675788447261, 0.013386609964072704, 0.011709090322256088, -... |
70 | LLY | 2015 | 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... | [-0.006708142347633839, -0.012431479059159756, -0.00809428934007883, 0.006620454136282206, -0.02049204148352146, -0.0034535634331405163, -0.044113874435424805, -0.008377589285373688, -0.03860975801944733, 0.013025060296058655, 0.01752413623034954, 0.014556230045855045, -0.004748649429529905, 0.0030825750436633825, 0.01... |
71 | LLY | 2015 | Generic manufacturers use Paragraph IV certifications extensively to challenge patents on innovative human pharmaceuticals. In addition, generic companies have shown an increasing willingness to launch “at risk,” i.e., after receiving ANDA approval but before final resolution of their patent challenge. We are currently... | [-0.004554146435111761, -0.01096152514219284, -0.011277261190116405, -0.012828485108911991, -0.018285224214196205, 0.02255452238023281, -0.01326776947826147, 0.0008468241430819035, -0.023639006540179253, -0.019026516005396843, 0.01661045104265213, 0.015416146256029606, -0.0032414402812719345, -0.0011599860154092312, 0.... |
72 | LLY | 2015 | The passage of the America Invents Act in 2011 added a new procedure to U.S. patent law. This procedure, inter partes review (IPR), 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 ... | [-0.002420122269541025, 0.0029245265759527683, 0.0012066643685102463, -0.018749577924609184, -0.006606508977711201, 0.018722405657172203, 2.213138031947892e-05, -0.013647790998220444, -0.005376916844397783, -0.007486244663596153, 0.015475194901227951, -0.002537307096645236, 0.0033236343879252672, -0.0009858813136816025... |
73 | LLY | 2015 | 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... | [0.007444916758686304, -0.019202478229999542, 0.0030135756824165583, -0.029674159362912178, -0.001253733178600669, 0.025691227987408638, -0.0015521233435720205, 0.008889059536159039, -0.027168340981006622, -0.01885957643389702, 0.008829711005091667, 0.004945693071931601, -0.005779866594821215, -0.007708687335252762, 0.... |
74 | LLY | 2015 | 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... | [0.015583685599267483, -0.0018984782509505749, -0.014369715005159378, -0.02302585169672966, -0.007376189809292555, 0.01782689243555069, 0.0018720875959843397, 0.026047583669424057, -0.025876043364405632, -0.0028369962237775326, -0.013960660435259342, -0.013003998436033726, -0.021284068003296852, -0.00740917818620801, -... |
75 | LLY | 2015 | 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... | [0.016300085932016373, -0.003514419309794903, -0.01972271129488945, -0.02006366103887558, -0.018529381603002548, 0.011035013943910599, -0.0074943676590919495, 0.019276851788163185, -0.009854799136519432, 0.004799542482942343, 0.016050929203629494, -0.015709977596998215, -0.012575850822031498, 0.004579891450703144, -0.0... |
76 | LLY | 2015 | 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... | [0.03051164746284485, -0.002822721377015114, -0.011658495292067528, -0.026257872581481934, -0.009649768471717834, 0.019745919853448868, -0.006236244924366474, 0.026179099455475807, -0.02305441163480282, -0.010319343768060207, 0.002189250197261572, -0.003049195511266589, -0.013398079201579094, -0.007293124217540026, -0.... |
77 | LLY | 2015 | wide quality systems in our manufacturing, product development, and process development operations to ensure sustained compliance with cGMP and similar regulations. However, in the event we fail to adhere to these requirements in the future, we could be subject to interruptions in production, fines and penalties, and d... | [-0.006504892371594906, -0.015090269036591053, -0.012057354673743248, -0.0069844843819737434, -0.014752528630197048, 0.030531788244843483, 0.0016118690837174654, 0.026073606684803963, -0.008247636258602142, -0.010152495466172695, 0.010294346138834953, 0.010942809283733368, 0.0011778718326240778, -0.00744381221011281, -... |
78 | LLY | 2015 | 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, ... |
79 | LLY | 2015 | 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... | [0.0005330188432708383, -0.013550742529332638, 0.016229378059506416, -0.04356721416115761, -0.0034730343613773584, 0.0014238456496968865, -0.01980089209973812, 0.011751855723559856, 0.002031954936683178, -0.01770000159740448, 0.016465727239847183, 0.009007567539811134, 0.01141046080738306, 0.006292823236435652, -0.0135... |
80 | LLY | 2015 | 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... |
81 | LLY | 2015 | 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... |
82 | LLY | 2015 | 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... | [-0.0020188787020742893, 0.004657689016312361, -0.0046412888914346695, -0.02336716651916504, -0.006491244304925203, 0.015206370502710342, -0.00651092454791069, -0.005835231393575668, -0.024377426132559776, 0.006707728374749422, 0.021648414433002472, 0.03471618518233299, -0.013894345611333847, 0.003388304729014635, -0.0... |
83 | LLY | 2015 | 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 ... | [0.009434268809854984, -0.014859789982438087, 0.002830280689522624, -0.028283221647143364, -0.007214441429823637, 0.024496454745531082, 0.0004733456880785525, 0.010687819682061672, -0.02854437753558159, -0.007136094383895397, 0.00968889705836773, 0.0278131403028965, -0.0017742302734404802, -0.006649690680205822, -0.008... |
84 | LLY | 2015 | 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... | [0.002451061038300395, -0.02710624225437641, -0.0028648334555327892, -0.027598116546869278, 0.005799459759145975, 0.02097775973379612, 0.002748511964455247, 0.01397187914699316, -0.016604069620370865, -0.003632555715739727, -0.003343413583934307, 0.01698959246277809, 0.0070391152985394, -0.0053773787803947926, -0.00960... |
85 | LLY | 2015 | 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,... | [-0.0003299943055026233, -0.004050793591886759, 0.01500049140304327, -0.049481797963380814, -0.0042556459084153175, 0.014273595064878464, 0.0033932828810065985, 0.010460695251822472, -0.02495235949754715, -0.007942991331219673, -0.007724922616034746, -0.0014116652309894562, 0.01842351071536541, -0.004083834122866392, -... |
86 | LLY | 2015 | We cannot predict the extent to which our business may be affected by these or other potential future legislative or regulatory developments. However, in general we expect that state, federal, and international legislative and regulatory developments could have further negative effects on pricing and reimbursement for ... | [-0.0056655555963516235, -0.015073376707732677, 0.0029729497618973255, -0.030329303815960884, -0.00223297206684947, 0.017172696068882942, -0.015177691355347633, 0.023118596524000168, -0.01815064065158367, 0.004690871573984623, -0.00722374627366662, 0.0073802173137664795, 0.021253982558846474, 0.001594863715581596, 0.00... |
87 | LLY | 2015 | Our commitment to research and development dates back more than 100 years. We invest heavily in research and development because we believe it is critical to our long-term competitiveness. At the end of 2015, we employed approximately 8,730 people in human pharmaceutical and animal health research and development activ... | [0.0024275181349366903, -0.00892276968806982, -0.002379951998591423, -0.034352660179138184, 0.012012934312224388, 0.018724694848060608, 0.005796519573777914, 0.020036865025758743, -0.013049550354480743, 0.017478130757808685, -0.0026112222112715244, 0.02616470865905285, -0.006593664176762104, -0.006295145023614168, -0.0... |
88 | LLY | 2015 | 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... | [-0.022462477907538414, -0.005934188142418861, 0.010472096502780914, -0.01882944069802761, -0.0004291356890462339, 0.03307691588997841, -0.01163114421069622, 0.021974459290504456, -0.01518284622579813, 0.007272854447364807, -0.003843157785013318, 0.0064459312707185745, 0.010851668193936348, -0.012722411192953587, -0.00... |
89 | LLY | 2015 | 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 ... | [0.003372455947101116, -0.008210022933781147, 0.0015571024268865585, -0.020254991948604584, -0.007453836966305971, 0.050286393612623215, 0.00895270612090826, 0.019525811076164246, 0.0039936089888215065, 0.003895709989592433, -0.008142506703734398, 0.00948608759790659, 0.015866409987211227, -0.003242486622184515, -0.010... |
90 | LLY | 2015 | 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 needs. Our animal health scientists also leverage discoveries from our human health laboratories to develop products to enhance ... | [-0.010281979106366634, -0.0071512265130877495, -0.002371477894484997, -0.023025745525956154, 0.006224711425602436, 0.02702615037560463, -0.0312807634472847, -0.0061009530909359455, -0.033635515719652176, 0.007532536052167416, 0.004829921294003725, 0.003629130544140935, -0.013740523718297482, -0.01012811716645956, 0.00... |
91 | LLY | 2015 | 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... | [0.012149261310696602, -0.005398953333497047, 0.006886090151965618, -0.017367171123623848, -0.009162056259810925, 0.011974683962762356, 0.005088594276458025, 0.01582830771803856, -0.039544906467199326, 0.006469045300036669, 0.0005124156014062464, 0.004820263013243675, -0.008418487384915352, -0.0039926390163600445, -0.0... |
92 | LLY | 2015 | 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... | [-0.015076782554388046, -0.01810513623058796, 0.00659934151917696, -0.01862502470612526, -0.0019333374220877886, 0.04052535071969032, -0.00269692437723279, 0.0012980980100110173, -0.04699797183275223, -0.0020486877765506506, 0.009630944579839706, 0.022355228662490845, -0.005354857072234154, 0.01876799575984478, -0.0162... |
93 | LLY | 2015 | 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... | [0.0051705618388950825, -0.0171679574996233, -0.004877704661339521, -0.011974617838859558, -0.0218927264213562, 0.03772004693746567, 0.00978144071996212, 0.02018764428794384, -0.0318368636071682, -0.004998101387172937, 0.015905417501926422, 0.003592385444790125, 0.002700797049328685, 0.005313736852258444, -0.0115060461... |
94 | LLY | 2015 | Product phase (Phase III) molecules have already demonstrated safety 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 statistical... | [0.0015534283593297005, -0.014764873310923576, -0.001954365521669388, -0.014686958864331245, -0.01305074617266655, 0.036568060517311096, -0.007629167288541794, 0.022153804078698158, -0.03737318143248558, -0.00534366350620985, 0.008278458379209042, 0.00853817444294691, -0.0025160019285976887, -9.840814163908362e-05, -0.... |
95 | LLY | 2015 | 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... | [0.02440071478486061, -0.0030908877961337566, -0.008760235272347927, -0.017494359984993935, -0.027312088757753372, 0.002113357884809375, -0.01639769785106182, 0.00885162316262722, -0.05300529673695564, 0.010490087792277336, 0.011723832227289677, -0.010633698664605618, -0.010914390906691551, 0.010366060771048069, -0.009... |
96 | LLY | 2015 | 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 50 drug candidates across all stages of human testing an... | [-0.002582052955403924, -0.011390052735805511, -0.004880508873611689, -0.032712601125240326, -0.006944832392036915, 0.02673727460205555, -0.009431254118680954, 0.024943357333540916, -0.011508767493069172, 0.004534256644546986, 0.015525294467806816, 0.0033240222837775946, 0.003604321740567684, -0.004461708478629589, -0.... |
97 | LLY | 2015 | Most of the principal materials we use in our manufacturing operations are available from more than one source. However, we obtain certain raw materials principally 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 inventor... | [0.003539976431056857, -0.007990706712007523, -0.022363344207406044, -0.003699524560943246, -0.028958003968000412, 0.013242502696812153, -0.0038889881689101458, 0.0025544336531311274, 0.004058508202433586, -0.01765667088329792, -0.0006959460442885756, 0.020036598667502403, 0.005295007023960352, 0.005933199543505907, -0... |
98 | LLY | 2015 | The majority of our revenue comes from products produced in our own facilities. Our principal active ingredient manufacturing occurs at four owned sites in the U.S. as well as owned sites in Ireland, Puerto Rico, and the U.K. Finishing operations, including formulation, filling, assembling, delivery device manufacturin... | [0.010560478083789349, 0.0029342216439545155, -0.023813776671886444, -0.01850973628461361, -0.008887666277587414, 0.026370596140623093, -0.012586893513798714, 0.013661300763487816, -0.00411403039470315, -0.013579700142145157, 0.010560478083789349, 0.020359350368380547, -0.029022615402936935, 0.00842526275664568, -0.007... |
99 | LLY | 2015 | 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... | [-0.0052622100338339806, -0.006563688162714243, -0.016041627153754234, 0.0008457123185507953, -0.01830679550766945, 0.024969832971692085, -0.025473203510046005, 0.01612110622227192, 0.012107388116419315, -0.006411352194845676, -0.002597988583147526, 0.01581643521785736, -0.007841984741389751, 0.008901712484657764, 0.00... |
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