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1、8008_Cover.indd 18008_Cover.indd 13/12/24 3:51 PM3/12/24 3:51 PMDear AbbVie Shareholder,Eleven years ago,we set out to create a company that would address some of the worlds most serious and complex health issues,while delivering outstanding shareholder return.Today,AbbVie has delivered on this miss

2、ion and much more.Our science,innovation and outstanding commercial execution have advanced the standard of care for countless patients.We have donated more than$680 million for nonprofits around the world,and we built a culture that has come to define our company.Additionally,we have provided excep

3、tional shareholder return and increased our quarterly dividend by more than 285%and market capitalization by more than$250 billion since our inception.Our business is performing very well,and we have a strong foundation for our companys growth in the years to come.In 2023,AbbVie delivered another ou

4、tstanding year of execution.We effectively managed through the biosimilar impact on Humira in the United States,and our non-Humira platform has performed well.These results are a testament to the strength of our on-market portfolio and our diverse growth platform.Total net revenues for the year of m

5、ore than$54.3 billion were primarily driven by our non-Humira growth platform that includes products across immunology,neuroscience,oncology,and aesthetics.Skyrizi and Rinvoq delivered exceptionally well with combined sales of$11.7 billion.Our neuroscience portfolio delivered sales of$7.7 billion,wh

6、ile global net revenues from our oncology portfolio were$5.9 billion and aesthetics delivered$5.3 billion.In addition to our strong financial performance,we continued to successfully manage the impact of the loss of exclusivity of Humira in the U.S.,while also investing in the future.We meaningfully

7、 increased our adjusted R&D investment to$7.8 billion and continued to drive our pipeline of innovative medicines.Through our commitment to external innovation,we identified business development opportunities to further advance our long-term growth.The acquisition of ImmunoGen and proposed Cerevel T

8、herapeutics transaction will further expand our presence in oncology and neuroscience and will help us deliver sustainable long-term performance in the 2030s and beyond.Giving back is an integral part of who we are at AbbVie.It is woven into the fabric of our company and is part of what makes us uni

9、que.In 2023,we marked the close of our transformative$350 million donation to support U.S.nonprofits strengthening health care systems,supporting effective education programs,and building community resiliency.Nearly 14,000 employees volunteered during our annual Week of Possibilities,and we raised m

10、ore than$23 million during our Employee Giving Campaign.I am proud of the passion,commitment,and dedication of our approximately 50,000 employees around the world who continually support our communities.Great companies are defined by their great strategy,great people,great culture,and outstanding ex

11、ecutionattributes that have come to define AbbVie.The evolution of our company since 2013 reflects our incredible culture and our dedication to each other,our communities,and to improving peoples lives.As the founding Chief Executive Officer(CEO),I am tremendously proud of the company we have built.

12、It has been my immense honor and privilege to serve with all my AbbVie colleagues for the past 11 years.I look forward to continuing to work with AbbVies management team as Executive Chairman of the board after I retire as CEO in July 2024.I am confident in our ability to deliver for patients and sh

13、areholders in the decades to come.Sincerely,Richard A.Gonzalez Chairman and Chief Executive Officer A Message from AbbVies Lead Independent Director Dear AbbVie Shareholder,AbbVies first decade as an independent company was marked by remarkable growth and significant innovation,improving the lives o

14、f the millions of patients that depend on AbbVie.As we continue to move through our second decade,the entire board of directors is dedicated to continuing our strong oversight of AbbVies business.AbbVie experienced the loss of exclusivity for Humira in the U.S.in 2023,an event for which the company

15、had long planned.The board has been actively overseeing the companys strategy for addressing this event,which was unprecedented across the biopharmaceutical industry.The board is pleased by the extraordinary growth of AbbVies non-Humira platform,reflecting the companys longstanding ability to meet c

16、hallenges head-on through robust planning and execution.We continue to expect the business to return to robust sales growth in 2025.Another key priority for the board in 2023 was management succession planning.In February 2024,we announced that the board had unanimously elected Robert A.Michael as A

17、bbVies next Chief Executive Officer,effective July 1,2024.This succession event is the result of years of planning and oversight by the board,and we are confident in Robs ability to lead AbbVie and build on the companys strong track record of success.The board has asked Richard Gonzalez,AbbVies curr

18、ent CEO and Chairman,to remain on the board as Executive Chairman following his retirement as CEO,for a period of transition.As Rick wraps up his distinguished tenure at AbbVie,the board extends our sincere appreciation for his leadership and his unwavering dedication to improving the lives of patie

19、nts around the world.At the same time,the board has been planning for our own refreshment and succession.In late 2023,we welcomed two new directors to the board,and effective July 1,2024,Roxanne Austin will replace me as AbbVies lead independent director.We believe these changes reflect our longstan

20、ding commitment to board refreshment and ensuring the board has the appropriate skillset and leadership structure to effectively oversee AbbVies business.We look forward to continuing to steward AbbVies business in 2024 and the years beyond.On behalf of the entire board,we thank you for your investm

21、ent in AbbVie.We appreciate your trust and confidence in our leadership.Sincerely,Glenn F.Tilton Lead Independent Director UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON,D.C.20549 FORM 10-K(MARK ONE)ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934For th

22、e fiscal year ended December 31,2023 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934For the transition period from to Commission file number 001-35565 AbbVie Inc.(Exact name of registrant as specified in its charter)Delaware 32-0375147(State or other jurisdi

23、ction of(I.R.S.employer incorporation or organization)identification number)1 North Waukegan Road North Chicago,Illinois 60064-6400(847)932-7900(Address,including zip code,and telephone number of principal executive offices)Securities Registered Pursuant to Section 12(b)of the Act:Title of Each Clas

24、s Trading Symbol(s)Name of Each Exchange on Which Registered Common Stock,par value$0.01 per share ABBV New York Stock Exchange Chicago Stock Exchange 1.375%Senior Notes due 2024 ABBV24 New York Stock Exchange 1.250%Senior Notes due 2024 ABBV24B New York Stock Exchange 0.750%Senior Notes due 2027 AB

25、BV27 New York Stock Exchange 2.125%Senior Notes due 2028 ABBV28 New York Stock Exchange 2.625%Senior Notes due 2028 ABBV28B New York Stock Exchange 2.125%Senior Notes due 2029 ABBV29 New York Stock Exchange 1.250%Senior Notes due 2031 ABBV31 New York Stock Exchange Indicate by check mark if the regi

26、strant is a well-known seasoned issuer,as defined in Rule 405 of the Securities Act.Yes No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d)of the Act.Yes No Indicate by check mark whether the registrant(1)has filed all reports required to be fi

27、led by Section 13 or 15(d)of the Securities Exchange Act of 1934 during the preceding 12 months(or for such shorter period that the registrant was required to file such reports)and(2)has been subject to such filing requirements for the past 90 days.Yes No Indicate by check mark whether the registran

28、t has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months(or for such shorter period that the registrant was required to submit such files).Yes No Indicate by check mark whether the registrant is a large

29、accelerated filer,an accelerated filer,a non-accelerated filer,or a smaller reporting company.See the definitions of“large accelerated filer,”“accelerated filer”and“smaller reporting company”in Rule 12b-2 of the Exchange Act.Large Accelerated Filer Accelerated Filer Non-Accelerated Filer Smaller rep

30、orting company Emerging growth company If an emerging growth company,indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a)of the Exchange Act.Indicate by c

31、heck mark whether the registrant has filed a report on and attestation to its managements assessment of the effectiveness of its internal control over financial reporting under Section 404(b)of the Sarbanes-Oxley Act(15 U.S.C.7262(b)by the registered public accounting firm that prepared or issued it

32、s audit report.If securities are registered pursuant to Section 12(b)of the Act,indicate by checkmark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.Indicate by check mark whether any of those err

33、or corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrants executive officers during the relevant recovery period pursuant to 240.10D-1(b).Indicate by check mark whether the registrant is a shell company(as defined in Rule 12b

34、-2 of the Act).Yes No The aggregate market value of the 1,748,902,939 shares of voting stock held by non-affiliates of the registrant,computed by reference to the closing price as reported on the New York Stock Exchange,as of the last business day of AbbVie Inc.s most recently completed second fisca

35、l quarter(June 30,2023),was$235,629,692,915.AbbVie has no non-voting common equity.Number of common shares outstanding as of January 31,2024:1,766,473,359 DOCUMENTS INCORPORATED BY REFERENCE Portions of the 2024 AbbVie Inc.Proxy Statement are incorporated by reference into Part III.The Definitive Pr

36、oxy Statement will be filed on or about March 18,2024.ABBVIE INC.FORM 10-K FOR THE YEAR ENDED DECEMBER 31,2023 TABLE OF CONTENTS Page No.PART I Item 1.BUSINESS 1 Item 1A.RISK FACTORS 18 Item 1B.UNRESOLVED STAFF COMMENTS 31 Item 1C CYBERSECURITY 31 Item 2.PROPERTIES 33 Item 3.LEGAL PROCEEDINGS 33 Ite

37、m 4.MINE SAFETY DISCLOSURES 33 INFORMATION ABOUT OUR EXECUTIVE OFFICERS 34 PART II Item 5.MARKET FOR REGISTRANTS COMMON EQUITY,RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 36 Item 6.RESERVED 37 Item 7.MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF

38、OPERATIONS 38 Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 54 Item 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 55 Item 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 104 Item 9A.CONTROLS AND PROCEDURES 104 Item 9B.OTHER INFORMATION 107

39、Item 9C.DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 107 PART III Item 10.DIRECTORS,EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 108 Item 11.EXECUTIVE COMPENSATION 108 Item 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 109 Ite

40、m 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS,AND DIRECTOR INDEPENDENCE 109 Item 14.PRINCIPAL ACCOUNTING FEES AND SERVICES 109 PART IV Item 15.EXHIBITS,FINANCIAL STATEMENT SCHEDULES 110 Item 16.FORM 10-K SUMMARY 116 SIGNATURES 117 PART I ITEM 1.BUSINESS.Overview AbbVie or“the company”refer to

41、AbbVie Inc.,or AbbVie Inc.and its consolidated subsidiaries,as the context requires.AbbVie is a global,diversified research-based biopharmaceutical company positioned for success with a comprehensive product portfolio that has leadership positions across immunology,oncology,aesthetics,neuroscience a

42、nd eye care.AbbVie uses its expertise,dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the worlds most complex and serious diseases.AbbVie was incorporated in Delaware on April 10,2012.On January 1,2013,AbbVie became an independent,publ

43、icly-traded company as a result of the distribution by Abbott Laboratories(Abbott)of 100%of the outstanding common stock of AbbVie to Abbotts shareholders.Segments AbbVie operates as a single global business segment dedicated to the research and development,manufacturing,commercialization and sale o

44、f innovative medicines and therapies.This operating structure enables the Chief Executive Officer,as chief operating decision maker(CODM),to allocate resources and assess business performance on a global basis in order to achieve established long-term strategic goals.Consistent with this structure,a

45、 global research and development and supply chain organization is responsible for the discovery,development,manufacturing and supply of products.Commercial efforts that coordinate the marketing,sales and distribution of these products are organized by geographic region or therapeutic area.All of the

46、se activities are supported by a global corporate administrative staff.The determination of a single business segment is consistent with the consolidated financial information regularly reviewed by the CODM for purposes of assessing performance,allocating resources and planning and forecasting futur

47、e periods.See Note 16,“Segment and Geographic Area Information”to the Consolidated Financial Statements included under Item 8,“Financial Statements and Supplementary Data”and the sales information related to AbbVies key products and geographies included under Item 7,“Managements Discussion and Analy

48、sis of Financial Condition and Results of Operations.”Products AbbVies portfolio of products includes a broad line of therapies that address some of the worlds most complex and serious diseases.Immunology products.AbbVie maintains an extensive immunology portfolio across rheumatology,dermatology and

49、 gastroenterology.AbbVies immunology products address unmet needs for patients with autoimmune diseases.These products are:2023 Form 10-K|1 Humira.Humira(adalimumab)is a biologic therapy administered as a subcutaneous injection.It is approved to treat the following autoimmune diseases in the United

50、States,Canada and Mexico(collectively,North America)and in the European Union:Condition Principal Markets Rheumatoid arthritis(moderate to severe)North America,European Union Psoriatic arthritis North America,European Union Ankylosing spondylitis North America,European Union Adult Crohns disease(mod

51、erate to severe)North America,European Union Plaque psoriasis(moderate to severe chronic)North America,European Union Juvenile idiopathic arthritis(moderate to severe polyarticular)North America,European Union Ulcerative colitis(moderate to severe)North America,European Union Axial spondyloarthropat

52、hy European Union Pediatric Crohns disease(moderate to severe)North America,European Union Hidradenitis suppurativa(moderate to severe)North America,European Union Pediatric enthesitis-related arthritis European Union Non-infectious intermediate,posterior and panuveitis North America,European Union

53、Pediatric ulcerative colitis(moderate to severe)U.S.,Canada,European Union Pediatric uveitis North America,European Union Humira is also approved in Japan for the treatment of intestinal Behets disease and pyoderma gangrenosum.Humira is sold in numerous other markets worldwide,including Japan,China,

54、Brazil and Australia,and accounted for approximately 27%of AbbVies total net revenues in 2023.Skyrizi.Skyrizi(risankizumab)is an interleukin-23(IL-23)inhibitor that selectively blocks IL-23 by binding to its p19 subunit.It is a biologic therapy approved to treat the following autoimmune diseases in

55、North America,the European Union and Japan:Condition Principal Markets Plaque psoriasis(moderate to severe)North America,European Union,Japan Psoriatic arthritis U.S.,European Union Crohns disease(moderate to severe)U.S.,Canada,European Union Skyrizi is also approved in Japan for the treatment of pl

56、aque psoriasis,psoriatic arthritis,erythrodermic psoriasis in patients who have an inadequate response to conventional therapies,and for induction and maintenance in moderately to severely active Crohns disease.Skyrizi is approved in multiple countries globally,including the United States,Canada and

57、 the European Union,for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.In psoriatic disease(psoriasis or psoriatic arthritis)Skyrizi is administered as a quarterly subcutaneous injection following two induction doses.When admini

58、stered for Crohns disease,Skyrizi is given in three induction doses via IV infusion,followed by subcutaneous injection via an on-body injector every eight weeks.|2023 Form 10-K 2 Rinvoq.Rinvoq(upadacitinib)is an oral,once-daily selective and reversible JAK inhibitor that is approved to treat the fol

59、lowing inflammatory diseases in North America,the European Union and Japan:Condition Principal Markets Rheumatoid arthritis(moderate to severe)North America,European Union,Japan Psoriatic arthritis U.S.,Canada,European Union,Japan Ankylosing spondylitis U.S.,European Union Atopic dermatitis(moderate

60、 to severe)U.S.,Canada,European Union,Japan Axial spondyloarthropathy U.S.,European Union Ulcerative colitis(moderate to severe)U.S.,European Union Crohns disease(moderate to severe)U.S.,European Union In the United States,Rinvoq is indicated for both the treatment of moderate to severe active rheum

61、atoid arthritis,for active psoriatic arthritis,for moderate to severe active ulcerative colitis,for active ankylosing spondylitis and for active non-radiographic axial spondyloarthritis in adult patients who have an inadequate response or intolerance to one or more TNF blockers.It is also indicated

62、for the treatment of Crohns disease in adult patients who have an inadequate response or intolerance to one or more TNF blockers and for moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease is not adequately controlled with other systemic drug products,

63、including biologics,or when use of those therapies are inadvisable.In the European Union,Rinvoq is indicated for the treatment of moderate to severe rheumatoid arthritis in adults,for active psoriatic arthritis in adults who have an inadequate response or intolerance to disease-modifying anti-rheuma

64、tic medicines(DMARDs),and for active axial spondyloarthritis in adults.It is also indicated for the treatment of Crohns disease in adult patients who have an inadequate response or intolerance to one or more TNF blockers and for moderate to severe atopic dermatitis in adults and children 12 years of

65、 age and older,and for moderately to severely active ulcerative colitis in adults.Oncology products.AbbVies oncology products target some of the most complex and difficult-to-treat cancers.These products are:Imbruvica.Imbruvica(ibrutinib)is an oral,once-daily therapy that inhibits a protein called B

66、rutons tyrosine kinase.Imbruvica was one of the first medicines to receive a United States Food and Drug Administration(FDA)approval after being granted a Breakthrough Therapy Designation and is one of the few therapies to receive four separate designations.Imbruvica currently is approved for the tr

67、eatment of adult patients with blood cancers such as chronic lymphocytic leukemia(CLL),as well as certain forms of non-Hodgkin lymphoma.Imbruvica is approved in adult and pediatric patients one year and older with chronic graft versus host disease after failure of one or more lines of systemic thera

68、py.Venclexta/Venclyxto.Venclexta(venetoclax)is a B-cell lymphoma 2(BCL-2)inhibitor used to treat blood cancers.Venclexta is approved by the FDA for adults with CLL or small lymphocytic lymphoma.In addition,Venclexta is approved in combination with azacitidine,or decitabine,or low-dose cytarabine to

69、treat adults with newly-diagnosed acute myeloid leukemia who are 75 years of age or older or have other medical conditions that prevent the use of standard chemotherapy.Epkinly.Epkinly(epcoritimab)is a product used to treat adults with certain types of diffuse large B-cell lymphoma(DLBCL)and high-gr

70、ade B-cell lymphoma that has recurred or that does not respond to previous treatment after receiving two or more treatments.Epkinly is administered as a subcutaneous injection.Elahere.Elahere(mirvetuximab soravtansine-gynx)is an antibody-drug conjugate(ADC)used to treat certain types of cancer.On No

71、vember 14,2022,the FDA granted accelerated approval for the treatment of adult patients with FR positive,platinum-resistant epithelial ovarian,fallopian tube,or primary peritoneal cancer,who have received one to three prior systemic treatment regimens.Continued approval may be contingent upon verifi

72、cation and description of clinical benefit in a confirmatory trial.2023 Form 10-K|3 Aesthetics products.AbbVies Aesthetics portfolio consists of facial injectables,plastics and regenerative medicine,body contouring and skincare products,which hold market-leading positions in the U.S.and in key marke

73、ts around the world.These products are:Botox Cosmetic.Botox Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for treatment in three areas:temporary improvement in the appearance of moderate to severe glabellar lines(frown lines between the eyebrows),moderat

74、e to severe crows feet and moderate to severe forehead lines in adults.Having received its initial FDA approval in 2002,Botox Cosmetic is now approved for use in all major markets around the world.The Juvederm Collection of Fillers.The Juvederm Collection of Fillers is a portfolio of hyaluronic acid

75、-based dermal fillers with a variety of approved indications in the U.S.and in other major markets around the world to augment or treat volume loss in the cheeks,chin,lips and lower face.Other aesthetics.Other aesthetics products include,but are not limited to,Alloderm regenerative dermal tissue,Coo

76、lSculpting body contouring technology,Natrelle breast implants,the SkinMedica skincare line,Latisse eyelash solution and DiamondGlow dermabrasion technology.Neuroscience products.AbbVies neuroscience products address some of the most difficult-to-treat neurologic diseases.These products are:Botox Th

77、erapeutic.Botox Therapeutic(onabotulinumtoxinA injection)is an acetylcholine release inhibitor and a neuromuscular blocking agent that is injected into muscle tissue.In the United States,it is approved to treat numerous indications,including chronic migraine,overactive bladder in adults who have an

78、inadequate response to an anticholinergic medication,and urinary incontinence due to detrusor overactivity associated with a neurologic condition in adults who have an inadequate response to an anticholinergic medication.In addition,Botox Therapeutic is approved to treat spasticity in patients two y

79、ears of age and older,cervical dystonia in adults,as well as other conditions.Botox is marketed in other countries around the world and licenses will vary.Botox Therapeutic is marketed by GSK in Japan.Vraylar.Vraylar(cariprazine)is a dopamine D3-preferring D3/D2 receptor partial agonist and a 5-HT1A

80、 receptor partial agonist.Vraylar is indicated for acute and maintenance treatment of schizophrenia in adults,acute treatment of manic or mixed episodes associated with bipolar disorder in adults,acute treatment of depressive episodes associated with bipolar I disorder in adults and as an adjunctive

81、 treatment in major depressive disorder.Duopa and Duodopa(carbidopa and levodopa).AbbVies levodopa-carbidopa intestinal gel for the treatment of advanced Parkinsons disease is marketed as Duopa in the United States and as Duodopa outside of the United States.Ubrelvy.Ubrelvy(ubrogepant)is a calcitoni

82、n gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults.Ubrelvy is commercialized in the United States,Israel,Saudi Arabia,United Arab Emirates and Canada.Qulipta.Qulipta(atogepant)is a calcitonin gene-related peptide receptor antagonis

83、t indicated for the preventive treatment of episodic and chronic migraine in adults.Qulipta is commercialized in the United States and Canada and is approved in the European Union under the brand name Aquipta.Eye care products.AbbVies eye care products address unmet needs and new approaches to help

84、preserve and protect patients vision.These products are:Ozurdex.Ozurdex(dexamethasone intravitreal implant)is a corticosteroid implant that slowly releases medication over time.Injected directly into the back of the eye,it dissolves naturally and does not need to be removed.Ozurdex is indicated for

85、the treatment of adult patients with visual impairment due to diabetic macular oedema(DME),adult patients with macular oedema following either Branch Retinal Vein Occlusion(BRVO)or Central Retinal Vein Occlusion(CRVO)and patients with inflammation of the posterior segment of the eye presenting as no

86、n-infectious uveitis.Ozurdex is commercially available in the United States and numerous markets around the world.|2023 Form 10-K 4 Lumigan/Ganfort.Lumigan(bimatoprost ophthalmic solution)0.01%is a once daily,topical prostaglandin analog indicated for the reduction of elevated intraocular pressure(I

87、OP)in patients with open angle glaucoma(OAG)or ocular hypertension(OHT).Ganfort is a once daily topical fixed combination of bimatoprost 0.03%and timolol 0.5%for the reduction of IOP in adult patients with OAG or OHT.Lumigan is sold in the United States and numerous markets around the world,while Ga

88、nfort is approved in the European Union and some markets in South America,the Middle East and Asia.Alphagan/Combigan.Alphagan(brimonidine tartrate ophthalmic solution)is an alpha-adrenergic receptor agonist indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hy

89、pertension.Combigan(brimonidine tartrate/timolol maleate ophthalmic solution)is approved for reducing elevated IOP in patients with glaucoma who require additional or adjunctive IOP-lowering therapy.Both Alphagan and Combigan are available for sale in the United States and numerous markets around th

90、e world.Restasis.Restasis is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.Restasis is approved in the United States and a number of

91、other markets in South America,the Middle East and Asia.Other eye care.Other eye care products include Refresh/Optive,Xen and Durysta.Other key products.AbbVies other key products include,among other things,treatments for patients with hepatitis C virus(HCV),metabolic and hormone products that targe

92、t a number of conditions,including exocrine pancreatic insufficiency and hypothyroidism,as well as endocrinology products for the palliative treatment of advanced prostate cancer,treatment of endometriosis and central precocious puberty and for the preoperative treatment of patients with anemia caus

93、ed by uterine fibroids.These products are:Mavyret/Maviret.Mavyret(glecaprevir/pibrentasvir)is approved in the United States and European Union(Maviret)for the treatment of adult and pediatric patients(12 years and older or weighing at least 45 kilograms)with chronic HCV genotype 1-6 infection withou

94、t cirrhosis and with compensated cirrhosis(Child-Pugh A).It is also indicated for the treatment of adult and pediatric patients(12 years and older or weighing at least 45 kilograms)with HCV genotype 1 infection,who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS

95、3/4A protease inhibitor,but not both.Creon.Creon(pancrelipase)is a pancreatic enzyme therapy for exocrine pancreatic insufficiency,a condition that occurs in patients with cystic fibrosis,chronic pancreatitis and several other conditions.Lupron.Lupron(leuprolide acetate),which is also marketed as Lu

96、crin and Lupron Depot,is a product for the palliative treatment of advanced prostate cancer,treatment of endometriosis and central precocious puberty and for the preoperative treatment of patients with anemia caused by uterine fibroids.Lupron is approved for daily subcutaneous injection and one-mont

97、h,three-month,four-month and six-month intramuscular injection.Linzess/Constella.Linzess(linaclotide)is a once-daily guanylate cyclase-C agonist used in adults to treat irritable bowel syndrome with constipation(IBS-C)and chronic idiopathic constipation.The product is marketed as Linzess in the Unit

98、ed States and as Constella outside of the United States.Synthroid.Synthroid(levothyroxine sodium tablets,USP)is used in the treatment of hypothyroidism.AbbVie has the rights to sell Creon and Synthroid only in the United States.Marketing,Sales and Distribution Capabilities AbbVie utilizes a combinat

99、ion of dedicated commercial resources,regional commercial resources and distributorships to market,sell and distribute its products worldwide.AbbVie directs its primary marketing efforts toward securing the prescription,or recommendation,of its brand of products by physicians,external experts and ot

100、her health care providers.Managed care providers(for example,health maintenance organizations and pharmacy benefit managers),hospitals and state and federal government agencies(for example,State Medicaid programs,the United States Department of 2023 Form 10-K|5 Veterans Affairs and the United States

101、 Department of Defense)are also important customers.AbbVie also markets directly to consumers themselves,although in the United States many of the companys products must be sold pursuant to a prescription.Outside of the United States,AbbVie focuses its promotional and market access efforts on extern

102、al experts,payers,physicians and health systems.AbbVie also provides patient support programs closely related to its products.AbbVies products are generally sold worldwide directly to wholesalers,distributors,government agencies,health care facilities,specialty pharmacies and independent retailers f

103、rom AbbVie-owned distribution centers and public warehouses.Certain products(including aesthetic products and devices)are also sold directly to physicians and other licensed healthcare providers.Although AbbVies business does not have significant seasonality,AbbVies product revenues may be affected

104、by end customer and retail buying patterns,fluctuations in wholesaler inventory levels and other factors.In the United States,AbbVie distributes pharmaceutical products principally through independent wholesale distributors,with some sales directly to retailers,pharmacies,patients or other customers

105、.In 2023,three wholesale distributors(McKesson Corporation,Cardinal Health,Inc.and AmerisourceBergen Corporation)accounted for substantially all of AbbVies pharmaceutical product sales in the United States.No individual wholesaler accounted for greater than 39%of AbbVies 2023 gross revenues in the U

106、nited States.Outside the United States,AbbVie sells products primarily to wholesalers or through distributors,and depending on the market works through largely centralized national payers systems to agree on reimbursement terms.Certain products are co-marketed or co-promoted with other companies.Abb

107、Vie has no single customer that,if the customer were lost,would have a material adverse effect on the companys business.No material portion of AbbVies business is subject to renegotiation of profits or termination of contracts at the election of the government.Orders are generally filled on a curren

108、t basis and order backlog is not material to AbbVies business.Competition The markets for AbbVies products are highly competitive.AbbVie competes with other research-based pharmaceuticals and biotechnology companies that discover,manufacture,market and sell proprietary pharmaceutical products,therap

109、ies and biologics.For example,AbbVies immunology products compete with anti-TNF products,JAK inhibitors and other competitive products intended to treat a number of disease states,and AbbVies oncology products compete with BTK inhibitors and other competitive products intended to treat certain cance

110、rs.In addition,in the past few years,a number of other companies have started to develop,have successfully developed and/or are currently marketing products that are being positioned as competitors to Botox.The search for technological innovations in pharmaceutical products is a significant aspect o

111、f competition.The introduction of new products by competitors and changes in medical practices and procedures can result in product obsolescence.Price is also a competitive factor.In addition,the substitution of generic and biosimilar pharmaceutical products for branded pharmaceutical products creat

112、es competitive pressures on AbbVies products that do not have patent protection.New products or treatments brought to market by AbbVies competitors could cause revenues for AbbVies products to decrease due to price reductions and sales volume decreases.Biosimilars.Competition for AbbVies biologic pr

113、oducts is affected by the approval of follow-on biologics,also known as“biosimilars.”Biologics have added major therapeutic options for the treatment of many diseases,including some for which therapies were unavailable or inadequate.The cost of developing and producing biologic therapies is typicall

114、y dramatically higher than for small molecule medications,and many biologic medications are used for ongoing treatment of chronic diseases,such as rheumatoid arthritis or inflammatory bowel disease,or for the treatment of previously untreatable cancer.Significant investments in biologics infrastruct

115、ure and manufacturing are necessary to produce biologic products.Humira is facing direct biosimilar competition globally,and AbbVie will continue to face competitive pressure from these biologics and from orally administered products.|2023 Form 10-K 6 In the United States,the FDA regulates biologics

116、 under the Federal Food,Drug,and Cosmetic Act(the FFDCA),the Public Health Service Act(PHSA)and the regulations implementing these statutes.The enactment of federal health care reform legislation in March 2010 provided a pathway for approval of biosimilars under the PHSA,but the approval process for

117、,and science behind,biosimilars is complex.Approval by the FDA is dependent upon many factors,including a showing that the biosimilar is“highly similar”to the original product and has no clinically meaningful differences from the original product in terms of safety,purity and potency.The types of da

118、ta that could ordinarily be required in an application to show similarity may include analytical data,bioequivalence studies and studies to demonstrate chemical similarity,animal studies(including toxicity studies)and clinical studies.Furthermore,the law provides that only a biosimilar product that

119、is determined to be“interchangeable”will be considered by the FDA as substitutable for the original biologic product without the intervention of the health care provider who prescribed the original biologic product.To prove that a biosimilar product is interchangeable,the applicant must demonstrate

120、that the product can be expected to produce the same clinical results as the original biologic product in any given patient,and if the product is administered more than once in a patient,that safety risks and potential for diminished efficacy of alternating or switching between the use of the interc

121、hangeable biosimilar biologic product and the original biologic product is no greater than the risk of using the original biologic product without switching.The law continues to be interpreted and implemented by the FDA.As a result,its full ultimate impact,implementation and meaning remains subject

122、to uncertainty.Intellectual Property Protection and Regulatory Exclusivity Generally,upon approval,products may be entitled to certain kinds of exclusivity under applicable intellectual property and regulatory regimes.AbbVies intellectual property is materially valuable to the company,and AbbVie see

123、ks patent protection,where available,in all significant markets and/or countries for each product in development.In the United States,the expiration date for patents is 20 years after the filing date.Given that patents relating to pharmaceutical products are often obtained early in the development p

124、rocess and given the amount of time needed to complete clinical trials and other development activities required for regulatory approval,the length of time between product launch and patent expiration is significantly less than 20 years.The Drug Price Competition and Patent Term Restoration Act of 1

125、984(commonly known as the Hatch-Waxman Act)permits a patent holder to seek a patent extension,commonly called a“patent term restoration,”for patents on products(or processes for making the product)regulated by the FFDCA.The length of the patent extension is roughly based on 50 percent of the period

126、of time from the filing of an Investigational New Drug Application(NDA)for a compound to the submission of the NDA for such compound,plus 100 percent of the time period from NDA submission to regulatory approval.The extension,however,cannot exceed five years and the patent term remaining after regul

127、atory approval cannot exceed 14 years.Biological products licensed under the PHSA are similarly eligible for terms of patent restoration.Pharmaceutical products may be entitled to other forms of legal or regulatory exclusivity upon approval.The scope,length and requirements for each of these exclusi

128、vities vary both in the United States and in other jurisdictions.In the United States,if the FDA approves a conventional drug product that contains an active ingredient not previously approved,the product is typically entitled to five years of non-patent regulatory exclusivity.Specific conditions of

129、 use approved for individual products may also be entitled to three years of exclusivity if approval was based on the FDAs reliance on new clinical studies essential to approval submitted by the NDA applicant.If the NDA applicant studies the product for use by children,the FDA may grant pediatric ex

130、clusivity,which extends by 180 days all existing exclusivities(patent and regulatory)related to the product.For products that are either used to treat conditions that afflict a relatively small population or for which there is not a reasonable expectation that the research and development costs will

131、 be recovered,the FDA may designate the pharmaceutical as an orphan drug and grant it seven years of exclusivity.Other types of regulatory exclusivity may also be available,such as Generating New Antibiotic Incentives Now(GAIN)exclusivity,which can provide new antibiotic or new antifungal drugs an a

132、dditional five years of exclusivity to be added to certain exclusivities already provided for by law.Applicable laws and regulations dictate the scope of any exclusivity to which a product or particular characteristics of a product is entitled upon approval in any particular country.In certain insta

133、nces,2023 Form 10-K|7 regulatory exclusivity may offer protection where patent protection is no longer available or for a period of time in excess of patent protection.It is not possible to estimate for each product in development the total period and scope of exclusivity to which it may become enti

134、tled until regulatory approval is obtained or sometimes even later.However,given the length of time required to complete clinical development of a pharmaceutical product,the periods of exclusivity that might be achieved in any individual case would not generally be expected to exceed a minimum of th

135、ree years and a maximum of 14 years.These estimates do not consider other factors,such as the difficulty of recreating the manufacturing process for a particular product or other proprietary knowledge that may delay the introduction of a generic or other follow-on product after the expiration of app

136、licable patent and other regulatory exclusivity periods.Biologics may be entitled to exclusivity under the Biologics Price Competition and Innovation Act,which was passed on March 23,2010 as Title VII to the Patient Protection and Affordable Care Act.The law provides a pathway for approval of biosim

137、ilars following the expiration of 12 years of regulatory exclusivity for the innovator biologic and a potential additional 180 day-extension term for conducting pediatric studies.Biologics are also eligible for orphan drug exclusivity,as discussed above.The law also includes an extensive process for

138、 the innovator biologic and biosimilar manufacturer to litigate patent infringement,validity and enforceability.The European Union has also created a pathway for approval of biosimilars and has published guidelines for approval of certain biosimilar products.The more complex nature of biologics and

139、biosimilar products has led to close regulatory scrutiny over follow-on biosimilar products,which can reduce the effect of biosimilars on sales of the innovator biologic as compared to the sales erosion caused by generic versions of small molecule pharmaceutical products.AbbVie owns or has licensed

140、rights to a substantial number of patents and patent applications.AbbVie licenses or owns a patent portfolio of thousands of patent families,each of which includes United States patent applications and/or issued patents and may also contain the non-United States counterparts to these patents and app

141、lications.These patents and applications,including various patents that expire during the period 2024 to the mid 2040s,in aggregate are believed to be of material importance in the operation of AbbVies business.However,AbbVie believes that no single patent,license,trademark(or related group of paten

142、ts,licenses,or trademarks),are material in relation to the companys business as a whole.In addition,the following patents,licenses and trademarks are significant:those related to ibrutinib(which is sold under the trademark Imbruvica),those related to risankizumab(which is sold under the trademark Sk

143、yrizi)and those related to upadacitinib(which is sold under the trademark Rinvoq).The United States composition of matter patent covering ibrutinib is expected to expire in 2027,with pediatric regulatory exclusivity then extending until May 2028.However,no generic entry for any ibrutinib product is

144、expected prior to March 30,2032.The United States composition of matter patent covering risankizumab is expected to expire in 2033.And the United States composition of matter patent covering upadacitinib is expected to expire in 2033.AbbVie may rely,in some circumstances,on trade secrets to protect

145、its technology.AbbVie seeks to protect its technology and product candidates,in part,by confidentiality agreements with its employees,consultants,advisors,contractors and collaborators.These agreements may be breached and AbbVie may not have adequate remedies for any breach.In addition,AbbVies trade

146、 secrets may otherwise become known or be independently discovered by competitors.To the extent that AbbVies employees,consultants,advisors,contractors and collaborators use intellectual property owned by others in their work for the company,disputes may arise as to the rights in related or resultin

147、g know-how and inventions.Licensing,Acquisitions and Other Arrangements In addition to its independent efforts to develop and market products,AbbVie enters into arrangements such as acquisitions,option-to-acquire agreements,licensing arrangements,option-to-license arrangements,strategic alliances,co

148、-promotion arrangements,co-development and co-marketing agreements and joint ventures.The acquisitions and option-to-acquire agreements typically include,among other terms and conditions,non-refundable purchase price payments or option fees,option|2023 Form 10-K 8 exercise payments,milestones or ear

149、n-outs and other customary terms and obligations.The licensing and other arrangements typically include,among other terms and conditions,non-refundable upfront license fees,option fees and option exercise payments,milestone payments and royalty and/or profit sharing obligations.See Note 5,“Licensing

150、,Acquisitions and Other ArrangementsOther Licensing&Acquisitions Activity,”to the Consolidated Financial Statements included under Item 8,“Financial Statements and Supplementary Data.”Third Party Agreements AbbVie has agreements with third parties for process development,product distribution,analyti

151、cal services and manufacturing of certain products.AbbVie procures certain products and services from a limited number of suppliers and,in some cases,a single supply source.In addition,AbbVie has agreements with third parties for active pharmaceutical ingredient and product manufacturing,formulation

152、 and development services,fill,finish and packaging services,transportation and distribution and logistics services for certain products.AbbVie does not believe that these manufacturing-related agreements are material because AbbVies business is not substantially dependent on any individual agreemen

153、t.In most cases,AbbVie maintains alternate supply relationships that it can utilize without undue disruption of its manufacturing processes if a third party fails to perform its contractual obligations.AbbVie seeks to maintain sufficient inventory of product to minimize the impact of any supply disr

154、uption.AbbVie is also party to certain collaborations and other arrangements,as discussed in Note 5,“Licensing,Acquisitions and Other ArrangementsOther Licensing&Acquisitions Activity,”to the Consolidated Financial Statements included under Item 8,“Financial Statements and Supplementary Data.”Source

155、s and Availability of Raw Materials AbbVie purchases,in the ordinary course of business,raw materials and supplies essential to its operations from numerous suppliers around the world.In addition,certain medical devices and components necessary for the manufacture of AbbVie products are provided by

156、unaffiliated third party suppliers.AbbVie has robust business continuity and supplier monitoring programs.Research and Development Activities AbbVie makes a significant investment in research and development and has numerous compounds(and complementary devices)in clinical development,including poten

157、tial treatments for complex,life-threatening diseases.AbbVies ability to discover and develop new compounds is enhanced by the companys use of integrated discovery and development project teams,which include chemists,biologists,physicians and pharmacologists who work on the same compounds as a team.

158、AbbVie also partners with third parties,such as biotechnology companies,other pharmaceutical companies and academic institutions to identify and prioritize promising new treatments that complement and enhance AbbVies existing portfolio.AbbVie also supplements its research and development efforts wit

159、h acquisitions.The research and development process generally begins with discovery research which focuses on the identification of a molecule that has a desired effect against a given disease.If preclinical testing of an identified compound proves successful,the compound moves into clinical develop

160、ment which generally includes the following phases:Phase 1involves the first human tests in a small number of healthy volunteers or patients to assess safety,tolerability and doses for later phases.Phase 2tests different doses of the drug in a disease state in order to assess efficacy.Phase 3tests a

161、 drug that demonstrates favorable results in the earlier phases in a significantly larger patient population to further demonstrate efficacy and safety in order to meet requirements to enable global approval.Preclinical data and clinical trials from all of the development phases provide the data req

162、uired to prepare and submit an NDA,a Biological License Application(BLA)or other submission for regulatory 2023 Form 10-K|9 approval to the FDA or similar government agencies outside the United States.The specific requirements(e.g.,scope of clinical trials)for obtaining regulatory approval vary acro

163、ss different countries and geographic regions.The research and development process from discovery through a new drug launch typically takes 8 to 12 years and can be even longer.The research and development of new pharmaceutical products has a significant amount of inherent uncertainty.There is no gu

164、arantee when,or if,a molecule will receive the regulatory approval required to launch a new drug or indication.In addition to the development of new products,delivery devices and new formulations,research and development projects also may include Phase 4 trials,sometimes called post-marketing studie

165、s.For such projects,clinical trials are designed and conducted to collect additional data regarding,among other parameters,the benefits and risks of an approved drug.RegulationDiscovery and Clinical Development United States.Securing approval to market a new pharmaceutical product in the United Stat

166、es requires substantial effort and financial resources and takes several years to complete.The applicant must complete preclinical tests and submit protocols to the FDA before commencing clinical trials.Clinical trials are intended to establish the safety and efficacy of the pharmaceutical product a

167、nd typically are conducted in sequential phases,although the phases may overlap or be combined.If the required clinical testing is successful,the results are submitted to the FDA in the form of an NDA or BLA requesting approval to market the product for one or more indications.The FDA reviews an NDA

168、 or BLA to determine whether a product is safe and effective for its intended use and whether its manufacturing is compliant with current Good Manufacturing Practices(cGMP).Compliance with regulatory requirements is assured through periodic,announced or unannounced inspections by the FDA and other r

169、egulatory authorities,and these inspections associated with clinical development may include the sponsor,investigator sites,laboratories,hospitals and manufacturing facilities of AbbVies subcontractors or other third-party manufacturers.Failure to comply with applicable regulatory requirements can r

170、esult in enforcement action by the FDA,including rejection of an NDA or BLA.Even if an NDA or a BLA receives approval,the applicant must comply with post-approval requirements.For example,holders of an approval must report adverse reactions,provide updated safety and efficacy information and comply

171、with requirements concerning advertising and promotional materials and activities.Also,quality control and manufacturing procedures must continue to conform to cGMP after approval,and certain changes to the manufacturing procedures and finished product must be submitted and approved by the FDA prior

172、 to implementation.The FDA periodically inspects manufacturing facilities to assess compliance with cGMP,which imposes extensive procedural and record keeping requirements.In addition,as a condition of approval,the FDA may require post-marketing testing and surveillance to further assess and monitor

173、 the products safety or efficacy after commercialization,which may require additional clinical trials,patient registries,observational data or additional work on chemistry,manufacturing and controls.Any post-approval regulatory obligations,and the cost of complying with such obligations,could expand

174、 in the future.Further,the FDA continues to regulate product labeling,and prohibits the promotion of products for unapproved or“off-label”uses along with other labeling restrictions.Outside the United States.AbbVie is subject to similar regulatory requirements outside the United States for approval

175、and marketing of pharmaceutical products.AbbVie must obtain approval of a clinical trial application or product from applicable supervising regulatory authorities before it can commence clinical trials or marketing of the product in target markets.The approval requirements and process for each count

176、ry can vary,and the time required to obtain approval may be longer or shorter than that required for FDA approval in the United States.For example,AbbVie may submit marketing authorizations in the European Union under either a centralized or decentralized procedure.The centralized procedure is manda

177、tory for the approval of biotechnology products and many pharmaceutical products and provides for a single marketing authorization that is valid for all European Union member states.Under the centralized procedure,a single marketing authorization application is submitted to the|2023 Form 10-K 10 Eur

178、opean Medicines Agency.After the agency evaluates the application,it makes a recommendation to the European Commission,which then makes the final determination on whether to approve the application.The decentralized procedure provides for mutual recognition of individual national approval decisions

179、and is available for products that are not subject to the centralized procedure.In Japan,applications for approval of a new product are made through the Pharmaceutical and Medical Devices Agency(PMDA).Japan-specific trials and/or bridging studies to demonstrate that the non-Japanese clinical data ap

180、plies to Japanese patients are usually required.After completing a comprehensive review,the PMDA reports to the Ministry of Health,Labour and Welfare,which then approves or denies the application.Similarly,applications for a new product in China are submitted to the Center for Drug Evaluation of the

181、 National Medical Products Administration for technical review and approval of a product for marketing in China.Clinical data in Chinese subjects are usually required to support approval in China,requiring the inclusion of China in global pivotal studies,or a separate China/Asian clinical trial.The

182、regulatory process in many emerging markets continues to evolve.Many emerging markets,including those in Asia,generally require regulatory approval to have been obtained in a large developed market(such as the United States or Europe)before the country will begin or complete its regulatory review pr

183、ocess.Similar to the requirements in Japan and China,certain countries(notably South Korea,Taiwan,India and Russia)also generally require that clinical studies that include data from patients in those countries be conducted in order to support local regulatory approval.The requirements governing the

184、 conduct of clinical trials and product licensing also vary.In addition,post-approval regulatory obligations such as adverse event reporting and cGMP compliance generally apply and may vary by country.For example,after a marketing authorization has been granted in the European Union,periodic safety

185、reports must be submitted and other pharmacovigilance measures may be required(such as Risk Management Plans).RegulationCommercialization,Distribution and Manufacturing The manufacturing,marketing,sale,promotion and distribution of AbbVies products are subject to comprehensive government regulation.

186、Government regulation by various national,regional,federal,state and local agencies,both in the United States and other countries,addresses(among other matters)inspection of,and controls over,research and laboratory procedures,clinical investigations,product approvals and manufacturing,labeling,pack

187、aging,marketing and promotion,pricing and reimbursement,sampling,distribution,quality control,post-marketing surveillance,record keeping,storage and disposal practices.AbbVies operations are also affected by trade regulations in many countries that limit the import of raw materials and finished prod

188、ucts and by laws and regulations that seek to prevent corruption and bribery in the marketplace(including the United States Foreign Corrupt Practices Act and the United Kingdom Bribery Act,which provide guidance on corporate interactions with government officials)and require safeguards for the prote

189、ction of personal data.In addition,AbbVie is subject to laws and regulations pertaining to health care fraud and abuse,including state and federal anti-kickback and false claims laws in the United States.Prescription drug manufacturers such as AbbVie are also subject to taxes,as well as application,

190、product,user and other fees.Compliance with these laws and regulations is costly and materially affects AbbVies business.Among other effects,health care regulations substantially increase the time,difficulty and costs incurred in obtaining and maintaining approval to market newly developed and exist

191、ing products.AbbVie expects compliance with these regulations to continue to require significant technical expertise and capital investment to ensure compliance.Failure to comply can delay the release of a new product or result in regulatory and enforcement actions,the seizure or recall of a product

192、,the suspension or revocation of the authority necessary for a products production and sale and other civil or criminal sanctions,including fines and penalties.In addition to regulatory initiatives,AbbVies business can be affected by ongoing studies of the utilization,safety,efficacy and outcomes of

193、 health care products and their components that are regularly conducted by industry participants,government agencies and others.These studies can lead to updates to the data regarding utilization,safety and efficacy of previously marketed products.In some 2023 Form 10-K|11 cases,these studies have r

194、esulted,and may in the future result,in the discontinuance of,or limitations on,marketing of such products domestically or worldwide,and may give rise to claims for damages from persons who believe they have been injured as a result of their use.Access to human health care products continues to be a

195、 subject of oversight,investigation and action by governmental agencies,legislative bodies and private organizations in the United States and other countries.A major focus is cost containment.Efforts to reduce health care costs are also being made in the private sector,notably by health care payers

196、and providers,which have instituted various cost reduction and containment measures.AbbVie expects insurers and providers to continue attempts to reduce the cost of health care products.Outside the United States,many countries control the price of health care products directly or indirectly,through

197、reimbursement,payment,pricing,coverage limitations,or compulsory licensing.Political and budgetary pressures in the United States and in other countries may also heighten the scope and severity of pricing pressures on AbbVies products for the foreseeable future.United States.Specifically,U.S.federal

198、 laws require pharmaceutical manufacturers to pay certain statutorily-prescribed rebates to state Medicaid programs on prescription drugs reimbursed under state Medicaid plans,and the efforts by states to seek additional rebates may affect AbbVies business.Similarly,the Veterans Health Care Act of 1

199、992,as a prerequisite to participation in Medicaid and other federal health care programs,requires that manufacturers extend additional discounts on pharmaceutical products to various federal agencies,including the United States Department of Veterans Affairs,Department of Defense and Public Health

200、Service entities and institutions.In addition,recent legislative changes would require similarly discounted prices to be offered to TRICARE program beneficiaries.The Veterans Health Care Act of 1992 also established the 340B drug discount program,which requires pharmaceutical manufacturers to provid

201、e products at reduced prices to various designated health care entities and facilities.In the United States,most states also have generic substitution legislation requiring or permitting a dispensing pharmacist to substitute a different manufacturers generic version of a pharmaceutical product for t

202、he one prescribed.In addition,the federal government follows a diagnosis-related group(DRG)payment system for certain institutional services provided under Medicare or Medicaid and has implemented a prospective payment system(PPS)for services delivered in hospital outpatient,nursing home and home he

203、alth settings.DRG and PPS entitle a health care facility to a fixed reimbursement based on the diagnosis and/or procedure rather than actual costs incurred in patient treatment,thereby increasing the incentive for the facility to limit or control expenditures for many health care products.Medicare r

204、eimburses Part B drugs based on average sales price plus a certain percentage to account for physician administration costs,which have been reduced in the hospital outpatient setting.Medicare enters into contracts with private plans to negotiate prices for most patient-administered medicine delivere

205、d under Part D.Under the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act(together,the Affordable Care Act),AbbVie pays a fee related to its pharmaceuticals sales to government programs.In addition,AbbVie provides a discount of 70%for branded prescripti

206、on drugs sold to patients who fall into the Medicare Part D coverage gap,or“donut hole.”The Affordable Care Act also includes provisions known as the Physician Payments Sunshine Act,which require manufacturers of drugs and biologics covered under Medicare and Medicaid to record any transfers of valu

207、e to physicians and teaching hospitals and to report this data to the Centers for Medicare and Medicaid Services for subsequent public disclosure.Similar reporting requirements have also been enacted on the state level in the United States,and an increasing number of countries worldwide either have

208、adopted or are considering similar laws requiring disclosure of interactions with health care professionals.Failure to report appropriate data may result in civil or criminal fines and/or penalties.The Inflation Reduction Act of 2022(the IRA)requires:(i)the government to set prices for select high e

209、xpenditure Medicare Part D drugs(prices effective beginning in 2026)and Part B drugs(prices effective beginning in 2028)that are more than nine years(for small-molecule drugs)or 13 years(for biological products)from their FDA approval,(ii)manufacturers to pay a rebate for Medicare Part B and|2023 Fo

210、rm 10-K 12 Part D drugs when prices for those drugs increase faster than inflation beginning in 2022 for Part D and 2023 for Part B,and(iii)a Medicare Part D redesign replacing the current coverage gap provisions and establishing a$2,000 cap for out-of-pocket costs for Medicare beneficiaries beginni

211、ng in 2025,with manufacturers being responsible for 10%of costs up to the$2,000 cap and 20%after that cap is reached.In August 2023,the U.S.Department of Health and Human Services,through the Centers for Medicare&Medicaid Services(the CMS),selected Imbruvica as one of the first 10 medicines subject

212、to government-set prices beginning in 2026.The price-setting process will conclude by August 1,2024,and on September 1,2024,the CMS will publish prices that will be applicable to the 10 drugs in the Medicare program beginning January 1,2026.It is possible that more of our products,including products

213、 that generate substantial revenues,could be selected in future years,which could,among other things,accelerate revenue erosion prior to expiration of intellectual property protections.The effect of reducing prices and reimbursement would significantly impact revenues for certain of our products.Eur

214、opean Union.The European Union has adopted directives and other legislation governing labeling,advertising,distribution,supply,pharmacovigilance and marketing of pharmaceutical products.Such legislation provides mandatory standards throughout the European Union and permits member states to supplemen

215、t these standards with additional regulations.European governments also regulate pharmaceutical product prices through their control of national health care systems that fund a large part of the cost of such products to consumers.As a result,patients are unlikely to use a pharmaceutical product that

216、 is not reimbursed by the government.In many European countries,the government either regulates the pricing of a new product at launch or subsequent launch through direct price controls or reference pricing.In recent years,many countries have also imposed new or additional cost containment measures

217、on pharmaceutical products.Differences between national pricing regimes create price differentials within the European Union that can lead to significant parallel trade in pharmaceutical products.Most governments also promote generic substitution by mandating or permitting a pharmacist to substitute

218、 a different manufacturers generic version of a pharmaceutical product for the one prescribed and by permitting or mandating that health care professionals prescribe generic versions in certain circumstances.Many governments are also following a similar path for biosimilar therapies.In addition,gove

219、rnments use reimbursement lists to limit the pharmaceutical products that are eligible for reimbursement by national health care systems.Japan.In Japan,the National Health Insurance system maintains a Drug Price List specifying which pharmaceutical products are eligible for reimbursement,and the Min

220、istry of Health,Labour and Welfare sets the prices of the products on this list.The government generally introduces price cut rounds every other year and also mandates price decreases for specific products.New products judged innovative or useful,that are indicated for pediatric use,or that target o

221、rphan or small population diseases,however,may be eligible for a pricing premium.The government has also promoted the use of generics,where available.Emerging Markets.Many emerging markets take steps to reduce pharmaceutical product prices,in some cases through direct price controls and in others th

222、rough the promotion of generic/biosimilar alternatives to branded pharmaceuticals.Since AbbVie markets its products worldwide,certain products of a local nature and variations of product lines must also meet other local regulatory requirements.Certain additional risks are inherent in conducting busi

223、ness outside the United States,including price and currency exchange controls,changes in currency exchange rates,limitations on participation in local enterprises,expropriation,nationalization and other governmental action.RegulationMedical Devices Medical devices are subject to regulation by the FD

224、A,state agencies and foreign government health authorities.FDA regulations,as well as various U.S.federal and state laws,govern the development,clinical testing,manufacturing,labeling,record keeping and marketing of medical device products agencies in the United States.AbbVies medical device product

225、 candidates,including AbbVies breast implants,must undergo rigorous clinical testing and an extensive government regulatory 2023 Form 10-K|13 clearance or approval process prior to sale in the United States and other countries.The lengthy process of clinical development and submissions for clearance

226、 or approval,and the continuing need for compliance with applicable laws and regulations,require the expenditure of substantial resources.Regulatory clearance or approval,when and if obtained,may be limited in scope,and may significantly limit the indicated uses for which a product may be marketed.C

227、leared or approved products and their manufacturers are subject to ongoing review,and discovery of previously unknown problems with products may result in restrictions on their manufacture,sale and/or use or require their withdrawal from the market.United States.AbbVies medical device products are s

228、ubject to extensive regulation by the FDA in the United States.Unless an exemption applies,each medical device AbbVie markets in the United States must have a 510(k)clearance or a Premarket Approval Application(PMA)in accordance with the FFDCA and its implementing regulations.The FDA classifies medi

229、cal devices into one of three classes,depending on the degree of risk associated with each medical device and the extent of controls that are needed to ensure safety and effectiveness.Devices deemed to pose a lower risk are placed in either Class I or Class II,and devices deemed by the FDA to pose t

230、he greatest risk,such as life-sustaining,life-supporting or implantable devices,or a device deemed to be not substantially equivalent to a previously cleared 510(k)device,are placed in Class III.In general,a Class III device cannot be marketed in the United States unless the FDA approves the device

231、after submission of a PMA,and any changes to the device subsequent to initial FDA approval must also be reviewed and approved by the FDA.The majority of AbbVies medical device products,including AbbVies breast implants,are regulated as Class III medical devices.A Class III device may have significan

232、t additional obligations imposed in its conditions of approval,and the time in which it takes to obtain approval can be long.Compliance with regulatory requirements is assured through periodic,unannounced facility inspections by the FDA and other regulatory authorities,and these inspections may incl

233、ude the manufacturing facilities of AbbVies subcontractors or other third-party manufacturers.Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA,which may include any of the following sanctions:warning letters or untitled letters;fines,injunctions a

234、nd civil penalties;recall or seizure of AbbVie products;operating restrictions,partial suspension or total shutdown of production;refusing AbbVie request for 510(k)clearance or PMA approval of new products;withdrawing 510(k)clearance or PMA approvals that are already granted;and criminal prosecution

235、.A clinical trial is almost always required to support a PMA application and is sometimes required for a 510(k)premarket notification.Clinical trials generally require submission of an application for an investigational device exemption(IDE),which must be supported by appropriate data,such as animal

236、 and laboratory testing results,showing that it is safe to test the device in humans and that the testing protocol is scientifically sound.A study sponsor must obtain approval for its IDE from the FDA,and it must also obtain approval of its study from the Institutional Review Board overseeing the tr

237、ial.The results of clinical testing may not be sufficient to obtain approval of the investigational device.Once a device is approved,the manufacture and distribution of the device remains subject to continuing regulation by the FDA,including Quality System Regulation requirements,which involve desig

238、n,testing,control,documentation and other quality assurance procedures during the manufacturing process.Medical device manufacturers and their subcontractors are required to register their establishments and list their manufactured devices with the FDA and are subject to periodic unannounced inspect

239、ions by the FDA and certain state agencies for compliance with regulatory requirements.Manufacturers must also report to the FDA if their devices may have caused or contributed to a death or serious injury or malfunctioned in a way that could likely cause or contribute to a death or serious injury,o

240、r if the manufacturer conducts a field correction or product recall or removal to reduce a risk to health posed by a device or to remedy a violation of the FFDCA that may present a health risk.Further,the FDA continues to regulate device labeling,and prohibits the promotion of products for unapprove

241、d or“off-label”uses along with other labeling restrictions.European Union.Medical device products that are marketed in the European Union must comply with the requirements of the Medical Device Regulation(the MDR),which came into effect in May 2021.The MDR provides for regulatory oversight with resp

242、ect to the design,manufacture,clinical trials,labeling and adverse event reporting for medical devices to ensure that medical devices marketed in the European Union are safe and effective for their intended uses.Medical devices that comply with|2023 Form 10-K 14 the MDR are entitled to bear a Confor

243、mit Europenne marking evidencing such compliance and may be marketed in the European Union.Failure to comply with these domestic and international regulatory requirements could affect AbbVies ability to market and sell AbbVies products in these countries.Environmental Matters AbbVie believes that it

244、s operations comply in all material respects with applicable laws and regulations concerning environmental protection.Regulations under federal and state environmental laws impose stringent limitations on emissions and discharges to the environment from various manufacturing operations.AbbVies capit

245、al expenditures for pollution control in 2023 were approximately$16 million and operating expenditures were approximately$43 million.In 2024,capital expenditures for pollution control are estimated to be approximately$22 million and operating expenditures are estimated to be approximately$45 million

246、.Abbott was identified as one of many potentially responsible parties in investigations and/or remediations at several locations in the United States,including Puerto Rico,under the Comprehensive Environmental Response,Compensation and Liability Act,commonly known as Superfund.Some of these location

247、s were transferred to AbbVie in connection with the separation and distribution,and AbbVie has become a party to these investigations and remediations.Abbott was also engaged in remediation at several other sites,some of which have been transferred to AbbVie in connection with the separation and dis

248、tribution,in cooperation with the Environmental Protection Agency or similar agencies.While it is not feasible to predict with certainty the final costs related to those investigations and remediation activities,AbbVie believes that such costs,together with other expenditures to maintain compliance

249、with applicable laws and regulations concerning environmental protection,should not have a material adverse effect on the companys financial position,cash flows,or results of operations.Employees AbbVie employed approximately 50,000 employees in over 70 countries as of January 31,2024.Outside the Un

250、ited States,some of AbbVies employees are represented by unions or works councils.AbbVie believes that it has good relations with its employees.Human Capital Management Attracting,retaining and providing meaningful growth and development opportunities to AbbVies employees is critical to the companys

251、 success in making a remarkable impact on peoples lives around the world.AbbVie leverages numerous resources to identify and enhance strategic and leadership capability,foster employee engagement and create a culture where talent is productive and engaged.AbbVie invests in its employees through comp

252、etitive compensation,benefits and employee support programs and offers best-in-class development and leadership opportunities.AbbVie has developed a deep talent base through ongoing investment in functional and leadership training and by sourcing world-class external talent,ensuring a sustainable ta

253、lent pipeline.AbbVie continuously cultivates and enhances its working culture and embraces equality,diversity and inclusion as fundamental to the companys mission.Attracting and Developing Talent.Attracting and developing high-performing talent is essential to AbbVies continued success.AbbVie implem

254、ents detailed talent attraction strategies,with an emphasis on STEM skill sets,a diverse talent base and other critical skillsets,including drug discovery,clinical development,market access and business development.AbbVie also invests in competitive compensation and benefits programs.In addition to

255、offering a comprehensive suite of benefits ranging from medical and dental coverage to retirement,disability and life insurance programs,AbbVie also provides health promotion programs,mental health awareness campaigns and employee assistance programs in several countries,financial wellness support,o

256、n-site health screenings and immunizations in several countries and on-site fitness and rehabilitation centers.AbbVie has on-site health care clinics at certain locations,offering convenient and affordable access to quality healthcare,flu shots and vaccines.In addition,the AbbVie Employee Assistance

257、 Fund(a part of the AbbVie Foundation)supports two programs for global employees:the AbbVie Possibilities Scholarship for children of employees,which is an annual merit-based scholarship for use at accredited colleges,universities or vocational-technical 2023 Form 10-K|15 schools;and the Employee Re

258、lief Program,which is financial assistance to support short term needs of employees when faced with large-scale disasters(e.g.a hurricane),individual disasters(e.g.a home fire)or financial hardship(e.g.the death of a spouse).Finally,AbbVie empowers managers and their teams with tools,tips and guidel

259、ines on effectively managing workloads,managing teams from a distance and supporting flexible work practices,including“Where We Work”,AbbVies hybrid work model,offering eligible employees predictable flexibility.New AbbVie employees are given a tailored onboarding experience for faster integration a

260、nd to support performance.One of AbbVies mentorship programs allows employees to self-nominate as mentors or mentees and facilitates meaningful relationships supporting employees career and development goals.AbbVie also provides structured,broad-based development opportunities,focusing on high-perfo

261、rmance skills and leadership training.AbbVies talent philosophy holds leaders accountable for building a high-performing organization,and the company provides development opportunities for all levels of leadership.AbbVies Learn,Develop,Perform program offers year-long,self-directed leadership educat

262、ion,supplemented with tools and resources,and leverages leaders as role models and teachers.In addition,a foundational success factor to AbbVies leadership pipeline is the companys Professional Development Programs,which attract graduates,postgraduates and post-doctoral talent to participate in form

263、al development programs lasting up to three years,with the objective of strengthening functional and leadership capabilities.Culture.AbbVies shared principles of transforming lives,acting with integrity,driving innovation,embracing diversity and inclusion and serving the community form the core of t

264、he companys culture.AbbVie articulates the behaviors associated with these values in the Ways We Work,a core set of working behaviors that emphasize how the company achieves results is equally as important as achieving them.The Ways We Work are designed to ensure that every AbbVie employee is aware

265、of the companys cultural expectations.AbbVie integrates the Ways We Work into all talent processes,forming the basis for assessing performance,prioritizing development and ultimately rewarding employees.AbbVie believes its culture creates strong engagement,which is measured regularly through a confi

266、dential,third-party all-employee survey,and this engagement supports AbbVies mission of making a remarkable impact on peoples lives.Equity,Equality,Diversity&Inclusion(EED&I).A cornerstone of AbbVies human capital management approach is to prioritize fostering an inclusive and diverse workforce.AbbV

267、ies Equity,Equality,Diversity&Inclusion roadmap defines key global focus areas,objectives and associated initiatives,and includes implementation plans organized by business function and geography.AbbVies senior leaders have adopted formal goals aligned with executing this strategy.Through December 2

268、023,women represented 52 percent of management positions globally and in the United States,37 percent of AbbVies workforce was comprised of members of historically underrepresented populations,consistent with 2022.Further,AbbVie is committed to pay equity and conducts pay equity analyses annually.A

269、critical component of AbbVies strategy is to instill an inclusive mindset in all AbbVie leaders and employees,so the company continues to realize the full value of its workforce from recruitment through retirement.AbbVies Employee Resource Groups also help the company nurture an inclusive culture by

270、 building community and creating connections.Additional information about AbbVies Equity,Equality,Diversity and Inclusion efforts can be found on the companys website at:https:/ Information Copies of AbbVies Annual Reports on Form 10-K,Quarterly Reports on Form 10-Q,Current Reports on Form 8-K and a

271、mendments to those reports filed or furnished pursuant to Section 13(a)or 15(d)of the Securities Exchange Act of 1934 are available free of charge through AbbVies investor relations website()as soon as reasonably practicable after AbbVie electronically files the material with,or furnishes it to,the

272、Securities and Exchange Commission(SEC).|2023 Form 10-K 16 AbbVies corporate governance guidelines,outline of directorship qualifications,code of business conduct and the charters of AbbVies audit committee,compensation committee,nominations and governance committee and public policy committee are a

273、ll available on AbbVies investor relations website().2023 Form 10-K|17 ITEM 1A.RISK FACTORS.You should carefully consider the following risks and other information in this Form 10-K in evaluating AbbVie and AbbVies common stock.Any of the following risks could materially and adversely affect AbbVies

274、 results of operations,financial condition or cash flows.The risk factors generally have been separated into two groups:risks related to AbbVies business and risks related to AbbVies common stock.Based on the information currently known to it,AbbVie believes that the following information identifies

275、 the most significant risk factors affecting it in each of these categories of risks.However,the risks and uncertainties AbbVie faces are not limited to those set forth in the risk factors described below and may not be in order of importance or probability of occurrence.Additional risks and uncerta

276、inties not presently known to AbbVie or that AbbVie currently believes to be immaterial may also adversely affect its business.In addition,past financial performance may not be a reliable indicator of future performance and historical trends should not be used to anticipate results or trends in futu

277、re periods.If any of the following risks and uncertainties develops into actual events,these events could have a material adverse effect on AbbVies business,results of operations,financial condition or cash flows.In such case,the trading price of AbbVies common stock could decline.Risks Related to A

278、bbVies Business The expiration or loss of patent protection and licenses,including the loss of exclusivity for Humira and increased competition from biosimilars,may adversely affect AbbVies revenues and operating earnings.AbbVie relies on patent,trademark and other intellectual property protection i

279、n the discovery,development,manufacturing and sale of its products.In particular,patent protection is,in the aggregate,important in AbbVies marketing of pharmaceutical products in the United States and most major markets outside of the United States.Patents covering AbbVie products normally provide

280、market exclusivity,which is important for the profitability of many of AbbVies products.As patents for certain of its products expire,AbbVie could face competition from lower priced generic or biosimilar products.The expiration or loss of patent protection for a product typically is followed promptl

281、y by substitutes that may significantly reduce sales for that product in a short amount of time.If AbbVies competitive position is compromised because of generics,biosimilars or otherwise,it could have a material adverse effect on AbbVies business and results of operations.In addition,proposals emer

282、ge from time to time for legislation to further encourage the early and rapid approval of generic drugs or biosimilars.Any such proposals that are enacted into law could increase the impact of generic competition.Large pharmaceutical companies and generics manufacturers of pharmaceutical products co

283、ntinue to expand into the biotechnology field and form partnerships to pursue biosimilars.Companies have developed and are developing biosimilars that compete with AbbVies biologic products,including Humira.As competitors obtain marketing approval for biosimilars referencing AbbVies biologic product

284、s,AbbVies products may become subject to competition from such biosimilars,with the attendant competitive pressure and consequences.Expiration of or successful challenges to AbbVies applicable patent rights could also trigger competition from other products,assuming any relevant exclusivity period h

285、as expired.As a result,AbbVie could face increased litigation and administrative proceedings with respect to the validity and/or scope of patents relating to its biologic products.For example,Humira accounted for approximately 27%of AbbVies total net revenues in 2023.Humira is facing competition fro

286、m biosimilar products in the United States following the loss of exclusivity in 2023,which AbbVie anticipates will continue to cause a significant decline in Humiras revenue and could adversely affect AbbVies revenues and operating earnings.AbbVies principal patents and trademarks are described in g

287、reater detail in Item 1,“Business Intellectual Property Protection and Regulatory Exclusivity”and Item 7,“Managements Discussion and Analysis of Financial Condition and Results of OperationsResults of Operations,”and litigation regarding these patents is described in Item 3,“Legal Proceedings.”|2023

288、 Form 10-K 18 AbbVies major products could lose patent protection earlier than expected,which could adversely affect AbbVies revenues and operating earnings.A significant portion of AbbVies revenue and operating earnings are derived from several major products.Third parties or government authorities

289、 may challenge or seek to invalidate or circumvent AbbVies patents and patent applications.For example,manufacturers of generic pharmaceutical products file,and may continue to file,Abbreviated New Drug Applications with the FDA seeking to market generic forms of AbbVies products prior to the expira

290、tion of relevant patents owned or licensed by AbbVie by asserting that the patents are invalid,unenforceable and/or not infringed.In addition,petitioners have filed,and may continue to file,challenges to the validity of AbbVies patents under the 2011 Leahy-Smith America Invents Act,which created int

291、er partes review and post grant review procedures for challenging patent validity in administrative proceedings at the United States Patent and Trademark Office.Although most of the challenges to AbbVies intellectual property have come from other businesses,governments may also challenge intellectua

292、l property rights.For example,court decisions and potential legislation relating to patents,such as legislation regarding biosimilars,and other regulatory initiatives may result in further erosion of intellectual property protection.In addition,certain governments outside the United States have indi

293、cated that compulsory licenses to patents may be sought to further their domestic policies or on the basis of national emergencies,such as HIV/AIDS.If triggered,compulsory licenses may diminish or eliminate sales and profits from those jurisdictions and negatively affect AbbVies results of operation

294、s.AbbVie normally responds to challenges by vigorously defending its patents,including by filing patent infringement lawsuits.Patent litigation,administrative proceedings and other challenges to AbbVies patents are costly and unpredictable and may deprive AbbVie of market exclusivity for a patented

295、product.To the extent AbbVies intellectual property is successfully challenged,circumvented or weakened,or to the extent such intellectual property does not allow AbbVie to compete effectively,AbbVies business will suffer.To the extent that countries do not enforce AbbVies intellectual property righ

296、ts or require compulsory licensing of AbbVies intellectual property,AbbVies revenues and operating earnings will be reduced.A third partys intellectual property may prevent AbbVie from selling its products or have a material adverse effect on AbbVies profitability and financial condition.Third parti

297、es may claim that an AbbVie product infringes upon their intellectual property.In addition,in its pursuit of valid business opportunities,AbbVie may be required to challenge intellectual property rights held by others that it believes were improperly granted.Resolving an intellectual property infrin

298、gement or other claim can be costly and time consuming and may require AbbVie to enter into license agreements.AbbVie cannot guarantee that it would be able to obtain license agreements on commercially reasonable terms.A successful claim of patent or other intellectual property infringement could su

299、bject AbbVie to significant damages or an injunction preventing the manufacture,sale,or use of the affected AbbVie product or products.Any of these events could have a material adverse effect on AbbVies profitability and financial condition.AbbVies research and development efforts may not succeed in

300、 developing and marketing commercially successful products and technologies,which may cause its revenues and profitability to decline.To remain competitive,AbbVie must continue to launch new products and new indications and/or brand extensions for existing products.Such launches must generate revenu

301、e sufficient both to cover its substantial research and development costs and to replace revenues of profitable products that are lost to or displaced by competing products or therapies.Failure to do so would have a material adverse effect on AbbVies revenue and profitability.Accordingly,AbbVie comm

302、its substantial effort,funds and other resources to research and development and must make ongoing substantial expenditures without any assurance that its efforts will be commercially successful.A high rate of failure in the biopharmaceutical industry is inherent in the research and development of n

303、ew products,and failure can occur at any point in the research and development process,including after significant funds have 2023 Form 10-K|19 been invested.Products that appear promising in development may fail to reach the market for numerous reasons,including failure to demonstrate effectiveness

304、,safety concerns,superior safety or efficacy of competing therapies,failure to achieve positive clinical or pre-clinical outcomes beyond the current standards of care,inability to obtain necessary regulatory approvals or delays in the approval of new products and new indications,limited scope of app

305、roved uses,excessive costs to manufacture or the failure to obtain or maintain intellectual property rights,or infringement of the intellectual property rights of others.Decisions about research studies made early in the development process of a pharmaceutical product candidate can affect the market

306、ing strategy once such candidate receives approval.More detailed studies may demonstrate additional benefits that can help in the marketing,but they also consume time and resources and may delay submitting the pharmaceutical product candidate for regulatory approval.AbbVie cannot guarantee that a pr

307、oper balance of speed and testing will be made with respect to each pharmaceutical product candidate or that decisions in this area would not adversely affect AbbVies results of operations.Even if AbbVie successfully develops and markets new products or enhancements to its existing products,they may

308、 be quickly rendered obsolete by changing clinical preferences,changing industry standards,or competitors innovations.AbbVies innovations may not be accepted quickly in the marketplace because of existing clinical practices or uncertainty over third-party reimbursement.AbbVie cannot state with certa

309、inty when or whether any of its products under development will be launched,whether it will be able to develop,license,or otherwise acquire compounds or products,or whether any products will be commercially successful.Failure to launch successful new products or new indications for existing products

310、 may cause AbbVies products to become obsolete,causing AbbVies revenues and operating results to suffer.AbbVie is subject to cost-containment efforts and pricing pressures that could cause a reduction in revenues and operating earnings,and changes in the terms of rebate and chargeback programs,which

311、 are common in the pharmaceuticals industry,could have a material adverse effect on AbbVies operations.Cost-containment efforts by governments and private organizations are described in greater detail in Item 1,“BusinessRegulationCommercialization,Distribution and Manufacturing.”To the extent these

312、cost containment efforts are not offset by greater demand,increased patient access to health care,or other factors,AbbVies revenues and operating earnings will be reduced.In the United States,the European Union and other countries,AbbVies business has experienced downward pressure on product pricing

313、,and this pressure could increase in the future.AbbVie is subject to increasing public and legislative pressure with respect to pharmaceutical pricing.In the United States,practices of managed care groups,and institutional and governmental purchasers,as well as federal laws and regulations related t

314、o Medicare and Medicaid,contribute to pricing pressures.In particular,the IRA will have the effect of reducing prices and reimbursements for certain of our products,which could significantly impact AbbVies results of operations.Under the IRA,the U.S Department of Health and Human Services can effect

315、ively set prices for certain single-source drugs and biologics reimbursed under Medicare Part B and Part D.Generally,these government prices can apply as soon as nine years(for small-molecule drugs)or 13 years(for biological products)from their FDA approval and will be capped at a statutory ceiling

316、price that is likely to represent a significant discount from average prices to wholesalers and direct purchasers.In August 2023,the U.S.Department of Health and Human Services,through the CMS,selected Imbruvica as one of the first 10 medicines subject to government-set prices beginning in 2026.The

317、price-setting process will conclude by August 1,2024,and on September 1,2024,the CMS will publish prices that will be applicable to the 10 drugs in the Medicare program beginning January 1,2026.It is possible that more of our products,including products that generate substantial revenues,could be se

318、lected in future years,which could,among other things,accelerate revenue erosion prior to expiration of intellectual property protections.In addition,beginning in January 2025,under the IRA,the 70%coverage gap discount program will be replaced by a 10%manufacturer discount for all Medicare Part D be

319、neficiaries that have met their deductible and incurred out of pocket drug costs below a$2,000 threshold and a 20%discount for beneficiaries that have incurred out of pocket drug costs above the$2,000 threshold under the new|2023 Form 10-K 20 Part D benefit redesign.Manufacturers that fail to comply

320、 with the IRA may be subject to various penalties,including civil monetary penalties,which could be significant.The IRA has and will continue to meaningfully impact AbbVies business strategies and those of others in the pharmaceutical industry.The full impact of the IRA on AbbVies business and the p

321、harmaceutical industry,including the implications to us of our or a competitors product being selected for price setting,remains uncertain.AbbVie continues to evaluate the impact that the IRA may have on the company.The potential for continuing changes to the health care system in the United States

322、and the increased purchasing power of entities that negotiate on behalf of Medicare,Medicaid and private sector beneficiaries may result in additional pricing pressures.Additionally,changes to U.S.tax laws now require(i)a 15%alternative minimum tax generally applied to U.S.corporations on adjusted f

323、inancial statement income beginning in 2023 and(ii)a non-deductible 1%excise tax provision on net stock repurchases.In major markets worldwide,governments play a significant role in funding health care services and determining the pricing and reimbursement of pharmaceutical products.Consequently,in

324、those markets,AbbVie is subject to government decision-making and budgetary actions with respect to its products.In particular,many European countries have ongoing government-mandated price reductions for many pharmaceutical products,and AbbVie anticipates continuing pricing pressures in Europe.Diff

325、erences between countries pricing regulations could lead to third-party cross-border trading in AbbVies products that results in a reduction in revenues and operating earnings.Rebates related to government programs,such as fee-for-service Medicaid or Medicaid managed care programs,arise from laws an

326、d regulations.AbbVie cannot predict with certainty if additional government initiatives to contain health care costs or other factors could lead to new or modified regulatory requirements that include higher or incremental rebates or discounts.Other rebate and discount programs arise from contractua

327、l agreements with private payers.Various factors,including market factors and the ability of private payers to control patient access to products,may provide payers the leverage to negotiate higher or additional rebates or discounts that could have a material adverse effect on AbbVies operations.A p

328、ortion of AbbVies near-term pharmaceutical pipeline relies on collaborations with third parties,which may adversely affect the development and sale of its products.AbbVie depends on alliances and joint ventures with pharmaceutical and biotechnology companies for a portion of the products in its near

329、-term pharmaceutical pipeline.Failures by these parties to meet their contractual,regulatory,or other obligations to AbbVie,or any disruption in the relationships between AbbVie and these third parties,could have an adverse effect on AbbVies pharmaceutical pipeline and business.In addition,AbbVies c

330、ollaborative relationships for research and development extend for many years and may give rise to disputes regarding the relative rights,obligations and revenues of AbbVie and its collaboration partners,including the ownership of intellectual property and associated rights and obligations.This coul

331、d result in the loss of intellectual property rights or protection,delay the development and sale of potential pharmaceutical products,affect the effective sale and delivery of AbbVies commercialized products and lead to lengthy and expensive litigation,administrative proceedings or arbitration.Biol

332、ogics carry unique risks and uncertainties,which could have a negative impact on AbbVies business and results of operations.The successful discovery,development,manufacturing and sale of biologics is a long,expensive and uncertain process.There are unique risks and uncertainties with biologics.For e

333、xample,access to and supply of necessary biological materials,such as cell lines,may be limited and current governmental regulations restrict access to and regulate the transport and use of such materials.In addition,the development,manufacturing and sale of biologics is subject to regulations that are often more complex and extensive than the regulations applicable to other pharmaceutical product