Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
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Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following is a discussion and analysis of the financial condition of AbbVie Inc. (AbbVie or the company). This commentary should be read in conjunction with the consolidated financial statements and accompanying notes appearing in Item 8, "Financial Statements and Supplementary Data." This section of this Form 10-K generally discusses 2020 and 2019 items and year-to-year comparisons between 2020 and 2019. Discussions of 2018 items and year-to-year comparisons between 2019 and 2018 that are not included in this Form 10-K can be found in “Management's Discussion and Analysis of Financial Condition and Results of Operations” in Part II, Item 7 of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019.
EXECUTIVE OVERVIEW
Company Overview
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories (Abbott). AbbVie uses its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases.
On May 8, 2020, AbbVie completed the acquisition of Allergan plc (Allergan). The acquisition of Allergan creates a diversified biopharmaceutical company positioned for success with a comprehensive product portfolio that has leadership positions in key therapeutic areas of immunology, hematologic oncology, aesthetics, neuroscience, eye care and women's health. AbbVie's existing product portfolio and pipeline is enhanced with numerous Allergan assets and Allergan's product portfolio benefits from AbbVie's commercial strength, expertise and international infrastructure. See Note 5 to the Consolidated Financial Statements for additional information on the acquisition. Subsequent to the acquisition date, AbbVie's consolidated financial statements include the assets, liabilities, operating results and cash flows of Allergan.
AbbVie's products are generally sold worldwide directly to wholesalers, distributors, government agencies, health care facilities, specialty pharmacies and independent retailers from 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. In the United States, AbbVie distributes pharmaceutical products principally through independent wholesale distributors, with some sales directly to retailers, pharmacies and patients. Outside the United States, AbbVie sells products primarily to customers or through distributors, depending on the market served. Certain products are co-marketed or co-promoted with other companies. AbbVie has approximately 47,000 employees. AbbVie operates as a single global business segment.
2020 Financial Results
AbbVie's strategy has focused on delivering strong financial results, maximizing the benefits of the Allergan acquisition, advancing and investing in its pipeline and returning value to shareholders while ensuring a strong, sustainable growth business over the long term. The company's financial performance in 2020 included delivering worldwide net revenues of $45.8 billion, operating earnings of $11.4 billion, diluted earnings per share of $2.72 and cash flows from operations of $17.6 billion. Worldwide net revenues increased by 38% on a reported basis and on a constant currency basis, which included $10.3 billion of contributed revenues from the Allergan acquisition, growth in the immunology portfolio from Skyrizi, Rinvoq and the continued strength of Humira in the U.S. as well as revenue growth from Imbruvica and Venclexta.
Diluted earnings per share in 2020 was $2.72 and included the following after-tax costs: (i) $5.7 billion for the change in fair value of contingent consideration liabilities; (ii) $4.8 billion related to the amortization of intangible assets; (iii) $3.0 billion of Allergan acquisition and integration expenses; (iv) $1.2 billion for acquired in-process research and development (IPR&D); and $241 million for milestones and other research and development (R&D) expenses. These costs were partially offset by $1.7 billion of certain tax benefits. Additionally, financial results reflected continued funding to support all stages of AbbVie’s pipeline assets and continued investment in AbbVie’s on-market brands.
In October 2020, AbbVie's board of directors declared a quarterly cash dividend of $1.30 per share of common stock payable in February 2021. This reflects an increase of approximately 10.2% over the previous quarterly dividend of $1.18 per share of common stock.
Following the closing of the Allergan acquisition, AbbVie implemented an integration plan designed to reduce costs, integrate and optimize the combined organization. The integration plan is expected to realize more than $2 billion of expected annual cost synergies over a three-year period, with approximately 50% realized in R&D, 40% in selling, general and administrative (SG&A) and 10% in cost of products sold.
2020 Form 10-K | ![]() | 32 |
To achieve these integration objectives, AbbVie expects to incur approximately $2 billion of charges through 2022. These costs will consist of severance and employee benefit costs (cash severance, non-cash severance, including accelerated equity award compensation expense, retention and other termination benefits) and other integration expenses.
Impact of the Coronavirus Disease 2019 (COVID-19)
In March 2020, the World Health Organization declared the outbreak of a novel coronavirus (COVID-19) as a pandemic, which continues to spread throughout the United States and around the world. In response to the growing public health crisis, AbbVie has partnered with global authorities to support the experimental use of multiple AbbVie assets to determine their efficacy in the treatment of COVID-19. In June 2020, AbbVie announced that it entered into a collaboration with Harbour BioMed, Utrecht University and Erasmus Medical Center to develop a novel antibody therapeutic to prevent and treat COVID-19. Additionally, AbbVie donated $35 million to increase healthcare capacity, supply critical equipment and deliver food and essential supplies during the crisis. AbbVie continues to closely manage manufacturing and supply chain resources around the world to help ensure that patients continue to receive an uninterrupted supply of their medicines. Clinical trial sites are being monitored locally to protect the safety of study participants, staff and employees. While the impact of COVID-19 on AbbVie's operations to date has not been material, AbbVie has experienced lower new patient starts across the therapeutic portfolio. AbbVie expects this matter could continue to negatively impact its results of operations throughout the duration of the outbreak. The extent to which COVID-19 may impact AbbVie's financial condition and results of operations remains uncertain.
2021 Strategic Objectives
AbbVie's mission is to discover and develop innovative medicines and products that solve serious health issues today and address the medical challenges of tomorrow while achieving top-tier financial performance through outstanding execution. AbbVie intends to continue to advance its mission in a number of ways, including: (i) maximizing the benefits of the Allergan acquisition to create a more diversified revenue base with multiple long-term growth drivers; (ii) growing revenues by leveraging AbbVie's commercial strength and international infrastructure across Allergan's therapeutic areas and ensuring strong commercial execution of new product launches; (iii) continuing to invest in and expand its pipeline in support of opportunities in immunology, oncology, aesthetics, neuroscience, eye care and women's health as well as continued investment in key on-market products; (iv) expanding operating margins; and (v) returning cash to shareholders via a strong and growing dividend while also reducing debt. In addition, AbbVie anticipates several regulatory submissions and key data readouts from key clinical trials in the next 12 months.
AbbVie expects to achieve its strategic objectives through:
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Immunology revenue growth driven by increasing market share and expanding patient access of Skyrizi and Rinvoq, as well as Humira U.S. sales growth.
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Hematologic oncology revenue growth from both Imbruvica and Venclexta.
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Expansion of the company’s revenue base from additional Allergan products contributing to key aesthetics and neuroscience portfolios.
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Effective management of Humira international biosimilar erosion.
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Optimization of combined AbbVie and Allergan research and development, commercial, and manufacturing operations while maintaining key growth portfolios.
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The favorable impact of pipeline products and indications recently approved or currently under regulatory review where approval is expected in 2021. These products are described in greater detail in the section labeled "Research and Development" included as part of this Item 7.
AbbVie remains committed to driving continued expansion of operating margins and expects to achieve this objective through continued leverage from revenue growth, realization of expense synergies from the Allergan acquisition, productivity initiatives in supply chain and ongoing efficiency programs to optimize manufacturing, commercial infrastructure, administrative costs and general corporate expenses.
The combination of AbbVie and Allergan creates a diverse entity with leadership positions across immunology, hematologic oncology, aesthetics, neuroscience, women's health, eye care and virology. AbbVie's existing product portfolio and pipeline is enhanced with numerous Allergan assets and Allergan's product portfolio benefits from AbbVie's commercial strength, expertise and international infrastructure.
| 33 | | 2020 Form 10-K |
Research and Development
Research and innovation are the cornerstones of AbbVie's business as a global biopharmaceutical company. AbbVie's long-term success depends to a great extent on its ability to continue to discover and develop innovative products and acquire or collaborate on compounds currently in development by other biotechnology or pharmaceutical companies.
AbbVie's pipeline currently includes more than 90 compounds, devices or indications in development individually or under collaboration or license agreements and is focused on such important specialties as immunology, oncology, aesthetics, neuroscience, eye care and women's health along with targeted investments in cystic fibrosis. Of these programs, more than 50 are in mid- and late-stage development.
The following sections summarize transitions of significant programs from mid-stage development to late-stage development as well as developments in significant late-stage and registration programs. AbbVie expects multiple mid-stage programs to transition into late-stage programs in the next 12 months.
Significant Programs and Developments
Immunology
Skyrizi
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In January 2021, AbbVie announced top-line results from its Phase 3 KEEPsAKE-1 and KEEPsAKE-2 clinical trials of Skyrizi in adults with active psoriatic arthritis (PsA) met the primary and ranked secondary endpoints.
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In January 2021, AbbVie announced top-line results from its Phase 3 ADVANCE and MOTIVATE induction studies of Skyrizi in patients with Crohn’s Disease met the primary and key secondary endpoints.
Rinvoq
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In February 2020, AbbVie announced top-line results from its second Phase 3 clinical trial of Rinvoq in adult patients with active PsA. Results from the SELECT-PsA 1 study, which evaluated Rinvoq versus placebo in patients who did not adequately respond to treatment with one or more non-biologic disease-modifying anti-rheumatic drugs (DMARDs), showed that both doses of Rinvoq met the primary and key secondary endpoints. The safety profile was consistent with that of previous studies across indications, with no new safety risks detected.
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In May 2020, AbbVie submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and, in June 2020, submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for Rinvoq for the treatment of adult patients with active PsA.
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In June 2020, AbbVie announced top-line results from its Phase 3 Measure Up 1 study and, in July 2020, announced top-line results from its Phase 3 Measure Up 2 and AD Up studies of Rinvoq for the treatment of moderate to severe atopic dermatitis (AD) met all primary and secondary endpoints versus placebo.
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In August 2020, AbbVie submitted an sNDA to the FDA and, earlier this year, submitted an MAA to the EMA for Rinvoq for the treatment of adult patients with active ankylosing spondylitis (AS).
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In October 2020, AbbVie submitted an sNDA to the FDA and an MAA to the EMA for Rinvoq for the treatment of adult and adolescent patients with moderate to severe AD.
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In December 2020, AbbVie announced its Phase 3 U-ACHIEVE induction study of Rinvoq for the treatment of adult patients with moderate to severe ulcerative colitis met the primary and all ranked secondary endpoints.
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In January 2021, AbbVie announced that the European Commission (EC) approved Rinvoq for the treatment of adults with active PsA and active AS.
2020 Form 10-K | ![]() | 34 |
Oncology
Imbruvica
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In April 2020, AbbVie received FDA approval for the use of Imbruvica in combination with rituximab for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
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In August 2020, the EC granted marketing authorization for Imbruvica in combination with rituximab for the treatment of adult patients with previously untreated CLL.
Venclexta
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In February 2020, AbbVie announced that the Phase 3 VIALE-C trial of Venclexta in combination with low-dose cytarabine in newly-diagnosed patients with acute myeloid leukemia (AML) did not meet its primary endpoint.
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In March 2020, AbbVie announced that top-line results from its Phase 3 VIALE-A trial of Venclexta in combination with azacitidine in patients with AML met its primary endpoints.
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In March 2020, AbbVie received EC approval of Venclyxto in combination with obinutuzumab for patients with previously untreated CLL.
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In June 2020, AbbVie submitted an MAA to the EMA for Venclyxto for the treatment of patients with AML.
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In October 2020, AbbVie received FDA full approval of Venclexta for the treatment of patients with AML. The approval is supported by data from a series of trials including the Phase 3 VIALE-A and VIALE-C studies.
Aesthetics
Juvederm Collection
- In June 2020, AbbVie received FDA approval of Juvederm Voluma XC for the augmentation of the chin region to improve the chin profile in adults over the age of 21.
Neuroscience
Botox Therapeutic
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In June 2020, the FDA accepted the company's supplemental Biologics License Application (sBLA) to expand the Botox prescribing information for the treatment of detrusor (bladder muscle) overactivity associated with an underlying neurologic condition in certain pediatric patients. In February 2021, AbbVie received FDA approval of Botox for the treatment of detrusor overactivity associated with a neurological condition in certain pediatric patients 5 years of age and older.
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In July 2020, AbbVie received FDA approval of Botox for the treatment of lower limb spasticity caused by cerebral palsy in pediatric patients over the age of 2.
Atogepant
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In July 2020, AbbVie announced that the Phase 3 ADVANCE trial evaluating atogepant, an orally administered calcitonin gene-related peptide receptor antagonist, for migraine prevention met its primary endpoint for all doses (10mg, 30mg, and 60mg) compared to placebo, all secondary endpoints with 30mg and 60mg doses, and four out of six secondary endpoints with the 10mg dose.
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In January 2021, AbbVie submitted a New Drug Application to the FDA for atogepant for the prevention of episodic migraine.
Elezanumab
- In September 2020, AbbVie announced that the FDA granted Orphan Drug and Fast Track designations for elezanumab, an investigational treatment for patients following spinal cord injury.
| 35 | | 2020 Form 10-K |
Virology/Liver Disease
Mavyret
- In March 2020, AbbVie announced that the EC granted marketing authorization for Maviret to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C virus (HCV) patients with genotype 3 infection.
Eye Care
AGN-190584
- In October 2020, AbbVie announced that top-line results from its Phase 3 GEMINI 1 and 2 studies of AGN-190584, an investigational ophthalmic solution, for the treatment of presbyopia met their primary endpoint and majority of the secondary endpoints.
Abicipar pegol
- In June 2020, AbbVie announced that the FDA issued a Complete Response Letter (CRL) to the Biologics License Application (BLA) for abicipar pegol, a novel, investigational DARPin therapy for patients with neovascular (wet) age-related macular degeneration (nAMD). The CRL indicated that the rate of intraocular inflammation observed following administration of abicipar pegol results in an unfavorable benefit-risk ratio in the treatment of nAMD. In July 2020, AbbVie withdrew the regulatory application with the EMA for abicipar pegol for the treatment of nAMD.
Women's Health
Oriahnn
- In May 2020, the FDA approved Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) for the management of heavy menstrual bleeding due to uterine fibroids in pre-menopausal women.
RESULTS OF OPERATIONS
Net Revenues
The comparisons presented at constant currency rates reflect comparative local currency net revenues at the prior year's foreign exchange rates. This measure provides information on the change in net revenues assuming that foreign currency exchange rates had not changed between the prior and current periods. AbbVie believes that the non-GAAP measure of change in net revenues at constant currency rates, when used in conjunction with the GAAP measure of change in net revenues at actual currency rates, may provide a more complete understanding of the company's operations and can facilitate analysis of the company's results of operations, particularly in evaluating performance from one period to another.
| Percent change | |||||||||||||||||||||||||||||||||||||||||
| At actual currency rates | At constant currency rates | ||||||||||||||||||||||||||||||||||||||||
| years ended (dollars in millions) | 2020 | 2019 | 2018 | 2020 | 2019 | 2020 | 2019 | ||||||||||||||||||||||||||||||||||
| United States | $ | 34,879 | $ | 23,907 | $ | 21,524 | 45.9 | % | 11.1 | % | 45.9 | % | 11.1 | % | |||||||||||||||||||||||||||
| International | 10,925 | 9,359 | 11,229 | 16.7 | % | (16.7) | % | 17.8 | % | (13.6) | % | ||||||||||||||||||||||||||||||
| Net revenues | $ | 45,804 | $ | 33,266 | $ | 32,753 | 37.7 | % | 1.6 | % | 38.0 | % | 2.6 | % |
2020 Form 10-K | ![]() | 36 |
The following table details AbbVie's worldwide net revenues:
| Percent change | |||||||||||||||||||||||||||||||||||||||||||||||
| At actual currency rates | At constant currency rates | ||||||||||||||||||||||||||||||||||||||||||||||
| years ended December 31 (dollars in millions) | 2020 | 2019 | 2018 | 2020 | 2019 | 2020 | 2019 | ||||||||||||||||||||||||||||||||||||||||
| Immunology | |||||||||||||||||||||||||||||||||||||||||||||||
| Humira | United States | $ | 16,112 | $ | 14,864 | $ | 13,685 | 8.4 | % | 8.6 | % | 8.4 | % | 8.6 | % | ||||||||||||||||||||||||||||||||
| International | 3,720 | 4,305 | 6,251 | (13.6) | % | (31.1) | % | (12.5) | % | (27.8) | % | ||||||||||||||||||||||||||||||||||||
| Total | $ | 19,832 | $ | 19,169 | $ | 19,936 | 3.5 | % | (3.9) | % | 3.7 | % | (2.9) | % | |||||||||||||||||||||||||||||||||
| Skyrizi | United States | $ | 1,385 | $ | 311 | $ | — | >100.0% | n/m | >100.0% | n/m | ||||||||||||||||||||||||||||||||||||
| International | 205 | 44 | — | >100.0% | n/m | >100.0% | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 1,590 | $ | 355 | $ | — | >100.0% | n/m | >100.0% | n/m | |||||||||||||||||||||||||||||||||||||
| Rinvoq | United States | $ | 653 | $ | 47 | $ | — | >100.0% | n/m | >100.0% | n/m | ||||||||||||||||||||||||||||||||||||
| International | 78 | — | — | >100.0% | n/m | >100.0% | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 731 | $ | 47 | $ | — | >100.0% | n/m | >100.0% | n/m | |||||||||||||||||||||||||||||||||||||
| Hematologic Oncology | |||||||||||||||||||||||||||||||||||||||||||||||
| Imbruvica | United States | $ | 4,305 | $ | 3,830 | $ | 2,968 | 12.4 | % | 29.1 | % | 12.4 | % | 29.1 | % | ||||||||||||||||||||||||||||||||
| Collaboration revenues | 1,009 | 844 | 622 | 19.5 | % | 35.8 | % | 19.5 | % | 35.8 | % | ||||||||||||||||||||||||||||||||||||
| Total | $ | 5,314 | $ | 4,674 | $ | 3,590 | 13.7 | % | 30.2 | % | 13.7 | % | 30.2 | % | |||||||||||||||||||||||||||||||||
| Venclexta | United States | $ | 804 | $ | 521 | $ | 247 | 54.4 | % | >100.0% | 54.4 | % | >100.0% | ||||||||||||||||||||||||||||||||||
| International | 533 | 271 | 97 | 97.0 | % | >100.0% | 97.8 | % | >100.0% | ||||||||||||||||||||||||||||||||||||||
| Total | $ | 1,337 | $ | 792 | $ | 344 | 69.0 | % | >100.0% | 69.3 | % | >100.0% | |||||||||||||||||||||||||||||||||||
| Aesthetics | |||||||||||||||||||||||||||||||||||||||||||||||
| Botox Cosmetic (a) | United States | $ | 687 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| International | 425 | — | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 1,112 | $ | — | $ | — | n/m | n/m | n/m | n/m | |||||||||||||||||||||||||||||||||||||
| Juvederm Collection (a) | United States | $ | 318 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| International | 400 | — | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 718 | $ | — | $ | — | n/m | n/m | n/m | n/m | |||||||||||||||||||||||||||||||||||||
| Other Aesthetics (a) | United States | $ | 666 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| International | 94 | — | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 760 | $ | — | $ | — | n/m | n/m | n/m | n/m | |||||||||||||||||||||||||||||||||||||
| Neuroscience | |||||||||||||||||||||||||||||||||||||||||||||||
| Botox Therapeutic (a) | United States | $ | 1,155 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| International | 232 | — | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 1,387 | $ | — | $ | — | n/m | n/m | n/m | n/m | |||||||||||||||||||||||||||||||||||||
| Vraylar (a) | United States | $ | 951 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| Duodopa | United States | $ | 103 | $ | 97 | $ | 80 | 5.9 | % | 20.4 | % | 5.9 | % | 20.4 | % | ||||||||||||||||||||||||||||||||
| International | 391 | 364 | 350 | 7.4 | % | 4.2 | % | 6.3 | % | 9.8 | % | ||||||||||||||||||||||||||||||||||||
| Total | $ | 494 | $ | 461 | $ | 430 | 7.1 | % | 7.2 | % | 6.2 | % | 11.7 | % | |||||||||||||||||||||||||||||||||
| Ubrelvy (a) | United States | $ | 125 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| Other Neuroscience (a) | United States | $ | 528 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| International | 11 | — | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 539 | $ | — | $ | — | n/m | n/m | n/m | n/m |
| 37 | | 2020 Form 10-K |
| Percent change | |||||||||||||||||||||||||||||||||||||||||||||||
| At actual currency rates | At constant currency rates | ||||||||||||||||||||||||||||||||||||||||||||||
| years ended December 31 (dollars in millions) | 2020 | 2019 | 2018 | 2020 | 2019 | 2020 | 2019 | ||||||||||||||||||||||||||||||||||||||||
| Eye Care | |||||||||||||||||||||||||||||||||||||||||||||||
| Lumigan/Ganfort (a) | United States | $ | 165 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| International | 213 | — | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 378 | $ | — | $ | — | n/m | n/m | n/m | n/m | |||||||||||||||||||||||||||||||||||||
| Alphagan/Combigan (a) | United States | $ | 223 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| International | 103 | — | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 326 | $ | — | $ | — | n/m | n/m | n/m | n/m | |||||||||||||||||||||||||||||||||||||
| Restasis (a) | United States | $ | 755 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| International | 32 | — | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 787 | $ | — | $ | — | n/m | n/m | n/m | n/m | |||||||||||||||||||||||||||||||||||||
| Other Eye Care (a) | United States | $ | 305 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| International | 388 | — | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 693 | $ | — | $ | — | n/m | n/m | n/m | n/m | |||||||||||||||||||||||||||||||||||||
| Women's Health | |||||||||||||||||||||||||||||||||||||||||||||||
| Lo Loestrin (a) | United States | $ | 346 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| International | 10 | — | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 356 | $ | — | $ | — | n/m | n/m | n/m | n/m | |||||||||||||||||||||||||||||||||||||
| Orilissa/Oriahnn | United States | $ | 121 | $ | 91 | $ | 11 | 33.3 | % | >100.0% | 33.3 | % | >100.0% | ||||||||||||||||||||||||||||||||||
| International | 4 | 2 | — | 96.1 | % | n/m | 97.7 | % | n/m | ||||||||||||||||||||||||||||||||||||||
| Total | $ | 125 | $ | 93 | $ | 11 | 34.6 | % | >100.0% | 34.6 | % | >100.0% | |||||||||||||||||||||||||||||||||||
| Other Women's Health (a) | United States | $ | 181 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| International | 11 | — | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 192 | $ | — | $ | — | n/m | n/m | n/m | n/m | |||||||||||||||||||||||||||||||||||||
| Other Key Products | |||||||||||||||||||||||||||||||||||||||||||||||
| Mavyret | United States | $ | 785 | $ | 1,473 | $ | 1,614 | (46.7) | % | (8.8) | % | (46.7) | % | (8.8) | % | ||||||||||||||||||||||||||||||||
| International | 1,045 | 1,420 | 1,824 | (26.4) | % | (22.1) | % | (26.8) | % | (19.6) | % | ||||||||||||||||||||||||||||||||||||
| Total | $ | 1,830 | $ | 2,893 | $ | 3,438 | (36.7) | % | (15.9) | % | (36.9) | % | (14.6) | % | |||||||||||||||||||||||||||||||||
| Creon | United States | $ | 1,114 | $ | 1,041 | $ | 928 | 6.9 | % | 12.2 | % | 6.9 | % | 12.2 | % | ||||||||||||||||||||||||||||||||
| Lupron | United States | $ | 600 | $ | 720 | $ | 726 | (16.6) | % | (0.8) | % | (16.6) | % | (0.8) | % | ||||||||||||||||||||||||||||||||
| International | 152 | 167 | 166 | (9.1) | % | 0.8 | % | (5.4) | % | 6.0 | % | ||||||||||||||||||||||||||||||||||||
| Total | $ | 752 | $ | 887 | $ | 892 | (15.2) | % | (0.5) | % | (14.5) | % | 0.5 | % | |||||||||||||||||||||||||||||||||
| Linzess/Constella (a) | United States | $ | 649 | $ | — | $ | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||
| International | 18 | — | — | n/m | n/m | n/m | n/m | ||||||||||||||||||||||||||||||||||||||||
| Total | $ | 667 | $ | — | $ | — | n/m | n/m | n/m | n/m | |||||||||||||||||||||||||||||||||||||
| Synthroid | United States | $ | 771 | $ | 786 | $ | 776 | (1.9) | % | 1.3 | % | (1.9) | % | 1.3 | % | ||||||||||||||||||||||||||||||||
| All other | $ | 2,923 | $ | 2,068 | $ | 2,408 | 41.3 | % | (14.1) | % | 42.4 | % | (11.5) | % | |||||||||||||||||||||||||||||||||
| Total net revenues | $ | 45,804 | $ | 33,266 | $ | 32,753 | 37.7 | % | 1.6 | % | 38.0 | % | 2.6 | % |
n/m – Not meaningful
(a)Net revenues include Allergan product revenues from the date of the acquisition, May 8, 2020, through December 31, 2020.
The following discussion and analysis of AbbVie's net revenues by product is presented on a constant currency basis.
Global Humira sales increased 4% in 2020 primarily driven by market growth across therapeutic categories, offset by direct biosimilar competition in certain international markets. In the United States, Humira sales increased 8% in 2020 driven by market growth across all indications and favorable pricing, partially offset by lower new patient starts due to the COVID-19 pandemic. Internationally, Humira revenues decreased 12% in 2020 primarily driven by direct biosimilar competition in certain international markets. Biosimilar competition for Humira is not expected in the United States until 2023. AbbVie continues to pursue strategies intended to maintain market leadership among its installed patient base and add to the sustainability of Humira.
Net revenues for Skyrizi increased more than 100% in 2020 primarily driven by market growth and market share gains over the prior year following the April 2019 regulatory approvals for the treatment of moderate to severe plaque psoriasis.
Net revenues for Rinvoq increased more than 100% in 2020 primarily driven by the August 2019 FDA approval and December 2019 EC approval for the treatment of moderate to severe rheumatoid arthritis.
2020 Form 10-K | ![]() | 38 |
Net revenues for Imbruvica represent product revenues in the United States and collaboration revenues outside of the United States related to AbbVie's 50% share of Imbruvica profit. AbbVie's global Imbruvica revenues increased 14% in 2020 as a result of continued penetration of Imbruvica for patients with CLL, partially offset by lower new patient starts due to the COVID-19 pandemic in 2020.
Net revenues for Venclexta increased 69% in 2020 primarily due to continued expansion of Venclexta for the treatment of patients with first-line CLL, relapsed/refractory CLL and first-line AML.
Net revenues for Botox Cosmetic used in facial aesthetics were $1.1 billion in 2020 for the period subsequent to the completion of the Allergan acquisition.
Net revenues for Juvederm Collection (including Juvederm Ultra XC, Juvederm Voluma XC and other Juvederm products) used in facial aesthetics were $718 million in 2020 for the period subsequent to the completion of the Allergan acquisition.
Net revenues for Botox Therapeutic used primarily in neuroscience and urology therapeutic areas were $1.4 billion in 2020 for the period subsequent to the completion of the Allergan acquisition.
Net revenues for Vraylar for the treatment of schizophrenia, bipolar I disorder and bipolar depression were $951 million in 2020 for the period subsequent to the completion of the Allergan acquisition.
Global Mavyret sales decreased 37% in 2020 primarily driven by lower global new patient starts due to the COVID-19 pandemic as well as competitive dynamics in the U.S.
Net revenues for Creon increased 7% in 2020 primarily driven by continued market growth, partially offset by lower new patient starts due to the COVID-19 pandemic. Creon maintains market leadership in the pancreatic enzyme market with approximately 80% total market share.
Net revenues for Lupron decreased 14% in 2020 primarily due to a near-term supply issue which has impacted product availability of certain formulations.
Gross Margin
| Percent change | |||||||||||||||||||||||||||||
| years ended December 31 (dollars in millions) | 2020 | 2019 | 2018 | 2020 | 2019 | ||||||||||||||||||||||||
| Gross margin | $ | 30,417 | $ | 25,827 | $ | 25,035 | 18 | % | 3 | % | |||||||||||||||||||
| as a percent of net revenues | 66 | % | 78 | % | 76 | % |
Gross margin as a percentage of net revenues in 2020 decreased from 2019 primarily due to the unfavorable impacts of higher amortization of intangible assets and inventory fair value step-up adjustments associated with the Allergan acquisition as well as collaboration profit sharing arrangements for Imbruvica and Venclexta.
Selling, General and Administrative
| Percent change | |||||||||||||||||||||||||||||
| years ended December 31 (dollars in millions) | 2020 | 2019 | 2018 | 2020 | 2019 | ||||||||||||||||||||||||
| Selling, general and administrative | $ | 11,299 | $ | 6,942 | $ | 7,399 | 63 | % | (6) | % | |||||||||||||||||||
| as a percent of net revenues | 25 | % | 21 | % | 23 | % |
Selling, general and administrative (SG&A) expenses as a percentage of net revenues in 2020 increased from 2019 primarily due to the unfavorable impacts of incremental SG&A expenses of Allergan, including transaction and integration costs resulting from the acquisition.
Research and Development and Acquired In-Process Research and Development
| Percent change | |||||||||||||||||||||||||||||
| years ended December 31 (dollars in millions) | 2020 | 2019 | 2018 | 2020 | 2019 | ||||||||||||||||||||||||
| Research and development | $ | 6,557 | $ | 6,407 | $ | 10,329 | 2 | % | (38) | % | |||||||||||||||||||
| as a percent of net revenues | 14 | % | 19 | % | 32 | % | |||||||||||||||||||||||
| Acquired in-process research and development | $ | 1,198 | $ | 385 | $ | 424 | >100% | (9) | % |
Research and Development (R&D) expenses as a percentage of net revenues decreased in 2020 primarily due to the $1.0 billion intangible asset impairment charge in 2019, which represented the remaining value of the IPR&D acquired as part
| 39 | | 2020 Form 10-K |
of the 2016 Stemcentrx acquisition following the decision to terminate the Rova-T R&D program. See Note 7 to the Consolidated Financial Statements for additional information regarding the impairment charge. R&D expenses as a percentage of net revenues in 2020 were also favorably impacted by increased scale of the combined company for the period subsequent to the completion of the Allergan acquisition.
Acquired IPR&D expenses reflect upfront payments related to various collaborations. Acquired IPR&D expense in 2020 included a charge of $750 million as a result of entering a collaboration agreement with Genmab A/S (Genmab) to research, develop and commercialize investigational bispecific antibody therapeutics for the treatment of cancer. Acquired IPR&D expense in 2020 also included a charge of $200 million as a result of a collaboration agreement with I-Mab Biopharma (I-Mab) for the development and commercialization of lemzoparlimab for the treatment of multiple cancers. See Note 5 to the Consolidated Financial Statements for additional information regarding the Genmab and I-Mab agreements. There were no individually significant transactions or cash flows during 2019.
Other Operating Expenses and Income
Other operating income in 2019 included $550 million of income from a legal settlement related to an intellectual property dispute with a third party and $330 million of income related to an amended and restated license agreement between AbbVie and Reata. See Note 5 to the Consolidated Financial Statements for additional information on the Reata agreement.
Other Non-Operating Expenses
| years ended December 31 (in millions) | 2020 | 2019 | 2018 | |||||||||||||||||
| Interest expense | $ | 2,454 | $ | 1,784 | $ | 1,348 | ||||||||||||||
| Interest income | (174) | (275) | (204) | |||||||||||||||||
| Interest expense, net | $ | 2,280 | $ | 1,509 | $ | 1,144 | ||||||||||||||
| Net foreign exchange loss | $ | 71 | $ | 42 | $ | 24 | ||||||||||||||
| Other expense, net | 5,614 | 3,006 | 18 |
Interest expense in 2020 increased compared to 2019 primarily due to a higher average debt balance associated with the financing of the Allergan acquisition as well as the incremental Allergan debt acquired, partially offset by the favorable impact of lower interest rates on the company’s debt obligations.
Interest income in 2020 decreased compared to 2019 primarily due to a lower average cash and cash equivalents balance as a result of the cash paid for the Allergan acquisition and the unfavorable impact of lower interest rates.
Other expense, net included charges related to the change in fair value of the contingent consideration liabilities of $5.8 billion in 2020 and $3.1 billion in 2019. The fair value of contingent consideration liabilities is impacted by the passage of time and multiple other inputs, including the probability of success of achieving regulatory/commercial milestones, discount rates, the estimated amount of future sales of the acquired products and other market-based factors. In 2020, the change in fair value primarily included the increase in the Skyrizi contingent consideration liability due to higher estimated future sales driven by stronger market share uptake and favorable clinical trial results as well as lower interest rates. In 2019, the Skyrizi contingent consideration liability increased due to higher probabilities of success, higher estimated future sales, declining interest rates and passage of time. The higher probabilities of success primarily resulted from the April 2019 regulatory approvals of Skyrizi for the treatment of moderate to severe plaque psoriasis. These changes were partially offset by a $91 million decrease in the Stemcentrx contingent consideration liability due to the termination of the Rova-T R&D program.
Income Tax Expense
The effective income tax rate was negative 36% in 2020, 6% in 2019 and negative 9% in 2018. The effective tax rate in each period differed from the statutory tax rate principally due to the impact of foreign operations which reflects the impact of lower income tax rates in locations outside the United States, tax incentives in Puerto Rico and other foreign tax jurisdictions, business development activities, changes in enacted tax rates and laws and related restructuring, the cost of repatriation decisions, tax audit settlements and Boehringer Ingelheim accretion on contingent consideration. The decrease in the effective tax rate for 2020 over the prior year was principally due to the recognition of a net tax benefit of $1.7 billion related to changes in tax laws and related restructuring, including certain intra-group transfers of intellectual property and deferred tax remeasurement.
2020 Form 10-K | ![]() | 40 |
FINANCIAL POSITION, LIQUIDITY AND CAPITAL RESOURCES
| years ended December 31 (in millions) | 2020 | 2019 | 2018 | ||||||||||||||
| Cash flows from: | |||||||||||||||||
| Operating activities | $ | 17,588 | $ | 13,324 | $ | 13,427 | |||||||||||
| Investing activities | (37,557) | 596 | (1,006) | ||||||||||||||
| Financing activities | (11,501) | 18,708 | (14,396) |
Operating cash flows in 2020 increased from 2019 and included the results of Allergan subsequent to the May 8 acquisition date. Operating cash flows in 2020 were favorably impacted by higher net revenues of the combined company and the timing of working capital cash flows, partially offset by acquisition-related cash expenses. Operating cash flows also reflected AbbVie’s contributions to its defined benefit plans of $367 million in 2020 and $727 million in 2019.
Investing cash flows in 2020 primarily included $39.7 billion cash consideration paid to acquire Allergan offset by cash acquired of $1.5 billion. Investing cash flows also included net sales and maturities of investments totaling $1.5 billion, payments made for other acquisitions and investments of $1.4 billion and capital expenditures of $798 million. Investing cash flows in 2019 included net sales and maturities of investment securities totaling $2.1 billion resulting from the sale of substantially all of the company's investments in debt securities, payments made for other acquisitions and investments of $1.1 billion and capital expenditures of $552 million.
Financing cash flows in 2020 included the issuance of term loans totaling $3.0 billion under the existing $6.0 billion term loan credit agreement which were used to finance the acquisition of Allergan. Subsequent to these borrowings, AbbVie terminated the unused commitments of the lenders under the term loan. Additionally, financing cash flows included the May 2020 repayment of $3.8 billion aggregate principal amount of the company's 2.50% senior notes at maturity, the September 2020 repayment of $650 million aggregate principal amount of 3.375% Allergan exchange notes at maturity, and the November 2020 repayments of €700 million aggregate principal amount of floating rate Allergan exchange notes at maturity and $450 million aggregate principal amount of 4.875% Allergan exchange notes due February 2021.
Financing cash flows in 2019 included the issuance of $30.0 billion aggregate principal amount of floating rate and fixed rate unsecured senior notes which were used to finance the acquisition of Allergan. Additionally, financing cash flows in 2019 included the issuance of €1.4 billion aggregate principal amount of unsecured senior Euro notes which the company used to redeem €1.4 billion aggregate principal amount of 0.38% senior Euro notes that were due to mature in November 2019, as well as the repayment of a $3.0 billion 364-day term loan credit agreement that was scheduled to mature in June 2019.
Cash dividend payments totaled $7.7 billion in 2020 and $6.4 billion in 2019. The increase in cash dividend payments was primarily driven by higher outstanding shares following the 286 million shares of AbbVie common stock issued to Allergan shareholders in May 2020 as well as an increase in the dividend rate. On October 30, 2020, AbbVie announced that its board of directors declared an increase in the quarterly cash dividend from $1.18 per share to $1.30 per share beginning with the dividend payable on February 16, 2021 to stockholders of record as of January 15, 2021. This reflects an increase of approximately 10.2% over the previous quarterly rate. The timing, declaration, amount of and payment of any dividends by AbbVie in the future is within the discretion of its board of directors and will depend upon many factors, including AbbVie's financial condition, earnings, capital requirements of its operating subsidiaries, covenants associated with certain of AbbVie's debt service obligations, legal requirements, regulatory constraints, industry practice, ability to access capital markets and other factors deemed relevant by its board of directors.
The company's stock repurchase authorization permits purchases of AbbVie shares from time to time in open-market or private transactions at management’s discretion. The program has no time limit and can be discontinued at any time. Under this authorization, AbbVie repurchased 8 million shares for $757 million in 2020 and 4 million shares for $300 million in 2019. AbbVie cash-settled $201 million of its December 2018 open market purchases in January 2019. AbbVie's remaining stock repurchase authorization was $3.2 billion as of December 31, 2020.
In 2020 and 2019, the company issued and redeemed commercial paper. There were no commercial paper borrowings outstanding as of December 31, 2020 or December 31, 2019. AbbVie may issue additional commercial paper or retire commercial paper to meet liquidity requirements as needed.
Credit Risk
AbbVie monitors economic conditions, the creditworthiness of customers and government regulations and funding, both domestically and abroad. AbbVie regularly communicates with its customers regarding the status of receivable balances, including their payment plans and obtains positive confirmation of the validity of the receivables. AbbVie establishes an
| 41 | | 2020 Form 10-K |
allowance for credit losses equal to the estimate of future losses over the contractual life of outstanding accounts receivable. AbbVie may also utilize factoring arrangements to mitigate credit risk, although the receivables included in such arrangements have historically not been a significant amount of total outstanding receivables.
Credit Facility, Access to Capital and Credit Ratings
Credit Facility
AbbVie currently has a $4.0 billion five-year revolving credit facility that matures in August 2024. This amended facility enables the company to borrow funds on an unsecured basis at variable interest rates and contains various covenants. At December 31, 2020, the company was in compliance with all covenants, and commitment fees under the credit facility were insignificant. No amounts were outstanding under the company's credit facility as of December 31, 2020 and 2019.
Access to Capital
The company intends to fund short-term and long-term financial obligations as they mature through cash on hand, future cash flows from operations or has the ability to issue additional debt. The company's ability to generate cash flows from operations, issue debt or enter into financing arrangements on acceptable terms could be adversely affected if there is a material decline in the demand for the company's products or in the solvency of its customers or suppliers, deterioration in the company's key financial ratios or credit ratings, or other material unfavorable changes in business conditions. At the current time, the company believes it has sufficient financial flexibility to issue debt, enter into other financing arrangements and attract long-term capital on acceptable terms to support the company's growth objectives.
Credit Ratings
Following the acquisition of Allergan, S&P Global Ratings revised its ratings outlook to stable from negative and lowered the issuer credit rating by one notch to BBB+ from A- and the short-term rating to A-2 from A-1. There were no changes in Moody's Investor Service of its Baa2 senior unsecured long-term rating and Prime-2 short-term rating with a stable outlook.
Unfavorable changes to the ratings may have an adverse impact on future financing arrangements; however, they would not affect the company’s ability to draw on its credit facility and would not result in an acceleration of scheduled maturities of any of the company’s outstanding debt.
Contractual Obligations
The following table summarizes AbbVie's estimated contractual obligations as of December 31, 2020:
| (in millions) | Total | Less than one year | One to three years | Three to five years | More than five years | ||||||||||||||||||||||||
| Short-term borrowings | $ | 34 | $ | 34 | $ | — | $ | — | $ | — | |||||||||||||||||||
| Long-term debt, including current portion | 84,948 | 8,422 | 16,643 | 16,197 | 43,686 | ||||||||||||||||||||||||
| Interest on long-term debt(a) | 33,664 | 2,752 | 4,652 | 3,898 | 22,362 | ||||||||||||||||||||||||
| Non-cancelable operating and finance lease payments | 1,154 | 229 | 323 | 208 | 394 | ||||||||||||||||||||||||
| Purchase obligations and other(b) | 5,432 | 5,040 | 249 | 112 | 31 | ||||||||||||||||||||||||
| Other long-term liabilities (c) (d) (e) | 18,478 | 1,029 | 3,036 | 4,144 | 10,269 | ||||||||||||||||||||||||
| Total | $ | 143,710 | $ | 17,506 | $ | 24,903 | $ | 24,559 | $ | 76,742 |
(a)Includes estimated future interest payments on long-term debt. Interest payments on debt are calculated for future periods using forecasted interest rates in effect at the end of 2020. Projected interest payments include the related effects of interest rate swap agreements. Certain of these projected interest payments may differ in the future based on changes in floating interest rates or other factors or events. The projected interest payments only pertain to obligations and agreements outstanding at December 31, 2020. See Note 10 to the Consolidated Financial Statements for additional information regarding the company's debt instruments and Note 11 for additional information on the interest rate swap agreements outstanding at December 31, 2020.
(b)Includes the company's significant unconditional purchase obligations. These commitments do not exceed the company's projected requirements and are made in the normal course of business.
(c)Excludes liabilities associated with the company's unrecognized tax benefits as it is not possible to reliably estimate the timing of the future cash outflows related to these liabilities. See Note 14 to the Consolidated Financial Statements for additional information on these unrecognized tax benefits.
2020 Form 10-K | ![]() | 42 |
(d)Includes $13.0 billion of contingent consideration liabilities which are recorded at fair value on the consolidated balance sheet. Potential contingent consideration payments that exceed the fair value recorded on the consolidated balance sheet are not included in the table of contractual obligations. See Note 11 to the Consolidated Financial Statements for additional information regarding these liabilities.
(e)Includes a one-time transition tax liability on a mandatory deemed repatriation of previously untaxed earnings of foreign subsidiaries resulting from U.S. tax reform enacted in 2017. The one-time transition tax is generally payable in eight annual installments.
AbbVie enters into R&D collaboration arrangements with third parties that may require future milestone payments to third parties contingent upon the achievement of certain development, regulatory, or commercial milestones. Individually, these arrangements are insignificant in any one annual reporting period. However, if milestones for multiple products covered by these arrangements would happen to be reached in the same reporting period, the aggregate charge to expense could be material to the results of operations in that period. From a business perspective, the payments are viewed as positive because they signify that the product is successfully moving through development and is now generating or is more likely to generate future cash flows from product sales. It is not possible to predict with reasonable certainty whether these milestones will be achieved or the timing for achievement. As a result, these potential payments are not included in the table of contractual obligations. See Note 5 to the Consolidated Financial Statements for additional information on these collaboration arrangements.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
The preparation of financial statements in accordance with generally accepted accounting principles in the United States requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses. A summary of the company's significant accounting policies is included in Note 2 to the Consolidated Financial Statements. Certain of these policies are considered critical as these most significantly impact the company's financial condition and results of operations and require the most difficult, subjective, or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Actual results may vary from these estimates.
Revenue Recognition
AbbVie recognizes revenue when control of promised goods or services is transferred to the company’s customers, in an amount that reflects the consideration AbbVie expects to be entitled to in exchange for those goods or services. Sales, value add and other taxes collected concurrent with revenue-producing activities are excluded from revenue. AbbVie generates revenue primarily from product sales. For the majority of sales, the company transfers control, invoices the customer and recognizes revenue upon shipment to the customer.
Rebates
AbbVie provides rebates to pharmacy benefit managers, state government Medicaid programs, insurance companies that administer Medicare drug plans, wholesalers, group purchasing organizations and other government agencies and private entities.
Rebate and chargeback accruals are accounted for as variable consideration and are recorded as a reduction to revenue in the period the related product is sold. Provisions for rebates and chargebacks totaled $27.0 billion in 2020, $18.8 billion in 2019 and $16.4 billion in 2018. Rebate amounts are typically based upon the volume of purchases using contractual or statutory prices, which may vary by product and by payer. For each type of rebate, the factors used in the calculations of the accrual for that rebate include the identification of the products subject to the rebate, the applicable price terms and the estimated lag time between sale and payment of the rebate, which can be significant.
In order to establish its rebate and chargeback accruals, the company uses both internal and external data to estimate the level of inventory in the distribution channel and the rebate claims processing lag time for each type of rebate. To estimate the rebate percentage or net price, the company tracks sales by product and by customer or payer. The company evaluates inventory data reported by wholesalers, available prescription volume information, product pricing, historical experience and other factors in order to determine the adequacy of its reserves. AbbVie regularly monitors its reserves and records adjustments when rebate trends, rebate programs and contract terms, legislative changes, or other significant events indicate that a change in the reserve is appropriate. Historically, adjustments to rebate accruals have not been material to net earnings.
| 43 | | 2020 Form 10-K |
The following table is an analysis of the three largest rebate accruals and chargeback allowances, which comprise approximately 89% of the total consolidated rebate and chargebacks recorded as reductions to revenues in 2020. Remaining rebate provisions charged against gross revenues are not significant in the determination of operating earnings.
| (in millions) | Medicaid and Medicare Rebates | Managed Care Rebates | Wholesaler Chargebacks | ||||||||||||||
| Balance at December 31, 2017 | $ | 1,340 | $ | 1,195 | $ | 522 | |||||||||||
| Provisions | 3,493 | 4,729 | 6,659 | ||||||||||||||
| Payments | (3,188) | (4,485) | (6,525) | ||||||||||||||
| Balance at December 31, 2018 | 1,645 | 1,439 | 656 | ||||||||||||||
| Provisions | 4,035 | 5,772 | 7,947 | ||||||||||||||
| Payments | (3,915) | (5,275) | (7,917) | ||||||||||||||
| Balance at December 31, 2019 | 1,765 | 1,936 | 686 | ||||||||||||||
| Additions(a) | 1,266 | 649 | 71 | ||||||||||||||
| Provisions | 6,715 | 8,656 | 8,677 | ||||||||||||||
| Payments | (6,801) | (8,334) | (8,693) | ||||||||||||||
| Balance at December 31, 2020 | $ | 2,945 | $ | 2,907 | $ | 741 |
(a)Represents rebate accruals and chargeback allowances assumed in the Allergan acquisition.
Cash Discounts and Product Returns
Cash discounts and product returns, which totaled $2.4 billion in 2020, $1.6 billion in 2019 and $1.6 billion in 2018, are accounted for as variable consideration and are recorded as a reduction to revenue in the same period the related product is sold. The reserve for cash discounts is readily determinable because the company's experience of payment history is fairly consistent. Product returns can be reliably estimated based on the company's historical return experience.
Pension and Other Post-Employment Benefits
AbbVie engages outside actuaries to assist in the determination of the obligations and costs under the pension and other post-employment benefit plans that are direct obligations of AbbVie. The valuation of the funded status and the net periodic benefit cost for these plans are calculated using actuarial assumptions. The significant assumptions, which are reviewed annually, include the discount rate, the expected long-term rate of return on plan assets and the health care cost trend rates, and are disclosed in Note 12 to the Consolidated Financial Statements.
The discount rate is selected based on current market rates on high-quality, fixed-income investments at December 31 each year. AbbVie employs a yield-curve approach for countries where a robust bond market exists. The yield curve is developed using high-quality bonds. The yield-curve approach reflects the plans' specific cash flows (i.e. duration) in calculating the benefit obligations by applying the corresponding individual spot rates along the yield curve. AbbVie reflects the plans' specific cash flows and applies them to the corresponding individual spot rates along the yield curve in calculating the service cost and interest cost portions of expense. For other countries, AbbVie reviews various indices such as corporate bond and government bond benchmarks to estimate the discount rate.
AbbVie's assumed discount rates have a significant effect on the amounts reported for defined benefit pension and other post-employment plans as of December 31, 2020. A 50 basis point change in the assumed discount rate would have had the following effects on AbbVie's calculation of net periodic benefit costs in 2021 and projected benefit obligations as of December 31, 2020:
| 50 basis point | |||||||||||
| (in millions) (brackets denote a reduction) | Increase | Decrease | |||||||||
| Defined benefit plans | |||||||||||
| Service and interest cost | $ | (89) | $ | 101 | |||||||
| Projected benefit obligation | (1,000) | 1,140 | |||||||||
| Other post-employment plans | |||||||||||
| Service and interest cost | $ | (6) | $ | 7 | |||||||
| Projected benefit obligation | (56) | 63 |
2020 Form 10-K | ![]() | 44 |
The expected long-term rate of return is based on the asset allocation, historical performance and the current view of expected future returns. AbbVie considers these inputs with a long-term focus to avoid short-term market influences. The current long-term rate of return on plan assets for each plan is supported by the historical performance of the trust's actual and target asset allocation. AbbVie's assumed expected long-term rate of return has a significant effect on the amounts reported for defined benefit pension plans as of December 31, 2020 and will be used in the calculation of net periodic benefit cost in 2021. A one percentage point change in assumed expected long-term rate of return on plan assets would increase or decrease the net period benefit cost of these plans in 2021 by $94 million.
The health care cost trend rate is selected by reviewing historical trends and current views on projected future health care cost increases. The current health care cost trend rate is supported by the historical trend experience of each plan. Assumed health care cost trend rates have a significant effect on the amounts reported for health care plans as of December 31, 2020 and will be used in the calculation of net periodic benefit cost in 2021.
Income Taxes
AbbVie accounts for income taxes under the asset and liability method. Provisions for federal, state and foreign income taxes are calculated on reported pretax earnings based on current tax laws. Deferred taxes are provided using enacted tax rates on the future tax consequences of temporary differences, which are the differences between the financial statement carrying amount of assets and liabilities and their respective tax bases and the tax benefits of carryforwards. A valuation allowance is established or maintained when, based on currently available information, it is more likely than not that all or a portion of a deferred tax asset will not be realized.
Litigation
The company is subject to contingencies, such as various claims, legal proceedings and investigations regarding product liability, intellectual property, commercial, securities and other matters that arise in the normal course of business. See Note 15 to the Consolidated Financial Statements for additional information. Loss contingency provisions are recorded for probable losses at management's best estimate of a loss, or when a best estimate cannot be made, a minimum loss contingency amount within a probable range is recorded. Accordingly, AbbVie is often initially unable to develop a best estimate of loss and therefore, the minimum amount, which could be zero, is recorded. As information becomes known, either the minimum loss amount is increased, resulting in additional loss provisions, or a best estimate can be made, also resulting in additional loss provisions. Occasionally, a best estimate amount is changed to a lower amount when events result in an expectation of a more favorable outcome than previously expected.
Valuation of Goodwill and Intangible Assets
AbbVie has acquired and may continue to acquire significant intangible assets in connection with business combinations that AbbVie records at fair value. Transactions involving the purchase or sale of intangible assets occur with some frequency between companies in the pharmaceuticals industry and valuations are usually based on a discounted cash flow analysis incorporating the stage of completion. The discounted cash flow model requires assumptions about the timing and amount of future net cash flows, risk, cost of capital, terminal values and market participants. Each of these factors can significantly affect the value of the intangible asset. IPR&D acquired in a business combination is capitalized as an indefinite-lived intangible asset until regulatory approval is obtained, at which time it is accounted for as a definite-lived asset and amortized over its estimated useful life, or discontinuation, at which point the intangible asset will be written off. IPR&D acquired in transactions that are not business combinations is expensed immediately, unless deemed to have an alternative future use. Payments made to third parties subsequent to regulatory approval are capitalized and amortized over the remaining useful life.
AbbVie reviews the recoverability of definite-lived intangible assets whenever events or changes in circumstances indicate the carrying value of an asset may not be recoverable. Goodwill and indefinite-lived intangible assets are reviewed for impairment annually or when an event occurs that could result in an impairment. See Note 2 to the Consolidated Financial Statements for further information.
Annually, the company tests its goodwill for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. Some of the factors considered in the assessment include general macro-economic conditions, conditions specific to the industry and market, cost factors, the overall financial performance and whether there have been sustained declines in the company's share price. If the company concludes it is more likely than not that the fair value of the reporting unit is less than its carrying amount, a quantitative impairment test is performed. AbbVie tests indefinite-lived intangible assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If the company concludes it is more likely than not that the fair value is less than its carrying amount, a quantitative impairment test is performed.
| 45 | | 2020 Form 10-K |
For its quantitative impairment tests, the company uses an estimated future cash flow approach that requires significant judgment with respect to future volume, revenue and expense growth rates, changes in working capital use, the selection of an appropriate discount rate, asset groupings and other assumptions and estimates. The estimates and assumptions used are consistent with the company's business plans and a market participant's views. The use of alternative estimates and assumptions could increase or decrease the estimated fair value of the assets and could potentially impact the company's results of operations. Actual results may differ from the company's estimates.
Contingent Consideration
The fair value measurements of contingent consideration liabilities are determined as of the acquisition date based on significant unobservable inputs, including the discount rate, estimated probabilities and timing of achieving specified development, regulatory and commercial milestones and the estimated amount of future sales of the acquired products. Contingent consideration liabilities are revalued to fair value at each subsequent reporting date until the related contingency is resolved. The potential contingent consideration payments are estimated by applying a probability-weighted expected payment model for contingent milestone payments and a Monte Carlo simulation model for contingent royalty payments, which are then discounted to present value. Changes to the fair value of the contingent consideration liabilities can result from changes to one or a number of inputs, including discount rates, the probabilities of achieving the milestones, the time required to achieve the milestones and estimated future sales. Significant judgment is employed in determining the appropriateness of certain of these inputs. Changes to the inputs described above could have a material impact on the company's financial position and results of operations in any given period. The fair value of the company's contingent consideration liabilities as of December 31, 2020 was calculated using the following significant unobservable inputs:
| Range | Weighted Average**(a)** | |||||||
| Discount rate | 0.1% - 2.2% | 1.1% | ||||||
| Probability of payment for unachieved milestones | 56% - 92% | 64% | ||||||
| Probability of payment for royalties by indication(b) | 56% - 100% | 91% | ||||||
| Projected year of payments | 2021 - 2034 | 2027 |
(a)Unobservable inputs were weighted by the relative fair value of the contingent consideration liabilities.
(b)Excludes early stage indications with 0% estimated probability of payment and includes approved indications with 100% probability of payment. Excluding approved indications, the estimated probability of payment ranged from 56% to 89% at December 31, 2020.
Recent Accounting Pronouncements
See Note 2 to the Consolidated Financial Statements for additional information on recent accounting pronouncements.
2020 Form 10-K | ![]() | 46 |
Previous: Item 6. [RESERVED] · Next: Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
