Document
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 _____________________________________________________
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): July 31, 2020
 
ABBVIE INC.
(Exact name of registrant as specified in its charter)
Delaware
 
001-35565
 
32-0375147
(State or other Jurisdiction
 
(Commission File Number)
 
(IRS Employer
of Incorporation)
 
 
 
Identification No.)
 _____________________________________________________
 
1 North Waukegan Road
North ChicagoIllinois 60064-6400
(Address of principal executive offices)(Zip Code)
 
Registrant’s telephone number, including area code:  (847) 932-7900
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
                      Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
                      Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
                      Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
                      Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
 
Trading Symbol(s)
 
Name of each exchange on which registered
Common Stock, $0.01 Par Value
 
ABBV
 
New York Stock Exchange
 
 
 
 
Chicago Stock Exchange
1.375% Senior Notes due 2024
 
ABBV24
 
New York Stock Exchange
0.750% Senior Notes due 2027
 
ABBV27
 
New York Stock Exchange
2.125% Senior Notes due 2028
 
ABBV28
 
New York Stock Exchange
1.250% Senior Notes due 2031
 
ABBV31
 
New York Stock Exchange
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
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.    
 





Item 2.02  Results of Operations and Financial Condition
 
On July 31, 2020, AbbVie Inc. issued a press release announcing financial results for the second quarter ended June 30, 2020.  A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated herein by reference.

Also furnished as Exhibit 99.2 to this report and incorporated herein by reference is certain unaudited financial information relating to the acquisition by AbbVie Inc. of Allergan plc, which closed on May 8, 2020. On page 1, AbbVie provides information with respect to its historical key product revenues for each of the quarters in the year ended December 31, 2019, the year ended December 31, 2019 as well as each of the quarters ended through June 30, 2020. On page 2, AbbVie provides information with respect to its comparable key product revenues for each of the quarters in the year ended December 31, 2019, the year ended December 31, 2019 as well as the each of the quarters ended through June 30, 2020, which was prepared as if the acquisition of Allergan had closed on January 1, 2019.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits






SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
 
ABBVIE INC.
 
 
 
 
Date:
July 31, 2020
By:
/s/ Robert A. Michael
 
 
 
Robert A. Michael
 
 
 
Executive Vice President,
 
 
 
Chief Financial Officer

 



Exhibit



https://cdn.kscope.io/7ffc72ecfb779f869aa3e6db8120179c-abbvieimage1a51.jpg
 



PRESS RELEASE
 
AbbVie Reports Second-Quarter 2020 Financial Results
 
On May 8, 2020, AbbVie Completed its Acquisition of Allergan, Significantly Expanding and Diversifying AbbVie's Revenue Base with New Therapeutic Areas, Enhancing Long-Term Growth Potential, and Enabling Investment in Innovation for each of its Therapeutic Categories

Reports Second-Quarter Diluted Loss Per Share of $0.46 on a GAAP Basis; Adjusted Diluted EPS of $2.34

Second-Quarter Net Revenues Were $10.425 Billion, an Increase of 26.3 Percent on a Reported Basis, Inclusive of a Partial Quarter of Allergan and COVID-19 Pandemic Impact

Second-Quarter Global Net Revenues From the Immunology Portfolio Were $5.316 Billion, an Increase of 8.1 Percent on a Reported Basis, or 8.6 percent on an Operational Basis; U.S. Humira Net Revenues Were $3.974 Billion, an Increase of 4.8 Percent; Internationally, Humira Net Revenues Were $863 Million, a Decrease of 19.9 Percent on a Reported Basis, or 17.4 Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $330 Million; Global Rinvoq Net Revenues Were $149 Million

Second-Quarter Global Net Revenues From the Hematologic Oncology Portfolio Were $1.591 Billion, an Increase of 25.5 Percent on a Reported Basis, or 25.8 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $1.288 Billion, an Increase of 17.2 Percent, with U.S. Net Revenues of $1.055 Billion and International Profit Sharing of $233 Million; Global Venclexta Net Revenues Were $303 Million

Second-Quarter Global Net Revenues from the Aesthetics Portfolio Were $481 Million; Global Botox Cosmetic Net Revenues Were $226 Million

Provides Combined Company 2020 GAAP Diluted EPS Guidance Range of $4.12 to $4.22; Provides Combined Company 2020 Adjusted Diluted EPS Guidance Range of $10.35 to $10.45, Representing Annualized Net Accretion From the Allergan Transaction of 11 Percent; Combined Company Guidance Includes the Results of Allergan From May 8, 2020 to December 31, 2020
 
NORTH CHICAGO, Ill., July 31, 2020 – AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2020.
 
"AbbVie delivered another strong quarterly performance, ahead of our guidance. The adverse impact from COVID-19 on legacy AbbVie was less than expected, demonstrating the robustness and resiliency of our key brands, and new patient starts have stabilized and started to recover,” said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. “The integration of Allergan is going well, with a strong recovery in the aesthetics portfolio and accretion ahead of expectations."

Note: "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year's foreign exchange rates.
1



Second-Quarter Results
 
Worldwide net revenues were $10.425 billion, an increase of 26.3 percent on a reported basis, or a decrease of 5.3 percent on a comparable operational basis, due to the COVID-19 pandemic.

Global net revenues from the immunology portfolio were $5.316 billion, an increase of 8.1 percent on a reported basis, or 8.6 percent on an operational basis.
Global Humira net revenues of $4.837 billion decreased 0.7 percent on a reported basis, or 0.2 percent on an operational basis. U.S. Humira net revenues were $3.974 billion, an increase of 4.8 percent. Internationally, Humira net revenues were $863 million, a decrease of 19.9 percent on a reported basis, or 17.4 percent on an operational basis, due to biosimilar competition.
Global Skyrizi net revenues were $330 million.
Global Rinvoq net revenues were $149 million.

Global net revenues from the hematologic oncology portfolio were $1.591 billion, an increase of 25.5 percent on a reported basis, or 25.8 percent on an operational basis.
Global Imbruvica net revenues were $1.288 billion, an increase of 17.2 percent, with U.S. net revenues of $1.055 billion and international profit sharing of $233 million.
Global Venclexta net revenues were $303 million, an increase of 79.2 percent on a reported basis, or 81.5 percent on an operational basis.

Global net revenues from the aesthetics portfolio were $481 million, a decrease of 47.9 percent on a comparable operational basis, due to the COVID-19 pandemic.
Global Botox Cosmetic net revenues were $226 million, a decrease of 43.1 percent on a comparable operational basis, due to the COVID-19 pandemic.

Global net revenues from the neuroscience portfolio were $734 million, an increase of over 100.0 percent on a reported basis, or 1.8 percent on a comparable operational basis.
Global Botox Therapeutic net revenues were $297 million, a decrease of 22.3 percent on a comparable operational basis, due to the COVID-19 pandemic.
Global Vraylar net revenues were $192 million, an increase of 70.4 percent on a comparable operational basis.
Global Ubrelvy net revenues were $22 million.

On a GAAP basis, the gross margin ratio in the second quarter was 64.4 percent. The adjusted gross margin ratio was 82.8 percent.

On a GAAP basis, selling, general and administrative expense was 33.8 percent of net revenues. The adjusted SG&A expense was 22.9 percent of net revenues.

On a GAAP basis, research and development expense was 15.2 percent of net revenues. The adjusted R&D expense was 12.8 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.

On a GAAP basis, the operating margin in the second quarter was 7.2 percent. The adjusted operating margin was 47.0 percent.

On a GAAP basis, net interest expense was $614 million. The adjusted net interest expense was $484 million.

On a GAAP basis, the tax rate in the quarter was negative 6.5 percent. The adjusted tax rate was 11.4 percent.

Diluted EPS in the second quarter was a loss of $0.46 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.34.

Note: "Comparable Operational" comparisons include full-quarter current year and prior year results for Allergan, which was acquired on May 8, 2020, as if the acquisition closed on January 1, 2019, and are presented at constant currency rates and reflect comparative local currency net revenues at the prior year’s foreign exchange rates. Refer to the Key Product Revenues schedules for further details. "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year's foreign exchange rates.
2



Recent Events

AbbVie announced it completed its acquisition of Allergan plc following receipt of regulatory approval from all government authorities required by the transaction agreement and approval by the Irish High Court. The transaction significantly expands and diversifies AbbVie’s revenue base, provides immediate scale and profitability to AbbVie’s Growth Platform (ex-Humira) and creates a biopharmaceutical company with leadership positions in key therapeutic areas including immunology, hematologic oncology, neuroscience and aesthetics. It also provides a robust portfolio of on-market and pipeline assets that position the company for enhanced long-term growth potential, a growing dividend, rapid debt repayment and investment in innovation in each of its therapeutic categories.

AbbVie and Genmab A/S announced a broad collaboration agreement to jointly develop and commercialize three of Genmab's early-stage investigational bispecific antibody product candidates and enter into a discovery research collaboration for future differentiated antibody therapeutics for cancer. The companies will partner to develop Genmab's next-generation bispecific antibody programs, epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4. The collaboration combines Genmab's world-class discovery and development engine and next-generation bispecific antibody therapeutic candidates with AbbVie's deep clinical expertise, innovative ADC platform and global commercial leadership in hematological cancers. Under the terms of the agreement AbbVie will pay Genmab an upfront payment of $750 million, in addition to potential milestone payments.

AbbVie announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for Rinvoq (upadacitinib), a selective and reversible JAK inhibitor, for the treatment of adult patients with active psoriatic arthritis (PsA). The applications are supported by data from two Phase 3 studies across a broad range of more than 2,000 patients with active PsA in which Rinvoq demonstrated improved joint outcomes, physical function and skin symptoms, with a greater proportion of patients achieving minimal disease activity versus placebo. Overall, the safety profile of Rinvoq in PsA was consistent with previously reported results across the Phase 3 rheumatoid arthritis (RA) clinical trial program, with no new significant safety risks detected.

AbbVie announced top-line results from the three Phase 3 studies in the registrational program for Rinvoq in atopic dermatitis (AD) - Measure Up 1 (MU1), Measure Up 2 (MU2) and AD Up (AU). In the MU1 and MU2 replicate studies, Rinvoq monotherapy showed significant improvement in skin clearance and reduction in itch at week 16 in adult and adolescent patients with moderate to severe AD. In the MU1 study, of patients receiving either 15mg/30mg of Rinvoq, 70/80 percent achieved at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) versus 16% on placebo. Similarly in the MU2 study, of patients receiving either 15mg/30mg of Rinvoq, 60/73 percent achieved EASI 75 versus 13 percent on placebo. In both the MU1 and MU2 studies, clinically meaningful reductions in itch compared to placebo were observed as early as one day after the first dose for patients receiving Rinvoq 30mg and two days after the first dose for patients receiving Rinvoq 15mg. In the AU study, significantly more patients receiving Rinvoq plus topical corticosteroids (TCS) showed improvement in skin clearance compared to placebo plus TCS at week 16. In the study, 65/77 percent of patients receiving Rinvoq 15mg/30mg plus TCS achieved EASI 75, respectively, versus 26 percent receiving placebo plus TCS. Additionally, more patients treated with Rinvoq plus TCS experienced a clinically meaningful reduction in itch compared to patients treated with placebo plus TCS and treatment with either dose of Rinvoq led to a higher mean number of TCS-free days. Full results from the Phase 3 studies will be presented at a future medical meeting and published in a peer-reviewed publication. AbbVie plans to submit regulatory applications later this year for Rinvoq in AD.







3



Recent Events (continued)

AbbVie announced top-line results from a proof-of-concept study evaluating ABBV-3373, an investigational anti-TNF - glucocorticoid receptor modulator steroid ADC, in adult patients with moderate to severe RA. Bayesian statistical methods incorporating historical data were used to achieve adequate statistical power in this proof of concept study, which was accomplished through pre-specified supplementation of adalimumab in-trial data with historical adalimumab data for comparison with ABBV-3373 for the primary endpoint analyses. Comparing ABBV-3373 to the mean outcome from historical adalimumab data showed a greater difference in the change in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) from baseline to week 12 for ABBV-3373 (-2.65) as compared to a pre-specified historical adalimumab mean (-2.13) (p=0.022). Comparing ABBV-3373 to combined in-trial and historical adalimumab data, based on a Bayesian analysis, predicted with a 90 percent probability that ABBV-3373 was associated with a greater improvement on DAS28-CRP from baseline to week 12 than adalimumab. In this study, the safety profile of ABBV-3373 was generally similar to the known safety profile of adalimumab and evaluations of serum cortisol levels over 12 weeks indicated that ABBV-3373 showed no systemic glucocorticoid effects. Based on these results, AbbVie plans to advance the development of the TNF-ADC platform in RA and begin clinical studies in other immune-mediated diseases.

At the Annual European E-Congress of Rheumatology (EULAR), AbbVie presented 25 abstracts across multiple rheumatic conditions, including new data from the Phase 3 SELECT-CHOICE clinical trial showing Rinvoq met both the primary (non-inferiority) and key secondary (superiority) endpoints compared to Orencia (abatacept) on change from baseline in DAS28-CRP at week 12 in patients with RA who have had an inadequate response to biologic disease-modifying anti-rheumatic drugs (DMARDs). AbbVie also presented long-term results from the SELECT-COMPARE and SELECT-MONOTHERAPY studies showing that Rinvoq continued to improve signs and symptoms in patients with RA through 72 and 84 weeks, respectively. Additionally, results from the SELECT-EARLY and SELECT-COMPARE clinical trials showed Rinvoq inhibited structural joint damage in RA patients receiving Rinvoq as monotherapy or in combination with methotrexate at almost two years. Rinvoq’s safety profile was consistent across the pivotal Phase 3 RA program, with no new safety signals identified.

At the American Academy of Dermatology (AAD) virtual annual meeting AbbVie announced new Phase 3b head-to-head data showing superior rates of skin clearance for Skyrizi (risankizumab) versus Cosentyx at week 52. Particularly, 66 percent of psoriasis patients receiving Skyrizi achieved completely clear skin (PASI 100) versus 40 percent of patients receiving Cosentyx at week 52. Skyrizi met both PASI 90 primary endpoints of non-inferiority to Cosentyx at week 16 and superiority to Cosentyx at week 52. At week 16, 74 percent of Skyrizi-treated patients achieved PASI 90 compared to 66 percent of Cosentyx-treated patients. Of patients treated with Skyrizi, 87 percent achieved PASI 90 at week 52 compared to 57 percent of patients treated with Cosentyx. The safety profile of Skyrizi was consistent with that observed in previously reported studies, with no new safety signals observed through week 52. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

At the European Hematology Association (EHA) Annual Congress, AbbVie presented more than 30 abstracts from studies of its on-market and investigational medicines from its oncology portfolio across chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), multiple myeloma (MM), myelodysplastic syndrome (MDS) and myelofibrosis (MF). Highlights included results from the Phase 3 CLL14 trial of Venclexta (venetoclax) plus obinutuzumab in previously untreated CLL patients, extended follow-up data from the Phase 3 MURANO trial on subgroup-analyses of Venclexta in combination with rituximab in relapsed/refractory (r/r) CLL, new data on safety and efficacy from the CAPTIVATE study evaluating Imbruvica (ibrutinib) plus Venclexta in first-line treatment of CLL. Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc.


4




Recent Events (continued)

At EHA, AbbVie also presented results from two Phase 3 studies evaluating Venclexta in patients with previously untreated AML. The Phase 3 VIALE-A trial demonstrated that previously untreated patients with AML who were ineligible for intensive chemotherapy treated with Venclexta plus azacitidine achieved a 34 percent reduction in the risk of death compared to azacitidine in combination with placebo. Patients receiving the Venclexta combination achieved improved median overall survival (OS) of 14.7 months versus 9.6 months in the placebo arm. Additionally, AbbVie presented updated six-month data from the Phase 3 VIALE-C study of Venclexta in combination with low-dose cytarabine in previously untreated older patients with AML.

AbbVie, in cooperation with Neurocrine Biosciences, announced the FDA approval of Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) for the management of heavy menstrual bleeding due to uterine fibroids in pre-menopausal women. Uterine fibroids are the most common type of benign tumor in women of reproductive age and Oriahnn is the first FDA-approved, non-surgical, oral medication option for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women.

Allergan Aesthetics, an AbbVie company, announced the FDA approved Juvederm Voluma XC for the augmentation of the chin region to improve the chin profile in adults over the age of 21. Juvederm Voluma XC is the first and only filler to receive FDA approval for the augmentation of the chin region and this latest approval marks the Juvederm Collection’s fifth approved indication in the U.S.

AbbVie announced that the Phase 3 ADVANCE trial evaluating atogepant, an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist, met its primary endpoint of statistically significantly greater reduction in mean monthly migraine days, compared to placebo, for all doses (10mg, 30mg, or 60mg) across the 12-week treatment period. The trial also demonstrated that treatment with 30mg and 60mg doses resulted in statistically significant improvements in all secondary endpoints, including ≥ 50% reduction in three-month average of monthly migraine days, improvements in acute medication use, and performance of daily activities and physical impairment. Treatment with the 10mg dose resulted in statistically significant improvements in four out of the six secondary endpoints. With these results, combined with the results from a long-term Phase 3 safety trial, and results from a prior positive Phase 2b/3 trial, AbbVie plans to move forward with regulatory submissions in the U.S. and other countries.

At the Annual Scientific Meeting of the American Headache Society (AHS), AbbVie presented 27 abstracts that highlighted the company's ongoing innovation in migraine, including its investigational product, atogepant, while reinforcing the efficacy and safety profiles of Botox and Ubrelvy (ubrogepant). In particular, AbbVie presented real-world studies that demonstrated significantly more patients starting Botox were persistent with their treatment compared to those starting on CGRP mAbs for migraine as well as results from several studies that added to the large body of evidence evaluating the long-term safety and sustained efficacy of Botox. Long-term Ubrelvy trial data showed that in addition to effectively treating migraine attacks when pain is moderate or severe, treating when pain is mild may significantly increase rates of pain freedom and absence of migraine-associated symptoms. Additionally, AbbVie presented results from studies that evaluated the pharmacokinetic (PK), safety and tolerability profiles of atogepant in addition to the potential for PK drug-drug interactions (DDIs) between atogepant and other compounds.









5



Recent Events (continued)

AbbVie and Molecular Partners announced that the FDA issued a Complete Response Letter to the Biologics License Application for abicipar pegol, a novel, investigational DARPin therapy for patients with neovascular (wet) age-related macular degeneration (nAMD). The letter from the FDA indicated that the rate of intraocular inflammation observed following administration of abicipar pegol 2mg/0.05 mL resulted in an unfavorable benefit-risk ratio in the treatment of nAMD. AbbVie also withdrew its regulatory application with the EMA for abicipar in nAMD. AbbVie plans to meet with the FDA and EMA to discuss their comments and determine next steps.

AbbVie announced a strategic collaboration with Jacobio Pharmaceuticals, a clinical-stage pharmaceutical company, to develop and commercialize SHP2 inhibitors, which target a key node in cancer and immune cells. Inhibition of SHP2 is believed to have dual effects by potentially reducing cancer cell growth and modulating immune responses to generate anti-tumor activities. Jacobio's early clinical stage SHP2 assets, JAB-3068 and JAB-3312, are oral small molecules designed to specifically inhibit SHP2 activity. Under the terms of the agreement, AbbVie will be granted an exclusive license to the SHP2 portfolio. Jacobio will continue to conduct early global clinical trials of JAB-3068 and JAB-3312 with AbbVie covering R&D expenses. Upon completion, AbbVie will assume global development and commercialization responsibilities.

AbbVie, Harbour BioMed (HBM), Utrecht University (UU) and Erasmus Medical Center (EMC) announced they have entered into a collaboration to develop a novel antibody therapeutic to prevent and treat COVID-19, the pandemic respiratory disease caused by the SARS-CoV-2 virus. The focus of the collaboration is on advancing the fully human, neutralizing antibody 47D11 discovered by UU, EMC and HBM and recently reported in Nature Communications. This antibody targets the conserved domain of the spike protein of SARS-CoV-2. Under the terms of the collaboration, AbbVie will support UU, EMC and HBM through the preclinical activities, while simultaneously undertaking preparations for later stage preclinical and clinical development work. AbbVie will receive an option to exclusively license the antibody from the three parties for therapeutic clinical development and commercialization worldwide.

AbbVie announced a donation of $5 million to the NAACP Legal Defense and Education Fund and the Equal Justice Initiative to address issues in our criminal justice system, as well as an additional commitment of $50 million over five years to partner with nonprofits on a long-term, multi-faceted program that will seek to bring lasting and real change at the community level to help secure quality education, jobs, healthcare and justice. AbbVie is also providing a 2:1 match for employees who wish to support organizations working to help address racial equality and social justice issues. AbbVie is committed to advancing racial equality, through our continued growth and acceptance of each other, our way of doing business, our attraction and development of talent, and our service to the community.

AbbVie announced donations to 26 nonprofit organizations totaling $5 million to support immediate COVID-19 relief efforts. As a result of AbbVie's donation, national and global nonprofit organizations will provide 55,000 frontline healthcare workers with critical personal protective equipment and training; improve the well-being of 50,000 children and families by providing access to essential resources including healthcare and education; and support vital services including shelter for more than 30,000 people experiencing homelessness and other at-risk populations. The donation is part of AbbVie's broader $35 million philanthropic contribution to COVID-19 relief efforts that also include donations to partners International Medical Corps, Direct Relief and Feeding America.








6




Full-Year 2020 Outlook
AbbVie previously issued standalone GAAP diluted EPS guidance for the full-year 2020 of $7.60 to $7.70. AbbVie is issuing combined company GAAP diluted EPS guidance for the full-year 2020, which includes the results of Allergan from May 8, 2020 through December 31, 2020, of $4.12 to $4.22.
AbbVie previously issued standalone adjusted diluted EPS for the full-year 2020 of $9.61 to $9.71. AbbVie is issuing combined company adjusted diluted EPS guidance for the full-year 2020, which includes the results of Allergan from May 8, 2020 through December 31, 2020, of $10.35 to $10.45, representing annualized net accretion from the Allergan transaction of 11 percent. The combined company's 2020 adjusted diluted EPS guidance excludes $6.23 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.
Combined company guidance supersedes previously issued standalone guidance.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

Conference Call
 
AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our second-quarter performance. The call will be webcast through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central time.

Non-GAAP Financial Results
 
Financial results for 2020 and 2019 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie’s management believes non-GAAP financial measures provide useful information to investors regarding AbbVie’s results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. The company’s 2020 financial guidance is also being provided on both a reported and a non-GAAP basis.














7




Forward-Looking Statements
 
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words “believe,” “expect,” “anticipate,” “project” and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties, including the impact of the COVID-19 pandemic on AbbVie’s operations, results and financial results, that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits of the Allergan acquisition, failure to promptly and effectively integrate Allergan's businesses, significant transaction costs and/or unknown or inestimable liabilities, potential litigation associated with the Allergan acquisition, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie’s operations is set forth in Item 1A, “Risk Factors,” of AbbVie’s 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission (SEC). AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

 
Media:
Investors:
Adelle Infante
Liz Shea
(847) 938-8745
(847) 935-2211
 
 
 
Todd Bosse
 
(847) 936-1182
 
 
 
Jeffrey Byrne
 
(847) 938-2923



8



AbbVie Inc.
Key Product Revenues
Quarter Ended June 30, 2020
(Unaudited) 
 
 
 
 
 
 
 
% Change vs. 2Q19
 
Net Revenues (in millions) a
 
Reported
 
Comparable Operational b, c
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int'l.
 
Total
 
U.S.
 
Int'l
 
Total
NET REVENUES
$8,147
 
$2,278
 
$10,425
 
36.6%
 
(0.5)%
 
26.3%
 
(0.1)%
 
(20.5)%
 
(5.3)%
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Immunology
4,399
 
917
 
5,316
 
14.8
 
(15.5)
 
8.1
 
14.8
 
(13.0)
 
8.6
Humira
3,974
 
863
 
4,837
 
4.8
 
(19.9)
 
(0.7)
 
4.8
 
(17.4)
 
(0.2)
Skyrizi
289
 
41
 
330
 
>100%
 
>100%
 
>100%
 
>100%
 
>100%
 
>100%
Rinvoq
136
 
13
 
149
 
n/m
 
n/m
 
n/m
 
n/m
 
n/m
 
n/m
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hematologic Oncology
1,246
 
345
 
1,591
 
24.2
 
30.1
 
25.5
 
24.2
 
31.6
 
25.8
Imbruvica d
1,055
 
233
 
1,288
 
19.0
 
9.4
 
17.2
 
19.0
 
9.4
 
17.2
Venclexta
191
 
112
 
303
 
63.5
 
>100%
 
79.2
 
63.5
 
>100%
 
81.5
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aesthetics
330
 
151
 
481
 
n/m
 
n/m
 
n/m
 
(47.7)
 
(48.3)
 
(47.9)
Botox Cosmetic*
147
 
79
 
226
 
n/m
 
n/m
 
n/m
 
(39.8)
 
(47.9)
 
(43.1)
Juvederm Collection*
56
 
57
 
113
 
n/m
 
n/m
 
n/m
 
(62.5)
 
(58.4)
 
(60.4)
Other Aesthetics*
127
 
15
 
142
 
n/m
 
n/m
 
n/m
 
(46.7)
 
>100%
 
(41.7)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Neuroscience
596
 
138
 
734
 
>100%
 
50.6
 
>100%
 
5.9
 
(17.2)
 
1.8
Botox Therapeutic*
254
 
43
 
297
 
n/m
 
n/m
 
n/m
 
(19.1)
 
(36.9)
 
(22.3)
Vraylar*
192
 
 
192
 
n/m
 
n/a
 
n/m
 
70.4
 
n/a
 
70.4
Duodopa
25
 
93
 
118
 
8.3
 
1.6
 
2.9
 
8.3
 
3.7
 
4.6
Ubrelvy*
22
 
 
22
 
n/m
 
n/a
 
n/m
 
n/m
 
n/a
 
n/m
Other Neuroscience*
103
 
2
 
105
 
n/m
 
n/m
 
n/m
 
(13.9)
 
(4.3)
 
(13.9)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eye Care
274
 
143
 
417
 
n/m
 
n/m
 
n/m
 
(17.0)
 
(25.4)
 
(20.0)
Lumigan/Ganfort*
35
 
41
 
76
 
n/m
 
n/m
 
n/m
 
(13.2)
 
(13.6)
 
(13.4)
Alphagan/Combigan*
47
 
22
 
69
 
n/m
 
n/m
 
n/m
 
(15.1)
 
(8.1)
 
(13.0)
Restasis*
138
 
6
 
144
 
n/m
 
n/m
 
n/m
 
(19.5)
 
(17.8)
 
(19.5)
Other Eye Care*
54
 
74
 
128
 
n/m
 
n/m
 
n/m
 
(14.2)
 
(35.6)
 
(27.5)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Women's Health
142
 
5
 
147
 
>100%
 
>100%
 
>100%
 
(14.9)
 
(35.7)
 
(15.6)
Lo Loestrin*
78
 
2
 
80
 
n/m
 
n/m
 
n/m
 
(8.8)
 
(18.8)
 
(8.9)
Orilissa/Oriahnn
30
 
1
 
31
 
57.3
 
90.2
 
58.0
 
57.3
 
95.4
 
58.1
Other Women's Health*
34
 
2
 
36
 
n/m
 
n/m
 
n/m
 
(39.6)
 
(52.3)
 
(40.4)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other Key Products
878
 
271
 
1,149
 
(14.1)
 
(36.4)
 
(20.7)
 
(21.3)
 
(35.5)
 
(25.0)
Mavyret
146
 
230
 
376
 
(62.9)
 
(40.2)
 
(51.7)
 
(62.9)
 
(39.6)
 
(51.4)
Creon
252
 
 
252
 
(1.9)
 
n/a
 
(1.9)
 
(1.9)
 
n/a
 
(1.9)
Lupron
167
 
38
 
205
 
(0.1)
 
(8.9)
 
(1.8)
 
(0.1)
 
(3.2)
 
(0.7)
Linzess/Constella*
130
 
3
 
133
 
n/m
 
n/m
 
n/m
 
5.4
 
18.8
 
5.7
Synthroid
183
 
 
183
 
(9.7)
 
n/a
 
(9.7)
 
(9.7)
 
n/a
 
(9.7)
a  
Net revenues include Allergan product revenues from the date of the acquisition, May 8, 2020, through June 30, 2020.
b  
"Comparable Operational" comparisons include full-quarter current year and prior year results for Allergan, as if the acquisition closed on January 1, 2019, and are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Refer to the Quarterly Comparable Historical Trend Analysis for additional information regarding comparable historical net revenues.
c All historically reported Allergan revenues have been recast to conform to AbbVie's revenue recognition accounting policies and reporting conventions for certain rebates and discounts. Historically reported Allergan revenues also exclude Zenpep and Viokace product revenues, which were both divested as part of the acquisition, as well as specified items.
d Reflects profit sharing for Imbruvica international revenues.
* Represents product(s) acquired as part of the Allergan acquisition.
n/a = not applicable
n/m = not meaningful


9



AbbVie Inc.
Key Product Revenues
Six Months Ended June 30, 2020
(Unaudited)
 
 
 
 
 
 
 
% Change vs. 6M19
 
Net Revenues (in millions) a
 
Reported
 
Comparable Operational b, c
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
NET REVENUES
$14,305
 
$4,739
 
$19,044
 
27.3%
 
(2.2)%
 
18.4%
 
5.7%
 
(12.1)%
 
0.8%
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Immunology
8,403
 
2,002
 
10,405
 
19.2
 
(13.5)
 
11.1
 
19.2
 
(11.2)
 
11.7
Humira
7,630
 
1,910
 
9,540
 
8.9
 
(17.2)
 
2.4
 
8.9
 
(14.9)
 
3.0
Skyrizi
555
 
75
 
630
 
>100%
 
>100%
 
>100%
 
>100%
 
>100%
 
>100%
Rinvoq
218
 
17
 
235
 
n/m
 
n/m
 
n/m
 
n/m
 
n/m
 
n/m
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hematologic Oncology
2,413
 
727
 
3,140
 
24.6
 
44.2
 
28.6
 
24.6
 
45.5
 
28.9
Imbruvica d
2,021
 
499
 
2,520
 
17.9
 
22.9
 
18.8
 
17.9
 
22.9
 
18.8
Venclexta
392
 
228
 
620
 
76.7
 
>100%
 
93.7
 
76.7
 
>100%
 
95.8
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aesthetics
330
 
151
 
481
 
n/m
 
n/m
 
n/m
 
(29.7)
 
(38.0)
 
(32.5)
Botox Cosmetic*
147
 
79
 
226
 
n/m
 
n/m
 
n/m
 
(24.3)
 
(35.3)
 
(28.7)
Juvederm Collection*
56
 
57
 
113
 
n/m
 
n/m
 
n/m
 
(41.9)
 
(43.3)
 
(42.7)
Other Aesthetics*
127
 
15
 
142
 
n/m
 
n/m
 
n/m
 
(28.3)
 
(21.9)
 
(27.7)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Neuroscience
621
 
237
 
858
 
>100%
 
31.6
 
>100%
 
11.4
 
(5.4)
 
8.3
Botox Therapeutic*
254
 
43
 
297
 
n/m
 
n/m
 
n/m
 
(10.3)
 
(19.9)
 
(12.1)
Vraylar*
192
 
 
192
 
n/m
 
n/a
 
n/m
 
80.0
 
n/a
 
80.0
Duodopa
50
 
192
 
242
 
9.3
 
6.7
 
7.2
 
9.3
 
9.2
 
9.2
Ubrelvy*
22
 
 
22
 
n/m
 
n/a
 
n/m
 
n/m
 
n/a
 
n/m
Other Neuroscience*
103
 
2
 
105
 
n/m
 
n/m
 
n/m
 
(10.2)
 
26.2
 
(9.8)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eye Care
274
 
143
 
417
 
n/m
 
n/m
 
n/m
 
0.1
 
(13.1)
 
(4.7)
Lumigan/Ganfort*
35
 
41
 
76
 
n/m
 
n/m
 
n/m
 
1.9
 
(7.9)
 
(3.6)
Alphagan/Combigan*
47
 
22
 
69
 
n/m
 
n/m
 
n/m
 
(7.6)
 
(3.4)
 
(6.4)
Restasis*
138
 
6
 
144
 
n/m
 
n/m
 
n/m
 
0.8
 
(2.8)
 
0.7
Other Eye Care*
54
 
74
 
128
 
n/m
 
n/m
 
n/m
 
4.0
 
(18.6)
 
(10.1)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Women's Health
172
 
6
 
178
 
>100%
 
>100%
 
>100%
 
(10.1)
 
(13.7)
 
(10.3)
Lo Loestrin*
78
 
2
 
80
 
n/m
 
n/m
 
n/m
 
(10.3)
 
(4.1)
 
(10.2)
Orilissa/Oriahnn
60
 
2
 
62
 
88.6
 
>100%
 
90.3
 
88.6
 
>100%
 
90.4
Other Women's Health*
34
 
2
 
36
 
n/m
 
n/m
 
n/m
 
(27.2)
 
(28.8)
 
(27.4)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other Key Products
1,788
 
634
 
2,422
 
(11.7)
 
(25.5)
 
(15.8)
 
(14.1)
 
(24.1)
 
(16.8)
Mavyret
380
 
555
 
935
 
(52.4)
 
(28.1)
 
(40.4)
 
(52.4)
 
(27.2)
 
(39.9)
Creon
528
 
 
528
 
9.3
 
n/a
 
9.3
 
9.3
 
n/a
 
9.3
Lupron
362
 
76
 
438
 
1.1
 
(4.7)
 
 
1.1
 
(0.6)
 
0.7
Linzess/Constella*
130
 
3
 
133
 
n/m
 
n/m
 
n/m
 
6.9
 
25.3
 
7.4
Synthroid
388
 
 
388
 
0.7
 
n/a
 
0.7
 
0.7
 
n/a
 
0.7
a  
Net revenues include Allergan product revenues from the date of the acquisition, May 8, 2020, through June 30, 2020.
b  
"Comparable Operational" comparisons include full-period current year and prior year results for Allergan, as if the acquisition closed on January 1, 2019, and are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. Refer to the Quarterly Comparable Historical Trend Analysis for additional information regarding comparable historical net revenues.
c All historically reported Allergan revenues have been recast to conform to AbbVie's revenue recognition accounting policies and reporting conventions for certain rebates and discounts. Historically reported Allergan revenues also exclude Zenpep and Viokace product revenues, which were both divested as part of the acquisition, as well as specified items.
d Reflects profit sharing for Imbruvica international revenues.
* Represents product(s) acquired as part of the Allergan acquisition.
n/a = not applicable
n/m = not meaningful


10



AbbVie Inc.
Consolidated Statements of Earnings
Quarter and Six Months Ended June 30, 2020 and 2019
(Unaudited) (In millions, except per share data)
 
 
Second Quarter
Ended June 30
 
Six Months
Ended June 30
 
2020
 
2019
 
2020
 
2019
Net revenues
$
10,425

 
$
8,255

 
$
19,044

 
$
16,083

Cost of products sold
3,711

 
1,819

 
5,653

 
3,513

Selling, general and administrative
3,527

 
1,654

 
5,222

 
3,334

Research and development
1,582

 
1,291

 
2,961

 
2,580

Acquired in-process research and development
853

 
91

 
853

 
246

Total operating costs and expenses
9,673

 
4,855

 
14,689

 
9,673

 
 
 
 
 
 
 
 
Operating earnings
752

 
3,400

 
4,355

 
6,410

 
 
 
 
 
 
 
 
Interest expense, net
614

 
309

 
1,042

 
634

Net foreign exchange loss
29

 
6

 
34

 
12

Other expense, net
802

 
2,278

 
874

 
2,413

Earnings (loss) before income tax expense
(693
)
 
807

 
2,405

 
3,351

Income tax expense
46

 
66

 
134

 
154

Net earnings (loss)
(739
)
 
741

 
2,271

 
3,197

Net loss attributable to noncontrolling interest
(1
)
 

 
(1
)
 

Net earnings (loss) attributable to AbbVie Inc.
$
(738
)
 
$
741

 
$
2,272

 
$
3,197

 
 
 
 
 
 
 
 
Diluted earnings (loss) per share attributable to AbbVie Inc.
$
(0.46
)
 
$
0.49

 
$
1.43

 
$
2.14

 
 
 
 
 
 
 
 
Adjusted diluted earnings per sharea
$
2.34

 
$
2.26

 
$
4.76

 
$
4.40

 
 
 
 
 
 
 
 
Weighted-average diluted shares outstanding
1,647

 
1,484

 
1,568

 
1,483

 
a 
Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details.






11



AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended June 30, 2020
(Unaudited) (In millions, except per share data)
 
1.     Specified items impacted results as follows:
 
2Q20
 
Earnings
 
Diluted
 
Pre-tax
 
After-taxa
 
EPS
As reported (GAAP)
$
(693
)
 
$
(738
)
 
$
(0.46
)
Adjusted for specified items:
 

 
 

 
 

Intangible asset amortization
1,406

 
1,190

 
0.72

Acquisition related costs
1,919

 
1,784

 
1.08

Milestones and other R&D expenses
50

 
49

 
0.03

Acquired IPR&D
853

 
853

 
0.52

Change in fair value of contingent consideration
809

 
809

 
0.49

Other
51

 
(52
)
 
(0.04
)
As adjusted (non-GAAP)
$
4,395

 
$
3,895

 
$
2.34

a  
Represents net earnings (loss) attributable to AbbVie Inc.
Acquisition related costs reflect transaction, financing and integration costs related to the Allergan acquisition as well as amortization of the acquisition date fair value step-up for inventory. Milestones and other R&D expenses include milestone payments for previously announced collaborations. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties. Other primarily includes COVID-19 related expenses and tax audit settlements.
2. The impact of the specified items by line item was as follows:
 
2Q20
 
Cost of
products sold
 
SG&A
 
R&D
 
Acquired
 IPR&D
 
Interest expense, net
 
Net foreign exchange loss
 
Other expense, net
As reported (GAAP)
$
3,711

 
$
3,527

 
$
1,582

 
$
853

 
$
614

 
$
29

 
$
802

Adjusted for specified items:
 
 
 
 
 
 
 
 
 
 
 
 
 
Intangible asset amortization
(1,406
)
 

 

 

 

 

 

Acquisition related costs
(469
)
 
(1,142
)
 
(178
)
 

 
(130
)
 

 

Milestones and other R&D expenses

 

 
(50
)
 

 

 

 

Acquired IPR&D

 

 

 
(853
)
 

 

 

Change in fair value of contingent consideration

 

 

 

 

 

 
(809
)
Other
(40
)
 
7

 
(22
)
 

 

 
4

 

As adjusted (non-GAAP)
$
1,796

 
$
2,392

 
$
1,332

 
$

 
$
484

 
$
33

 
$
(7
)
3. The adjusted tax rate for the second quarter of 2020 was 11.4 percent, as detailed below:
 
2Q20
 
Pre-tax
earnings
 
Income
taxes
 
Tax rate
As reported (GAAP)
$
(693
)
 
$
46

 
(6.5
)%
Specified items
5,088

 
455

 
8.9
 %
As adjusted (non-GAAP)
$
4,395

 
$
501

 
11.4
 %


12



AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended June 30, 2019
(Unaudited) (In millions, except per share data)
 
1.     Specified items impacted results as follows:
 
2Q19
 
Earnings
 
Diluted
 
Pre-tax
 
After-taxa
 
EPS
As reported (GAAP)
$
807

 
$
741

 
$
0.49

Adjusted for specified items:
 

 
 

 
 

Intangible asset amortization
388

 
321

 
0.22

Milestones and other R&D expenses
35

 
35

 
0.02

Acquired IPR&D
91

 
86

 
0.06

Change in fair value of contingent consideration
2,304

 
2,304

 
1.55

Restructuring
8

 
6

 

Litigation reserves
10

 
8

 

Acquisition related costs
31

 
27

 
0.02

Tax audit settlement

 
(178
)
 
(0.12
)
Other
20

 
20

 
0.02

As adjusted (non-GAAP)
$
3,694

 
$
3,370

 
$
2.26

a  
Represents net earnings attributable to AbbVie Inc.
Milestones and other R&D expenses are associated with milestone payments for previously announced collaborations. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties. Restructuring is primarily associated with streamlining global operations. Acquisition related costs reflect transaction and financing costs related to the Allergan acquisition.
2. The impact of the specified items by line item was as follows: 
 
2Q19
 
Cost of
products sold
 
SG&A
 
R&D
 
Acquired
 IPR&D
 
Interest expense, net
 
Other expense, net
As reported (GAAP)
$
1,819

 
$
1,654

 
$
1,291

 
$
91

 
$
309

 
$
2,278

Adjusted for specified items:
 
 
 
 
 
 
 
 
 
 
 
Intangible asset amortization
(388
)
 

 

 

 

 

Milestones and other R&D expenses

 

 
(35
)
 

 

 

Acquired IPR&D

 

 

 
(91
)
 

 

Change in fair value of contingent consideration

 

 

 

 

 
(2,304
)
Restructuring
(3
)
 

 
(5
)
 

 

 

Litigation reserves

 
(10
)
 

 

 

 

Acquisition related costs

 
(24
)
 

 

 
(7
)
 

Other
(1
)
 

 
(19
)
 

 

 

As adjusted (non-GAAP)
$
1,427

 
$
1,620

 
$
1,232

 
$

 
$
302

 
$
(26
)
 
3. The adjusted tax rate for the second quarter of 2019 was 8.7 percent, as detailed below:
 
2Q19
 
Pre-tax
earnings
 
Income
taxes
 
Tax rate
As reported (GAAP)
$
807

 
$
66

 
8.1
%
Specified items
2,887

 
258

 
8.9
%
As adjusted (non-GAAP)
$
3,694

 
$
324

 
8.7
%


13



AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Six Months Ended June 30, 2020
(Unaudited) (In millions, except per share data)
 1.     Specified items impacted results as follows:
 
6M20
 
Earnings
 
Diluted
 
Pre-tax
 
After-taxa
 
EPS
As reported (GAAP)
$
2,405

 
$
2,272

 
$
1.43

Adjusted for specified items:
 

 
 

 
 

Intangible asset amortization
1,850

 
1,561

 
0.99

Acquisition related costs
2,107

 
1,942

 
1.24

Milestones and other R&D expenses
185

 
164

 
0.11

Acquired IPR&D
853

 
853

 
0.54

Change in fair value of contingent consideration
881

 
881

 
0.56

Other
117

 
(165
)
 
(0.11
)
As adjusted (non-GAAP)
$
8,398

 
$
7,508

 
$
4.76

a  
Represents net earnings attributable to AbbVie Inc.
Acquisition related costs reflect transaction, financing and integration costs related to the Allergan acquisition as well as amortization of the acquisition date fair value step-up for inventory. Milestones and other R&D expenses include milestone payments for previously announced collaborations and the purchase of an FDA priority review voucher from a third party. Other primarily includes the impacts of tax law changes and COVID-19 related charitable contributions and expenses.
2. The impact of the specified items by line item was as follows: 
 
6M20
 
Cost of products sold
 
SG&A
 
R&D
 
Acquired
IPR&D
 
Interest expense, net
 
Net foreign exchange loss
 
Other expense, net
As reported (GAAP)
$
5,653

 
$
5,222

 
$
2,961

 
$
853

 
$
1,042

 
$
34

 
$
874

Adjusted for specified items:
 
 
 
 
 
 
 
 
 
 
 
 
 
Intangible asset amortization
(1,850
)
 

 

 

 

 

 

Acquisition related costs
(469
)
 
(1,186
)
 
(178
)
 

 
(274
)
 

 

Milestones and other R&D expenses

 

 
(185
)
 

 

 

 

Change in fair value of contingent consideration

 

 

 

 

 

 
(881
)
Other
(44
)
 
(45
)
 
(32
)
 

 

 
4

 

As adjusted (non-GAAP)
$
3,290

 
$
3,991

 
$
2,566

 
$

 
$
768

 
$
38

 
$
(7
)
3. The adjusted tax rate for the first six months of 2020 was 10.6 percent, as detailed below:
 
6M20
 
Pre-tax
earnings
 
Income
taxes
 
Tax rate
As reported (GAAP)
$
2,405

 
$
134

 
5.6
%
Specified items
5,993

 
757

 
12.6
%
As adjusted (non-GAAP)
$
8,398

 
$
891

 
10.6
%


14



AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Six Months Ended June 30, 2019
(Unaudited) (In millions, except per share data)
 
1.     Specified items impacted results as follows:
 
6M19
 
Earnings
 
Diluted
 
Pre-tax
 
After-taxa
 
EPS
As reported (GAAP)
$
3,351

 
$
3,197

 
$
2.14

Adjusted for specified items:
 

 
 

 
 

Intangible asset amortization
773

 
639

 
0.43

Milestones and other R&D expenses
75

 
75

 
0.05

Acquired IPR&D
246

 
241

 
0.16

Change in fair value of contingent consideration
2,473

 
2,475

 
1.67

Restructuring
171

 
139

 
0.09

Litigation reserves
20

 
16

 
0.01

Acquisition related costs
31

 
27

 
0.02

Tax audit settlement

 
(267
)
 
(0.18
)
Other
20

 
20

 
0.01

As adjusted (non-GAAP)
$
7,160

 
$
6,562

 
$
4.40

a  
Represents net earnings attributable to AbbVie Inc.
Milestones and other R&D expenses are associated with milestone payments for previously announced collaborations. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties. Restructuring is primarily associated with streamlining global operations. Acquisition related costs reflect transaction and financing costs related to the Allergan acquisition.
2. The impact of the specified items by line item was as follows: 
 
6M19
 
Cost of products sold
 
SG&A
 
R&D
 
Acquired
IPR&D
 
Interest expense, net
 
Other expense, net
As reported (GAAP)
$
3,513

 
$
3,334

 
$
2,580

 
$
246

 
$
634

 
$
2,413

Adjusted for specified items:
 
 
 
 
 
 
 
 
 
 
 
Intangible asset amortization
(773
)
 

 

 

 

 

Milestones and other R&D expenses

 

 
(75
)
 

 

 

Acquired IPR&D

 

 

 
(246
)
 

 

Change in fair value of contingent consideration

 

 

 

 

 
(2,473
)
Restructuring
(9
)
 
(107
)
 
(55
)
 

 

 

Litigation reserves

 
(20
)
 

 

 

 

Acquisition related costs

 
(24
)
 

 

 
(7
)
 

Other
(1
)
 

 
(19
)
 

 

 

As adjusted (non-GAAP)
$
2,730

 
$
3,183

 
$
2,431

 
$

 
$
627

 
$
(60
)
 
3. The adjusted tax rate for the first six months of 2019 was 8.3 percent, as detailed below:
 
6M19
 
Pre-tax
earnings
 
Income
taxes
 
Tax rate
As reported (GAAP)
$
3,351

 
$
154

 
4.6
%
Specified items
3,809

 
444

 
11.6
%
As adjusted (non-GAAP)
$
7,160

 
$
598

 
8.3
%


15
Exhibit


AbbVie Inc.
Key Product Revenues
Quarterly Trend Analysis a 
(Unaudited, in millions)
 
1Q19
 
2Q19
 
3Q19
 
4Q19
 
FY19
 
1Q20
 
2Q20
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NET REVENUES
$
5,270

 
$
2,558

 
$
7,828

 
$
5,964

 
$
2,291

 
$
8,255

 
$
6,244

 
$
2,235

 
$
8,479

 
$
6,429

 
$
2,275

 
$
8,704

 
$
23,907

 
$
9,359

 
$
33,266

 
$
6,158

 
$
2,461

 
$
8,619

 
$
8,147

 
$
2,278

 
$
10,425

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Immunology
3,215

 
1,231

 
4,446

 
3,835

 
1,083

 
4,918

 
3,977

 
1,064

 
5,041

 
4,195

 
971

 
5,166

 
15,222

 
4,349

 
19,571

 
4,004

 
1,085

 
5,089

 
4,399

 
917

 
5,316

Humira
3,215

 
1,231

 
4,446

 
3,793

 
1,077

 
4,870

 
3,887

 
1,049

 
4,936

 
3,969

 
948

 
4,917

 
14,864

 
4,305

 
19,169

 
3,656

 
1,047

 
4,703

 
3,974

 
863

 
4,837

Skyrizi

 

 

 
42

 
6

 
48

 
76

 
15

 
91

 
193

 
23

 
216

 
311

 
44

 
355

 
266

 
34

 
300

 
289

 
41

 
330

Rinvoq

 

 

 

 

 

 
14

 

 
14

 
33

 

 
33

 
47

 

 
47

 
82

 
4

 
86

 
136

 
13

 
149

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hematologic Oncology
934

 
239

 
1,173

 
1,003

 
265

 
1,268

 
1,184

 
294

 
1,478

 
1,230

 
317

 
1,547

 
4,351

 
1,115

 
5,466

 
1,167

 
382

 
1,549

 
1,246

 
345

 
1,591

Imbruvicab
829

 
193

 
1,022

 
886

 
213

 
1,099

 
1,042

 
215

 
1,257

 
1,073

 
223

 
1,296

 
3,830

 
844

 
4,674

 
966

 
266

 
1,232

 
1,055

 
233

 
1,288

Venclexta
105

 
46

 
151

 
117

 
52

 
169

 
142

 
79

 
221

 
157

 
94

 
251

 
521

 
271

 
792

 
201

 
116

 
317

 
191

 
112

 
303

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aesthetics

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
330

 
151

 
481

Botox Cosmetic*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
147

 
79

 
226

Juvederm Collection*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
56

 
57

 
113

Other Aesthetics*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
127

 
15

 
142

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Neuroscience
22

 
89

 
111

 
24

 
91

 
115

 
26

 
91

 
117

 
25

 
93

 
118

 
97

 
364

 
461

 
25

 
99

 
124

 
596

 
138

 
734

Botox Therapeutic*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
254

 
43

 
297

Vraylar*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
192

 

 
192

Duodopa
22

 
89

 
111

 
24

 
91

 
115

 
26

 
91

 
117

 
25

 
93

 
118

 
97

 
364

 
461

 
25

 
99

 
124

 
25

 
93

 
118

Ubrelvy*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
22

 

 
22

Other Neuroscience*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
103

 
2

 
105

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eye Care

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
274

 
143

 
417

Lumigan/Ganfort*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
35

 
41

 
76

Alphagan/Combigan*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
47

 
22

 
69

Restasis*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
138

 
6

 
144

Other Eye Care*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
54

 
74

 
128

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Women's Health
13

 

 
13

 
18

 
1

 
19

 
27

 

 
27

 
33

 
1

 
34

 
91

 
2

 
93

 
30

 
1

 
31

 
142

 
5

 
147

Lo Loestrin*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
78

 
2

 
80

Orilissa/Oriahnn
13

 

 
13

 
18

 
1

 
19

 
27

 

 
27

 
33

 
1

 
34

 
91

 
2

 
93

 
30

 
1

 
31

 
30

 
1

 
31

Other Women's Health*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
34

 
2

 
36

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other Key Products
1,003

 
425

 
1,428

 
1,024

 
425

 
1,449

 
1,017

 
370

 
1,387

 
976

 
367

 
1,343

 
4,020

 
1,587

 
5,607

 
910

 
363

 
1,273

 
878

 
271

 
1,149

Mavyret
403

 
387

 
790

 
396

 
384

 
780

 
368

 
327

 
695

 
306

 
322

 
628

 
1,473

 
1,420

 
2,893

 
234

 
325

 
559

 
146

 
230

 
376

Creon
227

 

 
227

 
257

 

 
257

 
265

 

 
265

 
292

 

 
292

 
1,041

 

 
1,041

 
276

 

 
276

 
252

 

 
252

Lupron
191

 
38

 
229

 
168

 
41

 
209

 
187

 
43

 
230

 
174

 
45

 
219

 
720

 
167

 
887

 
195

 
38

 
233

 
167

 
38

 
205

Linzess/Constella*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
130

 
3

 
133

Synthroid
182

 

 
182

 
203

 

 
203

 
197

 

 
197

 
204

 

 
204

 
786

 

 
786

 
205

 

 
205

 
183

 

 
183

 
a Net revenues include Allergan product revenues from the date of the acquisition, May 8, 2020, through June 30, 2020.
b Reflects profit sharing for Imbruvica international revenues.
* Represents product(s) acquired as part of the Allergan acquisition.

1




AbbVie Inc.
Key Product Revenues
Quarterly Comparable Historical Trend Analysis a, b 
(Unaudited, in millions)
 
1Q19
 
2Q19
 
3Q19
 
4Q19
 
FY19
 
1Q20
 
2Q20
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Int’l.
 
Total
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NET REVENUES
$
8,031

 
$
3,359

 
$
11,390

 
$
9,130

 
$
3,137

 
$
12,267

 
$
9,334

 
$
3,069

 
$
12,403

 
$
9,751

 
$
3,192

 
$
12,943

 
$
36,246

 
$
12,757

 
$
49,003

 
$
9,018

 
$
3,151

 
$
12,169

 
$
9,119

 
$
2,423

 
$
11,542

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Immunology
3,215

 
1,231

 
4,446

 
3,835

 
1,083

 
4,918

 
3,977

 
1,064

 
5,041

 
4,195

 
971

 
5,166

 
15,222

 
4,349

 
19,571

 
4,004

 
1,085

 
5,089

 
4,399

 
917

 
5,316

Humira
3,215

 
1,231

 
4,446

 
3,793

 
1,077

 
4,870

 
3,887

 
1,049

 
4,936

 
3,969

 
948

 
4,917

 
14,864

 
4,305

 
19,169

 
3,656

 
1,047

 
4,703

 
3,974

 
863

 
4,837

Skyrizi

 

 

 
42

 
6

 
48

 
76

 
15

 
91

 
193

 
23

 
216

 
311

 
44

 
355

 
266

 
34

 
300

 
289

 
41

 
330

Rinvoq

 

 

 

 

 

 
14

 

 
14

 
33

 

 
33

 
47

 

 
47

 
82

 
4

 
86

 
136

 
13

 
149

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hematologic Oncology
934

 
239

 
1,173

 
1,003

 
265

 
1,268

 
1,184

 
294

 
1,478

 
1,230

 
317

 
1,547

 
4,351

 
1,115

 
5,466

 
1,167

 
382

 
1,549

 
1,246

 
345

 
1,591

Imbruvicac
829

 
193

 
1,022

 
886

 
213

 
1,099

 
1,042

 
215

 
1,257

 
1,073

 
223

 
1,296

 
3,830

 
844

 
4,674

 
966

 
266

 
1,232

 
1,055

 
233

 
1,288

Venclexta
105

 
46

 
151

 
117

 
52

 
169

 
142

 
79

 
221

 
157

 
94

 
251

 
521

 
271

 
792

 
201

 
116

 
317

 
191

 
112

 
303

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Aesthetics
648

 
353

 
1,001

 
737

 
357

 
1,094

 
646

 
358

 
1,004

 
742

 
413

 
1,155

 
2,773

 
1,481

 
4,254

 
587

 
250

 
837

 
386

 
178

 
564

Botox Cosmetic*
230

 
147

 
377

 
252

 
176

 
428

 
238

 
166

 
404

 
272

 
183

 
455

 
992

 
672

 
1,664

 
213

 
114

 
327

 
151

 
89

 
240

Juvederm Collection*
129

 
158

 
287

 
157

 
173

 
330

 
135

 
144

 
279

 
167

 
181

 
348

 
588

 
656

 
1,244

 
108

 
113

 
221

 
59

 
69

 
128

Other Aesthetics*
289

 
48

 
337

 
328

 
8

 
336

 
273

 
48

 
321

 
303

 
49

 
352

 
1,193

 
153

 
1,346

 
266

 
23

 
289

 
176

 
20

 
196

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Neuroscience
780

 
185

 
965

 
903

 
192

 
1,095

 
923

 
189

 
1,112

 
1,005

 
198

 
1,203

 
3,611

 
764

 
4,375

 
919

 
192

 
1,111

 
955

 
155

 
1,110

Botox Therapeutic*
403

 
94

 
497

 
454

 
99

 
553

 
439

 
93

 
532

 
469

 
103

 
572

 
1,765

 
389

 
2,154

 
402

 
89

 
491

 
367

 
60

 
427

Vraylar*
148

 

 
148

 
201

 

 
201

 
241

 

 
241

 
291

 

 
291

 
881

 

 
881

 
285

 

 
285

 
343

 

 
343

Duodopa
22

 
89

 
111

 
24

 
91

 
115

 
26

 
91

 
117

 
25

 
93

 
118

 
97

 
364

 
461

 
25

 
99

 
124

 
25

 
93

 
118

Ubrelvy*

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
13

 

 
13

 
27

 

 
27

Other Neuroscience*
207

 
2

 
209

 
224

 
2

 
226

 
217

 
5

 
222

 
220

 
2

 
222

 
868

 
11

 
879

 
194

 
4

 
198

 
193

 
2

 
195

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eye Care
505

 
292

 
797

 
594

 
327

 
921

 
577

 
313

 
890

 
610

 
319

 
929

 
2,286

 
1,251

 
3,537

 
607

 
283

 
890

 
494

 
230

 
724

Lumigan/Ganfort*
70

 
85

 
155

 
69

 
91

 
160

 
69

 
89

 
158

 
79

 
96

 
175

 
287

 
361

 
648

 
81

 
81

 
162

 
61

 
75

 
136

Alphagan/Combigan*
91

 
38

 
129

 
98

 
41

 
139

 
94

 
40

 
134

 
95

 
43

 
138

 
378

 
162

 
540

 
92

 
37

 
129

 
83

 
35

 
118

Restasis*
248

 
10

 
258

 
315

 
12

 
327

 
300

 
10

 
310

 
331

 
18

 
349

 
1,194

 
50

 
1,244

 
314

 
11

 
325

 
254

 
9

 
263

Other Eye Care*
96

 
159

 
255

 
112

 
183

 
295

 
114

 
174

 
288

 
105

 
162

 
267

 
427

 
678

 
1,105

 
120

 
154

 
274

 
96

 
111

 
207

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Women's Health
230

 
8

 
238

 
262

 
10

 
272

 
280

 
11

 
291

 
285

 
13

 
298

 
1,057

 
42

 
1,099

 
219

 
9

 
228

 
223

 
6

 
229

Lo Loestrin*
129

 
3

 
132

 
150

 
3

 
153

 
167

 
3

 
170

 
161

 
5

 
166

 
607

 
14

 
621

 
114

 
3

 
117

 
136

 
3

 
139

Orilissa/Oriahnn
13

 

 
13

 
18

 
1

 
19

 
27

 

 
27

 
33

 
1

 
34

 
91

 
2

 
93

 
30

 
1

 
31

 
30

 
1

 
31

Other Women's Health*
88

 
5

 
93

 
94

 
6

 
100

 
86

 
8

 
94

 
91

 
7

 
98

 
359

 
26

 
385

 
75

 
5

 
80

 
57

 
2

 
59

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other Key Products
1,181

 
430

 
1,611

 
1,231

 
430

 
1,661

 
1,237

 
377

 
1,614

 
1,216

 
374

 
1,590

 
4,865

 
1,611

 
6,476

 
1,103

 
370

 
1,473

 
966

 
274

 
1,240

Mavyret
403

 
387

 
790

 
396

 
384

 
780

 
368

 
327

 
695

 
306

 
322

 
628

 
1,473

 
1,420

 
2,893

 
234

 
325

 
559

 
146

 
230

 
376

Creon
227

 

 
227

 
257

 

 
257

 
265

 

 
265

 
292

 

 
292

 
1,041

 

 
1,041

 
276

 

 
276

 
252

 

 
252

Lupron
191

 
38

 
229

 
168

 
41

 
209

 
187

 
43

 
230

 
174

 
45

 
219

 
720

 
167

 
887

 
195

 
38

 
233

 
167

 
38

 
205

Linzess/Constella*
178

 
5

 
183

 
207

 
5

 
212

 
220

 
7

 
227

 
240

 
7

 
247

 
845

 
24

 
869

 
193

 
7

 
200

 
218

 
6

 
224

Synthroid
182

 

 
182

 
203

 

 
203

 
197

 

 
197

 
204

 

 
204

 
786

 

 
786

 
205

 

 
205

 
183

 

 
183

 
a Comparable historical net revenues include total revenues for all reported periods for both AbbVie and Allergan products as if the acquisition closed on January 1, 2019.
b All historically reported Allergan revenues have been recast to conform to AbbVie's revenue recognition accounting policies and reporting conventions for certain rebates and discounts. Historically reported Allergan revenues also exclude Zenpep and Viokace product revenues, which were both divested as part of the acquisition, as well as specified items.
c Reflects profit sharing for Imbruvica international revenues.
* Represents product(s) acquired as part of the Allergan acquisition.

2