Document


 
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): January 25, 2019
 
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 Chicago, Illinois 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:
 
o                      Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o                      Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o                      Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o                      Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 January 25, 2019, AbbVie Inc. issued a press release announcing financial results for the fourth quarter and full year ended December 31, 2018.  A copy of the press release is furnished as Exhibit 99.1 to this report and incorporated herein by reference.
 
Item 9.01 Financial Statements and Exhibits

(d) Exhibits
Exhibit No.
 
Exhibit
 





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:
January 25, 2019
By:
/s/ Robert A. Michael
 
 
 
Robert A. Michael
 
 
 
Senior Vice President,
 
 
 
Chief Financial Officer



Exhibit



http://api.tenkwizard.com/cgi/image?quest=1&rid=23&ipage=12653630&doc=3
 



PRESS RELEASE
 
AbbVie Reports Full-Year and Fourth-Quarter 2018 Financial Results
 
Reports Full-Year Diluted EPS of $3.66 on a GAAP Basis; Adjusted Diluted EPS of $7.91 Reflects Growth of 41.3 Percent

Delivers Full-Year Net Revenues of $32.753 Billion on a GAAP Basis; Adjusted Net Revenues of $32.733 Billion Increased 15.2 Percent on an Operational Basis

Full-Year Global HUMIRA Sales of $19.936 Billion Increased 8.2 Percent on a Reported Basis, or 7.4 Percent on an Operational Basis

Full-Year Global Net Revenues from the Hematologic Oncology Portfolio Were $3.934 Billion, an Increase of 45.9 Percent on a Reported Basis; Full-Year Global IMBRUVICA Net Revenues Were $3.590 Billion, an Increase of 39.5 Percent; Full-Year Global VENCLEXTA Net Revenues Were $344 Million

Full-Year Global HCV Net Revenues Were $3.616 Billion

Reports Fourth-Quarter Diluted Loss Per Share of $1.23 on a GAAP Basis, Inclusive of the Recent Partial Impairment Charge Related to Intangible Assets Acquired as part of the 2016 Acquisition of Stemcentrx, Inc.; Adjusted Diluted EPS of $1.90 Reflects Growth of 28.4 Percent Over Fourth-Quarter 2017

Delivers Fourth-Quarter Net Revenues of $8.305 Billion; Adjusted Net Revenues Grew 8.3 Percent on an Operational Basis

Provides 2019 GAAP Diluted EPS Guidance Range of $7.39 to $7.49; Provides 2019 Adjusted Diluted EPS Guidance Range of $8.65 to $8.75, Representing Growth of 10.0 Percent at the Midpoint

NORTH CHICAGO, Ill., January 25, 2019 – AbbVie (NYSE:ABBV) announced financial results for the fourth quarter and full year ended December 31, 2018.
 
“We delivered exceptional performance in 2018, including operational revenue growth of more than 15 percent and EPS growth above 40 percent,” said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. “We’re entering an important new phase for AbbVie. The continued momentum of our business, combined with the launch and ramp of several new products, will allow us to drive strong earnings growth once again in 2019 and position us for growth over the longer term.”

 Fourth-Quarter Results
 
Worldwide GAAP net revenues were $8.305 billion in the fourth quarter, up 7.3 percent year-over-year. Worldwide adjusted net revenues of $8.305 billion increased 8.3 percent on an operational basis, excluding a 1.0 percent unfavorable impact from foreign exchange.


1



Fourth-Quarter Results (continued)

Global HUMIRA sales increased 0.5 percent on a reported basis, or 1.4 percent operationally, excluding a 0.9 percent unfavorable impact from foreign exchange. In the U.S., HUMIRA sales grew 9.1 percent in the quarter. Internationally, HUMIRA sales declined 14.8 percent operationally due to direct biosimilar competition in certain international markets.

Global net revenues from the hematologic oncology portfolio were $1.130 billion, an increase of 50.2 percent on a reported basis; global IMBRUVICA net revenues were $1.006 billion, an increase of 42.0 percent; global VENCLEXTA net revenues were $124 million.

Fourth-quarter global HCV net revenues were $862 million.

On a GAAP basis, the gross margin ratio in the fourth quarter was 75.7 percent. The adjusted gross margin ratio was 79.8 percent.
 
On a GAAP basis, selling, general and administrative expense was 23.2 percent of net revenues. The adjusted SG&A expense was 21.6 percent of net revenues.
 
On a GAAP basis, research and development expense was 78.2 percent of net revenues. The adjusted R&D expense was 16.5 percent, reflecting funding actions supporting all stages of our pipeline.

On a GAAP basis, the operating margin in the fourth quarter was negative 29.4 percent. The adjusted operating margin was 41.7 percent.
 
On a GAAP basis, net interest expense was $319 million. On a GAAP basis, the tax rate in the quarter was 23.1 percent. The adjusted tax rate was 9.1 percent.

Diluted loss per share in the fourth quarter was $1.23 on a GAAP basis, inclusive of the recent partial impairment charge related to intangible assets acquired as part of the 2016 acquisition of Stemcentrx, Inc. Adjusted diluted EPS, excluding specified items, was $1.90, up 28.4 percent.

Key Events from the Fourth Quarter
 
AbbVie announced the U.S. Food and Drug Administration (FDA) granted accelerated approval to VENCLEXTA (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytrabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, which are expected to be completed in 2019. The approval in AML is the third provided under priority review by the FDA for VENCLEXTA, which has been granted four Breakthrough Therapy Designations (BTDs) by the FDA. 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.

AbbVie announced the European Commission (EC) has approved the type-II variation application for VENCLYXTO (venetoclax) in combination with rituximab for the treatment of patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. This approval allows more patients to receive VENCLYXTO in combination with rituximab in the second-line setting. It also gives healthcare providers the ability to prescribe this medicine to a broader population of patients with R/R CLL than the previously approved indication for VENCLYXTO as monotherapy in the European Union. The approval is based on results from the Phase 3 MURANO trial, which demonstrated a statistically significant improvement in investigator-assessed progression-free survival (PFS) for patients who received VENCLYXTO plus rituximab compared with bendamustine plus rituximab.

2



Key Events from the Fourth Quarter (continued)

At the American Society of Hematology Annual Meeting & Exposition (ASH), AbbVie presented data from nearly 40 abstracts, including 13 oral presentations and more than 20 poster presentations. Multiple studies investigating VENCLEXTA and IMBRUVICA (ibrutinib) across a number of hematologic malignancies were presented, including updated results from the Phase 3 MURANO trial of venetoclax in combination with rituximab in patients with R/R CLL, which showed that treatment with VENCLEXTA and rituximab provided sustained benefits in PFS and minimal residual following an additional year of follow-up data.

AbbVie and its collaboration partners presented new and updated IMBRUVICA data at the ASH meeting, including results from three Phase 3 studies in patients with previously untreated CLL. In the Phase 3 iLLUMINATE trial, IMBRUVICA plus obinutuzumab significantly prolonged PFS with a 77 percent reduction in risk of progression or death versus chlorambucil plus obinutuzumab. In the Phase 3 ECOG-1912 trial, IMBRUVICA plus rituximab significantly prolonged PFS and improved overall survival (OS) compared to fludarabine, cyclophosphamide and rituximab (FCR) in previously untreated younger patients with CLL. And in the Phase 3 ALLIANCE trial, IMBRUVICA alone or in combination with rituximab produced superior PFS compared with bendamustine plus rituximab (BR) in untreated older patients with CLL. Also featured at ASH were seven-year data on patients treated with IMBRUVICA, which showed durable responses and sustained PFS rates with IMBRUVICA in CLL/SLL (small lymphocytic lymphoma) for previously untreated patients.

AbbVie announced topline results on the Phase 3 RESOLVE trial (PCYC-1137) of IMBRUVICA in combination with nab-paclitaxel and gemcitabine versus placebo in combination with these chemotherapy agents in patients with metastatic pancreatic adenocarcinoma (cancer). At conclusion, the study did not meet its primary endpoint of improving PFS or OS benefit among the study population. Full results from this study will be submitted for presentation at a future medical meeting.

Following the decision to stop enrollment for the TAHOE trial, a Phase 3 study evaluating Rovalpituzumab Tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC), and an evaluation of the Stemcentrx-related intangible assets, AbbVie recorded an impairment charge related to intangible assets acquired as part of its 2016 acquisition of Stemcentrx, Inc. The after-tax net impact of this impairment and the related adjustment to contingent consideration liabilities was $4.117 billion. AbbVie continues to evaluate information with respect to the Stemcentrx-related clinical development programs and will monitor the remaining $1 billion of intangible assets for further impairment.

AbbVie announced that it submitted a New Drug Application (NDA) to the FDA and a marketing authorization application (MAA) to the European Medicines Agency for upadacitinib, an oral investigational JAK1-selective inhibitor, for the treatment of adult patients with moderate to severe rheumatoid arthritis. The NDA and MAA are supported by data from the global upadacitinib SELECT Phase 3 rheumatoid arthritis program evaluating more than 4,900 patients with moderate to severe rheumatoid arthritis across five Phase 3 studies. In the SELECT program, results showed that upadacitinib improved signs and symptoms of rheumatoid arthritis, inhibited radiographic progression and improved physical function, both as a monotherapy and in combination with conventional synthetic DMARDs.

At the American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting, AbbVie presented new data for upadacitinib and HUMIRA, with 35 abstracts presented across multiple rheumatic conditions, including rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis and uveitis. Included in the presentations were data from three of the five pivotal studies from the SELECT Phase 3 program.






3



Key Events from the Fourth Quarter (continued)

At the United European Gastroenterology Week (UEGW) conference, AbbVie showcased its gastroenterology portfolio with 11 presentations of HUMIRA and pipeline data, including the first presentation of data from a Phase 2b study (U-ACHIEVE) evaluating upadacitinib in adult patients with moderately to severely active ulcerative colitis. Results from the U-ACHIEVE study demonstrated that after 8 weeks, upadacitinib (15/30/45 mg, once daily) met the primary endpoint of clinical remission (per adapted Mayo Score) and ranked secondary endpoints, including endoscopic improvement, clinical remission (per Full Mayo Score) and clinical response.

At the American Association of Gynecologic Laparoscopists (AAGL) Global Congress on Minimally Invasive Gynecology, AbbVie, in cooperation with Neurocrine Biosciences, presented additional results from two replicate pivotal Phase 3 clinical trials ELARIS UF-1 and ELARIS UF-2 evaluating the efficacy and safety of elagolix in women with uterine fibroids. Results demonstrated that at the final month of the six-month treatment period, elagolix, in combination with low-dose hormone (add-back) therapy, reduced heavy menstrual bleeding associated with uterine fibroids compared to placebo. Data from the Phase 3 clinical trial program will support regulatory submission for elagolix in uterine fibroids, anticipated in mid-2019.

At the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), AbbVie presented new data for its pan-genotypic chronic hepatitis C virus (HCV) treatment, MAVYRET (glecaprevir/pibrentasvir), in treatment-naïve patients with compensated cirrhosis. Results from the Phase 3b EXPEDITION-8 study showed that with 8 weeks of MAVYRET, 100 percent of genotype 1, 2, 4, 5 and 6 patients achieved a sustained virologic response 12 weeks after treatment per protocol analysis. MAVYRET is currently approved as an 8-week, pan-genotypic treatment for treatment-naïve patients without cirrhosis.

AbbVie announced global resolutions of all intellectual property-related litigation with Momenta and Pfizer over their proposed biosimilar adalimumab products. Under the terms of the settlement agreements, AbbVie will grant to Momenta and Pfizer non-exclusive licenses to AbbVie's intellectual property relating to HUMIRA beginning on certain dates in certain countries in which AbbVie has intellectual property. The license period will begin on November 20, 2023 in the U.S. for both Momenta and Pfizer, and will not be accelerated by the entry of companies who have already taken a license. Momenta and Pfizer will pay royalties to AbbVie for licensing its HUMIRA patents and both manufacturers acknowledge the validity of the licensed patents. AbbVie will make no payments to Momenta or Pfizer. AbbVie has entered into a total of seven settlement agreements with manufacturers related to the licensing of proposed biosimilar adalimumab products.

AbbVie announced its board of directors authorized a $5 billion increase to the company’s existing stock repurchase program. Purchases may be made from time to time at management's discretion. The stock repurchase authorization permits shares to be repurchased in open market or private transactions, has no time limit and may be discontinued at any time.

AbbVie made charitable contributions totaling $115 million in the fourth quarter, including a $50 million donation to St. Jude Children’s Research Hospital to enhance and expand patient and family-centered care. In 2018, AbbVie made a total of $350 million in charitable contributions to U.S. non-for-profit organizations. The contributions provide AbbVie with the opportunity to support charities creating long-term impact in communities in need, including Puerto Rico, North Chicago and cities across America.







4



Full-Year 2019 Outlook
 
AbbVie is issuing GAAP diluted EPS guidance for the full-year 2019 of $7.39 to $7.49. The company's 2019 GAAP guidance does not reflect non-cash charges for contingent consideration adjustments related to the expected approval of risankizumab in the first half of the year. AbbVie expects to deliver adjusted diluted EPS for the full-year 2019 of $8.65 to $8.75, representing growth of 10.0 percent at the mid-point. The company's 2019 adjusted diluted EPS guidance excludes $1.26 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments, and other specified items.
About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience.  In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. 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 fourth-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 2018 and 2017 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 2019 financial guidance is also being provided on both a reported and a non-GAAP basis.
Prior Period Reclassifications
Certain reclassifications were made to conform the prior period financial results to the current period presentation.
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 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, 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 2017 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.

5



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

6



AbbVie Inc.
Key Product Revenues
Quarter Ended December 31, 2018
(Unaudited)
 
 
 
 
 
 
 
 
% Change vs. 4Q17
 
Net Revenues (in millions)
 
 
 
International
Total
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Operational
 
Reported
Operational
 
Reported
ADJUSTED NET REVENUESa
$5,688
 
$2,617
 
$8,305
 
14.3%
 
(2.5)%
 
(5.2)%
8.3%
 
7.3%
Immunology
3,615
 
1,303
 
4,918
 
9.1
 
(14.8)
 
(17.5)
1.4
 
0.5
Humira
3,615
 
1,303
 
4,918
 
9.1
 
(14.8)
 
(17.5)
1.4
 
0.5
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hematologic Oncology
929
 
201
 
1,130
 
51.0
 
47.6
 
46.9
50.3
 
50.2
Imbruvicab
839
 
167
 
1,006
 
43.2
 
36.4
 
36.4
42.0
 
42.0
Venclexta
90
 
34
 
124
 
>100.0
 
>100.0
 
>100.0
>100.0
 
>100.0
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HCV
408
 
454
 
862
 
92.0
 
56.6
 
53.0
71.4
 
69.3
Mavyret
408
 
411
 
819
 
89.3
 
>100.0
 
>100.0
>100.0
 
>100.0
Viekira
 
43
 
43
 
n/m
 
(59.9)
 
(62.9)
(58.6)
 
(61.7)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other Key Products
798
 
531
 
1,329
 
(2.4)
 
(5.1)
 
(8.4)
(3.5)
 
(4.9)
Creon
261
 
 
261
 
11.4
 
n/a
 
n/a
11.4
 
11.4
Lupron
196
 
40
 
236
 
8.3
 
(0.9)
 
(7.2)
6.5
 
5.3
Synthroid
209
 
 
209
 
2.0
 
n/a
 
n/a
2.0
 
2.0
Synagis
 
264
 
264
 
n/a
 
(3.7)
 
(6.3)
(3.7)
 
(6.3)
AndroGel
76
 
 
76
 
(45.8)
 
n/a
 
n/a
(45.8)
 
(45.8)
Duodopa
23
 
90
 
113
 
34.8
 
12.8
 
9.6
16.7
 
14.0
Sevoflurane
20
 
66
 
86
 
(14.8)
 
(9.5)
 
(14.1)
(10.6)
 
(14.2)
Kaletra
13
 
71
 
84
 
(24.4)
 
(22.8)
 
(25.6)
(23.1)
 
(25.5)
Note: “Operational” growth reflects the percentage change over the prior year excluding the impact of exchange rate fluctuations.
n/a = not applicable
n/m = not meaningful
a
Adjusted net revenues exclude specified items. Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. Percentage change is calculated using adjusted net revenues.
b 
Reflects profit sharing for Imbruvica international revenues.

7



AbbVie Inc.
Key Product Revenues
Twelve Months Ended December 31, 2018
(Unaudited)
 
 
 
 
 
 
 
 
% Change vs. 12M17
 
Net Revenues (in millions)
 
 
 
International
Total
 
U.S.
 
Int’l.
 
Total
 
U.S.
 
Operational
 
Reported
Operational
 
Reported
ADJUSTED NET REVENUESa
$21,524
 
$11,209
 
$32,733
 
17.9%
 
10.2%
 
12.6%
15.2%
 
16.0%
Immunology
13,685
 
6,251
 
19,936
 
10.7
 
0.6
 
3.1
7.4
 
8.2
Humira
13,685
 
6,251
 
19,936
 
10.7
 
0.6
 
3.1
7.4
 
8.2
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Hematologic Oncology
3,215
 
719
 
3,934
 
43.9
 
55.3
 
55.7
45.8
 
45.9
Imbruvicab
2,968
 
622
 
3,590
 
38.4
 
45.0
 
45.0
39.5
 
39.5
Venclexta
247
 
97
 
344
 
>100.0
 
>100.0
 
>100.0
>100.0
 
>100.0
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
HCV
1,617
 
1,999
 
3,616
 
>100.0
 
>100.0
 
>100.0
>100.0
 
>100.0
Mavyret
1,614
 
1,824
 
3,438
 
>100.0
 
>100.0
 
>100.0
>100.0
 
>100.0
Viekira
3
 
175
 
178
 
(96.7)
 
(74.8)
 
(75.6)
(76.5)
 
(77.2)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Other Key Products
3,108
 
1,840
 
4,948
 
1.3
 
(2.9)
 
(1.9)
(0.3)
 
0.1
Creon
928
 
 
928
 
11.7
 
n/a
 
n/a
11.7
 
11.7
Lupron
726
 
166
 
892
 
8.6
 
4.7
 
3.4
7.9
 
7.6
Synthroid
776
 
 
776
 
(0.6)
 
n/a
 
n/a
(0.6)
 
(0.6)
Synagis
 
726
 
726
 
n/a
 
(2.8)
 
(1.6)
(2.8)
 
(1.6)
AndroGel
469
 
 
469
 
(18.8)
 
n/a
 
n/a
(18.8)
 
(18.8)
Duodopa
80
 
350
 
430
 
31.4
 
14.8
 
19.1
17.7
 
21.2
Sevoflurane
74
 
317
 
391
 
(6.2)
 
(4.3)
 
(4.4)
(4.6)
 
(4.7)
Kaletra
55
 
281
 
336
 
(22.1)
 
(20.1)
 
(20.2)
(20.4)
 
(20.5)
Note: “Operational” growth reflects the percentage change over the prior year excluding the impact of exchange rate fluctuations.
n/a = not applicable
a
Adjusted net revenues exclude specified items. Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. Percentage change is calculated using adjusted net revenues.
b 
Reflects profit sharing for Imbruvica international revenues.

8



AbbVie Inc.
Consolidated Statements of Earnings
Quarter and Twelve Months Ended December 31, 2018 and 2017
(Unaudited) (In millions, except per share data)
 
 
Fourth Quarter
Ended December 31
 
Twelve Months
Ended December 31
 
2018
 
2017
 
2018
 
2017
Net revenues
$
8,305

 
$
7,739

 
$
32,753

 
$
28,216

Cost of products sold
2,022

 
2,281

 
7,718

 
7,042

Selling, general and administrative
1,929

 
1,956

 
7,399

 
6,295

Research and development
6,495

 
1,408

 
10,329

 
5,007

Acquired in-process research and development
300

 
312

 
424

 
327

Other expense

 

 
500

 

Total operating costs and expenses
10,746

 
5,957

 
26,370

 
18,671

 
 
 
 
 
 
 
 
Operating earnings (loss)
(2,441
)
 
1,782

 
6,383

 
9,545

 
 
 
 
 
 
 
 
Interest expense, net
319

 
252

 
1,144

 
1,004

Net foreign exchange loss
6

 
320

 
24

 
348

Other (income) expense, net
(393
)
 
17

 
18

 
466

Earnings (loss) before income taxes
(2,373
)
 
1,193

 
5,197

 
7,727

Income tax expense (benefit)
(547
)
 
1,141

 
(490
)
 
2,418

Net earnings (loss)
$
(1,826
)
 
$
52

 
$
5,687

 
$
5,309

 
 
 
 
 
 
 
 
Diluted earnings (loss) per share
$
(1.23
)
 
$
0.03

 
$
3.66

 
$
3.30

 
 
 
 
 
 
 
 
Weighted-average diluted shares outstanding
1,496

 
1,602

 
1,546

 
1,603

 
 
 
 
 
 
 
 
Adjusted diluted earnings per sharea
$
1.90

 
$
1.48

 
$
7.91

 
$
5.60

 
 
 
 
 
 
 
 
Adjusted weighted-average diluted shares outstandinga
1,501

 
1,602

 
1,546

 
1,603

 
a 
Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. Weighted-average diluted shares outstanding includes the effect of dilutive securities. Due to the GAAP net loss in the fourth quarter ended December 31, 2018, certain shares issuable under stock-based compensation plans that were dilutive on a non-GAAP basis were excluded from the computation of GAAP diluted EPS because the effect would have been antidilutive.

9



AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended December 31, 2018
(Unaudited) (In millions, except per share data)
 
1.    Specified items impacted results as follows:
 
4Q18
 
Earnings (Loss)
 
Diluted
 
Pre-tax
 
After-tax
 
EPS
As reported (GAAP)
$
(2,373
)
 
$
(1,826
)
 
$
(1.23
)
Adjusted for specified items:
 
 
 
 
 
Intangible asset amortization
320

 
262

 
0.18

Milestones and other R&D expenses
50

 
50

 
0.03

Acquired IPR&D
300

 
300

 
0.20

Stemcentrx-related impairment
4,642

 
4,117

 
2.75

Charitable contributions
115

 
89

 
0.06

Change in fair value of contingent consideration
46

 
46

 
0.03

Litigation reserves
7

 
6

 

Impacts of U.S. tax reform

 
(86
)
 
(0.05
)
Tax audit settlement

 
(131
)
 
(0.09
)
Other
44

 
35

 
0.02

As adjusted (non-GAAP)
$
3,151

 
$
2,862

 
$
1.90

 
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. Stemcentrx-related impairment refers to the net impact of the intangible asset impairment and the related fair value adjustment to contingent consideration liabilities. Impacts of U.S. tax reform primarily reflects a net tax benefit related to the timing of the new legislation's phase in on certain subsidiaries. Other primarily includes restructuring charges associated with streamlining global operations.
2.    The impact of the specified items by line item was as follows:
 
4Q18
 
Cost of
products sold
 
SG&A
 
R&D
 
Acquired
IPR&D
 
Other (income) expense, net
As reported (GAAP)
$
2,022

 
$
1,929

 
$
6,495

 
$
300

 
$
(393
)
Adjusted for specified items:
 
 
 
 
 
 
 
 
 
Intangible asset amortization
(320
)
 

 

 

 

Milestones and other R&D expenses

 

 
(50
)
 

 

Acquired IPR&D

 

 

 
(300
)
 

Stemcentrx-related impairment

 

 
(5,070
)
 

 
428

Charitable contributions

 
(115
)
 

 

 

Change in fair value of contingent consideration

 

 

 

 
(46
)
Litigation reserves

 
(7
)
 

 

 

Other
(28
)
 
(10
)
 
(6
)
 

 

As adjusted (non-GAAP)
$
1,674

 
$
1,797

 
$
1,369

 
$

 
$
(11
)
3.    The adjusted tax rate for the fourth quarter of 2018 was 9.1 percent, as detailed below:
 
4Q18
 
Pre-tax
income (loss)
 
Income
taxes
 
Tax rate
As reported (GAAP)
$
(2,373
)
 
$
(547
)
 
23.1
%
Specified items
5,524

 
836

 
15.1
%
As adjusted (non-GAAP)
$
3,151

 
$
289

 
9.1
%

10



AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended December 31, 2017
(Unaudited) (In millions, except per share data)
 
1.
Specified items impacted results as follows:
 
4Q17
 
Earnings
 
Diluted
 
Pre-tax
 
After-tax
 
EPS
As reported (GAAP)
$
1,193

 
$
52

 
$
0.03

Adjusted for specified items:
 

 
 

 
 

Intangible asset amortization
268

 
203

 
0.13

Milestones and other R&D expenses
75

 
75

 
0.05

Acquired IPR&D
312

 
312

 
0.19

Change in fair value of contingent consideration
79

 
79

 
0.05

Litigation reserves
273

 
221

 
0.14

Intangible asset impairment
354

 
244

 
0.15

U.S. tax reform repatriation tax

 
4,509

 
2.81

Other impacts related to tax law change
316

 
(3,267
)
 
(2.04
)
Tax audit settlement

 
(91
)
 
(0.06
)
Other
75

 
52

 
0.03

As adjusted (non-GAAP)
$
2,945

 
$
2,389

 
$
1.48

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. Other primarily includes restructuring charges associated with streamlining global operations.
2.
The impact of the specified items by line item was as follows: 
 
4Q17
 
Cost of
products sold
 
SG&A
 
R&D
 
Acquired
IPR&D
 
Net foreign exchange loss
 
Other (income) expense, net
As reported (GAAP)
$
2,281

 
$
1,956

 
$
1,408

 
$
312

 
$
320

 
$
17

Adjusted for specified items:
 
 
 
 
 
 
 
 
 
 
 
Intangible asset amortization
(268
)
 

 

 

 

 

Milestones and other R&D expenses

 

 
(75
)
 

 

 

Acquired IPR&D

 

 

 
(312
)
 

 

Change in fair value of contingent consideration

 

 

 

 

 
(79
)
Litigation reserves

 
(273
)
 

 

 

 

Intangible asset impairment
(354
)
 

 

 

 

 

Other impacts related to tax law change

 

 

 

 
(316
)
 

Other
(33
)
 
(37
)
 
(5
)
 

 

 

As adjusted (non-GAAP)
$
1,626

 
$
1,646

 
$
1,328

 
$

 
$
4

 
$
(62
)
3.
The adjusted tax rate for the fourth quarter of 2017 was 18.9 percent, as detailed below:
 
4Q17
 
Pre-tax
income
 
Income
taxes
 
Tax rate
As reported (GAAP)
$
1,193

 
$
1,141

 
95.6
 %
Specified items
1,752

 
(585
)
 
(33.4
)%
As adjusted (non-GAAP)
$
2,945

 
$
556

 
18.9
 %

11



AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Twelve Months Ended December 31, 2018
(Unaudited) (In millions, except per share data)
 
1.
Specified items impacted results as follows:
 
12M18
 
Earnings
 
Diluted
 
Pre-tax
 
After-tax
 
EPS
As reported (GAAP)
$
5,197

 
$
5,687

 
$
3.66

Adjusted for specified items:
 
 
 
 
 
Intangible asset amortization
1,294

 
1,063

 
0.69

Milestones and other R&D expenses
137

 
137

 
0.09

Acquired IPR&D
424

 
424

 
0.27

Calico collaboration
500

 
500

 
0.32

Stemcentrx-related impairment
4,642

 
4,117

 
2.66

Charitable contributions
350

 
271

 
0.18

Change in fair value of contingent consideration
478

 
478

 
0.31

Litigation reserves
353

 
282

 
0.18

Impacts of U.S. tax reform

 
(620
)
 
(0.40
)
Tax audit settlement

 
(131
)
 
(0.09
)
Other
82

 
74

 
0.04

As adjusted (non-GAAP)
$
13,457

 
$
12,282

 
$
7.91

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. Stemcentrx-related impairment refers to the net impact of the intangible asset impairment and the related fair value adjustment to contingent consideration liabilities. Impacts of U.S. tax reform primarily reflects a net tax benefit related to the timing of the new legislation's phase in on certain subsidiaries. Other primarily includes restructuring charges associated with streamlining global operations and milestone revenue under a previously announced collaboration.
2.
The impact of the specified items by line item was as follows: 
 
12M18
 
Net revenues
 
Cost of
products sold
 
SG&A
 
R&D
 
Acquired
IPR&D
 
Other operating expense
 
Other (income) expense, net
As reported (GAAP)
$
32,753

 
$
7,718

 
$
7,399

 
$
10,329

 
$
424

 
$
500

 
$
18

Adjusted for specified items:
 
 
 
 
 
 
 
 
 
 
 
 
 
Intangible asset amortization

 
(1,294
)
 

 

 

 

 

Milestones and other R&D expenses

 

 

 
(137
)
 

 

 

Acquired IPR&D

 

 

 

 
(424
)
 

 

Calico collaboration

 

 

 

 

 
(500
)
 

Stemcentrx-related impairment

 

 

 
(5,070
)
 

 

 
428

Charitable contributions

 

 
(350
)
 

 

 

 

Change in fair value of contingent consideration

 

 

 

 

 

 
(478
)
Litigation reserves

 

 
(353
)
 

 

 

 

Other
(20
)
 
(62
)
 
(11
)
 
(29
)
 

 

 

As adjusted (non-GAAP)
$
32,733

 
$
6,362

 
$
6,685

 
$
5,093

 
$

 
$

 
$
(32
)
3.
The adjusted tax rate for the full-year 2018 was 8.7 percent, as detailed below:
 
12M18
 
Pre-tax
income
 
Income
taxes
 
Tax rate
As reported (GAAP)
$
5,197

 
$
(490
)
 
(9.4
)%
Specified items
8,260

 
1,665

 
20.2
 %
As adjusted (non-GAAP)
$
13,457

 
$
1,175

 
8.7
 %

12



AbbVie Inc.
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Twelve Months Ended December 31, 2017
(Unaudited) (In millions, except per share data)
 
1.
Specified items impacted results as follows:
 
12M17
 
Earnings
 
Diluted
 
Pre-tax
 
After-tax
 
EPS
As reported (GAAP)
$
7,727

 
$
5,309

 
$
3.30

Adjusted for specified items:
 
 
 
 
 
Intangible asset amortization
1,076

 
809

 
0.51

Milestones and other R&D expenses
143

 
143

 
0.09

Acquired IPR&D
327

 
327

 
0.20

Acquisition related costs
73

 
49

 
0.03

Change in fair value of contingent consideration
626

 
625

 
0.39

Litigation reserves
370

 
286

 
0.18

Intangible asset impairment
354

 
244

 
0.15

U.S. tax reform repatriation tax

 
4,509

 
2.81

Other impacts related to tax law change
316

 
(3,267
)
 
(2.04
)
Tax audit settlement

 
(91
)
 
(0.06
)
Other
94

 
68

 
0.04

As adjusted (non-GAAP)
$
11,106

 
$
9,011

 
$
5.60

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. Acquisition related costs primarily includes the amortization of the acquisition date fair value step-up for inventory related to the acquisition of Pharmacyclics. Other primarily includes restructuring charges associated with streamlining global operations.
2.
The impact of the specified items by line item was as follows:
 
12M17
 
Cost of
products sold
 
SG&A
 
R&D
 
Acquired
IPR&D
 
Net foreign exchange loss
 
Other (income) expense, net
As reported (GAAP)
$
7,042

 
$
6,295

 
$
5,007

 
$
327

 
$
348

 
$
466

Adjusted for specified items:
 
 
 
 
 
 
 
 
 
 
 
Intangible asset amortization
(1,076
)
 

 

 

 

 

Milestones and other R&D expenses

 

 
(143
)
 

 

 

Acquired IPR&D

 

 

 
(327
)
 

 

Acquisition related costs
(52
)
 
(14
)
 
(5
)
 

 

 
(2
)
Change in fair value of contingent consideration

 

 

 

 

 
(626
)
Litigation reserves

 
(370
)
 

 

 

 

Intangible asset impairment
(354
)
 

 

 

 

 

Other impacts related to tax law change

 

 

 

 
(316
)
 

Other
(47
)
 
(42
)
 
(5
)
 

 

 

As adjusted (non-GAAP)
$
5,513

 
$
5,869

 
$
4,854

 
$

 
$
32

 
$
(162
)
3.
The adjusted tax rate for the full-year 2017 was 18.9 percent, as detailed below:
 
12M17
 
Pre-tax
income
 
Income
taxes
 
Tax rate
As reported (GAAP)
$
7,727

 
$
2,418

 
31.3
 %
Specified items
3,379

 
(323
)
 
(9.6
)%
As adjusted (non-GAAP)
$
11,106

 
$
2,095

 
18.9
 %

13