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AbbVie Reports Full-Year and Fourth-Quarter 2018 Financial Results

Key Takeaway: AbbVie Reports Full-Year and Fourth-Quarter 2018 Financial Results 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 opera

Full Press Release Details

AbbVie Reports Full-Year and Fourth-Quarter 2018 Financial Results
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
Fourth-Quarter Results (continued)
Key Events from the Fourth Quarter
Key Events from the Fourth Quarter (continued)
Key Events from the Fourth Quarter (continued)
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.
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.
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.
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Key Product Revenues
Quarter Ended December 31, 2018
% Change vs. 4Q17
Net Revenues (in millions) International Total
U.S. Int'l. Total U.S. Operational Reported Operational Reported
ADJUSTED NET REVENUES a $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
Imbruvica b 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
Key Product Revenues
Twelve Months Ended December 31, 2018
% Change vs. 12M17
Net Revenues (in millions) International Total
U.S. Int'l. Total U.S. Operational Reported Operational Reported
ADJUSTED NET REVENUES a $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
Imbruvica b 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
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 share a $ 1.90 $ 1.48 $ 7.91 $ 5.60
Adjusted weighted-average diluted shares outstanding a 1,501 1,602 1,546 1,603
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 %
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended December 31, 2017
(Unaudited) (In millions, except per share data)
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.
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 )
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 %
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Twelve Months Ended December 31, 2018
(Unaudited) (In millions, except per share data)
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.
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 )
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 %
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Twelve Months Ended December 31, 2017
(Unaudited) (In millions, except per share data)
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.
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 )
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 %
Last updated: Jan 25, 2019