Full Press Release Details
AbbVie Reports Second-Quarter 2017 Financial Results
NORTH CHICAGO, Ill., July 28, 2017 - AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2017.
"We are pleased with the continued strength of our business. Our second quarter financial results reflected strong commercial and operational execution," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We also remain very encouraged about the recent progress we've made with our late-stage pipeline, including strong results from a registrational trial of our selective JAK1 inhibitor, upadacitinib. We look forward to seeing data from numerous additional pivotal studies in the second half."
Second-Quarter Results
Second-Quarter Results (continued)
Key Events from the Second Quarter
Key Events from the Second Quarter (continued)
Full-Year 2017 Outlook
AbbVie is confirming its GAAP diluted EPS guidance for the full-year 2017 of $4.55 to $4.65. AbbVie expects to deliver adjusted diluted EPS for the full-year 2017 of $5.44 to $5.54, representing growth of 13.9 percent at the mid-point. The company's 2017 adjusted diluted EPS guidance excludes $0.89 per share of intangible asset amortization expense 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 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 2017 and 2016 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 2017 financial guidance is also being provided on both a reported and a non-GAAP basis.
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 2016 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. 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 June 30, 2017
| % Change vs. 2Q16 | ||||||||||||||
| Net Revenues (in millions) | International | Total | ||||||||||||
| U.S. | Int'l. | Total | U.S. | Operational | Reported | Operational | Reported | |||||||
| ADJUSTED NET REVENUES a | $4,646 | $2,298 | $6,944 | 13.3% | 1.0% | (1.5)% | 8.9% | 8.0% | ||||||
| Humira | 3,201 | 1,515 | 4,716 | 18.0 | 9.1 | 5.5 | 14.9 | 13.7 | ||||||
| Imbruvica b | 528 | 98 | 626 | 37.6 | 77.0 | 77.0 | 42.6 | 42.6 | ||||||
| Viekira | 26 | 199 | 225 | (70.1) | (39.5) | (40.1) | (45.9) | (46.4) | ||||||
| Lupron | 172 | 38 | 210 | (3.5) | (2.9) | (4.8) | (3.5) | (3.8) | ||||||
| Creon | 196 | - | 196 | 9.5 | n/a | n/a | 9.5 | 9.5 | ||||||
| Synagis | - | 40 | 40 | n/a | (9.3) | (10.7) | (9.3) | (10.7) | ||||||
| Synthroid | 193 | - | 193 | 2.3 | n/a | n/a | 2.3 | 2.3 | ||||||
| AndroGel | 154 | - | 154 | (10.3) | n/a | n/a | (10.3) | (10.3) | ||||||
| Kaletra | 19 | 91 | 110 | (38.6) | (24.5) | (21.1) | (27.4) | (24.7) | ||||||
| Sevoflurane | 19 | 85 | 104 | (7.7) | (5.2) | (8.0) | (5.7) | (8.0) | ||||||
| Duodopa | 14 | 67 | 81 | 76.3 | 8.2 | 4.5 | 16.0 | 12.7 |
Note: "Operational" growth reflects the percentage change over the prior year excluding the impact of exchange rate fluctuations.
n/a = not applicable
Key Product Revenues
Six Months Ended June 30, 2017
| % Change vs. 6M16 | ||||||||||||||
| Net Revenues (in millions) | International | Total | ||||||||||||
| U.S. | Int'l. | Total | U.S. | Operational | Reported | Operational | Reported | |||||||
| ADJUSTED NET REVENUES a | $8,698 | $4,784 | $13,482 | 14.5% | 1.5% | (0.2)% | 9.5% | 8.8% | ||||||
| Humira | 5,897 | 2,937 | 8,834 | 20.1 | 6.9 | 4.2 | 15.3 | 14.3 | ||||||
| Imbruvica b | 985 | 192 | 1,177 | 39.0 | 72.4 | 72.4 | 43.6 | 43.6 | ||||||
| Viekira | 64 | 424 | 488 | (69.8) | (30.8) | (31.6) | (40.8) | (41.4) | ||||||
| Lupron | 327 | 77 | 404 | (1.0) | (1.6) | (1.9) | (1.1) | (1.2) | ||||||
| Creon | 381 | - | 381 | 15.6 | n/a | n/a | 15.6 | 15.6 | ||||||
| Synagis | - | 340 | 340 | n/a | (8.3) | (6.5) | (8.3) | (6.5) | ||||||
| Synthroid | 385 | - | 385 | 4.0 | n/a | n/a | 4.0 | 4.0 | ||||||
| AndroGel | 290 | - | 290 | (11.5) | n/a | n/a | (11.5) | (11.5) | ||||||
| Kaletra | 38 | 187 | 225 | (40.2) | (16.2) | (13.4) | (21.6) | (19.4) | ||||||
| Sevoflurane | 37 | 174 | 211 | (3.8) | (4.1) | (6.4) | (4.1) | (6.0) | ||||||
| Duodopa | 28 | 133 | 161 | 80.2 | 10.0 | 6.6 | 17.9 | 14.8 |
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 Six Months Ended June 30, 2017 and 2016
(Unaudited) (In millions, except per share data)
| Second Quarter Ended June 30 | Six Months Ended June 30 | ||||||||||||||
| 2017 | 2016 | 2017 | 2016 | ||||||||||||
| Net revenues | $ | 6,944 | $ | 6,452 | $ | 13,482 | $ | 12,410 | |||||||
| Cost of products sold | 1,528 | 1,405 | 3,144 | 2,774 | |||||||||||
| Selling, general and administrative | 1,504 | 1,466 | 2,872 | 2,821 | |||||||||||
| Research and development | 1,223 | 1,124 | 2,358 | 2,070 | |||||||||||
| Acquired in-process research and development | 15 | 70 | 15 | 80 | |||||||||||
| Total operating cost and expenses | 4,270 | 4,065 | 8,389 | 7,745 | |||||||||||
| Operating earnings | 2,674 | 2,387 | 5,093 | 4,665 | |||||||||||
| Interest expense, net | 253 | 225 | 500 | 425 | |||||||||||
| Net foreign exchange loss | 6 | 15 | 19 | 317 | |||||||||||
| Other expense, net | 62 | 51 | 135 | 51 | |||||||||||
| Earnings before income tax expense | 2,353 | 2,096 | 4,439 | 3,872 | |||||||||||
| Income tax expense | 438 | 486 | 813 | 908 | |||||||||||
| Net earnings | $ | 1,915 | $ | 1,610 | $ | 3,626 | $ | 2,964 | |||||||
| Diluted earnings per share | $ | 1.19 | $ | 0.98 | $ | 2.25 | $ | 1.81 | |||||||
| Adjusted diluted earnings per share a | $ | 1.42 | $ | 1.26 | $ | 2.70 | $ | 2.41 | |||||||
| Weighted-average diluted shares outstanding | 1,600 | 1,632 | 1,602 | 1,629 |
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended June 30, 2017
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
| 2Q17 | |||||||||||
| Earnings | Diluted | ||||||||||
| Pre-tax | After-tax | EPS | |||||||||
| As reported (GAAP) | $ | 2,353 | $ | 1,915 | $ | 1.19 | |||||
| Adjusted for specified items: | |||||||||||
| Intangible asset amortization | 269 | 202 | 0.12 | ||||||||
| Milestones and other R&D expenses | 8 | 8 | 0.01 | ||||||||
| Acquired IPR&D | 15 | 15 | 0.01 | ||||||||
| Acquisition related costs | 35 | 24 | 0.01 | ||||||||
| Change in fair value of contingent consideration | 61 | 61 | 0.04 | ||||||||
| Litigation reserves | 93 | 62 | 0.04 | ||||||||
| Other | 3 | 2 | - | ||||||||
| As adjusted (non-GAAP) | $ | 2,837 | $ | 2,289 | $ | 1.42 |
Milestones and other R&D expenses are associated with milestone payments for previously announced collaborations. Acquired IPR&D primarily reflects an upfront payment related to a licensing arrangement with a third party. Acquisition related costs primarily includes the amortization of the acquisition date fair value step-up for inventory related to the acquisition of Pharmacyclics. Other includes restructuring charges associated with streamlining global operations.
2. The impact of the specified items by line item was as follows:
| 2Q17 | |||||||||||||||||||
| Cost of products sold | SG&A | R&D | Acquired IPR&D | Other expense, net | |||||||||||||||
| As reported (GAAP) | $ | 1,528 | $ | 1,504 | $ | 1,223 | $ | 15 | $ | 62 | |||||||||
| Adjusted for specified items: | |||||||||||||||||||
| Intangible asset amortization | (269 | ) | - | - | - | - | |||||||||||||
| Milestones and other R&D expenses | - | - | (8 | ) | - | - | |||||||||||||
| Acquired IPR&D | - | - | - | (15 | ) | - | |||||||||||||
| Acquisition related costs | (26 | ) | (5 | ) | (3 | ) | - | (1 | ) | ||||||||||
| Change in fair value of contingent consideration | - | - | - | - | (61 | ) | |||||||||||||
| Litigation reserves | - | (93 | ) | - | - | - | |||||||||||||
| Other | (2 | ) | (1 | ) | - | - | - | ||||||||||||
| As adjusted (non-GAAP) | $ | 1,231 | $ | 1,405 | $ | 1,212 | $ | - | $ | - |
3. The adjusted tax rate for the second quarter of 2017 was 19.3 percent, as detailed below:
| 2Q17 | ||||||||||
| Pre-tax income | Income taxes | Tax rate | ||||||||
| As reported (GAAP) | $ | 2,353 | $ | 438 | 18.6 | % | ||||
| Specified items | 484 | 110 | 22.7 | % | ||||||
| As adjusted (non-GAAP) | $ | 2,837 | $ | 548 | 19.3 | % |
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Quarter Ended June 30, 2016
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
| 2Q16 | |||||||||||
| Earnings | Diluted | ||||||||||
| Pre-tax | After-tax | EPS | |||||||||
| As reported (GAAP) | $ | 2,096 | $ | 1,610 | $ | 0.98 | |||||
| Adjusted for specified items: | |||||||||||
| Intangible asset amortization | 181 | 144 | 0.09 | ||||||||
| Milestones and other R&D expenses | 55 | 55 | 0.03 | ||||||||
| Acquired IPR&D | 70 | 70 | 0.04 | ||||||||
| Acquisition related costs | 145 | 122 | 0.08 | ||||||||
| Change in fair value of contingent consideration | 41 | 41 | 0.02 | ||||||||
| Other | 4 | 30 | 0.02 | ||||||||
| As adjusted (non-GAAP) | $ | 2,592 | $ | 2,072 | $ | 1.26 |
Milestones and other R&D expenses are associated with milestone payments for previously announced collaborations. Acquired IPR&D primarily reflects upfront payments related to licensing arrangements with third parties. Acquisition related costs primarily includes compensation expense, financing and other costs associated with the acquisition of Stemcentrx and Boehringer Ingelheim compounds, as well as the amortization of the acquisition date fair value step-up for inventory related to the acquisition of Pharmacyclics. Other includes restructuring charges associated with streamlining global operations, a charge to increase tax reserves and milestone revenue under a previously announced collaboration.
2. The impact of the specified items by line item was as follows:
| 2Q16 | |||||||||||||||||||||||
| Net revenues | Cost of products sold | SG&A | R&D | Acquired IPR&D | Other expense, net | ||||||||||||||||||
| As reported (GAAP) | $ | 6,452 | $ | 1,405 | $ | 1,466 | $ | 1,124 | $ | 70 | $ | 51 | |||||||||||
| Adjusted for specified items: | |||||||||||||||||||||||
| Intangible asset amortization | - | (181 | ) | - | - | - | - | ||||||||||||||||
| Milestones and other R&D expenses | - | - | - | (55 | ) | - | - | ||||||||||||||||
| Acquired IPR&D | - | - | - | - | (70 | ) | - | ||||||||||||||||
| Acquisition related costs | - | (46 | ) | (15 | ) | (72 | ) | - | (12 | ) | |||||||||||||
| Change in fair value of contingent consideration | - | - | - | - | - | (41 | ) | ||||||||||||||||
| Other | (20 | ) | (9 | ) | (15 | ) | - | - | - | ||||||||||||||
| As adjusted (non-GAAP) | $ | 6,432 | $ | 1,169 | $ | 1,436 | $ | 997 | $ | - | $ | (2 | ) |
3. The adjusted tax rate for the second quarter of 2016 was 20.1 percent, as detailed below:
| 2Q16 | ||||||||||
| Pre-tax income | Income taxes | Tax rate | ||||||||
| As reported (GAAP) | $ | 2,096 | $ | 486 | 23.2 | % | ||||
| Specified items | 496 | 34 | 6.9 | % | ||||||
| As adjusted (non-GAAP) | $ | 2,592 | $ | 520 | 20.1 | % |
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Six Months Ended June 30, 2017
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
| 6M17 | |||||||||||
| Earnings | Diluted | ||||||||||
| Pre-tax | After-tax | EPS | |||||||||
| As reported (GAAP) | $ | 4,439 | $ | 3,626 | $ | 2.25 | |||||
| Adjusted for specified items: | |||||||||||
| Intangible asset amortization | 540 | 405 | 0.25 | ||||||||
| Milestones and other R&D expenses | 36 | 36 | 0.02 | ||||||||
| Acquired IPR&D | 15 | 15 | 0.01 | ||||||||
| Acquisition related costs | 73 | 49 | 0.03 | ||||||||
| Change in fair value of contingent consideration | 146 | 145 | 0.09 | ||||||||
| Litigation reserves | 93 | 62 | 0.04 | ||||||||
| Other | 13 | 11 | 0.01 | ||||||||
| As adjusted (non-GAAP) | $ | 5,355 | $ | 4,349 | $ | 2.70 |
Milestones and other R&D expenses are associated with milestone payments for previously announced collaborations. Acquired IPR&D primarily reflects an upfront payment related to a licensing arrangement with a third party. Acquisition related costs primarily includes the amortization of the acquisition date fair value step-up for inventory related to the acquisition of Pharmacyclics. Other includes restructuring charges associated with streamlining global operations.
2. The impact of the specified items by line item was as follows:
| 6M17 | |||||||||||||||||||
| Cost of products sold | SG&A | R&D | Acquired IPR&D | Other expense, net | |||||||||||||||
| As reported (GAAP) | $ | 3,144 | $ | 2,872 | $ | 2,358 | $ | 15 | $ | 135 | |||||||||
| Adjusted for specified items: | |||||||||||||||||||
| Intangible asset amortization | (540 | ) | - | - | - | - | |||||||||||||
| Milestones and other R&D expenses | - | - | (36 | ) | - | - | |||||||||||||
| Acquired IPR&D | - | - | - | (15 | ) | - | |||||||||||||
| Acquisition related costs | (52 | ) | (14 | ) | (5 | ) | - | (2 | ) | ||||||||||
| Change in fair value of contingent consideration | - | - | - | - | (146 | ) | |||||||||||||
| Litigation reserves | - | (93 | ) | - | - | - | |||||||||||||
| Other | (8 | ) | (5 | ) | - | - | - | ||||||||||||
| As adjusted (non-GAAP) | $ | 2,544 | $ | 2,760 | $ | 2,317 | $ | - | $ | (13 | ) |
3. The adjusted tax rate for the first six months of 2017 was 18.8 percent, as detailed below:
| 6M17 | ||||||||||
| Pre-tax income | Income taxes | Tax rate | ||||||||
| As reported (GAAP) | $ | 4,439 | $ | 813 | 18.3 | % | ||||
| Specified items | 916 | 193 | 21.0 | % | ||||||
| As adjusted (non-GAAP) | $ | 5,355 | $ | 1,006 | 18.8 | % |
Reconciliation of GAAP Reported to Non-GAAP Adjusted Information
Six Months Ended June 30, 2016
(Unaudited) (In millions, except per share data)
1. Specified items impacted results as follows:
| 6M16 | |||||||||||
| Earnings | Diluted | ||||||||||
| Pre-tax | After-tax | EPS | |||||||||
| As reported (GAAP) | $ | 3,872 | $ | 2,964 | $ | 1.81 | |||||
| Adjusted for specified items: | |||||||||||
| Intangible asset amortization | 346 | 277 | 0.17 | ||||||||
| Milestones and other R&D expenses | 70 | 70 | 0.04 | ||||||||
| Acquired IPR&D | 80 | 80 | 0.05 | ||||||||
| Acquisition related costs | 204 | 159 | 0.11 | ||||||||
| Change in fair value of contingent consideration | 41 | 41 | 0.02 | ||||||||
| Venezuela devaluation loss | 298 | 298 | 0.18 | ||||||||
| Other | 44 | 57 | 0.03 | ||||||||
| As adjusted (non-GAAP) | $ | 4,955 | $ | 3,946 | $ | 2.41 |
Milestones and other R&D expenses are associated with milestone payments for previously announced collaborations. Acquired IPR&D primarily reflects upfront payments related to licensing arrangements with third parties. Acquisition related costs primarily includes compensation expense, financing and other costs associated with the acquisition of Stemcentrx and Boehringer Ingelheim compounds, as well as the amortization of the acquisition date fair value step-up for inventory related to the acquisition of Pharmacyclics. Other includes a charge for the impairment of an intangible asset, restructuring charges associated with streamlining global operations, a charge to increase tax reserves and milestone revenue under a previously announced collaboration.
2. The impact of the specified items by line item was as follows:
| 6M16 | |||||||||||||||||||||||||||
| Net revenues | Cost of products sold | SG&A | R&D | Acquired IPR&D | Net foreign exchange loss | Other expense, net | |||||||||||||||||||||
| As reported (GAAP) | $ | 12,410 | $ | 2,774 | $ | 2,821 | $ | 2,070 | $ | 80 | $ | 317 | $ | 51 | |||||||||||||
| Adjusted for specified items: | |||||||||||||||||||||||||||
| Intangible asset amortization | - | (346 | ) | - | - | - | - | - | |||||||||||||||||||
| Milestones and other R&D expenses | - | - | - | (70 | ) | - | - | - | |||||||||||||||||||
| Acquired IPR&D | - | - | - | - | (80 | ) | - | - | |||||||||||||||||||
| Acquisition related costs | - | (91 | ) | (20 | ) | (81 | ) | - | - | (12 | ) | ||||||||||||||||
| Change in fair value of contingent consideration | - | - | - | - | - | - | (41 | ) | |||||||||||||||||||
| Venezuela devaluation loss | - | - | - | - | - | (298 | ) | - | |||||||||||||||||||
| Other | (20 | ) | (53 | ) | (18 | ) | 7 | - | - | - | |||||||||||||||||
| As adjusted (non-GAAP) | $ | 12,390 | $ | 2,284 | $ | 2,783 | $ | 1,926 | $ | - | $ | 19 | $ | (2 | ) |
3. The adjusted tax rate for the first six months of 2016 was 20.4 percent, as detailed below:
| 6M16 | ||||||||||
| Pre-tax income | Income taxes | Tax rate | ||||||||
| As reported (GAAP) | $ | 3,872 | $ | 908 | 23.4 | % | ||||
| Specified items | 1,083 | 101 | 9.4 | % | ||||||
| As adjusted (non-GAAP) | $ | 4,955 | $ | 1,009 | 20.4 | % |