Full Press Release Details
NORTH CHICAGO, Ill., April 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV ) announced financial results for the first quarter ended March 31, 2021 .
"We are off to an excellent start to 2021, with strong performance across our core therapeutic areas and first quarter revenue and earnings results ahead of our expectations," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "Our new products are delivering impressive performance and we are on the cusp of potential commercial approvals for more than a dozen new products or indications over the next two years – including five expected approvals in 2021."
First-Quarter Results
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.
Full-Year 2021 Outlook
AbbVie is raising its GAAP diluted EPS guidance for the full-year 2021 from $6.69 to $6.89 to $7.27 to $7.47 . AbbVie is raising its adjusted diluted EPS for the full-year 2021 from $12.32 to $12.52 to $12.37 to $12.57 . The company's 2021 adjusted diluted EPS guidance excludes $5.10 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.
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 first-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 2021 and 2020 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 2021 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, the failure to realize the expected benefits of AbbVie's acquisition of Allergan or to promptly and effectively integrate Allergan's business, 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 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. 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.
| AbbVie Inc. Key Product Revenues Quarter Ended March 31, 2021 (Unaudited) | |||||||||||||||||
| % Change vs. 1Q20 | |||||||||||||||||
| Net Revenues (in millions) | Reported | Comparable Operational a, b | |||||||||||||||
| U.S. | Int'l. | Total | U.S. | Int'l. | Total | U.S. | Int'l | Total | |||||||||
| ADJUSTED NET REVENUES c | $9,675 | $3,260 | $12,935 | 57.1% | 32.5% | 50.1% | 7.3% | (0.7)% | 5.2% | ||||||||
| Immunology | 4,633 | 1,111 | 5,744 | 15.7 | 2.3 | 12.9 | 15.7 | (2.8) | 11.8 | ||||||||
| Humira | 3,907 | 960 | 4,867 | 6.9 | (8.3) | 3.5 | 6.9 | (12.6) | 2.6 | ||||||||
| Skyrizi | 481 | 93 | 574 | 80.6 | >100.0 | 91.1 | 80.6 | >100.0 | 88.9 | ||||||||
| Rinvoq | 245 | 58 | 303 | >100.0 | >100.0 | >100.0 | >100.0 | >100.0 | >100.0 | ||||||||
| Hematologic Oncology | 1,224 | 449 | 1,673 | 4.8 | 17.7 | 8.0 | 4.8 | 14.9 | 7.3 | ||||||||
| Imbruvica d | 999 | 269 | 1,268 | 3.3 | 1.4 | 2.9 | 3.3 | 1.4 | 2.9 | ||||||||
| Venclexta | 225 | 180 | 405 | 12.2 | 54.9 | 27.9 | 12.2 | 45.6 | 24.5 | ||||||||
| Aesthetics | 728 | 413 | 1,141 | n/m | n/m | n/m | 23.8 | 61.2 | 34.9 | ||||||||
| Botox Cosmetic* | 305 | 172 | 477 | n/m | n/m | n/m | 43.1 | 47.7 | 44.7 | ||||||||
| Juvederm Collection* | 123 | 198 | 321 | n/m | n/m | n/m | 14.9 | 69.6 | 43.0 | ||||||||
| Other Aesthetics* | 300 | 43 | 343 | n/m | n/m | n/m | 12.1 | 87.4 | 17.8 | ||||||||
| Neuroscience | 1,037 | 211 | 1,248 | >100.0 | >100.0 | >100.0 | 12.9 | 1.5 | 10.9 | ||||||||
| Botox Therapeutic* | 429 | 103 | 532 | n/m | n/m | n/m | 6.7 | 8.0 | 7.0 | ||||||||
| Vraylar* | 346 | — | 346 | n/m | n/a | n/m | 21.2 | n/a | 21.2 | ||||||||
| Duodopa | 25 | 104 | 129 | 0.8 | 4.7 | 3.9 | 0.8 | (4.5) | (3.4) | ||||||||
| Ubrelvy* | 81 | — | 81 | n/m | n/a | n/m | >100.0 | n/a | >100.0 | ||||||||
| Other Neuroscience* | 156 | 4 | 160 | n/m | n/m | n/m | (19.5) | 2.0 | (19.1) | ||||||||
| Eye Care | 530 | 287 | 817 | n/m | n/m | n/m | (12.7) | (1.8) | (9.2) | ||||||||
| Lumigan/Ganfort* | 66 | 77 | 143 | n/m | n/m | n/m | (18.4) | (9.7) | (14.1) | ||||||||
| Alphagan/Combigan* | 80 | 38 | 118 | n/m | n/m | n/m | (13.5) | 4.1 | (8.5) | ||||||||
| Restasis* | 267 | 13 | 280 | n/m | n/m | n/m | (14.9) | 19.3 | (13.8) | ||||||||
| Other Eye Care* | 117 | 159 | 276 | n/m | n/m | n/m | (2.4) | (0.4) | (1.3) | ||||||||
| Women's Health | 177 | 3 | 180 | >100.0 | >100.0 | >100.0 | (19.6) | (61.0) | (21.2) | ||||||||
| Lo Loestrin* | 102 | 2 | 104 | n/m | n/m | n/m | (11.2) | (8.1) | (11.1) | ||||||||
| Orilissa/Oriahnn | 29 | 1 | 30 | (5.0) | 58.8 | (3.3) | (5.0) | 52.8 | (3.5) | ||||||||
| Other Women's Health* | 46 | — | 46 | n/m | n/m | n/m | (38.1) | (100.0) | (42.8) | ||||||||
| Other Key Products | 1,021 | 294 | 1,315 | 12.4 | (19.1) | 3.4 | (7.3) | (25.1) | (11.7) | ||||||||
| Mavyret | 170 | 245 | 415 | (26.9) | (24.8) | (25.7) | (26.9) | (29.5) | (28.4) | ||||||||
| Creon | 274 | — | 274 | (0.9) | n/a | (0.9) | (0.9) | n/a | (0.9) | ||||||||
| Lupron | 171 | 42 | 213 | (12.1) | 10.8 | (8.3) | (12.1) | 9.0 | (8.6) | ||||||||
| Linzess/Constella* | 215 | 7 | 222 | n/m | n/m | n/m | 11.7 | (6.6) | 11.1 | ||||||||
| Synthroid | 191 | — | 191 | (6.8) | n/a | (6.8) | (6.8) | n/a | (6.8) |
| a "Comparable Operational" comparisons include full-quarter current year and prior year results for Allergan products, 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. |
| 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 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. |
| 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 |
| AbbVie Inc. Consolidated Statements of Earnings Quarter Ended March 31, 2021 and 2020 (Unaudited) (In millions, except per share data) | ||||||||
| First Quarter Ended March 31 | ||||||||
| 2021 | 2020 | |||||||
| Net revenues | $ | 13,010 | $ | 8,619 | ||||
| Cost of products sold | 4,213 | 1,942 | ||||||
| Selling, general and administrative | 2,842 | 1,695 | ||||||
| Research and development | 1,782 | 1,379 | ||||||
| Acquired in-process research and development | 70 | — | ||||||
| Total operating costs and expenses | 8,907 | 5,016 | ||||||
| Operating earnings | 4,103 | 3,603 | ||||||
| Interest expense, net | 622 | 428 | ||||||
| Net foreign exchange loss | 9 | 5 | ||||||
| Other expense (income), net | (395) | 72 | ||||||
| Earnings before income tax expense | 3,867 | 3,098 | ||||||
| Income tax expense | 312 | 88 | ||||||
| Net earnings | 3,555 | 3,010 | ||||||
| Net earnings attributable to noncontrolling interest | 2 | — | ||||||
| Net earnings attributable to AbbVie Inc. | $ | 3,553 | $ | 3,010 | ||||
| Diluted earnings per share attributable to AbbVie Inc. | $ | 1.99 | $ | 2.02 | ||||
| Adjusted diluted earnings per share a | $ | 2.95 | $ | 2.42 | ||||
| Weighted-average diluted shares outstanding | 1,775 | 1,484 |
| AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information Quarter Ended March 31, 2021 (Unaudited) (In millions, except per share data) | |||||||||||||||||||||||
| 1. Specified items impacted results as follows: | |||||||||||||||||||||||
| 1Q21 | |||||||||||||||||||||||
| Earnings | Diluted | ||||||||||||||||||||||
| Pre-tax | After-tax a | EPS | |||||||||||||||||||||
| As reported (GAAP) | $ | 3,867 | $ | 3,553 | $ | 1.99 | |||||||||||||||||
| Adjusted for specified items: | |||||||||||||||||||||||
| Intangible asset amortization | 2,009 | 1,682 | 0.94 | ||||||||||||||||||||
| Milestones and other R&D expenses | 210 | 180 | 0.10 | ||||||||||||||||||||
| Acquisition and integration costs | 224 | 155 | 0.09 | ||||||||||||||||||||
| Acquired IPR&D | 70 | 62 | 0.03 | ||||||||||||||||||||
| Change in fair value of contingent consideration | (343) | (343) | (0.19) | ||||||||||||||||||||
| Other | (29) | (21) | (0.01) | ||||||||||||||||||||
| As adjusted (non-GAAP) | $ | 6,008 | $ | 5,268 | $ | 2.95 | |||||||||||||||||
| a Represents net earnings attributable to AbbVie Inc. | |||||||||||||||||||||||
| 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. Acquisition and integration costs reflect integration costs as well as amortization of the acquisition date fair value step-up for inventory related to the Allergan acquisition. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties. Other primarily includes milestone revenue under an existing collaboration agreement, restructuring charges associated with streamlining global operations and COVID-19 related expenses. | |||||||||||||||||||||||
| 2. The impact of the specified items by line item was as follows: | |||||||||||||||||||||||
| 1Q21 | |||||||||||||||||||||||
| Net revenues | Cost of products sold | SG&A | R&D | Acquired IPR&D | Other expense (income), net | ||||||||||||||||||
| As reported (GAAP) | $ | 13,010 | $ | 4,213 | $ | 2,842 | $ | 1,782 | $ | 70 | $ | (395) | |||||||||||
| Adjusted for specified items: | |||||||||||||||||||||||
| Intangible asset amortization | — | (2,009) | — | — | — | — | |||||||||||||||||
| Milestones and other R&D expenses | — | — | — | (210) | — | — | |||||||||||||||||
| Acquisition and integration costs | — | (99) | (76) | (49) | — | — | |||||||||||||||||
| Acquired IPR&D | — | — | — | — | (70) | — | |||||||||||||||||
| Change in fair value of contingent consideration | — | — | — | — | — | 343 | |||||||||||||||||
| Other | (75) | (20) | (23) | (18) | — | 15 | |||||||||||||||||
| As adjusted (non-GAAP) | $ | 12,935 | $ | 2,085 | $ | 2,743 | $ | 1,505 | $ | — | $ | (37) | |||||||||||
| 3. The adjusted tax rate for the first quarter of 2021 was 12.3 percent, as detailed below: | |||||||||||||||||||||||
| 1Q21 | |||||||||||||||||||||||
| Pre-tax earnings | Income taxes | Tax rate | |||||||||||||||||||||
| As reported (GAAP) | $ | 3,867 | $ | 312 | 8.1 | % | |||||||||||||||||
| Specified items | 2,141 | 426 | 19.9 | % | |||||||||||||||||||
| As adjusted (non-GAAP) | $ | 6,008 | $ | 738 | 12.3 | % |
| AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information Quarter Ended March 31, 2020 (Unaudited) (In millions, except per share data) | |||||||||||||||||||
| 1. Specified items impacted results as follows: | |||||||||||||||||||
| 1Q20 | |||||||||||||||||||
| Earnings | Diluted | ||||||||||||||||||
| Pre-tax | After-tax a | EPS | |||||||||||||||||
| As reported (GAAP) | $ | 3,098 | $ | 3,010 | $ | 2.02 | |||||||||||||
| Adjusted for specified items: | |||||||||||||||||||
| Intangible asset amortization | 444 | 371 | 0.24 | ||||||||||||||||
| Acquisition related costs | 188 | 158 | 0.11 | ||||||||||||||||
| Milestones and other R&D expenses | 135 | 115 | 0.08 | ||||||||||||||||
| Change in fair value of contingent consideration | 72 | 72 | 0.05 | ||||||||||||||||
| Other | 66 | (113) | (0.08) | ||||||||||||||||
| As adjusted (non-GAAP) | $ | 4,003 | $ | 3,613 | $ | 2.42 | |||||||||||||
| a Represents net earnings attributable to AbbVie Inc. | |||||||||||||||||||
| Acquisition related costs reflect transaction and financing costs related to the Allergan acquisition. 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, charitable contributions to support COVID-19 relief efforts and restructuring charges associated with streamlining global operations. | |||||||||||||||||||
| 2. The impact of the specified items by line item was as follows: | |||||||||||||||||||
| 1Q20 | |||||||||||||||||||
| Cost of products sold | SG&A | R&D | Interest expense, net | Other expense (income), net | |||||||||||||||
| As reported (GAAP) | $ | 1,942 | $ | 1,695 | $ | 1,379 | $ | 428 | $ | 72 | |||||||||
| Adjusted for specified items: | |||||||||||||||||||
| Intangible asset amortization | (444) | — | — | — | — | ||||||||||||||
| Acquisition related costs | — | (44) | — | (144) | — | ||||||||||||||
| Milestones and other R&D expenses | — | — | (135) | — | — | ||||||||||||||
| Change in fair value of contingent consideration | — | — | — | — | (72) | ||||||||||||||
| Other | (4) | (52) | (10) | — | — | ||||||||||||||
| As adjusted (non-GAAP) | $ | 1,494 | $ | 1,599 | $ | 1,234 | $ | 284 | $ | — | |||||||||
| 3. The adjusted tax rate for the first quarter of 2020 was 9.7 percent, as detailed below: | |||||||||||||||||||
| 1Q20 | |||||||||||||||||||
| Pre-tax earnings | Income taxes | Tax rate | |||||||||||||||||
| As reported (GAAP) | $ | 3,098 | $ | 88 | 2.8 | % | |||||||||||||
| Specified items | 905 | 302 | 33.4 | % | |||||||||||||||
| As adjusted (non-GAAP) | $ | 4,003 | $ | 390 | 9.7 | % |