Full Press Release Details
NORTH CHICAGO, Ill. , April 29, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV ) announced financial results for the first quarter ended March 31, 2022 .
"This year is off to a strong start. Our first quarter results highlight the diversity of our portfolio and include compelling performance from key growth drivers Skyrizi, Rinvoq, Aesthetics and Neuroscience," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "Our momentum combined with ramping contributions from new products and new indications will drive accelerating revenue and EPS growth through the rest of the year."
| Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. |
| 1 Beginning in the first quarter 2022, AbbVie includes the impact of upfront and milestone payments related to collaborations, licensing agreements and other asset acquisitions in its reported non-GAAP financial measures. |
First-Quarter Results
Full-Year 2022 Outlook
AbbVie is updating its adjusted diluted EPS guidance range for the full-year 2022 from $14.00 - $14.20 to $13.92 - $14.12 which includes an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense incurred during the first quarter 2022. The company's 2022 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2022, as both cannot be reliably forecasted.
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 and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , LinkedIn or Instagram .
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 2022 and 2021 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. Beginning in the first quarter of 2022, the company includes the impact of upfront and milestone payments related to collaborations, licensing agreements, and other asset acquisitions in its reported non-GAAP financial measures. Prior periods have been revised to conform to the current period presentation. 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.
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 2021 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, 2022 (Unaudited) | |||||||||||||||
| % Change vs. 1Q21 | |||||||||||||||
| Net Revenues (in millions) | Reported | Operational a | |||||||||||||
| U.S. | Int'l. | Total | U.S. | Int'l. | Total | Int'l. | Total | ||||||||
| NET REVENUES | $10,348 | $3,190 | $13,538 | 6.1% | (2.1)% | 4.1% | 3.2% | 5.4% | |||||||
| Immunology | 5,085 | 1,056 | 6,141 | 9.7 | (4.9) | 6.9 | 1.1 | 8.1 | |||||||
| Humira | 3,993 | 743 | 4,736 | 2.2 | (22.6) | (2.7) | (17.9) | (1.8) | |||||||
| Skyrizi | 781 | 159 | 940 | 62.3 | 71.2 | 63.7 | 82.9 | 65.6 | |||||||
| Rinvoq | 311 | 154 | 465 | 26.8 | >100.0 | 53.6 | >100.0 | 57.3 | |||||||
| Hematologic Oncology | 1,102 | 544 | 1,646 | (9.8) | 20.9 | (1.6) | 24.7 | (0.6) | |||||||
| Imbruvica b | 874 | 299 | 1,173 | (12.4) | 11.0 | (7.4) | 11.0 | (7.4) | |||||||
| Venclexta | 228 | 245 | 473 | 1.7 | 35.8 | 16.9 | 45.2 | 21.1 | |||||||
| Aesthetics | 846 | 528 | 1,374 | 16.3 | 27.9 | 20.5 | 33.5 | 22.5 | |||||||
| Botox Cosmetic | 413 | 228 | 641 | 35.5 | 32.5 | 34.4 | 38.6 | 36.6 | |||||||
| Juvederm Collection | 148 | 262 | 410 | 20.1 | 32.2 | 27.5 | 37.7 | 30.9 | |||||||
| Other Aesthetics | 285 | 38 | 323 | (4.9) | (9.9) | (5.5) | (6.2) | (5.0) | |||||||
| Neuroscience | 1,273 | 215 | 1,488 | 22.7 | 2.0 | 19.2 | 8.8 | 20.4 | |||||||
| Botox Therapeutic | 500 | 114 | 614 | 16.5 | 10.7 | 15.4 | 17.1 | 16.6 | |||||||
| Vraylar | 427 | — | 427 | 23.4 | n/a | 23.4 | n/a | 23.4 | |||||||
| Duodopa | 24 | 97 | 121 | (5.6) | (6.9) | (6.7) | 0.5 | (0.8) | |||||||
| Ubrelvy | 138 | — | 138 | 70.0 | n/a | 70.0 | n/a | 70.0 | |||||||
| Qulipta | 11 | — | 11 | n/m | n/a | n/m | n/a | n/m | |||||||
| Other Neuroscience | 173 | 4 | 177 | 11.0 | 11.4 | 11.0 | 12.2 | 11.0 | |||||||
| Eye Care | 496 | 275 | 771 | (6.3) | (4.2) | (5.6) | 3.7 | (2.8) | |||||||
| Lumigan/Ganfort | 67 | 73 | 140 | 1.5 | (5.7) | (2.4) | 0.7 | 1.0 | |||||||
| Alphagan/Combigan | 70 | 37 | 107 | (11.5) | (3.9) | (9.0) | 5.5 | (6.0) | |||||||
| Restasis | 235 | 11 | 246 | (11.9) | (18.1) | (12.2) | 1.9 | (11.3) | |||||||
| Other Eye Care | 124 | 154 | 278 | 5.5 | (2.4) | 0.9 | 4.8 | 5.1 | |||||||
| Other Key Products | 689 | 218 | 907 | 4.3 | (13.4) | (0.6) | (6.7) | 1.2 | |||||||
| Mavyret | 169 | 211 | 380 | (1.0) | (13.9) | (8.6) | (7.2) | (4.6) | |||||||
| Creon | 287 | — | 287 | 4.7 | n/a | 4.7 | n/a | 4.7 | |||||||
| Linzess/Constella | 233 | 7 | 240 | 7.9 | 6.0 | 7.8 | 10.2 | 7.9 |
| a | "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates. |
| b | Reflects profit sharing for Imbruvica international revenues. |
| n/a = not applicable | |
| n/m = not meaningful |
| AbbVie Inc. Consolidated Statements of Earnings Quarter Ended March 31, 2022 and 2021 (Unaudited) (In millions, except per share data) | |||||||||||||||||||||||
| First Quarter Ended March 31 | |||||||||||||||||||||||
| 2022 | 2021 | ||||||||||||||||||||||
| Net revenues | $ 13,538 | $ 13,010 | |||||||||||||||||||||
| Cost of products sold | 4,052 | 4,213 | |||||||||||||||||||||
| Selling, general and administrative | 3,127 | 2,842 | |||||||||||||||||||||
| Research and development a | 1,497 | 1,667 | |||||||||||||||||||||
| Acquired IPR&D and milestones a | 145 | 185 | |||||||||||||||||||||
| Total operating costs and expenses | 8,821 | 8,907 | |||||||||||||||||||||
| Operating earnings | 4,717 | 4,103 | |||||||||||||||||||||
| Interest expense, net | 539 | 622 | |||||||||||||||||||||
| Net foreign exchange loss | 25 | 9 | |||||||||||||||||||||
| Other income, net | (776) | (395) | |||||||||||||||||||||
| Earnings before income tax expense | 4,929 | 3,867 | |||||||||||||||||||||
| Income tax expense | 436 | 312 | |||||||||||||||||||||
| Net earnings | 4,493 | 3,555 | |||||||||||||||||||||
| Net earnings attributable to noncontrolling interest | 3 | 2 | |||||||||||||||||||||
| Net earnings attributable to AbbVie Inc. | $ 4,490 | $ 3,553 | |||||||||||||||||||||
| Diluted earnings per share attributable to AbbVie Inc. | $ 2.51 | $ 1.99 | |||||||||||||||||||||
| Adjusted diluted earnings per share b | $ 3.16 | $ 2.89 | |||||||||||||||||||||
| Weighted-average diluted shares outstanding | 1,778 | 1,775 |
| a | During the three months ended March 31, 2022, AbbVie changed its classification of development milestone expense associated with licensing and collaboration arrangements in the consolidated statement of earnings. Milestone payments incurred prior to regulatory approval, which were previously included in research and development expense, are now presented as acquired IPR&D and milestones expense. The reclassification decreased research and development expense and increased acquired IPR&D and milestones expense by $115 million for the three months ended March 31, 2021. The company believes this presentation assists users of the financial statements to better understand the total upfront and subsequent development milestone payments incurred to acquire in-process research and development projects. Prior periods have been revised to conform to the current period presentation. The reclassification had no impact on total operating costs and expenses, operating earnings, net earnings, net earnings attributable to AbbVie, Inc., earnings per share, or total equity. |
| b | Refer to the Reconciliation of GAAP Reported to Non-GAAP Adjusted Information for further details. |
| AbbVie Inc. Reconciliation of GAAP Reported to Non-GAAP Adjusted Information Quarter Ended March 31, 2022 (Unaudited) (In millions, except per share data) | |||||||
| 1. Specified items impacted results as follows: | |||||||
| 1Q22 | |||||||
| Earnings | Diluted | ||||||
| Pre-tax | After-tax a | EPS | |||||
| As reported (GAAP) | $ 4,929 | $ 4,490 | $ 2.51 | ||||
| Adjusted for specified items: | |||||||
| Intangible asset amortization | 1,855 | 1,565 | 0.88 | ||||
| Acquisition and integration costs | 138 | 121 | 0.07 | ||||
| Change in fair value of contingent consideration | (748) | (746) | (0.42) | ||||
| Litigation matters | 184 | 148 | 0.08 | ||||
| Other | 64 | 63 | 0.04 | ||||
| As adjusted (non-GAAP) | $ 6,422 | $ 5,641 | $ 3.16 | ||||
| a Represents net earnings attributable to AbbVie Inc. | |||||||
| Acquisition and integration costs reflect integration costs related to the Allergan acquisition. Other primarily includes restructuring charges associated with streamlining global operations. | |||||||
| Beginning in the first quarter of 2022, the company includes the impact of upfront and milestone payments related to collaborations, licensing agreements, and other asset acquisitions in its reported non-GAAP financial measures. Reported GAAP earnings and adjusted non-GAAP earnings for the first quarter of 2022 included acquired IPR&D and milestones expense of $145 million on a pre-tax and after-tax basis, representing an unfavorable impact of $0.08 to both diluted EPS and adjusted diluted EPS. | |||||||
| 2. The impact of the specified items by line item was as follows: | |||||||
| 1Q22 | |||||||
| Cost of products sold | SG&A | R&D | Other income, net | ||||
| As reported (GAAP) | $ 4,052 | $ 3,127 | $ 1,497 | $ (776) | |||
| Adjusted for specified items: | |||||||
| Intangible asset amortization | (1,855) | — | — | — | |||
| Acquisition and integration costs | (34) | (93) | (11) | — | |||
| Change in fair value of contingent consideration | — | — | — | 748 | |||
| Litigation matters | — | (184) | — | — | |||
| Other | (60) | 2 | (6) | — | |||
| As adjusted (non-GAAP) | $ 2,103 | $ 2,852 | $ 1,480 | $ (28) | |||
| 3. The adjusted tax rate for the first quarter of 2022 was 12.1 percent, as detailed below: | |||||||
| 1Q22 | |||||||
| Pre-tax earnings | Income taxes | Tax rate | |||||
| As reported (GAAP) | $ 4,929 | $ 436 | 8.8% | ||||
| Specified items | 1,493 | 342 | 22.9% | ||||
| As adjusted (non-GAAP) | $ 6,422 | $ 778 | 12.1% |
| 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 | ||||
| Acquisition and integration costs | 224 | 155 | 0.09 | ||||
| Change in fair value of contingent consideration | (343) | (343) | (0.19) | ||||
| Other | 141 | 112 | 0.06 | ||||
| As adjusted (non-GAAP) | $ 5,898 | $ 5,159 | $ 2.89 | ||||
| a Represents net earnings attributable to AbbVie Inc. | |||||||
| 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. Other primarily includes the purchase of an FDA priority review voucher from a third party, restructuring charges associated with streamlining global operations and COVID-19 related expenses. | |||||||
| Beginning in the first quarter of 2022, the company includes upfront and milestone payments related to collaborations, licensing agreements, and other asset acquisitions in its reported non-GAAP financial measures. Reported GAAP earnings and adjusted non-GAAP earnings for the first quarter of 2021 included acquired IPR&D and milestones expense of $185 million on a pre-tax and $168 million on an after-tax basis, representing an unfavorable impact of $0.09 to both diluted EPS and adjusted diluted EPS. | |||||||
| 2. The impact of the specified items by line item was as follows: | |||||||
| 1Q21 | |||||||
| Cost of products sold | SG&A | R&D | Other income, net | ||||
| As reported (GAAP) | $ 4,213 | $ 2,842 | $ 1,667 | $ (395) | |||
| Adjusted for specified items: | |||||||
| Intangible asset amortization | (2,009) | — | — | — | |||
| Acquisition and integration costs | (99) | (76) | (49) | — | |||
| Change in fair value of contingent consideration | — | — | — | 343 | |||
| Other | (20) | (23) | (113) | 15 | |||
| As adjusted (non-GAAP) | $ 2,085 | $ 2,743 | $ 1,505 | $ (37) | |||
| 3. The adjusted tax rate for the first quarter of 2021 was 12.5 percent, as detailed below: | |||||||
| 1Q21 | |||||||
| Pre-tax earnings | Income taxes | Tax rate | |||||
| As reported (GAAP) | $ 3,867 | $ 312 | 8.1% | ||||
| Specified items | 2,031 | 425 | 20.9% | ||||
| As adjusted (non-GAAP) | $ 5,898 | $ 737 | 12.5% |