Life Science News

  • Reports First-Quarter Diluted EPS of $2.51 on a GAAP Basis, an Increase of 26.1 Percent; Adjusted Diluted EPS of $3.16 , an Increase of 9.3 Percent; These Results Include an Unfavorable Impact of $0.08 Per Share related to Acquired IPR&D and Milestones Expense 1
  • Delivers First-Quarter Net Revenues of $13.538 Billion , an Increase of 4.1 Percent on a Reported Basis and 5.4 Percent Operationally
  • First-Quarter Global Net Revenues from the Immunology Portfolio Were $6.141 Billion , an Increase of 6.9 Percent on a Reported Basis, or 8.1 Percent on an Operational Basis; U.S. Humira Net Revenues Were $3.993 Billion , an Increase of 2.2 Percent; Internationally, Humira Net Revenues Were $743 Million , a Decrease of 22.6 Percent on a Reported Basis, or 17.9 Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $940 Million ; Global Rinvoq Net Revenues Were $465 Million
  • First-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.646 Billion , a Decrease of 1.6 Percent on a Reported Basis, or 0.6 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $1.173 Billion , a Decrease of 7.4 Percent , with U.S. Net Revenues of $874 Million and International Profit Sharing of $299 Million ; Global Venclexta Net Revenues Were $473 Million
  • First-Quarter Global Net Revenues from the Neuroscience Portfolio Were $1.488 Billion , an Increase of 19.2 Percent on a Reported Basis, or 20.4 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $614 Million ; Vraylar Net Revenues Were $427 Million
  • First-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.374 Billion , an Increase of 20.5 Percent on a Reported Basis, or 22.5 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $641 Million ; Global Juvederm Net Revenues Were $410 Million
  • Updates 2022 Adjusted Diluted EPS Guidance Range 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

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

  • Worldwide net revenues were $13.538 billion , an increase of 4.1 percent on a GAAP basis, or 5.4 percent on an operational basis.

  • Global net revenues from the immunology portfolio were $6.141 billion , an increase of 6.9 percent on a reported basis, or 8.1 percent on an operational basis.
    • Global Humira net revenues of $4.736 billion decreased 2.7 percent on a reported basis, or 1.8 percent on an operational basis. U.S. Humira net revenues were $3.993 billion , an increase of 2.2 percent. Internationally, Humira net revenues were $743 million , a decrease of 22.6 percent on a reported basis, or 17.9 percent on an operational basis, due to biosimilar competition.
    • Global Skyrizi net revenues were $940 million , an increase of 63.7 percent on a reported basis, or 65.6 percent on an operational basis.
    • Global Rinvoq net revenues were $465 million , an increase of 53.6 percent on a reported basis, or 57.3 percent on an operational basis.
  • Global net revenues from the hematologic oncology portfolio were $1.646 billion , a decrease of 1.6 percent on a reported basis, or 0.6 percent on an operational basis.
    • Global Imbruvica net revenues were $1.173 billion , a decrease of 7.4 percent, with U.S. net revenues of $874 million and international profit sharing of $299 million .
    • Global Venclexta net revenues were $473 million , an increase of 16.9 percent on a reported basis, or 21.1 percent on an operational basis.
  • Global net revenues from the neuroscience portfolio were $1.488 billion , an increase of 19.2 percent on a reported basis, or 20.4 percent on an operational basis.
    • Global Botox Therapeutic net revenues were $614 million , an increase of 15.4 percent on a reported basis, or 16.6 percent on an operational basis.
    • Vraylar net revenues were $427 million , an increase of 23.4 percent.
    • Global Ubrelvy net revenues were $138 million .
  • Global net revenues from the aesthetics portfolio were $1.374 billion , an increase of 20.5 percent on a reported basis, or 22.5 percent on an operational basis.
    • Global Botox Cosmetic net revenues were $641 million , an increase of 34.4 percent on a reported basis, or 36.6 percent on an operational basis.
    • Global Juvederm net revenues were $410 million , an increase of 27.5 percent on a reported basis, or 30.9 percent on an operational basis.
  • On a GAAP basis, the gross margin ratio in the first quarter was 70.1 percent. The adjusted gross margin ratio was 84.5 percent.
  • On a GAAP basis, selling, general and administrative expense was 23.1 percent of net revenues. The adjusted SG&A expense was 21.1 percent of net revenues.
  • On a GAAP basis, research and development expense was 11.1 percent of net revenues. The adjusted R&D expense was 10.9 percent of net revenues.
  • Acquired IPR&D and milestones expense was 1.1 percent of net revenues.
  • On a GAAP basis, the operating margin in the first quarter was 34.8 percent. The adjusted operating margin was 51.4 percent, which includes an unfavorable 110 basis point impact from acquired IPR&D and milestones expense.
  • Net interest expense was $539 million .
  • On a GAAP basis, the tax rate in the quarter was 8.8 percent. The adjusted tax rate was 12.1 percent.
  • Diluted EPS in the first quarter was $2.51 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.16 . These results include an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense.

Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year's foreign exchange rates.

Recent Events

  • AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Rinvoq (upadacitinib, 45 mg (induction dose) and 15 mg and 30 mg (maintenance dose)) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The approval is supported by data from two Phase 3 induction studies and one maintenance study. In these studies, significantly more patients treated with Rinvoq achieved the primary and all secondary endpoints compared to placebo. The safety of Rinvoq, including the 45 mg dose as induction therapy, in these studies was generally consistent with the known safety profile of Rinvoq, with no new important safety risks observed. This approval marks the first indication for Rinvoq in gastroenterology and represents Rinvoq's fourth FDA approved indication.
  • AbbVie announced positive top-line results from the Phase 3 induction study U-EXCEL, which showed Rinvoq (45 mg, once daily) achieved both primary endpoints of clinical remission and endoscopic response, compared to placebo at week 12, as well as most key secondary endpoints in patients with moderate to severe Crohn's disease (CD). The safety results in this study were consistent with the known profile of Rinvoq, with no new safety risks observed. U-EXCEL is the second of two Phase 3 induction studies to evaluate the safety and efficacy of Rinvoq in adults with moderate to severe CD and full results will be presented at upcoming medical conferences and published in a peer-reviewed journal. Positive top-line results from the Phase 3 portion of the first induction study, U-EXCEED, were announced in December 2021 and the maintenance study for both clinical trials is ongoing.
  • AbbVie announced that the FDA extended the review period for Skyrizi (risankizumab) for the treatment of moderate to severe CD by three months to review additional data submitted by AbbVie, including information about the on-body injector. Currently approved indications for Skyrizi were not affected by this extension. Skyrizi is a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
  • AbbVie announced that it resolved all U.S. Humira (adalimumab) litigation with Alvotech. Under the terms of the resolution, AbbVie will grant Alvotech a non-exclusive license to its Humira-related patents in the U.S., which will begin on July 1, 2023 . AbbVie will make no payments of any form to Alvotech, and Alvotech will pay royalties to AbbVie for licensing its Humira patents and acknowledges the validity and enforceability of the licensed patents. The resolution included dismissal of the patent and trade secret litigation between AbbVie and Alvotech.
  • At the Congress of European Crohn's and Colitis Organization (ECCO), AbbVie shared 26 abstracts, including 16 oral and digital oral presentations, that reinforced AbbVie's commitment to research that helps advance standards of care for inflammatory bowel disease (IBD) patients. Highlights included new post-hoc analyses from the pivotal Phase 3 Skyrizi program in CD as well as results from a post-hoc analysis of Phase 3 Rinvoq pivotal trials evaluating UC symptoms.
  • At the American Academy of Dermatology (AAD) Annual Meeting, AbbVie and Allergan Aesthetics presented new research that demonstrated their shared commitment to advancing science across a spectrum of dermatologic conditions and aesthetic indications. The research included new data on the efficacy, durability and safety of Rinvoq and Skyrizi as well as data from across the Allergan Aesthetics portfolio.
  • AbbVie and Genmab announced topline results from the first cohort of the EPCORE NHL-1 phase 1/2 clinical trial evaluating epcoritamab (DuoBody-CD3xCD20) in patients with relapsed/refractory large B-cell lymphoma (LBCL) who received at least two prior lines of systemic therapy. Results from this cohort demonstrated a confirmed overall response rate (ORR) of 63.1 percent with a 12-month median duration of response. Based on the topline results, the companies will engage global regulatory authorities and data from the clinical trial will be presented at a future medical meeting. Epcoritamab is being co-developed by AbbVie and Genmab.
  • At the American Association of Cancer Research (AACR) Annual Meeting, AbbVie presented positive results from a Phase 2 trial evaluating navitoclax in combination with ruxolitinib in patients with myelofibrosis that previously had a suboptimal response or disease progression with ruxolitinib monotherapy. The study evaluated 34 patients and median overall survival was not reached for patients who had a ≥ 1 grade improvement in bone marrow fibrosis (BMF) or ≥ 20% variant allele frequency (VAF) reduction. Additionally, at the time of analysis with > 2 year follow up, the survival estimate was 100% in patients who had improvements in BMF or VAF.
  • AbbVie announced that it submitted a supplemental New Drug Application (sNDA) to the FDA for Vraylar (cariprazine) for the adjunctive treatment of major depressive disorder (MDD). The submission is based on clinical trial results that showed clinically and statistically significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score in patients with MDD treated with Vraylar and an antidepressant. If approved, this milestone will be the fourth indication for Vraylar joining approvals for the treatment of adults with schizophrenia, the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of depressive episodes associated with bipolar I disorder. Vraylar is being co-developed by AbbVie and Gedeon Richter Plc.
  • AbbVie announced that the Phase 3 PROGRESS trial evaluating Qulipta (atogepant), an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the preventive treatment of chronic migraine in adults, met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo, for both the 60 mg once daily (QD) and 30 mg twice daily (BID) doses, across the 12-week treatment period. The study also demonstrated statistically significant improvement in all secondary endpoints and the overall safety profile of Qulipta was consistent with safety findings observed in previous studies with an episodic migraine population. Data from this study will support a submission to expand the use of Qulipta to include preventive treatment of chronic migraine in the U.S. and additional submissions globally.
  • At the American Academy of Neurology (AAN) Annual Meeting, AbbVie shared 30 abstracts demonstrating the breadth of its neuroscience portfolio. The abstracts highlighted AbbVie's continued migraine treatment research across the spectrum of the disease, AbbVie's commitment to patients with advanced Parkinson's disease and new studies in spasticity and cervical dystonia.
  • AbbVie and Gedeon Richter Plc. (Richter) announced a new co-development and license agreement to research, develop and commercialize novel dopamine receptor modulators for the potential treatment of neuropsychiatric diseases. The collaboration is based on the results of preclinical research carried out by Richter and includes several new chemical entities selected for development. AbbVie and Richter have collaborated for 15 years on Central Nervous System (CNS) projects, including globally launched products such as Vraylar.
  • AbbVie announced the successful completion of its acquisition of Syndesi Therapeutics SA. The acquisition gives AbbVie access to Syndesi's portfolio of novel modulators of the synaptic vesicle protein 2A (SV2A), including its lead molecule SDI-118, which is currently being evaluated for the potential treatment of cognitive impairment and other symptoms associated with a range of neuropsychiatric and neurodegenerative disorders, such as Alzheimer's disease and MDD.
  • Allergan Aesthetics announced that the FDA approved Juvederm Volbella XC for improvement of infraorbital (undereye) hollows in adults over the age of 21. With this approval, Juvederm Volbella XC became the first and only dermal filler to receive FDA approval for the improvement of infraorbital hollows.
  • At the Aesthetic and Anti-aging Medicine World Congress (AMWC), Allergan Aesthetics presented research that demonstrated its commitment to the future of aesthetics with a forward-facing trends report. The meeting also marked Allergan Aesthetics' entry into the emerging category of Hybrid Injectables with the launch of HArmonyCa with lidocaine across Europe . The dual-effect Hybrid Injectable contains two active ingredients, hyaluronic acid, a well-known ingredient found in facial fillers, and calcium hydroxyapatite (CaHA), which is known to help stimulate collagen production.
  • AbbVie announced positive results from the Phase 3 VIRGO trial evaluating the safety and efficacy of investigational twice-daily administration of Vuity (pilocarpine HCl ophthalmic solution) 1.25% in adults with age-related blurry near vision (presbyopia). Additional details of this trial will be presented at future medical congresses and will serve as the basis for a sNDA submission for an optional twice-daily administration to the FDA in the second quarter of 2022. Approved by the FDA in October 2021 for once-daily use, Vuity is the first and only eye drop to treat age-related blurry near vision in adults.
  • At the American Glaucoma Society (AGS) Annual Meeting and the American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, AbbVie presented data from its leading portfolio of eye care treatments. Highlights included updated analyses that help further scientific understanding of Durysta (bimatoprost intracameral implant), a first-of-its-kind biodegradable implant to lower eye pressure for glaucoma patients; new data on the Xen Gel Stent, a surgical implant designed to lower high eye pressure approved for refractory glaucoma patients; and new data on Vuity 1.25%.
  • AbbVie and Scripps Research, an independent, non-profit biomedical research and drug discovery institute, announced a global collaboration to develop potential novel, direct-acting antiviral treatments for COVID-19.

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.

About AbbVie

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%

Cision View original content: https://www.prnewswire.com/news-releases/abbvie-reports-first-quarter-2022-financial-results-301536204.html

SOURCE AbbVie

News Provided by PR Newswire via QuoteMedia

ABBV

Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be 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,” in AbbVie’s 2014 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.

Enbrel Biosimilar Marks Victory for Merck and Samsung

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel.
According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.
Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.
The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.
Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

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CLASS ACTION UPDATE for ABBV, SDIG and AUPH: Levi & Korsinsky, LLP Reminds Investors of Class Actions on Behalf of Shareholders

Levi & Korsinsky, LLP announces that class action lawsuits have commenced on behalf of shareholders of the following publicly-traded companies. Shareholders interested in serving as lead plaintiff have until the deadlines listed to petition the court. Further details about the cases can be found at the links provided. There is no cost or obligation to you

ABBV Shareholders Click Here: https://www.zlk.com/pslra-1/abbvie-inc-loss-submission-form?prid=27797&wire=1
SDIG Shareholders Click Here: https://www.zlk.com/pslra-1/stronghold-digital-mining-inc-loss-submission-form?prid=27797&wire=1
AUPH Shareholders Click Here: https://www.zlk.com/pslra-1/aurinia-pharmaceuticals-inc-information-loss-submission-form?prid=27797&wire=1

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Komo Plant-Based Foods Appoints US Sales Management Consultants

Komo Plant-Based Foods Appoints US Sales Management Consultants

Komo Plant Based Foods Inc. (CSE:YUM)(OTCQB:KOMOF)(FRA:9HB) ("Komo") is pleased to announce the appointment of a U.S. sales consultant, Caboodle Consulting LLC (Caboodle), to develop Komo's retail expansion throughout the United States. Komo will work closely with the Caboodle sales management team to build out the US retail strategy. Heather Barry Whittier will be representing Komo as the Director of Sales. Ms. Whittier has 20+ years experience in the natural products industry including a pivotal role in growing a brokerage, Yin Yang Naturals, from regional to national coverage

Other members of the Caboodle management team include Lisa Thorson and Constance Wolfe. Lisa Thorson comes from a Market Analysis background with 10+ years' experience in Consumer Packaged Goods (CPG) brokerage and brand management with experience at Laird Superfood and Alliance Sales & Marketing. Constance Wolfe offers 10+ years of brand management experience including specializing in data analysis and trade spend promotional management with experience at Coconut Bliss and Hilary's Eat Well.

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The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Upadacitinib in Ulcerative Colitis

ABBVie (NYSE: ABBV) today announced The Lancet published results from three pivotal Phase 3 clinical trials U-ACHIEVE (induction), U-ACCOMPLISH and U-ACHIEVE (maintenance) evaluating upadacitinib (RINVOQ ® ) in patients with moderately to severely active ulcerative colitis who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

Data from the three studies formed the basis of the company's application for approval by regulatory agencies. The publication reports the efficacy and safety results of the two induction studies and a maintenance study evaluating clinical remission and endoscopic improvement with oral upadacitinib versus placebo over 8 weeks and 52 weeks, respectively. 1

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The Lancet Publishes Results from Phase 3 Induction and Maintenance Programs Evaluating Risankizumab in Crohn's Disease

ABBVie (NYSE: ABBV) today announced The Lancet published results from three pivotal Phase 3 clinical trials ADVANCE, MOTIVATE (induction studies) and FORTIFY (maintenance study) evaluating risankizumab (SKYRIZI ® ) in patients with moderately to severely active Crohn's disease who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

Data from the three studies formed the basis of the company's application for approval by the global health authorities. The publication of ADVANCE and MOTIVATE reports the efficacy and safety results of the two induction studies evaluating clinical remission and endoscopic response with intravenous (IV) risankizumab versus placebo over 12 weeks. 1 The publication of FORTIFY shares the results of the maintenance study evaluating the safety and efficacy of subcutaneous (SC) risankizumab versus placebo (the withdrawal from IV risankizumab) over 52 weeks in patients who achieved clinical response during the ADVANCE and MOTIVATE studies. 2

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Data from Phase 2 PILOT Study of Bristol Myers Squibb's CAR T cell Therapy Breyanzi Show Substantial Durable Responses in Patients with Refractory or Relapsed Large B-cell Lymphoma After First-Line Therapy

First disclosure of results from primary analysis of Phase 2 PILOT study shows Breyanzi delivered complete responses in more than half of patients with refractory or relapsed large B-cell lymphoma after first-line therapy who were not deemed candidates for stem cell transplant

PILOT patient-reported outcomes analysis showed treatment with Breyanzi improved health-related quality of life measures for patients

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NEW DATA SHOWCASES HOW AMGEN IS ADVANCING ALL ANGLES OF CANCER CARE THROUGH INNOVATIVE ONCOLOGY PORTFOLIO AND PIPELINE AT ASCO 2022

Results From the PARADIGM Phase 3 Head-to-Head Trial of Vectibix ® (panitumumab) Versus Bevacizumab in Untreated RAS Wild-Type Metastatic Colorectal Cancer*

Largest Evaluation of Acquired Resistance to LUMAKRAS ® /LUMYKRAS ® (sotorasib) in KRAS G12C-mutated Cancers Inform Combination Treatment Approaches

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