Life Science News

ABBVie (NYSE:ABBV) announced financial results for the third quarter ended September 30, 2021 .

"We continue to deliver excellent results, with balanced performance across our portfolio driving double-digit operational sales and EPS growth," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "Based upon our strong momentum, we are increasing our full-year 2021 EPS guidance. We remain highly confident in AbbVie's long-term outlook and are once again raising our dividend, which has grown over 250 percent since inception."

Third-Quarter Results

  • Worldwide net revenues were $14.342 billion , an increase of 11.2 percent on a GAAP basis. Adjusted net revenues increased 11.3 percent on a reported basis, or 10.8 percent on an operational basis.
  • Global net revenues from the immunology portfolio were $6.674 billion , an increase of 15.3 percent on a reported basis, or 14.9 percent on an operational basis.
    • Global Humira net revenues of $5.425 billion increased 5.6 percent on a reported basis, or 5.2 percent on an operational basis. U.S. Humira net revenues were $4.613 billion , an increase of 10.1 percent. Internationally, Humira net revenues were $812 million , a decrease of 14.6 percent on a reported basis, or 16.7 percent on an operational basis, due to biosimilar competition.
    • Global Skyrizi net revenues were $796 million .
    • Global Rinvoq net revenues were $453 million .
  • Global net revenues from the hematologic oncology portfolio were $1.866 billion , an increase of 8.4 percent on a reported basis, or 8.1 percent on an operational basis.
    • Global Imbruvica net revenues were $1.374 billion , an increase of 0.3 percent, with U.S. net revenues of $1.109 billion and international profit sharing of $265 million .
    • Global Venclexta net revenues were $492 million , an increase of 40.1 percent on a reported basis, or 38.7 percent on an operational basis.
  • Global net revenues from the neuroscience portfolio were $1.566 billion , an increase of 25.5 percent on a reported basis, or 25.0 percent on an operational basis.
    • Global Botox Therapeutic net revenues were $645 million , an increase of 23.4 percent on a reported basis, or 22.5 percent on an operational basis.
    • Vraylar net revenues were $461 million , an increase of 29.0 percent on a reported and operational basis.
    • Global Ubrelvy net revenues were $162 million .
  • Global net revenues from the aesthetics portfolio were $1.251 billion , an increase of 29.3 percent on a reported basis, or 27.7 percent on an operational basis.
    • Global Botox Cosmetic net revenues were $545 million , an increase of 38.5 percent on a reported basis, or 36.9 percent on an operational basis.
    • Global Juvederm net revenues were $354 million , an increase of 29.1 percent on a reported basis, or 26.6 percent on an operational basis.
  • On a GAAP basis, the gross margin ratio in the third quarter was 69.4 percent. The adjusted gross margin ratio was 83.2 percent.
  • On a GAAP basis, selling, general and administrative expense was 21.5 percent of net revenues. The adjusted SG&A expense was 20.6 percent of net revenues.
  • On a GAAP basis, research and development expense was 11.7 percent of net revenues. The adjusted R&D expense was 11.4 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
  • On a GAAP basis, the operating margin in the third quarter was 30.0 percent. The adjusted operating margin was 51.1 percent.
  • On a GAAP basis, net interest expense was $585 million .
  • On a GAAP basis, the tax rate in the quarter was 13.8 percent. The adjusted tax rate was 12.6 percent.
  • Diluted EPS in the third quarter was $1.78 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.33 .

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 the European Commission (EC) approved Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents 12 years and older who are candidates for systemic therapy. The recommended dose of Rinvoq for AD in adults is 15 mg or 30 mg once daily based on individual patient presentation, and 15 mg once daily for adolescents and adults 65 years and older. The approval is supported by data from one of the largest registrational Phase 3 programs in AD evaluating Rinvoq monotherapy or with topical corticosteroids. This milestone marks the fourth EC-approved indication for Rinvoq.
  • AbbVie announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Skyrizi (risankizumab) for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). The positive opinion is based on data from two pivotal Phase 3 studies which evaluated the efficacy and safety of Skyrizi in adults with active PsA. If the CHMP recommendation is accepted by the EC, this will mark the second indication for Skyrizi in the European Union. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
  • AbbVie announced that it submitted applications to the U.S. Food and Drug Administration (FDA) and EMA seeking approval for Rinvoq (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). The applications are 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 results of Rinvoq, including the 45 mg dose as induction therapy, in these studies were generally consistent with the known safety profile of Rinvoq, with no new important safety risks observed.
  • AbbVie announced that it submitted an application to the FDA seeking approval for Skyrizi (600 mg intravenous induction and 360 mg subcutaneous maintenance therapy) for the treatment of patients 16 years and older with moderate to severe Crohn's disease (CD). The submission is supported by three pivotal Phase 3 studies in which Skyrizi demonstrated significant improvements in clinical remission and endoscopic response as both induction and maintenance therapy. The overall safety findings in these pivotal studies were generally consistent with the known safety profile of Skyrizi.
  • AbbVie announced positive top-line results from two studies of the Phase 3 SELECT-AXIS 2 clinical trial evaluating the efficacy and safety of Rinvoq in patients with active ankylosing spondylitis (AS) or non-radiographic axial spondyloarthritis (nr-axSpA). In Study 1, Rinvoq (15 mg, once daily) met the primary endpoint of Assessment in SpondyloArthritis International Society (ASAS) 40 at week 14 versus placebo (45 percent compared to 18 percent) in patients with AS who have had an inadequate response to biologic DMARD therapy. All ranked secondary endpoints were also met. In Study 2, Rinvoq (15 mg, once daily) met the primary endpoint of ASAS40 at week 14 versus placebo (45 percent compared to 23 percent) and met the first 12 of 14 ranked secondary endpoints in patients with nr-axSpA. Across both studies, safety data were consistent with SELECT-AXIS 1, previous Phase 3 studies in other indications and the known safety profile of Rinvoq, with no new risks identified. Full results from the SELECT-AXIS 2 trial will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal.
  • At the United European Gastroenterology (UEG) Week, AbbVie shared 13 abstracts including 7 live presentations that reinforced AbbVie's commitment to advancing research in inflammatory bowel disease (IBD). Highlights included new results from the 52-week Phase 3 maintenance studies evaluating the efficacy and safety of Skyrizi in patients with CD and Rinvoq in patients with UC.
  • At the European Academy of Dermatology and Venereology (EADV) Congress, AbbVie shared 27 abstracts from across its dermatology portfolio that underscored AbbVie's commitment to advancing standards of care in dermatology for people living with serious skin diseases. Highlights included new analyses from the Phase 3 Rinvoq AD clinical trial program as well as new long-term efficacy and safety data from the KEEPsAKE 1 and KEEPsAKE 2 trials evaluating Skyrizi in adults with PsA treated through 52 weeks.
  • AbbVie announced that Skyrizi is now available in the U.S. as a single-dose 150 mg injection for the treatment of adults with moderate to severe plaque psoriasis (PsO). Previously two 75 mg injections per dose, Skyrizi 150 mg is now administered with one injection per dose via either a prefilled pen or syringe every 12 weeks following two starter doses.
  • AbbVie announced that the FDA approved Qulipta (atogepant) for the preventive treatment of episodic migraine in adults. The approval is supported by data from a robust clinical program evaluating the efficacy, safety and tolerability of Qulipta in nearly 2,000 patients who experienced 4 to 14 migraine days per month including the pivotal Phase 3 ADVANCE study, the pivotal Phase 2b /3 study and the Phase 3 long-term safety study. AbbVie is the only pharmaceutical company to offer three treatments across the full spectrum of migraine to help patients living with this debilitating disease.
  • At the International Headache Congress (IHC) 2021, AbbVie presented data showcasing its migraine portfolio and shared a total of 23 abstracts including 2 oral presentations and 1 abstract lecture. Highlights included results from an open-label, multicenter extension to the pivotal Phase 3 ADVANCE trial evaluating the safety and tolerability of oral Qulipta for the preventive treatment of migraine, data from the observational cross-sectional UNIVERSE study highlighting the real-world effectiveness and patient satisfaction of Ubrelvy (ubrogepant) in acute migraine as well as results from a post-hoc analysis of the Phase 3 PREEMPT trials evaluating the use of Botox (onabotulinumtoxinA) for chronic migraine.
  • ABBVie announced ABBV-951 (foslevodopa/foscarbidopa) met the primary endpoint in a pivotal Phase 3 trial in patients with advanced Parkinson's Disease (PD). Patients who received the continuous 24 hours/day subcutaneous infusion of ABBV-951 showed statistically significant increases in "On" time without troublesome dyskinesia, compared to oral levodopa/carbidopa, after 12 weeks. A significant reduction in "Off" time was also observed. Systemic adverse events were generally consistent with the well-established safety profile of levodopa/carbidopa medications and infusion site adverse events were mostly non-serious and mild or moderate in severity. Data from this head-to-head superiority study will be a key component of global regulatory submissions and full results will be presented at a future medical meeting or submitted for publication in a peer-reviewed journal.
  • At the International Parkinson and Movement Disorder Society (MDS) Virtual Congress 2021, AbbVie presented more than 20 abstracts showcasing AbbVie's continued focus on advancing the management of movement disorders. Highlights included final results from PROviDE, a long-term, real-world study, evaluating the effectiveness of Duodopa (levodopa-carbidopa intestinal gel) in patients with advanced PD as well as additional data on the long-term, real-world use of Botox in patients with spasticity and cervical dystonia.
  • AbbVie and REGENXBIO announced a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases. RGX-314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery as well as in patients with wet AMD and DR in two separate Phase II clinical trials utilizing in-office suprachoroidal delivery. Under the terms of the agreement, AbbVie will pay REGENXBIO a $370 million upfront payment with the potential for REGENXBIO to receive up to $1.38 billion in additional development, regulatory and commercial milestones. The transaction is expected to close by the end of 2021, subject to the satisfaction of customary closing conditions, including applicable regulatory approvals.

Full-Year 2021 Outlook

AbbVie is raising its GAAP diluted EPS guidance for the full-year 2021 from $6.04 to $6.14 to $6.29 to $6.33 . AbbVie is raising its adjusted diluted EPS for the full-year 2021 from $12.52 to $12.62 to $12.63 to $12.67 . The company's 2021 adjusted diluted EPS guidance excludes $6.34 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.

Company Declares Dividend Increase of 8.5 Percent

AbbVie is announcing today that its board of directors declared an increase in the company's quarterly cash dividend from $1.30 per share to $1.41 per share beginning with the dividend payable on February 15, 2022 to shareholders of record as of January 14, 2022 . This reflects an increase of approximately 8.5 percent, continuing AbbVie's strong commitment to returning cash to shareholders through a growing dividend. Since the company's inception in 2013, AbbVie has increased its quarterly dividend by more than 250 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

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, 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 , Instagram , YouTube, and LinkedIn .

Conference Call

AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our third-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 September 30, 2021

(Unaudited)









% Change vs. 3Q20


Net Revenues (in millions)


Reported


Operational a


U.S.


Int'l.


Total


U.S.


Int'l.


Total


Int'l.


Total

ADJUSTED NET REVENUES b

$11,279


$3,063


$14,342


14.1%


2.4%


11.3%


0.1%


10.8%

















Immunology

5,640


1,034


6,674


18.6


0.2


15.3


(2.1)


14.9

Humira

4,613


812


5,425


10.1


(14.6)


5.6


(16.7)


5.2

Skyrizi

679


117


796


79.6


>100.0


83.3


>100.0


82.8

Rinvoq

348


105


453


82.5


>100.0


>100.0


>100.0


>100.0

















Hematologic Oncology

1,346


520


1,866


1.8


30.6


8.4


29.3


8.1

Imbruvica c

1,109


265


1,374


(0.9)


5.7


0.3


5.7


0.3

Venclexta

237


255


492


16.3


73.0


40.1


69.5


38.7

















Aesthetics

820


431


1,251


32.7


23.2


29.3


18.9


27.7

Botox Cosmetic

356


189


545


49.6


21.6


38.5


17.5


36.9

Juvederm Collection

159


195


354


37.6


22.9


29.1


18.6


26.6

Other Aesthetics

305


47


352


15.4


31.5


17.3


26.5


16.7

















Neuroscience

1,346


220


1,566


28.0


11.5


25.5


8.0


25.0

Botox Therapeutic

534


111


645


24.4


18.6


23.4


13.8


22.5

Vraylar

461



461


29.0


n/a


29.0


n/a


29.0

Duodopa

23


104


127


(3.9)


6.0


3.9


3.9


2.2

Ubrelvy

162



162


>100.0


n/a


>100.0


n/a


>100.0

Other Neuroscience

166


5


171


(17.8)


(12.1)


(17.7)


(18.5)


(17.8)

















Eye Care

585


286


871


6.5


(1.4)


3.8


(3.9)


2.9

Lumigan/Ganfort

63


75


138


(0.1)


(12.9)


(7.5)


(15.8)


(9.2)

Alphagan/Combigan

89


39


128


6.2


1.2


4.6


(0.9)


3.9

Restasis

305


14


319


7.5


(7.4)


6.7


(6.5)


6.7

Other Eye Care

128


158


286


8.1


5.1


6.4


2.4


4.9

















Women's Health

199


3


202


(12.9)


(67.4)


(15.6)


(70.4)


(15.8)

Lo Loestrin

105


2


107


(20.3)


(27.2)


(20.6)


(32.4)


(20.8)

Orilissa/Oriahnn

37


1


38


50.5


47.5


50.4


38.4


50.0

Other Women's Health

57



57


(20.9)


(100.0)


(28.4)


(100.0)


(28.4)

















Other Key Products

1,068


297


1,365


7.4


9.6


7.9


8.4


7.6

Mavyret

183


243


426


0.2


5.7


3.3


4.9


2.9

Creon

310



310


10.0


n/a


10.0


n/a


10.0

Lupron

134


46


180


35.7


34.7


35.4


31.4


34.5

Linzess/Constella

253


8


261


4.8


10.7


5.0


4.5


4.8

Synthroid

188



188


(0.8)


n/a


(0.8)


n/a


(0.8)



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

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.



c

Reflects profit sharing for Imbruvica international revenues.


n/a = not applicable

AbbVie Inc.

Key Product Revenues

Nine Months Ended September 30, 2021

(Unaudited)









% Change vs. 9M20


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

$31,758


$9,478


$41,236


31.3%


22.6%


29.2%


13.3%


6.0%


11.6%



















Immunology

15,391


3,147


18,538


16.9


3.7


14.5


16.9


(1.2)


13.6

Humira

12,777


2,583


15,360


8.1


(9.7)


4.6


8.1


(13.9)


3.8

Skyrizi

1,725


319


2,044


84.9


>100.0


92.0


84.9


>100.0


90.4

Rinvoq

889


245


1,134


>100.0


>100.0


>100.0


>100.0


>100.0


>100.0



















Hematologic Oncology

3,892


1,463


5,355


4.2


30.0


10.1


4.2


27.3


9.5

Imbruvica d

3,207


816


4,023


2.1


8.8


3.4


2.1


8.8


3.4

Venclexta

685


647


1,332


14.9


72.3


37.1


14.9


64.1


33.9



















Aesthetics

2,473


1,353


3,826


>100.0


>100.0


>100.0


55.4


66.5


59.0

Botox Cosmetic*

1,027


579


1,606


>100.0


>100.0


>100.0


70.5


55.0


64.7

Juvederm Collection*

478


625


1,103


>100.0


>100.0


>100.0


69.6


75.4


72.8

Other Aesthetics*

968


149


1,117


>100.0


>100.0


>100.0


37.0


80.2


41.3



















Neuroscience

3,621


652


4,273


>100.0


50.5


>100.0


23.8


12.0


22.0

Botox Therapeutic*

1,451


329


1,780


>100.0


>100.0


>100.0


21.1


26.3


21.9

Vraylar*

1,239



1,239


>100.0


n/a


>100.0


25.6


n/a


25.6

Duodopa

73


310


383


(1.5)


6.9


5.2


(1.5)


0.1


(0.2)

Ubrelvy*

369



369


>100.0


n/a


>100.0


>100.0


n/a


>100.0

Other Neuroscience*

489


13


502


59.7


97.2


60.5


(16.9)


7.6


(16.5)



















Eye Care

1,731


876


2,607


>100.0


>100.0


>100.0


4.9


4.6


4.7

Lumigan/Ganfort*

201


229


430


>100.0


79.4


90.7


(2.1)


(10.6)


(6.7)

Alphagan/Combigan*

271


117


388


>100.0


90.5


>100.0


4.6


3.7


4.3

Restasis*

884


42


926


>100.0


>100.0


>100.0


3.8


22.4


4.5

Other Eye Care*

375


488


863


>100.0


>100.0


>100.0


12.4


12.1


12.2



















Women's Health

555


18


573


38.9


5.0


37.4


(17.2)


(36.6)


(18.0)

Lo Loestrin*

300


9


309


43.7


55.6


44.1


(21.4)


(9.0)


(21.1)

Orilissa/Oriahnn

102


4


106


20.5


63.2


21.8


20.5


51.9


21.5

Other Women's Health*

153


5


158


44.0


(51.3)


36.8


(25.0)


(73.5)


(28.2)



















Other Key Products

3,176


884


4,060


14.1


(2.3)


10.1


3.6


(7.2)


1.1

Mavyret

557


726


1,283


(1.3)


(7.4)


(4.8)


(1.3)


(11.2)


(7.0)

Creon

864



864


6.6


n/a


6.6


6.6


n/a


6.6

Lupron

456


135


591


(1.2)


22.8


3.4


(1.2)


18.7


2.6

Linzess/Constella*

728


23


751


96.4


>100.0


96.9


11.4


7.2


11.2

Synthroid

571



571


(1.1)


n/a


(1.1)


(1.1)


n/a


(1.1)



a

"Comparable Operational" comparisons include full-period 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

AbbVie Inc.

Consolidated Statements of Earnings

Quarter and Nine Months Ended September 30, 2021 and 2020

(Unaudited) (In millions, except per share data)













Third Quarter

Ended September 30


Nine Months

Ended September 30












2021


2020


2021


2020

Net revenues











$

14,342



$

12,902



$

41,311



$

31,946


Cost of products sold











4,390



5,050



13,126



10,703


Selling, general and administrative











3,083



2,846



9,089



8,068


Research and development











1,673



1,706



5,257



4,667


Acquired in-process research and development











390



45



557



898


Other operating expense, net











500





432




Total operating costs and expenses











10,036



9,647



28,461



24,336




















Operating earnings











4,306



3,255



12,850



7,610




















Interest expense, net











585



620



1,813



1,662


Net foreign exchange loss











12



20



35



54


Other expense, net











21



115



2,284



989


Earnings before income tax expense











3,688



2,500



8,718



4,905


Income tax expense











508



187



1,214



321


Net earnings











3,180



2,313



7,504



4,584


Net earnings attributable to noncontrolling interest











1



5



6



4


Net earnings attributable to AbbVie Inc.











$

3,179



$

2,308



$

7,498



$

4,580




















Diluted earnings per share attributable to AbbVie Inc.











$

1.78



$

1.29



$

4.19



$

2.77




















Adjusted diluted earnings per share a











$

3.33



$

2.83



$

9.39



$

7.62




















Weighted-average diluted shares outstanding











1,777



1,774



1,776



1,637




a

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 September 30, 2021

(Unaudited) (In millions, except per share data)


1.     Specified items impacted results as follows:


3Q21


Earnings


Diluted


Pre-tax


After-tax a


EPS

As reported (GAAP)

$

3,688



$

3,179



$

1.78


Adjusted for specified items:






Intangible asset amortization

1,904



1,585



0.88


Acquisition and integration costs

176



166



0.09


Milestones and other R&D expenses

12



12



0.01


Acquired IPR&D

390



384



0.21


Calico collaboration

500



500



0.28


Change in fair value of contingent consideration

98



98



0.06


Other

48



29



0.02


As adjusted (non-GAAP)

$

6,816



$

5,953



$

3.33



a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs reflect Allergan-related integration costs. Milestones and other R&D expenses include milestone payments for previously announced collaborations. Acquired IPR&D represents initial costs to acquire rights to in-process R&D projects through R&D collaborations, licensing arrangements or other asset acquisitions. Other primarily includes 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:


3Q21


Cost of products
sold


SG&A


R&D


Acquired
IPR&D


Other
operating
expense,
net


Other
expense,
net

As reported (GAAP)

$

4,390



$

3,083



$

1,673



$

390



$

500



$

21


Adjusted for specified items:












Intangible asset amortization

(1,904)












Acquisition and integration costs

(49)



(105)



(22)








Milestones and other R&D expenses





(12)








Acquired IPR&D







(390)






Calico collaboration









(500)




Change in fair value of contingent consideration











(98)


Other

(24)



(17)



(7)








As adjusted (non-GAAP)

$

2,413



$

2,961



$

1,632



$



$



$

(77)



3.     The adjusted tax rate for the third quarter of 2021 was 12.6 percent, as detailed below:


3Q21


Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)

$

3,688



$

508



13.8

%

Specified items

3,128



354



11.3

%

As adjusted (non-GAAP)

$

6,816



$

862



12.6

%


AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

Quarter Ended September 30, 2020

(Unaudited) (In millions, except per share data)


1.     Specified items impacted results as follows:


3Q20


Earnings


Diluted


Pre-tax


After-tax a


EPS

As reported (GAAP)

$

2,500



$

2,308



$

1.29


Adjusted for specified items:






Intangible asset amortization

2,117



1,800



1.02


Acquisition and integration costs

792



682



0.38


Milestones and other R&D expenses

40



38



0.02


Acquired IPR&D

45



45



0.02


Change in fair value of contingent consideration

197



197



0.11


Other

30



(22)



(0.01)


As adjusted (non-GAAP)

$

5,721



$

5,048



$

2.83



a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs reflect amortization of the acquisition date fair value step-up for inventory as well as compensation expense and other integration costs related to the Allergan acquisition. Milestones and other R&D expenses include milestone payments for previously announced collaborations. Acquired IPR&D represents initial costs to acquire rights to in-process R&D projects through R&D collaborations, licensing arrangements or other asset acquisitions. Other primarily includes tax settlements and COVID-19 related expenses.


2.     The impact of the specified items by line item was as follows:


3Q20


Net revenues


Cost of products
sold


SG&A


R&D


Acquired
IPR&D


Net
foreign
exchange
loss


Other
expense, net

As reported (GAAP)

$

12,902



$

5,050



$

2,846



$

1,706



$

45



$

20



$

115


Adjusted for specified items:














Intangible asset amortization



(2,117)












Acquisition and integration costs



(551)



(104)



(137)








Milestones and other R&D expenses







(40)








Acquired IPR&D









(45)






Change in fair value of contingent consideration













(197)


Other

(20)



(20)



(19)



(16)





5




As adjusted (non-GAAP)

$

12,882



$

2,362



$

2,723



$

1,513



$



$

25



$

(82)



3.     The adjusted tax rate for the third quarter of 2020 was 11.7 percent, as detailed below:


3Q20


Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)

$

2,500



$

187



7.5

%

Specified items

3,221



481



14.9

%

As adjusted (non-GAAP)

$

5,721



$

668



11.7

%

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

Nine Months Ended September 30, 2021

(Unaudited) (In millions, except per share data)


1.     Specified items impacted results as follows:


9M21


Earnings


Diluted


Pre-tax


After-tax a


EPS

As reported (GAAP)

$

8,718



$

7,498



$

4.19


Adjusted for specified items:






Intangible asset amortization

5,912



4,929



2.77


Acquisition and integration costs

535



427



0.23


Milestones and other R&D expenses

359



307



0.17


Acquired IPR&D

557



543



0.30


Calico collaboration

500



500



0.28


Change in fair value of contingent consideration

2,447



2,445



1.38


Litigation matters

107



86



0.05


Other

47



42



0.02


As adjusted (non-GAAP)

$

19,182



$

16,777



$

9.39



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. Milestones and other R&D expenses include milestone payments for previously announced collaborations and the purchase of FDA priority review vouchers from third parties. Acquired IPR&D represents initial costs to acquire rights to in-process R&D projects through R&D collaborations, licensing arrangements or other asset acquisitions. Other primarily includes restructuring charges associated with streamlining global operations and COVID-19 related expenses, offset by milestone revenue under an existing collaboration agreement.


2.     The impact of the specified items by line item was as follows:


9M21


Net
revenues


Cost of
products
sold


SG&A


R&D


Acquired
IPR&D


Other
operating
expense,
net


Other
expense,
net

As reported (GAAP)

$

41,311



$

13,126



$

9,089



$

5,257



$

557



$

432



$

2,284


Adjusted for specified items:














Intangible asset amortization



(5,912)












Acquisition and integration costs



(172)



(275)



(88)








Milestones and other R&D expenses







(359)








Acquired IPR&D









(557)






Calico collaboration











(500)




Change in fair value of contingent consideration













(2,447)


Litigation matters





(107)










Other

(75)



(65)



(50)



(90)





68



15


As adjusted (non-GAAP)

$

41,236



$

6,977



$

8,657



$

4,720



$



$



$

(148)



3.     The adjusted tax rate for the first nine months of 2021 was 12.5 percent, as detailed below:


9M21


Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)

$

8,718



$

1,214



13.9

%

Specified items

10,464



1,185



11.3

%

As adjusted (non-GAAP)

$

19,182



$

2,399



12.5

%

AbbVie Inc.

Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

Nine Months Ended September 30, 2020

(Unaudited) (In millions, except per share data)


1.     Specified items impacted results as follows:


9M20


Earnings


Diluted


Pre-tax


After-tax a


EPS

As reported (GAAP)

$

4,905



$

4,580



$

2.77


Adjusted for specified items:






Intangible asset amortization

3,967



3,361



2.05


Acquisition and integration costs

2,899



2,624



1.60


Milestones and other R&D expenses

225



202



0.12


Acquired IPR&D

898



898



0.54


Change in fair value of contingent consideration

1,078



1,078



0.65


Other

147



(187)



(0.11)


As adjusted (non-GAAP)

$

14,119



$

12,556



$

7.62



a Represents net earnings attributable to AbbVie Inc.


Acquisition and integration costs reflect transaction and financing costs, compensation expense and other integration costs as well as amortization of the acquisition date fair value step-up for inventory 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. Acquired IPR&D represents initial costs to acquire rights to in-process R&D projects through R&D collaborations, licensing arrangements or other asset acquisitions. Other primarily includes the impacts of tax law changes, tax settlements and COVID-19 related charitable contributions and expenses.


2.     The impact of the specified items by line item was as follows:


9M20


Net
revenues


Cost of
products
sold


SG&A


R&D


Acquired
IPR&D


Interest
expense,
net



Net
foreign
exchange
loss


Other
expense,
net

As reported (GAAP)

$

31,946



$

10,703



$

8,068



$

4,667



$

898



$

1,662



$

54



$

989


Adjusted for specified items:
















Intangible asset amortization



(3,967)














Acquisition and integration costs



(1,020)



(1,290)



(315)





(274)






Milestones and other R&D expenses







(225)










Acquired IPR&D









(898)








Change in fair value of contingent consideration















(1,078)


Other

(20)



(64)



(64)



(48)







9




As adjusted (non-GAAP)

$

31,926



$

5,652



$

6,714



$

4,079



$



$

1,388



$

63



$

(89)



3.     The adjusted tax rate for the first nine months of 2020 was 11.0 percent, as detailed below:


9M20


Pre-tax
earnings


Income taxes


Tax rate

As reported (GAAP)

$

4,905



$

321



6.5

%

Specified items

9,214



1,238



13.4

%

As adjusted (non-GAAP)

$

14,119



$

1,559



11.0

%

Cision View original content: https://www.prnewswire.com/news-releases/abbvie-reports-third-quarter-2021-financial-results-301411843.html

SOURCE AbbVie

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ABBV DEADLINE REMINDER: Kessler Topaz Meltzer & Check, LLP - Important June 6, 2022 Deadline Reminder for AbbVie, Inc.

The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) informs investors that the firm has filed a securities class action lawsuit against ABBVie, Inc. (ABBVie) (NYSE: ABBV) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period").

CLICK HERE TO SUBMIT YOUR ABBVIE LOSSES. YOU CAN ALSO CLICK ON THEFOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/abbvie-inc?utm_source=PR&utm_medium=link&utm_campaign=abbvie&mktm=r

TO VIEW OUR COMPLAINT, PLEASE CLICK HERE

LEAD PLAINTIFF DEADLINE:JUNE 6, 2022
CLASS PERIOD: APRIL 30, 2021 through AUGUST 31, 2021

CONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS:
James Maro, Esq. (484) 270-1453 or Email at info@ktmc.com

Kessler Topaz is one of the world's foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our securities fraud litigators are regularly recognized as leaders in the field individually and our firm is both feared and respected among the defense bar and the insurance bar. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent.

ABBVIE'S ALLEGED MISCONDUCT

AbbVie is one of the world's largest pharmaceutical companies. The company's revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVie's future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humira's lost sales. Rinvoq-an anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes-was touted as one such drug. Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases.

As is relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of RA, it required an additional safety trial to evaluate Xeljanz's risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz's use could lead to serious heart-related issue, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the Class Period, Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks.

However, investors began to learn the truth about Rinvoq's significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021, to close at $112.98 per share on June 25, 2021.

Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021.

After the Class Period, on December 3, 2021, AbbVie announced that the FDA had updated Rinvoq's label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed. On January 11, 2022, Defendants admitted that these changes to Rinvoq's label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq's sales in 2025.

The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the company's business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis, As a result of the Defendants' wrongful acts and omissions, and the significant decline in the market value of AbbVie's securities, AbbVie investors have suffered significant damages.

WHAT CAN I DO?

AbbVieinvestors may, no later than June 6, 2022, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. Kessler Topaz Meltzer & Check, LLP encourages AbbVie investors who have suffered significant losses to contact the firm directly to acquire more information.

CLICK HERE TO SIGN UP FOR THE CASE

WHO CAN BE A LEAD PLAINTIFF?

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.

CONTACT:

Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
280 King of Prussia Road
Radnor, PA 19087
(484) 270-1453
info@ktmc.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/124414

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