ABBV AbbVie Inc.

92.75
-0.17  -0%
Previous Close 92.92
Open 92.63
52 Week Low 62.55
52 Week High 101.28
Market Cap $163,688,283,567
Shares 1,764,833,246
Float 1,763,480,422
Enterprise Value $163,319,305,218
Volume 4,938,926
Av. Daily Volume 7,547,994
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Upcoming Catalysts

Drug Stage Catalyst Date
Risankizumab vs secukinumab
Psoriasis
Phase 3
Phase 3
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Ibrutinib in combination with prednisone
Chronic Graft Versus Host Disease
Phase 3
Phase 3
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Risankizumab KEEPSAKE2
Psoriatic Arthritis
Phase 3
Phase 3
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RELAMORELIN
Diabetic Gastroparesis
Phase 3
Phase 3
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Imbruvica + Venclexta (CAPTIVATE)
Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
Phase 2
Phase 2
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Risankizumab MOTIVATE
Crohn’s Disease
Phase 3
Phase 3
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Botox
Neurogenic Detrusor Overactivity
PDUFA
PDUFA
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ABBV-951
Parkinson's disease
Phase 3
Phase 3
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Venetoclax - CANOVA
Relapsed or refractory multiple myeloma
Phase 3
Phase 3
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Cenicriviroc (CVC)
Nonalcoholic steatohepatitis (NASH)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Ibrutinib
COVID-19
Phase 2
Phase 2
Phase 2 trial has been initiated.
Cenicriviroc + Otezla (apremilast) + Firazyr (icatibant)
COVID-19 (severe)
Phase 2
Phase 2
Phase 2 trial initiation announced August 3, 2020.
ATOGEPANT
Chronic migraine
Phase 3
Phase 3
Phase 3 trial met primary endpoint - July 29, 2020.
Risankizumab vs secukinumab
Plaque psoriasis
Phase 3
Phase 3
Phase 3 trial met primary endpoint - January 14, 2020.
Upadacitinib
Atopic dermatitis
Phase 3
Phase 3
Phase 3 data met co-primary endpoints - June 18, 2020. Second Phase 3 trial also met primary endpoint - July 21, 2020.
ABICIPAR
Age-related macular degeneration (AMD)
CRL
CRL
CRL issued June 26, 2020.
Botox
Forehead lines
Approved
Approved
Approval (third indication) announced October 3, 2017.
JUVÉDERM VOLUMA
Augmentation of the chin region
Approved
Approved
FDA Approval announced June 15, 2020.
Upadacitinib
Psoriatic arthritis
sNDA Filing
sNDA Filing
sNDA filing announced June 1, 2020.
Elagolix
Uterine Fibroids
Approved
Approved
FDA approval announced May 29, 2020.
Upadacitinib - U-ACHIEVE
Ulcerative colitis
Phase 2/3
Phase 2/3
Phase 2b data released October 22, 2018 - primary endpoint met. Phase 3 trial initiation announced October 2018.
Oxymetazoline HCl cream 1.0%
Facial Erythema (Redness) Associated with Rosacea
Approved
Approved
Approved January 19, 2017.
MVASITM (bevacizumab-awwb)
Biosimilar candidate to Avastin (bevacizumab)
Approved
Approved
Approved September 14, 2017.
Botox
Lower limb spasticity
Approved
Approved
FDA Approval announced October 24, 2019.
Ubrogepant
Migraine
Approved
Approved
FDA Approval announced December 23, 2019.
Botox
Upper limb spasticity
Approved
Approved
FDA Approval announced June 21, 2019.
Juvéderm VOLUMA
Mid-Face Injection Via Cannula
Approved
Approved
FDA Approval announced September 3, 2019.
IMBRUVICA (ibrutinib) and rituximab
Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Approved
Approved
FDA Approval announced April 21, 2020.
Depatuxizumab mafodotin ABT-414
Glioblastoma (rGBM)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint at interim analysis - May 17, 2019.
Venclexta (VIALE-A)
Acute Myeloid Leukemia (AML)
Phase 3
Phase 3
Phase 3 trial met dual primary endpoints of overall survival and composite complete remission rate - March 23, 2020.
Venetoclax - Viale-C
Treatment-naïve Acute Myeloid Leukemia
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - February 28, 2020.
Rova-T (MERU)
First-line Small Cell Lung Cancer
Phase 3
Phase 3
Phase 3 trial demonstrated no survival benefit at interim analysis - October 29, 2019.
Upadacitinib
Atopic Dermatitis
Phase 3
Phase 3
Phase 3 trial met primary and secondary endpoints - October 31, 2019.
Risankizumab ( LIMMITLESS )
Psoriasis
Phase 3
Phase 3
Phase 3 data presented at EADV October 10, 2019.
Veliparib
Ovarian cancer
Phase 3
Phase 3
Phase 3 presentation at ESMO 28 September 2019.
ABT-494 upadacitinib
Rheumatoid arthritis
Approved
Approved
FDA Approval announced August 16, 2019.
ABT-494
Psoriatic Arthritis
Phase 3
Phase 3
Phase 3 trial to commenced 2017.
ABBV-8E12
Alzheimer's disease
Phase 2
Phase 2
Phase 2 initiation announced January 25, 2017.
Rova-T (TAHOE)
Second-line Small Cell Lung Cancer
Phase 3
Phase 3
Phase 3 enrolment to be stopped due to shorted overall survival following recommendation from Independent Data Monitoring Committee (IDMC) December 5, 2018.
Venetoclax and obinutuzumab
Chronic lymphocytic leukemia
sNDA Filing
sNDA Filing
sNDA filing announced June 4, 2019.
Venetoclax and obinutuzumab
Chronic Lymphocytic Leukemia
Phase 3
Phase 3
FDA approval announced May 15, 2019.
Risankizumab
Psoriasis
Approved
Approved
FDA approval announced April 23, 2019.
Venclexta BELLINI
Multiple myeloma
Phase 3
Phase 3
Phase 3 primary endpoint met.
Imbruvica and Gazyva - iLLUMINATE
Chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL)
Approved
Approved
FDA approval announced January 28, 2019.
Ibrutinib (Imbruvica)
Pancreatic cancer
Phase 3
Phase 3
Phase 3 primary endpoint not met (PFS/OS).
Venclexta
First line unfit AML
Approved
Approved
FDA approval announced November 21, 2018.
IMBRUVICA (ibrutinib)
Waldenström’s Macroglobulinemia
Approved
Approved
FDA approval announced August 27, 2018.
Elagolix
Endometriosis
Approved
Approved
FDA approval announced July 24, 2018.
IMBRUVICA (ibrutinib)
Diffuse large B-cell lymphoma (DLBCL)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - noted July 11, 2018.
Venclexta (MURANO)
Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)
Approved
Approved
Approval announced June 11, 2018.
Rova-T (TRINITY)
Third-line Small Cell Lung Cancer
Phase 2
Phase 2
Phase 2 pivotal data released March 22, 2018. ORR of 16% + overall survival 5.6 months noted. Abstract 8507.
Glecaprevir/Pibrentasvir (G/P)
Hepatitis C virus (HCV)
Approved
Approved
Approval announced August 3, 2017.
Imbruvica
Marginal zone lymphoma
Approved
Approved
sNDA filing announced September 26, 2017. Priority Review. Approved January 19, 2017.
Imbruvica
Second-line Chronic graft-versus-host disease (GVHD)
Approved
Approved
Approval announced August 2, 2017.
VIEKIRA PAK
HCV - genotype 1
Approved
Approved
Approved December 19, 2014.
Imbruvica
Deletion 17p
Approved
Approved
Approved July 19, 2014.
Imbruvica
Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy
Approved
Approved
Approved February 12, 2014.
Ibrutinib
Relapsed or refractory MCL mantle cell lymphoma
Approved
Approved
Approved November 13, 2013.
IMBRUVICA
Waldenström’s Macroglobulinemia
Approved
Approved
Approved January 29, 2015 - PCYC
Veliparib
Squamous non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoints - April 19, 2017.

Latest News

  1. SAN FRANCISCO, Aug. 3, 2020 /PRNewswire/ -- Today, members of the COVID R&D Alliance AbbVie, Inc. (NYSE:ABBV), Amgen Inc. (NASDAQ:AMGN), and Takeda Pharmaceutical Co. Ltd. (NYSE:TAK) announced the first patients enrolled in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) clinical trial. The I-SPY COVID Trial will evaluate the efficacy of cenicriviroc, a chemokine (CCR2 and CCR5) dual-receptor antagonist, Otezla® (apremilast), a PDE4 inhibitor, and Firazyr® (icatibant injection), a bradykinin B2 receptor antagonist in severely ill, hospitalized COVID-19 patients who require high-flow oxygen.

    SAN FRANCISCO, Aug. 3, 2020 /PRNewswire/ -- Today, members of the COVID R&D Alliance AbbVie, Inc. (NYSE:ABBV), Amgen Inc. (NASDAQ:AMGN), and Takeda Pharmaceutical Co. Ltd. (NYSE:TAK) announced the first patients enrolled in the I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) clinical trial. The I-SPY COVID Trial will evaluate the efficacy of cenicriviroc, a chemokine (CCR2 and CCR5) dual-receptor antagonist, Otezla® (apremilast), a PDE4 inhibitor, and Firazyr® (icatibant injection), a bradykinin B2 receptor antagonist in severely ill, hospitalized COVID-19 patients who require high-flow oxygen.

    The I-SPY COVID Trial utilizes Quantum Leap Healthcare Collaborative's adaptive platform trial design, which is intended to increase trial efficiency by minimizing the number of participants and time required to evaluate potential treatments.

    "Collaborative research efforts leveraging adaptive platform trials enable faster and more complete learning about what works for patients, and they are especially critical for addressing urgent public health threats like COVID-19," said Dr. Mark McClellan, director of the Robert J. Margolis, Center for Health Policy at Duke University and former commissioner of the U.S. FDA and administrator of the Centers for Medicare and Medicaid Services. "Platform trials bring down the cost and increase the ease of executing well-powered, high quality studies, especially when multiple, potential therapies need to be evaluated quickly. The I-SPY COVID Trial is expanding a timely and effective platform trial strategy to evaluate promising treatments while maintaining an appropriate level of safety and statistical rigor necessary for regulatory evaluation."

    The study is a collaboration between members of the COVID R&D Alliance, Quantum Leap, and the U.S. Food and Drug Administration (FDA). AbbVie, Amgen, and Takeda are members of the COVID R&D Alliance (COVID R&D), a group of more than 20 of the world's leading biopharmaceutical and life science companies working to speed the development of potential therapies, novel antibodies, and anti-viral therapies for COVID-19 and its related symptoms.

    "Sick patients in hospitals cannot wait; options are urgently needed. I'm proud to partner with AbbVie and Amgen and the dozens of other companies who have joined the COVID R&D Alliance, to initiate critical platform trials like I-SPY COVID," remarked Andy Plump, President of R&D at Takeda Pharmaceuticals and co-founder of the COVID R&D Alliance. "The world learned of COVID-19 only six months ago, and the speed at which the scientific community has joined forces to address the critically high unmet need is inspiring. Together, experts across our companies and industry can accelerate trials with promising, well-understood therapies that upon investigation, may show efficacy in this devastating disease."

    The therapies under investigation were selected based on their potential to impact the immune system response of COVID-19 patients who need respiratory support. Approximately 10-15 percent of patients afflicted by COVID-19 develop acute respiratory distress syndrome (ARDS), and up to 60 percent of those patients admitted to an ICU require ventilation for an average of two weeks. It is estimated that half of those patients will not survive. Based on the respective mechanisms of action, Otezla® may suppress inflammation resulting from an immune response, Firazyr® may ameliorate bradykinin-driven pulmonary edema, and cenicriviroc acts by blocking monocytes trafficking to tissues, features that may help to reduce or mitigate the severity of ARDS response in severely ill COVID-19 patients.

    Dr. Laura Esserman, co-founder of Quantum Leap Healthcare Collaborative and lead investigator of the I-SPY Trials stated, "The level of cooperation among pharma companies in response to the pandemic is unprecedented. The COVID R&D Alliance stepped forward to streamline the process of identifying safe, scalable and potentially effective agents and joined with the I-SPY consortium to propel our efforts forward at record speed. We are excited to open the trial and work to reduce the devastating effects of the virus in severely ill COVID patients, and to do it now, when we need it most."

    I-SPY COVID is one of several platform studies being pursued by members of COVID R&D to test promising therapeutic candidates faster than any single company could do operating alone. Members are investigating marketed and late-stage therapies indicated for other disease states, which, based on their mechanisms of action may have a potential treatment effect in COVID-19 patients. The group is employing adaptive platform trial methodologies that enable the ability to test multiple therapies simultaneously and modify protocols in real-time based on outcomes observed.

    In addition to designing and sponsoring several platform trials, the COVID R&D Alliance is:

    • Evaluating more than 1,900 preclinical candidates against active controls to uncover which hold the greatest promise for COVID-19.
    • Reviewing promising early-stage candidates that may show potential efficacy against COVID-19, and connecting them with potential funders from venture capital or pharmaceutical developers to enable rapid advancement.
    • Working with TransCelerate's DataCelerate® platform to enable real-time data sharing and real-world evidence to inform ongoing and future studies in COVID-19, so research communities benefit from learnings and avoid duplication.
    • Operating as an interlocutor with governments, regulators, and non-governmental organizations to share insights and engage in other platform trials.

    About the I-SPY COVID Trial

    The I-SPY COVID Trial (Investigation of Serial Studies to Predict Your COVID Therapeutic Response with Biomarker Integration and Adaptive Learning) is an adaptive platform trial designed to increase trial efficiency by minimizing the number of participants and time required to evaluate experimental and/or repurposed drugs. The focus of the trial is to improve outcomes for severely-ill COVID-19 patients—those who require at least 6L of high-flow oxygen either by mask or nasal cannula, known as level 5 on the World Health Organization (WHO) COVID scale, an 8 point ordinal scale of clinical severity status. The primary endpoint of I-SPY COVID is time to achieve level 4 (or less) for at least 48 hours on the WHO COVID scale. Key secondary endpoints include duration of time on ventilator and mortality.

    The I-SPY COVID Trial is sponsored and managed by Quantum Leap Healthcare Collaborative. For more information, visit www.quantumleaphealth.org or www.ispytrials.org

    About the COVID R&D Alliance

    Organized in March 2020, the COVID R&D Alliance is operating unconstrained by past models of development and is accelerating study candidates without regard to company affiliation. Members are sharing clinical trial data and real-world evidence, as well as crowd-sourcing early stage candidates to identify mechanisms and treatments that may be effective against COVID-19. Initial efforts by the group focus on advancing well understood therapies and late-stage investigational medicines for severely ill patients who need options. Future activities will expand to testing re-purposed molecules, early stage candidates, and therapeutic drug combinations.

    Additional information on the COVID R&D Alliance is available at www.CovidRDAlliance.com.

    About Cenicriviroc (CVC)

    CVC is an oral, once-daily, potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are intricately involved in the inflammatory and fibrogenic pathways in nonalcoholic steatohepatitis (NASH) known to cause liver damage including cirrhosis, liver cancer, or liver failure. These pathways have also been shown to be closely involved with the respiratory sequelae of COVID-19 and of related viral infections. Because of CVC's unique mechanisms of action, the drug has been viewed as having a potential role in the treatment of COVID-19 patients, in addition to its potential in the management liver fibrosis due to NASH, including as a part of combination-treatment strategies. CVC has been studied in both NASH patients and in HIV+ patients, and is in Phase 3 development for NASH. CVC has been granted Fast Track status in adults with liver fibrosis due to NASH, the population at highest risk of progression to cirrhosis.

    About Otezla® (apremilast)

    OTEZLA® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.

    Otezla is currently approved for use in more than 45 countries as an oral treatment for inflammatory diseases including psoriasis, psoriatic arthritis and Behçet's disease. By inhibiting PDE4, Otezla is thought to modulate the production of inflammatory cytokines and other mediators, which may prove helpful in inhibiting the inflammatory response associated with the signs, symptoms and pulmonary involvements observed in some COVID-19 patients. Amgen plans to collaborate with platform trials to investigate Otezla's ability to prevent clinical deterioration in patients with COVID-19.

    Otezla® (apremilast) U.S. INDICATIONS

    Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

    Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

    Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.

    Otezla® (apremilast) U.S. IMPORTANT SAFETY INFORMATION

    Contraindications

    • Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

    Warnings and Precautions

    • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
    • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes, and they should contact their healthcare provider if such changes occur
      • Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
      • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
      • Behçet's Disease: Treatment with Otezla is associated with an increase in depression. During the phase 3 clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
    • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
      • Psoriasis: During clinical trials, body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
      • Psoriatic Arthritis: During clinical trials, body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
      • Behçet's Disease: During the phase 3 clinical trial, body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo
    • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

    Adverse Reactions

    • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
    • Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)
    • Behçet's Disease: Adverse reactions reported in at least ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)

    Use in Specific Populations

    • Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
    • Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition
    • Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min) for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

    Please click here for Otezla® Full Prescribing Information.

    About Firazyr® (icatibant injection)

    FIRAZYR® (icatibant injection) is a bradykinin B2 receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Indication may vary by country. It is administered by subcutaneous injection. It is thought that icatibant may ameliorate bradykinin-driven pulmonary edema by blocking the bradykinin-2 receptors.

    Firazyr® (icatibant injection) IMPORTANT SAFETY INFORMATION

    Laryngeal attacks can become life threatening. If you have an HAE attack of the throat (laryngeal attack), inject icatibant injection and then go to the nearest hospital emergency room right away.

    The most common side effects of icatibant injection include:

    • redness, bruising, swelling, warmth, burning, itching, irritation, hives, numbness, pressure, or pain at the injection site
    • fever
    • too much of an enzyme called transaminase in your blood
    • dizziness
    • nausea
    • headache
    • rash

    These are not all of the possible side effects of icatibant injection. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    Tell your healthcare provider if you have any other medical conditions, if you are breastfeeding or plan to breastfeed, or if you are pregnant or planning to become pregnant. Icatibant injection has not been evaluated in pregnant or nursing women. You and your healthcare provider will decide if icatibant injection is right for you.

    If your symptoms continue or come back, you may repeat your icatibant injection at least 6 hours apart. Do not use more than 3 doses of icatibant injection in a 24-hour period. Tiredness, drowsiness, and dizziness have been reported following the use of icatibant injection. If this occurs, do not drive a car, use machinery, or do anything that needs you to be alert.

    Please see the full Prescribing Information.

    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.

    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, competition from other products, challenges to intellectual property, 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 2019 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.

    About Amgen

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

    Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

    Amgen Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including Adaptive Biotechnologies (including statements regarding such collaboration's, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19), or the Otezla® (apremilast) acquisition, including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on Amgen's business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

    No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product.

    The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

    About Takeda Pharmaceutical Company Limited

    Takeda Pharmaceutical Company Limited (NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing better health and a brighter future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

    For more information, visit https://www.takeda.com.

    Takeda Forward-Looking Statements

    This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could" "anticipates", "estimates", "projects" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda's operations and the timing of any such divestment(s); and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results.

    About Quantum Leap Healthcare Collaborative

    Quantum Leap Healthcare Collaborative is a 501(C)(3) charitable organization established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Our mission is to integrate high-impact research with clinical processes and systems technology, resulting in improved data management and information systems, greater access to clinical trial matching and sponsorship, and greater benefit to providers, patients, and researchers. Our goal is to improve and save lives. Quantum Leap provides operational, financial, and regulatory oversight to the I-SPY Trials. For more information, visit www.QuantumLeapHealth.org.

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  2. NORTH CHICAGO, Ill., July 31, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2020.

    "AbbVie delivered another strong quarterly performance, ahead of our guidance. The adverse impact from COVID-19 on legacy AbbVie was less than expected, demonstrating the robustness and resiliency of our key brands, and new patient starts have stabilized and started to recover," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "The integration of Allergan is going well, with a strong recovery in the aesthetics portfolio and accretion ahead of expectations."

    Second-Quarter Results

    • Worldwide net revenues were $10.425 billion, an increase of 26.3 percent on a reported basis, or a decrease…

    NORTH CHICAGO, Ill., July 31, 2020 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2020.

    "AbbVie delivered another strong quarterly performance, ahead of our guidance. The adverse impact from COVID-19 on legacy AbbVie was less than expected, demonstrating the robustness and resiliency of our key brands, and new patient starts have stabilized and started to recover," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "The integration of Allergan is going well, with a strong recovery in the aesthetics portfolio and accretion ahead of expectations."

    Second-Quarter Results

    • Worldwide net revenues were $10.425 billion, an increase of 26.3 percent on a reported basis, or a decrease of 5.3 percent on a comparable operational basis, due to the COVID-19 pandemic.
    • Global net revenues from the immunology portfolio were $5.316 billion, an increase of 8.1 percent on a reported basis, or 8.6 percent on an operational basis.
      • Global Humira net revenues of $4.837 billion decreased 0.7 percent on a reported basis, or 0.2 percent on an operational basis. U.S. Humira net revenues were $3.974 billion, an increase of 4.8 percent. Internationally, Humira net revenues were $863 million, a decrease of 19.9 percent on a reported basis, or 17.4 percent on an operational basis, due to biosimilar competition.
      • Global Skyrizi net revenues were $330 million.
      • Global Rinvoq net revenues were $149 million.
    • Global net revenues from the hematologic oncology portfolio were $1.591 billion, an increase of 25.5 percent on a reported basis, or 25.8 percent on an operational basis.
      • Global Imbruvica net revenues were $1.288 billion, an increase of 17.2 percent, with U.S. net revenues of $1.055 billion and international profit sharing of $233 million.
      • Global Venclexta net revenues were $303 million, an increase of 79.2 percent on a reported basis, or 81.5 percent on an operational basis.
    • Global net revenues from the aesthetics portfolio were $481 million, a decrease of 47.9 percent on a comparable operational basis, due to the COVID-19 pandemic.
      • Global Botox Cosmetic net revenues were $226 million, a decrease of 43.1 percent on a comparable operational basis, due to the COVID-19 pandemic.
    • Global net revenues from the neuroscience portfolio were $734 million, an increase of over 100.0 percent on a reported basis, or 1.8 percent on a comparable operational basis.
      • Global Botox Therapeutic net revenues were $297 million, a decrease of 22.3 percent on a comparable operational basis, due to the COVID-19 pandemic.
      • Global Vraylar net revenues were $192 million, an increase of 70.4 percent on a comparable operational basis.
      • Global Ubrelvy net revenues were $22 million.
    • On a GAAP basis, the gross margin ratio in the second quarter was 64.4 percent. The adjusted gross margin ratio was 82.8 percent.
    • On a GAAP basis, selling, general and administrative expense was 33.8 percent of net revenues. The adjusted SG&A expense was 22.9 percent of net revenues.
    • On a GAAP basis, research and development expense was 15.2 percent of net revenues. The adjusted R&D expense was 12.8 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
    • On a GAAP basis, the operating margin in the second quarter was 7.2 percent. The adjusted operating margin was 47.0 percent.
    • On a GAAP basis, net interest expense was $614 million. The adjusted net interest expense was $484 million.
    • On a GAAP basis, the tax rate in the quarter was negative 6.5 percent. The adjusted tax rate was 11.4 percent.
    • Diluted EPS in the second quarter was a loss of $0.46 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.34.

    Note: "Comparable Operational" comparisons include full-quarter current year and prior year results for Allergan, which was acquired on May 8, 2020, as if the acquisition closed on January 1, 2019, and are presented at constant currency rates and reflect comparative local currency net revenues at the prior year's foreign exchange rates. Refer to the Key Product Revenues schedules for further details. "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year's foreign exchange rates.

    Recent Events

    • AbbVie announced it completed its acquisition of Allergan plc following receipt of regulatory approval from all government authorities required by the transaction agreement and approval by the Irish High Court. The transaction significantly expands and diversifies AbbVie's revenue base, provides immediate scale and profitability to AbbVie's Growth Platform (ex-Humira) and creates a biopharmaceutical company with leadership positions in key therapeutic areas including immunology, hematologic oncology, neuroscience and aesthetics. It also provides a robust portfolio of on-market and pipeline assets that position the company for enhanced long-term growth potential, a growing dividend, rapid debt repayment and investment in innovation in each of its therapeutic categories.
    • AbbVie and Genmab A/S announced a broad collaboration agreement to jointly develop and commercialize three of Genmab's early-stage investigational bispecific antibody product candidates and enter into a discovery research collaboration for future differentiated antibody therapeutics for cancer. The companies will partner to develop Genmab's next-generation bispecific antibody programs, epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4. The collaboration combines Genmab's world-class discovery and development engine and next-generation bispecific antibody therapeutic candidates with AbbVie's deep clinical expertise, innovative ADC platform and global commercial leadership in hematological cancers. Under the terms of the agreement AbbVie will pay Genmab an upfront payment of $750 million, in addition to potential milestone payments.
    • AbbVie announced that it has submitted applications for a new indication to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for Rinvoq (upadacitinib), a selective and reversible JAK inhibitor, for the treatment of adult patients with active psoriatic arthritis (PsA). The applications are supported by data from two Phase 3 studies across a broad range of more than 2,000 patients with active PsA in which Rinvoq demonstrated improved joint outcomes, physical function and skin symptoms, with a greater proportion of patients achieving minimal disease activity versus placebo. Overall, the safety profile of Rinvoq in PsA was consistent with previously reported results across the Phase 3 rheumatoid arthritis (RA) clinical trial program, with no new significant safety risks detected.
    • AbbVie announced top-line results from the three Phase 3 studies in the registrational program for Rinvoq in atopic dermatitis (AD) - Measure Up 1 (MU1), Measure Up 2 (MU2) and AD Up (AU). In the MU1 and MU2 replicate studies, Rinvoq monotherapy showed significant improvement in skin clearance and reduction in itch at week 16 in adult and adolescent patients with moderate to severe AD. In the MU1 study, of patients receiving either 15mg/30mg of Rinvoq, 70/80 percent achieved at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) versus 16% on placebo. Similarly in the MU2 study, of patients receiving either 15mg/30mg of Rinvoq, 60/73 percent achieved EASI 75 versus 13 percent on placebo. In both the MU1 and MU2 studies, clinically meaningful reductions in itch compared to placebo were observed as early as one day after the first dose for patients receiving Rinvoq 30mg and two days after the first dose for patients receiving Rinvoq 15mg. In the AU study, significantly more patients receiving Rinvoq plus topical corticosteroids (TCS) showed improvement in skin clearance compared to placebo plus TCS at week 16. In the study, 65/77 percent of patients receiving Rinvoq 15mg/30mg plus TCS achieved EASI 75, respectively, versus 26 percent receiving placebo plus TCS. Additionally, more patients treated with Rinvoq plus TCS experienced a clinically meaningful reduction in itch compared to patients treated with placebo plus TCS and treatment with either dose of Rinvoq led to a higher mean number of TCS-free days. Full results from the Phase 3 studies will be presented at a future medical meeting and published in a peer-reviewed publication. AbbVie plans to submit regulatory applications later this year for Rinvoq in AD.
    • AbbVie announced top-line results from a proof-of-concept study evaluating ABBV-3373, an investigational anti-TNF - glucocorticoid receptor modulator steroid ADC, in adult patients with moderate to severe RA. Bayesian statistical methods incorporating historical data were used to achieve adequate statistical power in this proof of concept study, which was accomplished through pre-specified supplementation of adalimumab in-trial data with historical adalimumab data for comparison with ABBV-3373 for the primary endpoint analyses. Comparing ABBV-3373 to the mean outcome from historical adalimumab data showed a greater difference in the change in Disease Activity Score 28 C-Reactive Protein (DAS28-CRP) from baseline to week 12 for ABBV-3373 (-2.65) as compared to a pre-specified historical adalimumab mean (-2.13) (p=0.022). Comparing ABBV-3373 to combined in-trial and historical adalimumab data, based on a Bayesian analysis, predicted with a 90 percent probability that ABBV-3373 was associated with a greater improvement on DAS28-CRP from baseline to week 12 than adalimumab. In this study, the safety profile of ABBV-3373 was generally similar to the known safety profile of adalimumab and evaluations of serum cortisol levels over 12 weeks indicated that ABBV-3373 showed no systemic glucocorticoid effects. Based on these results, AbbVie plans to advance the development of the TNF-ADC platform in RA and begin clinical studies in other immune-mediated diseases.
    • At the Annual European E-Congress of Rheumatology (EULAR), AbbVie presented 25 abstracts across multiple rheumatic conditions, including new data from the Phase 3 SELECT-CHOICE clinical trial showing Rinvoq met both the primary (non-inferiority) and key secondary (superiority) endpoints compared to Orencia (abatacept) on change from baseline in DAS28-CRP at week 12 in patients with RA who have had an inadequate response to biologic disease-modifying anti-rheumatic drugs (DMARDs). AbbVie also presented long-term results from the SELECT-COMPARE and SELECT-MONOTHERAPY studies showing that Rinvoq continued to improve signs and symptoms in patients with RA through 72 and 84 weeks, respectively. Additionally, results from the SELECT-EARLY and SELECT-COMPARE clinical trials showed Rinvoq inhibited structural joint damage in RA patients receiving Rinvoq as monotherapy or in combination with methotrexate at almost two years. Rinvoq's safety profile was consistent across the pivotal Phase 3 RA program, with no new safety signals identified.
    • At the American Academy of Dermatology (AAD) virtual annual meeting AbbVie announced new Phase 3b head-to-head data showing superior rates of skin clearance for Skyrizi (risankizumab) versus Cosentyx at week 52. Particularly, 66 percent of psoriasis patients receiving Skyrizi achieved completely clear skin (PASI 100) versus 40 percent of patients receiving Cosentyx at week 52. Skyrizi met both PASI 90 primary endpoints of non-inferiority to Cosentyx at week 16 and superiority to Cosentyx at week 52. At week 16, 74 percent of Skyrizi-treated patients achieved PASI 90 compared to 66 percent of Cosentyx-treated patients. Of patients treated with Skyrizi, 87 percent achieved PASI 90 at week 52 compared to 57 percent of patients treated with Cosentyx. The safety profile of Skyrizi was consistent with that observed in previously reported studies, with no new safety signals observed through week 52. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
    • At the European Hematology Association (EHA) Annual Congress, AbbVie presented more than 30 abstracts from studies of its on-market and investigational medicines from its oncology portfolio across chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), multiple myeloma (MM), myelodysplastic syndrome (MDS) and myelofibrosis (MF). Highlights included results from the Phase 3 CLL14 trial of Venclexta (venetoclax) plus obinutuzumab in previously untreated CLL patients, extended follow-up data from the Phase 3 MURANO trial on subgroup-analyses of Venclexta in combination with rituximab in relapsed/refractory (r/r) CLL, new data on safety and efficacy from the CAPTIVATE study evaluating Imbruvica (ibrutinib) plus Venclexta in first-line treatment of CLL. Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc.
    • At EHA, AbbVie also presented results from two Phase 3 studies evaluating Venclexta in patients with previously untreated AML. The Phase 3 VIALE-A trial demonstrated that previously untreated patients with AML who were ineligible for intensive chemotherapy treated with Venclexta plus azacitidine achieved a 34 percent reduction in the risk of death compared to azacitidine in combination with placebo. Patients receiving the Venclexta combination achieved improved median overall survival (OS) of 14.7 months versus 9.6 months in the placebo arm. Additionally, AbbVie presented updated six-month data from the Phase 3 VIALE-C study of Venclexta in combination with low-dose cytarabine in previously untreated older patients with AML.
    • AbbVie, in cooperation with Neurocrine Biosciences, announced the FDA approval of Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) for the management of heavy menstrual bleeding due to uterine fibroids in pre-menopausal women. Uterine fibroids are the most common type of benign tumor in women of reproductive age and Oriahnn is the first FDA-approved, non-surgical, oral medication option for the management of heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women.
    • Allergan Aesthetics, an AbbVie company, announced the FDA approved Juvederm Voluma XC for the augmentation of the chin region to improve the chin profile in adults over the age of 21. Juvederm Voluma XC is the first and only filler to receive FDA approval for the augmentation of the chin region and this latest approval marks the Juvederm Collection's fifth approved indication in the U.S.
    • AbbVie announced that the Phase 3 ADVANCE trial evaluating atogepant, an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist, met its primary endpoint of statistically significantly greater reduction in mean monthly migraine days, compared to placebo, for all doses (10mg, 30mg, or 60mg) across the 12-week treatment period. The trial also demonstrated that treatment with 30mg and 60mg doses resulted in statistically significant improvements in all secondary endpoints, including ≥ 50% reduction in three-month average of monthly migraine days, improvements in acute medication use, and performance of daily activities and physical impairment. Treatment with the 10mg dose resulted in statistically significant improvements in four out of the six secondary endpoints. With these results, combined with the results from a long-term Phase 3 safety trial, and results from a prior positive Phase 2b/3 trial, AbbVie plans to move forward with regulatory submissions in the U.S. and other countries.
    • At the Annual Scientific Meeting of the American Headache Society (AHS), AbbVie presented 27 abstracts that highlighted the company's ongoing innovation in migraine, including its investigational product, atogepant, while reinforcing the efficacy and safety profiles of Botox and Ubrelvy (ubrogepant). In particular, AbbVie presented real-world studies that demonstrated significantly more patients starting Botox were persistent with their treatment compared to those starting on CGRP mAbs for migraine as well as results from several studies that added to the large body of evidence evaluating the long-term safety and sustained efficacy of Botox. Long-term Ubrelvy trial data showed that in addition to effectively treating migraine attacks when pain is moderate or severe, treating when pain is mild may significantly increase rates of pain freedom and absence of migraine-associated symptoms. Additionally, AbbVie presented results from studies that evaluated the pharmacokinetic (PK), safety and tolerability profiles of atogepant in addition to the potential for PK drug-drug interactions (DDIs) between atogepant and other compounds.
    • AbbVie and Molecular Partners announced that the FDA issued a Complete Response Letter to the Biologics License Application for abicipar pegol, a novel, investigational DARPin therapy for patients with neovascular (wet) age-related macular degeneration (nAMD). The letter from the FDA indicated that the rate of intraocular inflammation observed following administration of abicipar pegol 2mg/0.05 mL resulted in an unfavorable benefit-risk ratio in the treatment of nAMD. AbbVie also withdrew its regulatory application with the EMA for abicipar in nAMD. AbbVie plans to meet with the FDA and EMA to discuss their comments and determine next steps.
    • AbbVie announced a strategic collaboration with Jacobio Pharmaceuticals, a clinical-stage pharmaceutical company, to develop and commercialize SHP2 inhibitors, which target a key node in cancer and immune cells. Inhibition of SHP2 is believed to have dual effects by potentially reducing cancer cell growth and modulating immune responses to generate anti-tumor activities. Jacobio's early clinical stage SHP2 assets, JAB-3068 and JAB-3312, are oral small molecules designed to specifically inhibit SHP2 activity. Under the terms of the agreement, AbbVie will be granted an exclusive license to the SHP2 portfolio. Jacobio will continue to conduct early global clinical trials of JAB-3068 and JAB-3312 with AbbVie covering R&D expenses. Upon completion, AbbVie will assume global development and commercialization responsibilities.
    • AbbVie, Harbour BioMed (HBM), Utrecht University (UU) and Erasmus Medical Center (EMC) announced they have entered into a collaboration to develop a novel antibody therapeutic to prevent and treat COVID-19, the pandemic respiratory disease caused by the SARS-CoV-2 virus. The focus of the collaboration is on advancing the fully human, neutralizing antibody 47D11 discovered by UU, EMC and HBM and recently reported in Nature Communications. This antibody targets the conserved domain of the spike protein of SARS-CoV-2. Under the terms of the collaboration, AbbVie will support UU, EMC and HBM through the preclinical activities, while simultaneously undertaking preparations for later stage preclinical and clinical development work. AbbVie will receive an option to exclusively license the antibody from the three parties for therapeutic clinical development and commercialization worldwide.
    • AbbVie announced a donation of $5 million to the NAACP Legal Defense and Education Fund and the Equal Justice Initiative to address issues in our criminal justice system, as well as an additional commitment of $50 million over five years to partner with nonprofits on a long-term, multi-faceted program that will seek to bring lasting and real change at the community level to help secure quality education, jobs, healthcare and justice. AbbVie is also providing a 2:1 match for employees who wish to support organizations working to help address racial equality and social justice issues. AbbVie is committed to advancing racial equality, through our continued growth and acceptance of each other, our way of doing business, our attraction and development of talent, and our service to the community.
    • AbbVie announced donations to 26 nonprofit organizations totaling $5 million to support immediate COVID-19 relief efforts. As a result of AbbVie's donation, national and global nonprofit organizations will provide 55,000 frontline healthcare workers with critical personal protective equipment and training; improve the well-being of 50,000 children and families by providing access to essential resources including healthcare and education; and support vital services including shelter for more than 30,000 people experiencing homelessness and other at-risk populations. The donation is part of AbbVie's broader $35 million philanthropic contribution to COVID-19 relief efforts that also include donations to partners International Medical Corps, Direct Relief and Feeding America.

    Full-Year 2020 Outlook

    AbbVie previously issued standalone GAAP diluted EPS guidance for the full-year 2020 of $7.60 to $7.70. AbbVie is issuing combined company GAAP diluted EPS guidance for the full-year 2020, which includes the results of Allergan from May 8, 2020 through December 31, 2020, of $4.12 to $4.22.

    AbbVie previously issued standalone adjusted diluted EPS for the full-year 2020 of $9.61 to $9.71. AbbVie is issuing combined company adjusted diluted EPS guidance for the full-year 2020, which includes the results of Allergan from May 8, 2020 through December 31, 2020, of $10.35 to $10.45, representing annualized net accretion from the Allergan transaction of 11 percent. The combined company's 2020 adjusted diluted EPS guidance excludes $6.23 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.

    Combined company guidance supersedes previously issued standalone guidance.

    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 or LinkedIn.

    Conference Call

    AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our second-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central time.

    Non-GAAP Financial Results

    Financial results for 2020 and 2019 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 2020 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, including the impact of the COVID-19 pandemic on AbbVie's operations, results and financial results, 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, failure to realize the expected benefits of the Allergan acquisition, failure to promptly and effectively integrate Allergan's businesses, significant transaction costs and/or unknown or inestimable liabilities, potential litigation associated with the Allergan acquisition, 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 2019 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission (SEC). 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 June 30, 2020

    (Unaudited)

















    % Change vs. 2Q19



    Net Revenues (in millions) a



    Reported



    Comparable Operational b, c



    U.S.



    Int'l.



    Total



    U.S.



    Int'l.



    Total



    U.S.



    Int'l



    Total

    NET REVENUES

    $8,147



    $2,278



    $10,425



    36.6%



    (0.5)%



    26.3%



    (0.1)%



    (20.5)%



    (5.3)%





































    Immunology

    4,399



    917



    5,316



    14.8



    (15.5)



    8.1



    14.8



    (13.0)



    8.6

    Humira

    3,974



    863



    4,837



    4.8



    (19.9)



    (0.7)



    4.8



    (17.4)



    (0.2)

    Skyrizi

    289



    41



    330



    >100%



    >100%



    >100%



    >100%



    >100%



    >100%

    Rinvoq

    136



    13



    149



    n/m



    n/m



    n/m



    n/m



    n/m



    n/m





































    Hematologic Oncology

    1,246



    345



    1,591



    24.2



    30.1



    25.5



    24.2



    31.6



    25.8

    Imbruvica d

    1,055



    233



    1,288



    19.0



    9.4



    17.2



    19.0



    9.4



    17.2

    Venclexta

    191



    112



    303



    63.5



    >100%



    79.2



    63.5



    >100%



    81.5





































    Aesthetics

    330



    151



    481



    n/m



    n/m



    n/m



    (47.7)



    (48.3)



    (47.9)

    Botox Cosmetic*

    147



    79



    226



    n/m



    n/m



    n/m



    (39.8)



    (47.9)



    (43.1)

    Juvederm Collection*

    56



    57



    113



    n/m



    n/m



    n/m



    (62.5)



    (58.4)



    (60.4)

    Other Aesthetics*

    127



    15



    142



    n/m



    n/m



    n/m



    (46.7)



    >100%



    (41.7)





































    Neuroscience

    596



    138



    734



    >100%



    50.6



    >100%



    5.9



    (17.2)



    1.8

    Botox Therapeutic*

    254



    43



    297



    n/m



    n/m



    n/m



    (19.1)



    (36.9)



    (22.3)

    Vraylar*

    192





    192



    n/m



    n/a



    n/m



    70.4



    n/a



    70.4

    Duodopa

    25



    93



    118



    8.3



    1.6



    2.9



    8.3



    3.7



    4.6

    Ubrelvy*

    22





    22



    n/m



    n/a



    n/m



    n/m



    n/a



    n/m

    Other Neuroscience*

    103



    2



    105



    n/m



    n/m



    n/m



    (13.9)



    (4.3)



    (13.9)





































    Eye Care

    274



    143



    417



    n/m



    n/m



    n/m



    (17.0)



    (25.4)



    (20.0)

    Lumigan/Ganfort*

    35



    41



    76



    n/m



    n/m



    n/m



    (13.2)



    (13.6)



    (13.4)

    Alphagan/Combigan*

    47



    22



    69



    n/m



    n/m



    n/m



    (15.1)



    (8.1)



    (13.0)

    Restasis*

    138



    6



    144



    n/m



    n/m



    n/m



    (19.5)



    (17.8)



    (19.5)

    Other Eye Care*

    54



    74



    128



    n/m



    n/m



    n/m



    (14.2)



    (35.6)



    (27.5)





































    Women's Health

    142



    5



    147



    >100%



    >100%



    >100%



    (14.9)



    (35.7)



    (15.6)

    Lo Loestrin*

    78



    2



    80



    n/m



    n/m



    n/m



    (8.8)



    (18.8)



    (8.9)

    Orilissa/Oriahnn

    30



    1



    31



    57.3



    90.2



    58.0



    57.3



    95.4



    58.1

    Other Women's Health*

    34



    2



    36



    n/m



    n/m



    n/m



    (39.6)



    (52.3)



    (40.4)





































    Other Key Products

    878



    271



    1,149



    (14.1)



    (36.4)



    (20.7)



    (21.3)



    (35.5)



    (25.0)

    Mavyret

    146



    230



    376



    (62.9)



    (40.2)



    (51.7)



    (62.9)



    (39.6)



    (51.4)

    Creon

    252





    252



    (1.9)



    n/a



    (1.9)



    (1.9)



    n/a



    (1.9)

    Lupron

    167



    38



    205



    (0.1)



    (8.9)



    (1.8)



    (0.1)



    (3.2)



    (0.7)

    Linzess/Constella*

    130



    3



    133



    n/m



    n/m



    n/m



    5.4



    18.8



    5.7

    Synthroid

    183





    183



    (9.7)



    n/a



    (9.7)



    (9.7)



    n/a



    (9.7)



    a

    Net revenues include Allergan product revenues from the date of the acquisition, May 8, 2020, through June 30, 2020.

    b

    "Comparable Operational" comparisons include full-quarter current year and prior year results for Allergan, 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. Refer to the Quarterly Comparable Historical Trend Analysis for additional information regarding comparable historical net revenues.

    c

    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.

    d

    Reflects profit sharing for Imbruvica international revenues.

    *

    Represents product(s) acquired as part of the Allergan acquisition.

    n/a = not applicable

    n/m = not meaningful

     

    AbbVie Inc.

    Key Product Revenues

    Six Months Ended June 30, 2020

    (Unaudited)

















    % Change vs. 6M19



    Net Revenues (in millions) a



    Reported



    Comparable Operational b, c



    U.S.



    Int'l.



    Total



    U.S.



    Int'l.



    Total



    U.S.



    Int'l.



    Total

    NET REVENUES

    $14,305



    $4,739



    $19,044



    27.3%



    (2.2)%



    18.4%



    5.7%



    (12.1)%



    0.8%





































    Immunology

    8,403



    2,002



    10,405



    19.2



    (13.5)



    11.1



    19.2



    (11.2)



    11.7

    Humira

    7,630



    1,910



    9,540



    8.9



    (17.2)



    2.4



    8.9



    (14.9)



    3.0

    Skyrizi

    555



    75



    630



    >100%



    >100%



    >100%



    >100%



    >100%



    >100%

    Rinvoq

    218



    17



    235



    n/m



    n/m



    n/m



    n/m



    n/m



    n/m





































    Hematologic Oncology

    2,413



    727



    3,140



    24.6



    44.2



    28.6



    24.6



    45.5



    28.9

    Imbruvica d

    2,021



    499



    2,520



    17.9



    22.9



    18.8



    17.9



    22.9



    18.8

    Venclexta

    392



    228



    620



    76.7



    >100%



    93.7



    76.7



    >100%



    95.8





































    Aesthetics

    330



    151



    481



    n/m



    n/m



    n/m



    (29.7)



    (38.0)



    (32.5)

    Botox Cosmetic*

    147



    79



    226



    n/m



    n/m



    n/m



    (24.3)



    (35.3)



    (28.7)

    Juvederm Collection*

    56



    57



    113



    n/m



    n/m



    n/m



    (41.9)



    (43.3)



    (42.7)

    Other Aesthetics*

    127



    15



    142



    n/m



    n/m



    n/m



    (28.3)



    (21.9)



    (27.7)





































    Neuroscience

    621



    237



    858



    >100%



    31.6



    >100%



    11.4



    (5.4)



    8.3

    Botox Therapeutic*

    254



    43



    297



    n/m



    n/m



    n/m



    (10.3)



    (19.9)



    (12.1)

    Vraylar*

    192





    192



    n/m



    n/a



    n/m



    80.0



    n/a



    80.0

    Duodopa

    50



    192



    242



    9.3



    6.7



    7.2



    9.3



    9.2



    9.2

    Ubrelvy*

    22





    22



    n/m



    n/a



    n/m



    n/m



    n/a



    n/m

    Other Neuroscience*

    103



    2



    105



    n/m



    n/m



    n/m



    (10.2)



    26.2



    (9.8)





































    Eye Care

    274



    143



    417



    n/m



    n/m



    n/m



    0.1



    (13.1)



    (4.7)

    Lumigan/Ganfort*

    35



    41



    76



    n/m



    n/m



    n/m



    1.9



    (7.9)



    (3.6)

    Alphagan/Combigan*

    47



    22



    69



    n/m



    n/m



    n/m



    (7.6)



    (3.4)



    (6.4)

    Restasis*

    138



    6



    144



    n/m



    n/m



    n/m



    0.8



    (2.8)



    0.7

    Other Eye Care*

    54



    74



    128



    n/m



    n/m



    n/m



    4.0



    (18.6)



    (10.1)





































    Women's Health

    172



    6



    178



    >100%



    >100%



    >100%



    (10.1)



    (13.7)



    (10.3)

    Lo Loestrin*

    78



    2



    80



    n/m



    n/m



    n/m



    (10.3)



    (4.1)



    (10.2)

    Orilissa/Oriahnn

    60



    2



    62



    88.6



    >100%



    90.3



    88.6



    >100%



    90.4

    Other Women's Health*

    34



    2



    36



    n/m



    n/m



    n/m



    (27.2)



    (28.8)



    (27.4)





































    Other Key Products

    1,788



    634



    2,422



    (11.7)



    (25.5)



    (15.8)



    (14.1)



    (24.1)



    (16.8)

    Mavyret

    380



    555



    935



    (52.4)



    (28.1)



    (40.4)



    (52.4)



    (27.2)



    (39.9)

    Creon

    528





    528



    9.3



    n/a



    9.3



    9.3



    n/a



    9.3

    Lupron

    362



    76



    438



    1.1



    (4.7)





    1.1



    (0.6)



    0.7

    Linzess/Constella*

    130



    3



    133



    n/m



    n/m



    n/m



    6.9



    25.3



    7.4

    Synthroid

    388





    388



    0.7



    n/a



    0.7



    0.7



    n/a



    0.7





    a

    Net revenues include Allergan product revenues from the date of the acquisition, May 8, 2020, through June 30, 2020.

    "Comparable Operational" comparisons include full-period current year and prior year results for Allergan, 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. Refer to the Quarterly Comparable Historical Trend Analysis for additional information regarding comparable historical net revenues.

    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.

    Reflects profit sharing for Imbruvica international revenues.

    Represents product(s) acquired as part of the Allergan acquisition.



    n/a = not applicable



    n/m = not meaningful

     

    AbbVie Inc.

    Consolidated Statements of Earnings

    Quarter and Six Months Ended June 30, 2020 and 2019

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





    Second Quarter

    Ended June 30



    Six Months

    Ended June 30



    2020



    2019



    2020



    2019

    Net revenues

    $

    10,425





    $

    8,255





    $

    19,044





    $

    16,083



    Cost of products sold

    3,711





    1,819





    5,653





    3,513



    Selling, general and administrative

    3,527





    1,654





    5,222





    3,334



    Research and development

    1,582





    1,291





    2,961





    2,580



    Acquired in-process research and development

    853





    91





    853





    246



    Total operating costs and expenses

    9,673





    4,855





    14,689





    9,673



















    Operating earnings

    752





    3,400





    4,355





    6,410



















    Interest expense, net

    614





    309





    1,042





    634



    Net foreign exchange loss

    29





    6





    34





    12



    Other expense, net

    802





    2,278





    874





    2,413



    Earnings (loss) before income tax expense

    (693)





    807





    2,405





    3,351



    Income tax expense

    46





    66





    134





    154



    Net earnings (loss)

    (739)





    741





    2,271





    3,197



    Net loss attributable to noncontrolling interest

    (1)









    (1)







    Net earnings (loss) attributable to AbbVie Inc.

    $

    (738)





    $

    741





    $

    2,272





    $

    3,197



















    Diluted earnings (loss) per share attributable to AbbVie Inc.

    $

    (0.46)





    $

    0.49





    $

    1.43





    $

    2.14



















    Adjusted diluted earnings per sharea

    $

    2.34





    $

    2.26





    $

    4.76





    $

    4.40



















    Weighted-average diluted shares outstanding

    1,647





    1,484





    1,568





    1,483





    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 June 30, 2020

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



    1.     Specified items impacted results as follows:





    2Q20



    Earnings



    Diluted



    Pre-tax



    After-taxa



    EPS

    As reported (GAAP)

    $

    (693)





    $

    (738)





    $

    (0.46)



    Adjusted for specified items:











    Intangible asset amortization

    1,406





    1,190





    0.72



    Acquisition related costs

    1,919





    1,784





    1.08



    Milestones and other R&D expenses

    50





    49





    0.03



    Acquired IPR&D

    853





    853





    0.52



    Change in fair value of contingent consideration

    809





    809





    0.49



    Other

    51





    (52)





    (0.04)



    As adjusted (non-GAAP)

    $

    4,395





    $

    3,895





    $

    2.34







    a

    Represents net earnings (loss) attributable to AbbVie Inc.

     

    Acquisition related costs reflect transaction, financing and integration costs related to the Allergan acquisition as well as amortization of the acquisition date fair value step-up for inventory. Milestones and other R&D expenses include milestone payments for previously announced collaborations. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties. Other primarily includes COVID-19 related expenses and tax audit settlements.



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





    2Q20



    Cost of

    products

    sold



    SG&A



    R&D



    Acquired

     IPR&D



    Interest

    expense,

    net



    Net

    foreign

    exchange

    loss



    Other

    expense,

    net

    As reported (GAAP)

    $

    3,711





    $

    3,527





    $

    1,582





    $

    853





    $

    614





    $

    29





    $

    802



    Adjusted for specified items:



























    Intangible asset amortization

    (1,406)



























    Acquisition related costs

    (469)





    (1,142)





    (178)









    (130)











    Milestones and other R&D expenses









    (50)



















    Acquired IPR&D













    (853)















    Change in fair value of contingent consideration

























    (809)



    Other

    (40)





    7





    (22)













    4







    As adjusted (non-GAAP)

    $

    1,796





    $

    2,392





    $

    1,332





    $





    $

    484





    $

    33





    $

    (7)



     

    3.     The adjusted tax rate for the second quarter of 2020 was 11.4 percent, as detailed below:





    2Q20



    Pre-tax

    earnings



    Income

    taxes



    Tax rate

    As reported (GAAP)

    $

    (693)





    $

    46





    (6.5)

    %

    Specified items

    5,088





    455





    8.9

    %

    As adjusted (non-GAAP)

    $

    4,395





    $

    501





    11.4

    %

     

    AbbVie Inc.

    Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

    Quarter Ended June 30, 2019

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



    1. Specified items impacted results as follows:





    2Q19



    Earnings



    Diluted



    Pre-tax



    After-taxa



    EPS

    As reported (GAAP)

    $

    807





    $

    741





    $

    0.49



    Adjusted for specified items:











    Intangible asset amortization

    388





    321





    0.22



    Milestones and other R&D expenses

    35





    35





    0.02



    Acquired IPR&D

    91





    86





    0.06



    Change in fair value of contingent consideration

    2,304





    2,304





    1.55



    Restructuring

    8





    6







    Litigation reserves

    10





    8







    Acquisition related costs

    31





    27





    0.02



    Tax audit settlement





    (178)





    (0.12)



    Other

    20





    20





    0.02



    As adjusted (non-GAAP)

    $

    3,694





    $

    3,370





    $

    2.26







    a

    Represents net earnings attributable to AbbVie Inc.

     

    Milestones and other R&D expenses are associated with milestone payments for previously announced collaborations. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties. Restructuring is primarily associated with streamlining global operations. Acquisition related costs reflect transaction and financing costs related to the Allergan acquisition.



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





    2Q19



    Cost of

    products sold



    SG&A



    R&D



    Acquired

     IPR&D



    Interest

    expense,

    net



    Other

    expense,

    net

    As reported (GAAP)

    $

    1,819





    $

    1,654





    $

    1,291





    $

    91





    $

    309





    $

    2,278



    Adjusted for specified items:























    Intangible asset amortization

    (388)























    Milestones and other R&D expenses









    (35)















    Acquired IPR&D













    (91)











    Change in fair value of contingent consideration





















    (2,304)



    Restructuring

    (3)









    (5)















    Litigation reserves





    (10)



















    Acquisition related costs





    (24)













    (7)







    Other

    (1)









    (19)















    As adjusted (non-GAAP)

    $

    1,427





    $

    1,620





    $

    1,232





    $





    $

    302





    $

    (26)



     

    3.     The adjusted tax rate for the second quarter of 2019 was 8.7 percent, as detailed below:





    2Q19



    Pre-tax

    earnings



    Income

    taxes



    Tax rate

    As reported (GAAP)

    $

    807





    $

    66





    8.1

    %

    Specified items

    2,887





    258





    8.9

    %

    As adjusted (non-GAAP)

    $

    3,694





    $

    324





    8.7

    %

     

    AbbVie Inc.

    Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

    Six Months Ended June 30, 2020

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



     1. Specified items impacted results as follows:





    6M20



    Earnings



    Diluted



    Pre-tax



    After-taxa



    EPS

    As reported (GAAP)

    $

    2,405





    $

    2,272





    $

    1.43



    Adjusted for specified items:











    Intangible asset amortization

    1,850





    1,561





    0.99



    Acquisition related costs

    2,107





    1,942





    1.24



    Milestones and other R&D expenses

    185





    164





    0.11



    Acquired IPR&D

    853





    853





    0.54



    Change in fair value of contingent consideration

    881





    881





    0.56



    Other

    117





    (165)





    (0.11)



    As adjusted (non-GAAP)

    $

    8,398





    $

    7,508





    $

    4.76







    a

    Represents net earnings attributable to AbbVie Inc.

     

    Acquisition related costs reflect transaction, financing and integration costs related to the Allergan acquisition as well as amortization of the acquisition date fair value step-up for inventory. Milestones and other R&D expenses include milestone payments for previously announced collaborations and the purchase of an FDA priority review voucher from a third party. Other primarily includes the impacts of tax law changes and COVID-19 related charitable contributions and expenses.



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





    6M20



    Cost of

    products

    sold



    SG&A



    R&D



    Acquired

     IPR&D



    Interest

    expense,

    net



    Net

    foreign

    exchange

    loss



    Other

    expense,

    net

    As reported (GAAP)

    $

    5,653





    $

    5,222





    $

    2,961





    $

    853





    $

    1,042





    $

    34





    $

    874



    Adjusted for specified items:



























    Intangible asset amortization

    (1,850)



























    Acquisition related costs

    (469)





    (1,186)





    (178)









    (274)











    Milestones and other R&D expenses









    (185)



















    Change in fair value of contingent consideration

























    (881)



    Other

    (44)





    (45)





    (32)













    4







    As adjusted (non-GAAP)

    $

    3,290





    $

    3,991





    $

    2,566





    $





    $

    768





    $

    38





    $

    (7)



     

    3.     The adjusted tax rate for the first six months of 2020 was 10.6 percent, as detailed below:





    6M20



    Pre-tax

    earnings



    Income

    taxes



    Tax rate

    As reported (GAAP)

    $

    2,405





    $

    134





    5.6

    %

    Specified items

    5,993





    757





    12.6

    %

    As adjusted (non-GAAP)

    $

    8,398





    $

    891





    10.6

    %

     

    AbbVie Inc.

    Reconciliation of GAAP Reported to Non-GAAP Adjusted Information

    Six Months Ended June 30, 2019

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



    1. Specified items impacted results as follows:





    6M19



    Earnings



    Diluted



    Pre-tax



    After-taxa



    EPS

    As reported (GAAP)

    $

    3,351





    $

    3,197





    $

    2.14



    Adjusted for specified items:











    Intangible asset amortization

    773





    639





    0.43



    Milestones and other R&D expenses

    75





    75





    0.05



    Acquired IPR&D

    246





    241





    0.16



    Change in fair value of contingent consideration

    2,473





    2,475





    1.67



    Restructuring

    171





    139





    0.09



    Litigation reserves

    20





    16





    0.01



    Acquisition related costs

    31





    27





    0.02



    Tax audit settlement





    (267)





    (0.18)



    Other

    20





    20





    0.01



    As adjusted (non-GAAP)

    $

    7,160





    $

    6,562





    $

    4.40







    a

    Represents net earnings attributable to AbbVie Inc.

     

    Milestones and other R&D expenses are associated with milestone payments for previously announced collaborations. Acquired IPR&D primarily reflects upfront payments related to R&D collaborations and licensing arrangements with third parties. Restructuring is primarily associated with streamlining global operations. Acquisition related costs reflect transaction and financing costs related to the Allergan acquisition.



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





    6M19



    Cost of

    products

    sold



    SG&A



    R&D



    Acquired

     IPR&D



    Interest

    expense,

    net



    Other

    expense,

    net

    As reported (GAAP)

    $

    3,513





    $

    3,334





    $

    2,580





    $

    246





    $

    634





    $

    2,413



    Adjusted for specified items:























    Intangible asset amortization

    (773)























    Milestones and other R&D expenses









    (75)















    Acquired IPR&D













    (246)











    Change in fair value of contingent consideration





















    (2,473)



    Restructuring

    (9)





    (107)





    (55)















    Litigation reserves





    (20)



















    Acquisition related costs





    (24)













    (7)







    Other

    (1)









    (19)















    As adjusted (non-GAAP)

    $

    2,730





    $

    3,183





    $

    2,431





    $





    $

    627





    $

    (60)



     

    3.     The adjusted tax rate for the first six months of 2019 was 8.3 percent, as detailed below:





    6M19



    Pre-tax

    earnings



    Income

    taxes



    Tax rate

    As reported (GAAP)

    $

    3,351





    $

    154





    4.6

    %

    Specified items

    3,809





    444





    11.6

    %

    As adjusted (non-GAAP)

    $

    7,160





    $

    598





    8.3

    %

     

    AbbVie Inc.

    Key Product Revenues

    Quarterly Trend Analysisa

    (Unaudited, dollars in millions)





    1Q19



    2Q19



    3Q19



    4Q19



    FY19



    1Q20



    2Q20





    U.S.



    Int'l.



    Total



    U.S.



    Int'l.



    Total



    U.S.



    Int'l.



    Total



    U.S.



    Int'l.



    Total



    U.S.



    Int'l.



    Total



    U.S.



    Int'l.



    Total



    U.S.



    Int'l.



    Total

























































































    NET REVENUES

    $5,270





    $2,558





    $7,828





    $5,964





    $2,291





    $8,255





    $6,244





    $2,235





    $8,479





    $6,429





    $2,275





    $8,704





    $23,907





    $9,359





    $33,266





    $6,158





    $2,461





    $8,619





    $8,147





    $2,278





    $10,425

































































































































    Immunology

    3,215





    1,231





    4,446





    3,835





    1,083





    4,918





    3,977





    1,064





    5,041





    4,195





    971





    5,166





    15,222





    4,349





    19,571





    4,004





    1,085





    5,089





    4,399





    917





    5,316



    Humira

    3,215





    1,231





    4,446





    3,793





    1,077





    4,870





    3,887





    1,049





    4,936





    3,969





    948





    4,917





    14,864





    4,305





    19,169





    3,656





    1,047





    4,703





    3,974





    863





    4,837



    Skyrizi













    42





    6





    48





    76





    15





    91





    193





    23





    216





    311





    44





    355





    266





    34





    300





    289





    41





    330



    Rinvoq

























    14









    14





    33









    33





    47









    47





    82





    4





    86





    136





    13





    149























































































    Hematologic Oncology

    934





    239





    1,173





    1,003





    265





    1,268





    1,184





    294





    1,478





    1,230





    317





    1,547





    4,351





    1,115





    5,466





    1,167





    382





    1,549





    1,246





    345





    1,591



    Imbruvicab

    829





    193





    1,022





    886





    213





    1,099





    1,042





    215





    1,257





    1,073





    223





    1,296





    3,830





    844





    4,674





    966





    266





    1,232





    1,055





    233





    1,288



    Venclexta

    105





    46





    151





    117





    52





    169





    142





    79





    221





    157





    94





    251





    521





    271





    792





    201





    116





    317





    191





    112





    303























































































    Aesthetics









































































    330





    151





    481



    Botox Cosmetic*