Company and Industry Overview * **Company**: AbbVie Inc. (ABBV) * **Industry**: Biopharmaceuticals, Healthcare Key Points Financial Performance and Outlook * **First Quarter Performance**: AbbVie exceeded expectations in the first quarter, beating both top and bottom line guidance. * **Full Year Outlook**: The company raised its full year outlook following the strong first quarter performance. * **HUMIRA Erosion**: AbbVie expects HUMIRA erosion to be in the mid-40s for the second half of the year, with a full year erosion of 37%. * **Aesthetics**: AbbVie expects the U.S. aesthetics market to remain stable in the near term, with potential for recovery in 2024. Product Portfolio * **Immunology**: AbbVie's immunology portfolio performed well, with IMBRUVICA, VENCLEXTA, and VRAYLAR all exceeding expectations. * **Aesthetics**: AbbVie's aesthetics portfolio, including SKYRIZI, RINVOQ, and VRAYLAR, is performing exceptionally well. * **Neuroscience**: AbbVie's migraine portfolio, including Botox, QULIPTA, and UBRELVY, is growing rapidly. * **Neurodegeneration**: AbbVie is focused on developing novel therapies for neurodegenerative diseases, including Alzheimer's and ALS. * **Hem/Onc**: AbbVie is focused on driving growth for VENCLEXTA and launching epcoritamab and navitoclax. Pipeline and Pipeline Development * **INI Portfolio**: AbbVie is developing RINVOQ in additional indications, including atopic dermatitis, Giant Cell Arteritis, and lupus. * **Neuroscience Pipeline**: AbbVie is developing Botox for episodic migraine and exploring combinations with anti-CGRPs and other oral CGRPs. * **Hem/Onc Pipeline**: AbbVie is developing venetoclax in multiple indications, including multiple myeloma, MDS, and AML. Mergers and Acquisitions * **Strategic Focus**: AbbVie's M&A efforts are focused on the five key therapeutic areas that will drive long-term growth. * **Financial Capacity**: AbbVie has a net leverage target of 2x and a flexible approach to M&A. Aesthetics * **Market Growth**: AbbVie expects significant market growth in the aesthetics industry, driven by long-acting toxins, regenerative fillers, and cellulite treatments. Policy and Regulatory * **IRA**: AbbVie expects to deliver high single-digit growth even with the IRA, although it continues to evaluate the potential impact of policy changes.

Financial Performance - AbbVie reported worldwide net revenues of $12.2 billion for the three months ended March 31, 2023, a decrease of 10% on a reported basis and 8% on a constant currency basis compared to the same period in 2022[107]. - Total net revenues for the three months ended March 31, 2023 were $12,225 million, a decrease of 9.7% compared to $13,538 million for the same period in 2022[120]. - International net revenues decreased by 5.2% to $3.0 billion, with a slight increase of 0.9% on a constant currency basis[115]. - Gross margin for the three months ended March 31, 2023 was $8,239 million, representing a 13% decrease from $9,486 million in the prior year[122]. - Operating cash flows decreased to $4,193 million for the three months ended March 31, 2023, compared to $4,908 million in the prior year[130]. - The effective tax rate increased to 49% for the three months ended March 31, 2023, compared to 9% for the same period in 2022[129]. - Cash dividend payments increased to $2.7 billion for the three months ended March 31, 2023, up from $2.5 billion in the prior year[133]. Earnings and Costs - Diluted earnings per share for the same period was $0.13, impacted by after-tax costs including $1.8 billion for contingent consideration liabilities and $1.6 billion for amortization of intangible assets[107]. - Research and development expenses increased to $2,292 million for the three months ended March 31, 2023, a 53% increase compared to $1,497 million in the prior year[124]. - Interest expense for the three months ended March 31, 2023 was $553 million, up from $548 million in the prior year, primarily due to higher interest rates[126]. Product Performance - The U.S. net revenues for Humira decreased by 26.1% to $2.9 billion, while Skyrizi's U.S. revenues increased by 45.9% to $1.1 billion[116]. - Global Humira sales decreased 24% for the three months ended March 31, 2023, with U.S. sales down 26% due to direct biosimilar competition[118]. - Net revenues for Skyrizi increased 46% for the three months ended March 31, 2023, driven by strong volume and market share uptake[118]. - Net revenues for Rinvoq increased 51% for the three months ended March 31, 2023, primarily due to continued strong volume and market share uptake[119]. Pipeline and Development - AbbVie's pipeline includes over 90 compounds, with more than 50 in mid- and late-stage development, focusing on immunology, oncology, aesthetics, neuroscience, and eye care[108]. - AbbVie expects multiple mid-stage programs to transition into late-stage programs within the next 12 months, indicating a strong pipeline progression[110]. - The company anticipates several regulatory submissions and data readouts from key clinical trials in the next 12 months, supporting its growth strategy[106]. - Qulipta received FDA approval for the preventive treatment of chronic migraine in adults, marking a significant addition to AbbVie's neuroscience portfolio[113]. Financial Strategy and Flexibility - AbbVie aims to generate substantial operating cash flows to support investment in innovative research and development while returning cash to shareholders through dividends[106]. - AbbVie authorized a $5.0 billion increase to its stock repurchase program, repurchasing 10 million shares for $1.6 billion in Q1 2023[135]. - The company entered into a five-year revolving credit facility, increasing commitments from $4.0 billion to $5.0 billion, maturing in March 2028[136]. - AbbVie had no outstanding amounts under its credit facility as of March 31, 2023, and was in compliance with all covenants[136]. - The company believes it has sufficient financial flexibility to issue debt and attract long-term capital to support growth objectives[137]. Risk Management and Accounting - AbbVie continues to monitor economic conditions and customer creditworthiness to mitigate credit risk[136]. - The company has established an allowance for credit losses based on estimated future losses over the life of outstanding accounts receivable[136]. - AbbVie cautions that forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially[140]. - The company has not made significant changes to its critical accounting policies in Q1 2023[139]. - For detailed market risk disclosures, refer to Item 7A in AbbVie's Annual Report on Form 10-K for the year ended December 31, 2022[141].

AbbVie Inc. (NYSE:ABBV) Q1 2023 Earnings Conference Call April 27, 2023 9:00 AM ET Company Participants Liz Shea - Vice President of Investor Relations Rick Gonzalez - Chairman and Chief Executive Officer Rob Michael - Vice Chairman and President Jeff Stewart - EVP, Chief Commercial Officer Scott Reents - EVP, Chief Financial Officer Carrie Strom - SVP and President of Allergan Aesthetics Tom Hudson - SVP of R&D and Chief Scientific Officer Roopal Thakkar - SVP of Development and Regulatory Affairs, and Chi ...

AbbVie Inc. (NYSE:ABBV) Barclays Global Healthcare Conference Call March 15, 2023 1:35 PM ET Company Participants Robert Michael - Vice Chairman & President Scott Reents - Senior Vice President & Chief Financial Officer Jeff Stewart - Executive Vice President & Chief Commercial Officer Roopal Thakkar - Development & Regulatory Affairs Conference Call Participants Carter Gould - Barclays Carter Gould Hi, good afternoon. Welcome to the Day 2 of the Barclays Global Healthcare Conference. My name is Carter Goul ...

AbbVie Inc. (NYSE:ABBV) Conference Call Summary Company Overview - **Company**: AbbVie Inc. - **Event**: Cowen 43rd Annual Healthcare Conference Call - **Date**: March 7, 2023 Key Points Industry and Pipeline Developments - **RINVOQ**: Expected to receive approvals for new indications in rheumatology and inflammatory bowel disease (IBD) by mid-year, with potential Phase III trials for alopecia areata, hidradenitis suppurativa, and lupus starting this year [5][6] - **Oncology Pipeline**: Introduction of Teliso-V targeting non-small cell lung cancer, with a readout expected by the end of the year for potential accelerated approval [6] - **Epcoritamab**: Strong efficacy observed in DLBCL, with plans for accelerated approval and expansion into earlier treatment lines [51][52] Financial Projections and Market Dynamics - **RINVOQ and SKYRIZI**: Potential to exceed HUMIRA's peak sales, with indications expected to add a couple of billion dollars in revenue by the second half of the decade [7] - **HUMIRA Erosion**: Anticipated erosion of 35% to 55% in the U.S. market, with a current erosion rate of 37% compared to 45% in Europe [12][18] - **Biosimilars**: Seven to nine biosimilars expected to enter the market mid-year, contributing to increased volume impact in the second half of 2023 [18] Market Trends and Consumer Behavior - **Aesthetics Market**: Stability observed in the U.S. market, with economic indicators such as consumer confidence and Google searches showing positive trends, although no recovery is assumed for 2023 [26][27] - **Imbruvica**: Expected significant erosion due to competition from Brukinsa and Venclexta, with stabilization anticipated in 2024 and 2025 [29][30] Growth Drivers - **Inflammatory Bowel Disease (IBD)**: Significant growth expected for RINVOQ and SKYRIZI, with high adoption rates due to superior performance in approved indications [32][34] - **Vraylar**: Positive early results in the MDD indication, with expectations for significant market share growth [45][47] Long-term Outlook - **Pipeline Potential**: Investors may underestimate the growth potential of SKYRIZI and RINVOQ, as well as the breadth of the pipeline in oncology [59] - **Aesthetics Business**: Projected to exceed $9 billion by 2029, contrary to sell-side expectations [60] Additional Insights - **Switchback Phenomenon**: Observed in European markets where patients switch back to HUMIRA due to adverse events or loss of efficacy with biosimilars [20][24] - **Market Competition**: The migraine market is competitive, with AbbVie holding a significant share of new prescriptions, indicating strong positioning against competitors [40][41] Conclusion AbbVie is navigating a complex landscape with a robust pipeline and strategic focus on growth areas such as immunology and oncology. The company anticipates significant revenue contributions from new indications and is closely monitoring market dynamics, particularly in the face of increasing competition and the evolving biosimilar landscape.

AbbVie Pipeline Update AbbVie R&D Pipeline Phase 1 Phase 2 Registrational / Phase 3 Submitted ■ CUG-252* (IL-2 Mutein) SLE ■ ABBV-154 (TNF-Steroid ADC) PMR ■ Rinvoq (JAK 1) GCA ■ Rinvoq (JAK 1) CD ■ CLF065* (GLP-2 agonist) IBD ■ ABBV-154 (TNF-Steroid ADC) CD ■ Skyrizi* (IL-23) UC ■ Epcoritamab* (CD3-CD20): R/R DLBCL ■ ABBV-151 (GARP+TGFb1) Solid Tumors ■ Rinvoq (JAK 1) Vitiligo ■ Imbruvica* (BTK) 1L FL ■ ABBV-951 (dopamine receptor) Advanced PD ■ ABBV-400 (cMet ADC) NSCLC ■ Rinvoq (JAK 1) SLE ■ Imbruvica* ( ...

Revenue and Financial Performance - Net revenues for 2022 were $58,054 million, an increase of 3.3% from $56,197 million in 2021[276] - Operating earnings for 2022 were $18,117 million, compared to $17,924 million in 2021, reflecting a growth of 1.1%[276] - Net earnings attributable to AbbVie Inc. for 2022 were $11,836 million, up from $11,542 million in 2021, representing a 2.6% increase[276] - Basic earnings per share attributable to AbbVie Inc. for 2022 were $6.65, compared to $6.48 in 2021, marking a 2.6% rise[276] - Comprehensive income for 2022 was $12,545 million, an increase from $11,767 million in 2021, reflecting a growth of 6.6%[278] - Total stockholders' equity increased to $17,254 million in 2022 from $15,408 million in 2021, a growth of 12%[280] - AbbVie reported net earnings of $11,845 million for the year ended December 31, 2022, compared to $11,549 million in 2021, reflecting a year-over-year increase of 2.6%[283] - The company declared dividends totaling $10,043 million in 2022, an increase from $9,261 million in 2021[283] - Cash flows from operating activities amounted to $24,943 million in 2022, up from $22,777 million in 2021, indicating a growth of 9.5%[283] Product Portfolio and Market Presence - Humira accounted for approximately 37% of AbbVie's total net revenues in 2022[13] - AbbVie's immunology portfolio includes therapies for conditions such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, with significant market presence in North America and the European Union[12] - Skyrizi is approved for multiple autoimmune diseases and is administered via subcutaneous injection, with a quarterly dosing schedule after initial induction[14] - Rinvoq is indicated for several inflammatory diseases and is available in North America, the European Union, and Japan, targeting conditions like rheumatoid arthritis and atopic dermatitis[16] - Imbruvica and Venclexta are key oncology products, with Imbruvica approved for chronic lymphocytic leukemia and Venclexta for hematological malignancies[16][19] - Botox Cosmetic and the Juvederm Collection of Fillers are leading products in AbbVie's aesthetics portfolio, addressing cosmetic needs globally[19][20] - AbbVie’s neuroscience products include Vraylar for schizophrenia and bipolar disorder, and Ubrelvy for acute migraine treatment[21][22] - Mavyret is an 8-week treatment for chronic hepatitis C virus infection, approved in the U.S. and European Union[25] - Creon is a pancreatic enzyme therapy for exocrine pancreatic insufficiency, targeting patients with cystic fibrosis and chronic pancreatitis[26] Research and Development - AbbVie invests significantly in research and development, with numerous compounds in clinical development targeting complex diseases[50] - The research and development process for new pharmaceutical products typically takes 8 to 12 years, with significant uncertainty regarding regulatory approval timelines[53] - Clinical trials are conducted in sequential phases: Phase 1 focuses on safety, Phase 2 assesses efficacy, and Phase 3 involves larger populations to confirm results[53] - AbbVie collaborates with third parties, including biotechnology companies and academic institutions, to enhance its research and development efforts[50] Regulatory and Compliance - AbbVie must navigate various pricing regulations and cost containment measures imposed by governments, affecting product reimbursement and market access[66] - The Affordable Care Act mandates that AbbVie pays fees related to pharmaceutical sales to government programs and provides discounts for certain Medicare beneficiaries[70] - AbbVie faces ongoing regulatory scrutiny regarding the marketing and distribution of its products, which can impact operational costs and market strategies[63] - Compliance with regulatory requirements is ensured through inspections by the FDA and other authorities, with non-compliance potentially leading to enforcement actions[56] - Post-approval obligations include reporting adverse reactions and maintaining compliance with Good Manufacturing Practices (cGMP)[57] Competition and Market Challenges - AbbVie faces significant competition in the pharmaceutical market, particularly from anti-TNF products, JAK inhibitors, and biosimilars, which could impact revenues for its products[32][33] - Humira is experiencing direct biosimilar competition in Europe and the United States, which is expected to exert competitive pressure on AbbVie's revenues[33] Acquisitions and Investments - AbbVie completed the acquisition of Allergan plc on May 8, 2020, which significantly impacted its financial performance and product offerings[286] - The acquisition of Allergan was valued at $64,084 million, comprising $39,675 million in cash and $23,979 million in AbbVie common stock issued to Allergan shareholders[323] - AbbVie made an upfront payment of $130 million for the acquisition of Syndesi Therapeutics SA, with potential future payments of up to $870 million based on milestones[332] - AbbVie completed the acquisition of Soliton, Inc. for a total consideration of $535 million, which included cash and equity-based awards, enhancing its product portfolio in aesthetics[320] Financial Position and Debt Management - Total assets as of December 31, 2022, were $138,805 million, down from $146,529 million in 2021, a decrease of 5.3%[280] - Long-term debt and finance lease obligations decreased to $59,135 million in 2022 from $64,189 million in 2021, a reduction of 7.9%[280] - The fair value of long-term debt is estimated to decrease by $4.2 billion with a 100 basis point increase in long-term interest rates[274] - The company estimates a $155 million adverse impact on the fair value of interest rate swap contracts with a 100 basis point increase in interest rates[274] - Long-term debt as of December 31, 2022, was $63,270 million, with total obligations and commitments amounting to $63,128 million[373] Workforce and Diversity - As of January 31, 2023, AbbVie employed approximately 50,000 employees across over 70 countries[81] - Women represented 52% of management positions globally, and 37% of AbbVie's workforce comprised members of historically underrepresented populations as of December 2022[85] - AbbVie has implemented a five-year Equality, Diversity & Inclusion roadmap with formal goals aligned with this strategy[85] Environmental and Social Responsibility - AbbVie's capital expenditures for pollution control in 2022 were approximately $12 million, with estimated expenditures of $9 million for 2023[79] - AbbVie believes its operations comply with environmental protection laws, and it has ongoing remediation activities related to Superfund sites[80] - AbbVie has invested in on-site health care clinics at certain locations, providing convenient access to quality healthcare[82] Foreign Exchange and Financial Instruments - AbbVie has €5.9 billion aggregate principal amount of unsecured senior Euro notes outstanding, which are exposed to foreign currency risk[273] - A 10% appreciation in the underlying currencies being hedged would decrease the fair value of foreign exchange forward contracts by $1.4 billion at December 31, 2022[272] - The company had foreign currency forward exchange contracts with notional amounts totaling $1.7 billion as of December 31, 2022, designated as cash flow hedges[381] - In 2022, the company recognized pre-tax gains of $406 million related to foreign currency denominated debt designated as net investment hedges[389]

AbbVie Inc. (NYSE:ABBV) Q4 2022 Earnings Conference Call February 9, 2023 9:00 AM ET Company Participants Liz Shea - Vice President of Investor Relations Rick Gonzalez - Chairman & Chief Executive Officer Jeff Stewart - Executive Vice President & Chief Commercial Officer Carrie Strom - Senior Vice President & President of Allergan Aesthetics Tom Hudson - Senior Vice President of R&D & Chief Scientific Officer Rob Michael - Vice Chairman & President Scott Reents - Senior Vice President & Chief Financial Offi ...

J.P. Morgan Healthcare Conference Rick Gonzalez Chairman and Chief Executive Officer January 10, 2023 J.P. Morgan Healthcare Conference | January 10, 2023 1 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35565 AbbVie Inc. (Exact name of registrant as specified in its charter) Delaware 32-0375147 (State or other jurisdiction o ...