ABBV
Abbvie INC
NYSE
10-K: AbbVie's 2024 10-K Filing: Diversified Portfolio Drives Revenue Growth Amid Humira Biosimilar Competition
Sentiment:
Annual Report (Form 10-K)
14 February 2025 1:17 PM
AbbVie's 2024 Form 10-K reveals a 4% revenue increase driven by Skyrizi and Rinvoq, offsetting Humira's biosimilar impact, alongside strategic acquisitions and pipeline advancements.
Delay expected
AbbVie received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951 for the treatment of motor fluctuations in adults with advanced Parkinson's disease.
Worse than expected
Humira sales declined by 37% globally due to biosimilar competition, which is worse than expected.
Summary
- AbbVie's 2024 Form 10-K filing highlights a year of strategic portfolio management and pipeline development.
- The company reported worldwide net revenues of $56.3 billion, a 4% increase on a reported basis and 5% on a constant currency basis.
- Key growth drivers included Skyrizi and Rinvoq, which saw revenue increases of 51% and 53%, respectively.
- These gains helped offset a 37% decline in global Humira sales due to biosimilar competition, particularly in the U.S. where sales fell by 41%.
- AbbVie completed the acquisitions of ImmunoGen and Cerevel Therapeutics, expanding its oncology and neuroscience portfolios.
- The company's operating earnings were $9.1 billion, with diluted earnings per share at $2.39.
- R&D expenses increased significantly to $12.8 billion, reflecting investment in pipeline assets and acquisition-related costs.
- AbbVie is navigating the impact of the Inflation Reduction Act, which will affect pricing and reimbursement for certain drugs, including Imbruvica, Vraylar and Linzess.
- The company employed approximately 55,000 people as of January 31, 2025, and continues to focus on attracting, developing, and retaining talent.
- AbbVie anticipates several regulatory submissions and data readouts from key clinical trials in the next 12 months.
Sentiment
Score: 6
Explanation: The sentiment is neutral to slightly positive. While AbbVie shows revenue growth and strategic pipeline expansion, the Humira biosimilar impact and regulatory challenges temper the overall outlook.
Positives
- Strong revenue growth from Skyrizi and Rinvoq indicates successful portfolio diversification.
- Strategic acquisitions of ImmunoGen and Cerevel Therapeutics enhance AbbVie's pipeline and market position.
- Continued investment in R&D demonstrates a commitment to future innovation.
- Increased quarterly dividend reflects confidence in the company's financial performance.
- The company maintains a robust business continuity and supplier monitoring program.
Negatives
- Significant decline in Humira sales due to biosimilar competition.
- Increased R&D expenses may impact short-term profitability.
- The Inflation Reduction Act poses a risk to future revenue and pricing.
- Intangible asset impairment charge of $4.5 billion related to emraclidine.
- Complete Response Letter from the FDA for Vyalev/Produodopa (ABBV-951) due to third-party manufacturing observations.
Risks
- Expiration or loss of patent protection and increased competition from generics and biosimilars may adversely affect revenues and operating earnings.
- Cost-containment efforts and pricing pressures could cause a reduction in revenues and operating earnings.
- The international nature of AbbVie's business subjects it to additional business risks that may cause its revenue and profitability to decline.
- A failure of, or significant disruption to, information technology systems, or a failure to adequately adopt emerging technologies such as artificial intelligence, could have a material adverse effect on AbbVie's business.
- Failure to attract, develop and retain highly qualified personnel could affect AbbVie's ability to successfully develop and commercialize products.
Future Outlook
AbbVie expects to achieve its strategic objectives through maximizing revenue growth of key on-market products, advancing its research and development pipeline, maximizing the value of key acquisitions, continuing to invest in external innovation, and effectively managing the impact of Humira biosimilar erosion. AbbVie anticipates several regulatory submissions and data readouts from key clinical trials in the next 12 months.
Management Comments
- AbbVie's strategy has focused on delivering strong financial results, maximizing the benefits of a diversified revenue base, advancing and investing in its pipeline and returning value to shareholders while ensuring a strong, sustainable growth business over the long term.
Industry Context
AbbVie operates in a highly competitive biopharmaceutical industry, facing competition from other research-based pharmaceuticals and biotechnology companies, as well as generic and biosimilar manufacturers. The company's strategic acquisitions and focus on innovative therapies are aimed at maintaining a competitive edge in this dynamic landscape.
Comparison to Industry Standards
- AbbVie's performance can be compared to other major pharmaceutical companies such as Johnson & Johnson, Pfizer, and Merck.
- These companies also face similar challenges related to patent expirations, biosimilar competition, and pricing pressures.
- AbbVie's R&D investment as a percentage of revenue is a key metric to compare with industry peers to assess its commitment to innovation.
- The success of Skyrizi and Rinvoq can be benchmarked against other leading immunology drugs like Dupixent and Stelara.
- The impact of Humira biosimilars can be compared to the experience of other companies facing generic erosion of blockbuster drugs.
Stakeholder Impact
- Shareholders: Impacted by dividend payments, stock repurchases, and overall financial performance.
- Employees: Affected by changes in compensation, benefits, and employment opportunities.
- Customers/Patients: Impacted by the availability and pricing of AbbVie's therapies.
- Suppliers: Affected by AbbVie's purchasing decisions and supply chain management.
- Creditors: Impacted by AbbVie's debt levels and credit ratings.
Next Steps
- Maximize revenue growth of key on-market products.
- Advance the research and development pipeline.
- Maximize the value of key acquisitions and continue to invest in external innovation.
- Effectively manage the impact of Humira biosimilar erosion.
Legal Proceedings
- AbbVie is subject to various claims, legal proceedings and investigations regarding product liability, intellectual property, commercial, securities and other matters that arise in the normal course of business.
- Lawsuits are pending against AbbVie and others generally alleging that the 2005 patent litigation settlement involving Niaspan entered into between Kos Pharmaceuticals, Inc. violated federal and state antitrust laws.
- Lawsuits are pending against Allergan and several other manufacturers generally alleging that they improperly promoted and sold prescription opioid products.
- In March 2023, AbbVie Inc. filed a petition in the United States Tax Court, AbbVie Inc. and Subsidiaries v. Commissioner of Internal Revenue, disputing the Internal Revenue Service determination concerning a $572 million income tax benefit recorded in 2014 related to a payment made to a third party for the termination of a proposed business combination.
- In October 2018, a federal securities lawsuit, Holwill v. AbbVie Inc., et al., was filed in the United States District Court for the Northern District of Illinois against AbbVie, its chief executive officer and former chief financial officer, alleging that reasons stated for Humira sales growth in financial filings between 2013 and 2018 were misleading because they omitted alleged misconduct in connection with Humira patient and reimbursement support services and other services and items of value that allegedly induced Humira prescriptions.
- In April 2023, a putative class action lawsuit, Camargo v. AbbVie Inc., was filed in the United States District Court for the Northern District of Illinois on behalf of Humira patients who paid for Humira based on its list price or who, after losing insurance coverage, discontinued Humira because they could not pay based on its list price, alleging that Humiras list price is excessive in violation of multiple states unfair and deceptive trade practices statutes.
- Lawsuits are pending against various Allergan entities in the United States and other countries including Brazil, Canada, South Korea, and the Netherlands, in which plaintiffs generally allege that they developed, or may develop, breast implant-associated anaplastic large cell lymphoma (ALCL) or other injuries from Allergans Biocell textured breast implants, which were voluntarily withdrawn from worldwide markets in 2019.
- AbbVie Inc. is seeking to enforce patent rights relating to upadacitinib (a drug sold under the trademark Rinvoq).
- AbbVie Inc. is seeking to enforce patent rights related to ubrogepant (a drug sold under the trademark Ubrelvy).
Key Dates
- April 10, 2012: AbbVie was incorporated in Delaware.
- January 1, 2013: AbbVie became an independent, publicly-traded company.
- January 31, 2023: Humira faced competition from biosimilar products in the United States following the loss of exclusivity.
- August 2023: HHS selected Imbruvica as one of the first 10 medicines subject to government-set prices beginning in 2026.
- February 12, 2024: AbbVie completed the acquisition of ImmunoGen, Inc.
- August 1, 2024: AbbVie completed the acquisition of Cerevel Therapeutics Holdings, Inc.
- July 1, 2024: Robert A. Michael succeeded Richard A. Gonzalez as AbbVie's CEO.
- August 2024: CMS published Medicare Part D prices that will be applicable to these medicines, including Imbruvica, beginning January 1, 2026.
- October 30, 2024: AbbVie's board declared an increase in the quarterly dividend from $1.55 per share to $1.64 per share.
- December 31, 2024: End of the fiscal year.
- January 2025: HHS selected Vraylar and Linzess as two of the 15 medicines subject to government-set prices beginning in 2027.
- January 31, 2025: AbbVie employed approximately 55,000 employees.
- February 13, 2025: The Board of Directors of AbbVie unanimously elected Mr. Michael to succeed Mr. Gonzalez as Chairman of the Board of Directors, effective July 1, 2025.
- February 14, 2025: Dividend payable to stockholders of record as of January 15, 2025.
- March 24, 2025: The Definitive Proxy Statement will be filed on or about this date.
- July 1, 2025: Mr. Gonzalez will retire from the Board and Mr. Michael will succeed Mr. Gonzalez as Chairman of the Board of Directors.
Keywords
AbbVie, Humira, Skyrizi, Rinvoq, Oncology, Immunology, Biosimilars, Pharmaceuticals, Acquisition, Revenue, Research and Development, Venclexta, Elahere, Vraylar, Linzess, Botox, Juvederm
ABBV
Abbvie INC
NYSE
Sector: TBD
Filings with Classifications
Better than expected
9 May 2025 1:24 PM
Quarterly Report
- The company reported an 8% increase in net revenues on a reported basis and a 10% increase on a constant currency basis, indicating strong growth.
- Operating earnings reached $3.7 billion, with diluted earnings per share at $0.72, reflecting improved profitability.
- Key growth drivers included Skyrizi and Rinvoq in immunology, and Vraylar and Botox Therapeutic in neuroscience, demonstrating successful product performance.
Better than expected
25 April 2025 7:48 AM
Quarterly Report
- AbbVie's first-quarter results exceeded expectations, leading to an increase in the company's full-year adjusted diluted EPS guidance.
Worse than expected
3 April 2025 4:13 PM
8-K Filing
- The company's full-year adjusted diluted EPS guidance has been lowered from $12.12 $12.32 to $11.99 $12.19 due to the $248 million IPR&D expense in Q1 2025.
Better than expected
24 March 2025 4:28 PM
Proxy Statement
- AbbVie's 2024 results exceeded expectations with strong revenue growth and a robust R&D pipeline, indicating better-than-expected performance.
Capital raise
26 February 2025 5:04 PM
Debt Offering Announcement
- AbbVie completed an underwritten public offering of $4 billion in senior notes.
- The offering was registered under the Securities Act of 1933.
- The proceeds from the notes offering are likely to be used for general corporate purposes, including refinancing existing debt, funding acquisitions, and investing in research and development.
Capital raise
19 February 2025 9:22 AM
Debt Offering Announcement
- AbbVie is issuing $4 billion in senior notes.
- The offering includes notes due in 2028, 2030, 2035, and 2055.
- The company expects to receive approximately $3.98 billion in net proceeds.
Better than expected
18 February 2025 5:00 PM
SEC Form 4
- The vesting of performance-based awards suggests that the company exceeded its performance targets, leading to the release of these shares to the executive.
Worse than expected
14 February 2025 1:17 PM
Annual Report (Form 10-K)
- Humira sales declined by 37% globally due to biosimilar competition, which is worse than expected.
Delay expected
14 February 2025 1:17 PM
Annual Report (Form 10-K)
- AbbVie received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951 for the treatment of motor fluctuations in adults with advanced Parkinson's disease.
Worse than expected
31 January 2025 7:42 AM
Quarterly Report
- The full-year diluted EPS decreased by 12.1% on a GAAP basis and 8.9% on an adjusted basis.
- The company experienced a diluted loss per share in the fourth quarter on a GAAP basis.
- The fourth-quarter results included a significant unfavorable impact from acquired IPR&D and milestones expense.
- The company recorded a non-cash after-tax intangible asset impairment charge of $3.5 billion related to emraclidine.
Worse than expected
10 January 2025 8:31 AM
8-K Filing
- The document details a $3.5 billion impairment charge due to failed clinical trials, indicating worse than expected results for the emraclidine program.
Worse than expected
6 January 2025 4:02 PM
Earnings Guidance Update
- The updated guidance includes a $1.6 billion charge for acquired IPR&D and milestones expense, which significantly reduces both Q4 and full-year adjusted diluted EPS compared to previous guidance.
Worse than expected
4 November 2024 2:19 PM
Quarterly Report
- The company's diluted earnings per share of $0.88 for the quarter and $2.41 for the nine months ended September 30, 2024 were negatively impacted by significant expenses related to amortization of intangible assets, changes in fair value of contingent consideration liabilities, acquisition and integration costs, and litigation matters.
- The company's operating cash flows decreased compared to the prior year due to the timing of working capital, higher contingent consideration payments and decreased results from operations driven by acquisition-related cash expenses.
Delay expected
4 November 2024 2:19 PM
Quarterly Report
- AbbVie received a Complete Response Letter from the FDA for the New Drug Application for ABBV-951 due to observations identified during inspection of a third-party manufacturer.
Better than expected
30 October 2024 7:43 AM
Quarterly Report
- The company raised its full-year adjusted diluted EPS guidance, indicating better than expected performance.
- The company's adjusted diluted EPS of $3.00 was better than the previous year's $2.95.
- The company's net revenues increased by 3.8 percent on a reported basis, indicating better than expected performance.
Worse than expected
3 October 2024 4:07 PM
Earnings Guidance Update
- The $82 million expense for acquired IPR&D and milestones will negatively impact both GAAP and adjusted non-GAAP diluted earnings per share by $0.04.
- The full-year and third quarter adjusted diluted EPS guidance ranges have been lowered to reflect this expense.
Delay expected
7 August 2024 3:00 PM
Quarterly Report
- AbbVie received a Complete Response Letter from the FDA for ABBV-951 due to observations identified during inspection of a third-party manufacturer, delaying the potential approval of the drug.
Worse than expected
7 August 2024 3:00 PM
Quarterly Report
- The company's earnings per share were negatively impacted by acquisition-related costs and amortization of intangible assets.
- Humira sales declined significantly due to biosimilar competition, which was worse than expected.
- Operating cash flows decreased compared to the prior year due to working capital timing and acquisition-related expenses.
Capital raise
7 August 2024 3:00 PM
Quarterly Report
- AbbVie issued $15 billion in senior notes to finance the acquisitions of ImmunoGen and Cerevel Therapeutics.
- The company also borrowed and repaid $5.0 billion under a term loan credit agreement in connection with these acquisitions.
Better than expected
25 July 2024 7:41 AM
Quarterly Report
- The company's second-quarter results exceeded expectations, driven by strong performance in its ex-Humira portfolio.
- AbbVie raised its full-year adjusted diluted EPS guidance, indicating better than previously anticipated financial performance.
Delay expected
25 July 2024 7:41 AM
Quarterly Report
- AbbVie received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951, citing observations identified during inspection of a third-party manufacturer, which will delay the launch of the product.
Worse than expected
3 July 2024 2:07 PM
Earnings Guidance Update
- The company's earnings guidance for both the full year and the second quarter has been lowered due to a significant $937 million IPR&D expense.
Better than expected
3 May 2024 11:04 AM
Quarterly Report
- The diluted earnings per share significantly increased to $0.77 from $0.13 year-over-year, indicating better than expected profitability.
- Net earnings attributable to AbbVie Inc. were $1.369 billion, a substantial increase from $239 million in the first quarter of 2023, showing better than expected results.
Capital raise
3 May 2024 11:04 AM
Quarterly Report
- AbbVie issued $15 billion in senior notes to finance the acquisition of ImmunoGen and the proposed acquisition of Cerevel Therapeutics.
- The company borrowed and repaid $5.0 billion under a term loan credit agreement in February 2024.
Delay expected
3 May 2024 11:04 AM
Quarterly Report
- The company made a decision to revise the research and development plan for AGN-151607, a novel investigational neurotoxin, which contributed to a delay in the estimated timing of regulatory approval.
Better than expected
26 April 2024 7:43 AM
Quarterly Report
- The company raised its full-year adjusted diluted EPS guidance, indicating better than expected future performance.
- First quarter results were well ahead of expectations, driven by excellent performance from the ex-Humira growth platform.
Worse than expected
3 April 2024 4:06 PM
Earnings Guidance Update
- The company's earnings per share guidance has been lowered due to a $164 million expense related to acquired IPR&D and milestones.
Capital raise
26 February 2024 5:08 PM
Debt Offering Announcement
- AbbVie is raising $15 billion through the issuance of senior notes.
- The notes are being sold to underwriters in a registered public offering.
- The proceeds will be used for specific purposes including acquisitions and debt repayment.
Worse than expected
12 February 2024 7:49 AM
Merger Announcement
- The acquisition is expected to be dilutive to AbbVie's EPS in 2024, with a $0.42 per share impact for the full year and $0.04 per share in the first quarter.
Worse than expected
2 February 2024 7:51 AM
Quarterly Report
- The full-year GAAP diluted EPS decreased by 59.0%, indicating worse than expected profitability.
- The overall net revenues decreased by 6.4% on a reported basis, showing worse than expected sales performance.
- Humira revenues experienced a substantial decline due to biosimilar competition, which was worse than expected.
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