8-K: AbbVie Reports Mixed Full-Year and Fourth-Quarter 2024 Results, Provides 2025 Guidance
Summary
- AbbVie reported full-year 2024 net revenues of $56.334 billion, a 3.7% increase on a reported basis and 4.6% on an operational basis.
- Full-year diluted EPS was $2.39 on a GAAP basis, a 12.1% decrease, and adjusted diluted EPS was $10.12, an 8.9% decrease, which includes a $1.52 per share unfavorable impact from acquired IPR&D and milestones expense.
- The immunology portfolio generated $26.682 billion in global net revenues, a 2.1% increase on a reported basis, with Humira revenues at $8.993 billion, Skyrizi at $11.718 billion, and Rinvoq at $5.971 billion.
- The oncology portfolio's global net revenues were $6.555 billion, a 10.8% increase, with Imbruvica at $3.347 billion and Venclexta at $2.583 billion.
- The neuroscience portfolio saw global net revenues of $8.999 billion, a 16.6% increase, with Botox Therapeutic at $3.283 billion and Vraylar at $3.267 billion.
- The aesthetics portfolio's global net revenues were $5.176 billion, a 2.2% decrease, with Botox Cosmetic at $2.720 billion and Juvederm at $1.177 billion.
- Fourth-quarter net revenues were $15.102 billion, a 5.6% increase on a reported basis and 6.1% on an operational basis.
- The fourth-quarter diluted loss per share was $0.02 on a GAAP basis, including an impairment charge related to emraclidine, while adjusted diluted EPS was $2.16, which includes a $0.88 per share unfavorable impact from acquired IPR&D and milestones expense.
- AbbVie provides 2025 adjusted diluted EPS guidance of $12.12 to $12.32, excluding any unfavorable impact related to acquired IPR&D and milestones expense.
- The company reaffirms expectations for high single-digit compound annual revenue growth through 2029 and raises the 2027 combined sales outlook for Skyrizi and Rinvoq to more than $31 billion.
Sentiment
Score: 5
Explanation: The sentiment is neutral to slightly negative due to mixed results. While there is strong growth in some areas, the decrease in EPS, the loss in the fourth quarter, and the impairment charge are concerning. The long-term outlook is positive, but there are significant challenges to overcome.
Positives
- AbbVie's net revenues increased for both the full year and the fourth quarter.
- Skyrizi and Rinvoq demonstrated strong growth in both full-year and fourth-quarter revenues.
- The neuroscience portfolio showed significant revenue growth.
- AbbVie has reaffirmed its long-term revenue growth expectations.
- The company has raised its combined sales outlook for Skyrizi and Rinvoq for 2027.
- The aesthetics portfolio is expected to see high single-digit growth from 2025 through 2029.
- AbbVie completed several strategic acquisitions to strengthen its pipeline and R&D capabilities.
Negatives
- 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.
- Humira revenues decreased significantly due to loss of exclusivity.
- The aesthetics portfolio experienced a decrease in full-year and fourth-quarter revenues.
- The company recorded a non-cash after-tax intangible asset impairment charge of $3.5 billion related to emraclidine.
Risks
- The loss of exclusivity for Humira is significantly impacting revenues.
- Acquired IPR&D and milestones expenses are negatively affecting earnings per share.
- The company is facing challenges in the aesthetics portfolio.
- The intangible asset impairment charge related to emraclidine has negatively impacted the company's financials.
- There are risks associated with the development and regulatory approval of new drugs.
- The company is exposed to litigation and regulatory risks.
Future Outlook
AbbVie provides 2025 adjusted diluted EPS guidance of $12.12 to $12.32, excluding any unfavorable impact related to acquired IPR&D and milestones expense, and reaffirms expectations for high single-digit compound annual revenue growth through 2029. The company also raised its 2027 combined sales outlook for Skyrizi and Rinvoq to more than $31 billion and updated its outlook for aesthetics to deliver high single-digit compound annual revenue growth from 2025 through 2029.
Management Comments
- Robert A. Michael, chief executive officer, stated that 2024 was a year of significant progress for AbbVie.
- He also mentioned that the company's growth platform delivered outstanding results, they advanced their pipeline, and strengthened their business through strategic transactions.
- He noted that AbbVie is entering 2025 with significant momentum and expects net revenues to exceed their previous peak in just the second full year following the U.S. Humira loss of exclusivity.
Industry Context
The results reflect the ongoing challenges and opportunities in the pharmaceutical industry, including the impact of patent expirations (Humira), the growth of new products (Skyrizi, Rinvoq), and the strategic importance of acquisitions and collaborations. The company's focus on immunology, oncology, neuroscience, and aesthetics aligns with key growth areas in the healthcare sector.
Comparison to Industry Standards
- AbbVie's performance is mixed when compared to industry standards. While the growth in Skyrizi and Rinvoq is impressive, the decline in Humira sales due to patent expiration is a significant headwind, similar to what other companies face with biosimilar competition.
- The company's adjusted EPS guidance for 2025 is a positive sign, but the impact of IPR&D expenses and the impairment charge are concerning. Companies like Johnson & Johnson and Pfizer also face similar challenges with patent cliffs and R&D investments.
- The aesthetics portfolio's performance is below expectations, which contrasts with the growth seen in other companies in the medical aesthetics market, such as Allergan (now part of AbbVie) and Galderma.
- The neuroscience portfolio's growth is a strong point, aligning with the increasing focus on neurological treatments in the pharmaceutical industry. Companies like Biogen and Eli Lilly are also heavily invested in this area.
- AbbVie's long-term revenue growth outlook is positive, but it will depend on the successful launch and uptake of new products and the management of biosimilar competition.
Stakeholder Impact
- Shareholders may be concerned about the decrease in EPS and the fourth-quarter loss, but encouraged by the long-term growth outlook.
- Employees may be affected by the company's strategic decisions and restructuring efforts.
- Customers will benefit from the development of new and innovative medicines.
- Suppliers may see changes in demand based on the company's product portfolio.
- Creditors will be monitoring the company's financial performance and debt levels.
Next Steps
- AbbVie will host an investor conference call to discuss the fourth-quarter performance.
- The company will continue to evaluate information with respect to the Cerevel-related clinical development programs.
- AbbVie remains on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tavapadon later this year.
Key Dates
- January 31, 2025: Date of the press release announcing financial results for the fourth quarter and full year ended December 31, 2024.
- December 31, 2024: End of the reporting period for the fourth quarter and full year 2024.
Keywords
Filings with Classifications
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.
Quarterly Report
- AbbVie's first-quarter results exceeded expectations, leading to an increase in the company's full-year adjusted diluted EPS guidance.
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.
Proxy Statement
- AbbVie's 2024 results exceeded expectations with strong revenue growth and a robust R&D pipeline, indicating better-than-expected performance.
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.
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.
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.
Annual Report (Form 10-K)
- Humira sales declined by 37% globally due to biosimilar competition, which is worse than expected.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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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