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AbbVie Inc. is a global, diversified research-based biopharmaceutical company with leadership positions across several therapeutic areas, including immunology, oncology, aesthetics, neuroscience, and eye care . The company operates as a single global business segment dedicated to the research, development, manufacturing, commercialization, and sale of innovative medicines and therapies . AbbVie's product portfolio includes blockbuster products such as Humira, Skyrizi, Rinvoq, Imbruvica, Venclexta, Botox, Juvederm, Vraylar, Ubrelvy, and Qulipta, among others .
- Immunology - Develops and markets treatments for autoimmune diseases, with key products including Humira, Skyrizi, and Rinvoq.
- Oncology - Focuses on cancer treatment solutions, featuring products like Imbruvica and Venclexta.
- Neuroscience - Offers therapies for neurological disorders, with significant products such as Vraylar and Botox Therapeutic.
- Aesthetics - Provides cosmetic products and treatments, including Botox and Juvederm.
- Eye Care - Engages in the development and sale of treatments for various eye conditions.
What went well
- AbbVie's Immunology Portfolio is Demonstrating Superior Efficacy and Expanding Market Share Across Multiple Indications
- Strong Confidence in Long-Term Growth of the Aesthetics Business Driven by Innovative Products
- Strategic Investments in Neuroscience Pipeline Position AbbVie for Long-Term Growth
What went wrong
- AbbVie's long-term revenue target of greater than $9 billion by 2029 for its aesthetics business is uncertain and highly dependent on economic recovery and new product launches. The company acknowledges that achieving this requires compound growth of around 11%, but current market conditions suggest growth may only reach high single digits.
- Persistent challenging economic conditions have negatively impacted Juvederm sales, potentially impairing future growth in the aesthetics segment if these conditions continue. AbbVie moderated its Juvederm outlook due to poor performance and admits that achieving long-term guidance is dependent on market recovery.
- Uncertainty surrounds the success of the Cerevel Therapeutics acquisition, particularly regarding pending emraclidine data for schizophrenia. Analysts express skepticism about the potential effect size in upcoming studies, suggesting that if results are unfavorable, it could impact the value of the acquisition and AbbVie's growth in neuroscience.
Q&A Summary
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2025 Growth Outlook
Q: Is mid-single-digit growth still expected in 2025?
A: Management expressed strong confidence in achieving robust mid-single-digit growth in both top line and bottom line for 2025. They noted that overperformance from SKYRIZI and RINVOQ is more than offsetting HUMIRA's decline. They highlighted a $1.3 billion increase in guidance for SKYRIZI and RINVOQ , and expect positive momentum across their portfolio, including oncology and neuroscience. -
Aesthetics Long-Term Targets
Q: Can you still hit the $9B Aesthetics target by 2029?
A: Management believes they can achieve the over $9 billion target by 2029 for the Aesthetics business. They acknowledge it requires around 11% compound annual growth. While market recovery to high single digits is anticipated, they expect innovations like the short-acting BoNT/E launching in 2026 to drive growth beyond market recovery. They will reassess the target in 2026 based on market recovery and BoNT/E performance. -
SKYRIZI and RINVOQ Pricing
Q: Any changes in SKYRIZI and RINVOQ pricing/access in 2025?
A: Contracting for 2025 is nearly complete, with no material changes expected in access for SKYRIZI and RINVOQ across Medicare and commercial plans. They anticipate low single-digit negative pricing impact due to rebates, which is modest compared to prior years. -
Neuroscience Pipeline Strategy
Q: How does the Alliad acquisition fit into neuroscience plans?
A: The Alliad acquisition strengthens their neuroscience portfolio, particularly in Alzheimer's disease. They see differentiation in Alliad's approach, offering higher concentrations in CSF and extended half-life, potentially enabling monthly subcutaneous dosing. This could result in better cognitive benefits and reduced side effects, addressing challenges like ARIA. Neuroscience is a key growth area, focusing on psychiatry, migraine, Parkinson's, and neurodegeneration. -
Imaraclidine Data Expectations
Q: Any insights on upcoming imaraclidine data?
A: Management is encouraged by imaraclidine's profile as a once-daily agent with no food effect and a favorable safety profile. They have not observed significant GI or bladder issues in Phase Ib data and do not anticipate hepatic monitoring requirements. Data readout is expected in the coming months, and they are optimistic about its potential in neurodegenerative-associated psychosis. -
VRAYLAR Guidance Adjustment
Q: Explain the VRAYLAR guidance reduction.
A: VRAYLAR guidance was reduced by $100 million due to slight channel mix changes accumulating over the year, leading to a small negative price impact. However, this was offset by an increase in BOTOX Therapeutics, keeping the neuroscience growth area guidance stable. They also extended their collaboration with Gideon Richter to develop additional psychiatric treatments. -
Eye Care Strategy
Q: How strategic is the eye care business?
A: Eye care is one of their five key growth areas, though not as high a growth driver as others. They are building depth in areas like diabetic retinopathy and dry eye. While their primary focus is within these growth areas, they remain open to opportunistic investments in other therapeutic areas like metabolics if they see differentiation. -
Pipeline Mechanisms (TL1A)
Q: Thoughts on new pipeline mechanisms like TL1A?
A: Management is confident in SKYRIZI's efficacy over emerging orals. They view mechanisms like TL1A as important, especially in combination therapies. While TL1A shows encouraging data in ulcerative colitis, they believe it needs to be part of a combination approach to be differentiated. They are excited about other early-stage mechanisms and will share more as data matures. -
Erapiden Placebo Effect Management
Q: How are you managing placebo effects in erapiden studies?
A: They have implemented strategies to manage placebo responses, such as limiting countries and sites, central eligibility review, and training raters. While it's difficult to predict erosion due to placebo, they are confident that even if effect size diminishes, erapiden's safety and tolerability will keep it competitive. -
Head-to-Head Trial Against ENTYVIO
Q: What's your confidence in SKYRIZI vs. ENTYVIO trial?
A: Management is confident due to SKYRIZI's high 76% endoscopic improvement in maintenance phase among biologic-naïve ulcerative colitis patients. They believe this provides potential for superiority over ENTYVIO, especially on objective endpoints like endoscopic improvement. They view endoscopic improvements as highly predictive of long-term outcomes.
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Given the ongoing economic challenges in China that have significantly impacted Juvederm's performance, particularly within the Aesthetics segment, what specific strategies does AbbVie have to navigate these headwinds and stimulate growth in this critical market?
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With the recent $100 million downward adjustment in VRAYLAR's full-year sales guidance due to channel mix pressures and negative pricing impact, can you elaborate on the factors leading to this shift and how you plan to mitigate similar issues moving forward?
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In the competitive immunology space, your head-to-head trial of SKYRIZI against ENTYVIO aims for potential superiority in endoscopic improvement for ulcerative colitis patients; what gives you confidence in achieving this outcome, and what are the implications if the trial does not meet its superiority endpoints?
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As SKYRIZI and RINVOQ continue to drive significant growth, what challenges do you foresee in maintaining their momentum across existing indications, and how do you plan to address potential competition from new market entrants and evolving treatment paradigms?
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With the integration of Cerevel Therapeutics and the upcoming pivotal study readouts for emraclidine in schizophrenia, how is AbbVie preparing to compete against existing therapies, especially considering recent approvals with safety considerations like hepatic monitoring, and what are your expectations regarding emraclidine's safety and efficacy profile?
Q3 2024 Earnings Call
- Issued Period: Q3 2024
- Guided Period: FY 2024
- Guidance:
- Adjusted EPS: $10.90 to $10.94
- Total Net Revenues: Approximately $56 billion
- Adjusted Gross Margin: 84% of sales
- Adjusted R&D Investment: 14% of sales
- Adjusted SG&A Expense: 23.5% of sales
- Adjusted Operating Margin Ratio: 44.5% of sales
- Q4 2024 Net Revenues: Approximately $14.8 billion
- Q4 2024 Adjusted EPS: $2.94 to $2.98
- Product-Specific Guidance:
- SKYRIZI Global Sales: $11.5 billion
- RINVOQ Total Revenue: $5.8 billion
- U.S. HUMIRA Total Sales: $7.4 billion
- IMBRUVICA Total Revenue: $3.3 billion
- VENCLEXTA Total Sales: $2.6 billion
- Aesthetics Global Revenue: $5.3 billion
- VRAYLAR Total Sales: $3.3 billion
- BOTOX Global Revenue in Therapeutic Space: $3.3 billion .
Q2 2024 Earnings Call
- Issued Period: Q2 2024
- Guided Period: FY 2024
- Guidance:
- Adjusted EPS: $10.71 to $10.91
- Total Net Revenues: Approximately $55.5 billion
- Foreign Exchange Impact: 1% unfavorable
- Adjusted Gross Margin: 84% of sales
- Adjusted R&D Investment: 14% of sales
- Adjusted SG&A Expense: 23.5% of sales
- Adjusted Operating Margin Ratio: 44.5% of sales
- Non-GAAP Tax Rate: 16.3%
- Q3 2024 Net Revenues: Approximately $14.2 billion
- Q3 2024 Adjusted EPS: $2.92 to $2.96
- Product-Specific Guidance:
- SKYRIZI Global Sales: $11 billion
- Rinvoq Total Revenue: $5.7 billion
- SYNCLEXA Total Sales: $2.5 billion
- Aesthetics Global Revenue: $5.5 billion .
Q1 2024 Earnings Call
- Issued Period: Q1 2024
- Guided Period: FY 2024 and Q2 2024
- Guidance:
- Adjusted EPS: $11.13 to $11.33
- Total Net Revenues: Approximately $55 billion
- Foreign Exchange Impact: 0.9% unfavorable
- Adjusted Gross Margin: 84% of sales
- Adjusted R&D Investment: 14% of sales
- Adjusted SG&A Expense: 23.5% of sales
- Adjusted Operating Margin Ratio: 46.5%
- Adjusted Net Interest Expense: $2.2 billion
- Q2 2024 Net Revenues: Approximately $14 billion
- Q2 2024 Adjusted Operating Margin Ratio: 49.5% of sales
- Q2 2024 Non-GAAP Tax Rate: 16.4%
- Q2 2024 Adjusted EPS: $3.05 to $3.09 .
Q4 2023 Earnings Call
- Issued Period: Q4 2023
- Guided Period: FY 2024 and Q1 2024
- Guidance:
- Adjusted EPS: $11.05 to $11.25
- Total Net Revenues: Approximately $54.2 billion
- Foreign Exchange Impact: 0.5% unfavorable
- Key Product and Therapeutic Area Revenue Assumptions:
- Global Immunology Sales: $25.6 billion
- Humira Sales: $9.6 billion
- Skyrizi Revenue: $10.5 billion
- Rinvoq Sales: $5.5 billion
- Oncology Sales: $5.7 billion
- Imbruvica Revenue: $2.9 billion
- Venclexta Sales: $2.4 billion
- Aesthetics Sales: $5.7 billion
- Neuroscience Revenue: $8.9 billion
- Eye Care Sales: $2.2 billion
- Adjusted Gross Margin: 84% of sales
- Adjusted R&D Investment: 14% of sales
- Adjusted SG&A Expense: 23.5% of sales
- Adjusted Operating Margin Ratio: 46.5% of sales
- Adjusted Net Interest Expense: $2.1 billion
- Non-GAAP Tax Rate: 15.7%
- Share Count: Roughly flat
- Q1 2024 Net Revenues: Approximately $11.9 billion
- Q1 2024 Adjusted Gross Margin: 83.5% of sales
- Q1 2024 Adjusted Operating Margin Ratio: 44.5% of sales
- Q1 2024 Non-GAAP Tax Rate: 14.8%
- Q1 2024 Adjusted EPS: $2.30 to $2.34 .
Competitors mentioned in the company's latest 10K filing.
- Anti-TNF products: Compete with AbbVie's immunology products .
- JAK inhibitors: Compete with AbbVie's immunology products .
- BTK inhibitors: Compete with AbbVie's oncology products .
- Biosimilars: Compete with AbbVie's biologic products, including Humira .
- Generic pharmaceutical products: Create competitive pressures on AbbVie's products that do not have patent protection .
- Orally administered products: Compete with AbbVie's biologics .
- Other companies developing products positioned as competitors to Botox: Compete in the aesthetics market .
Recent developments and announcements about ABBV.
Financial Reporting
- Adjusted Diluted EPS Range: $2.06 to $2.10, including the impact of $1.6 billion in acquired IPR&D and milestones expense. This represents an unfavorable impact of $0.88 per share on both GAAP and adjusted non-GAAP diluted EPS.
- Adjusted Diluted EPS Range: $10.02 to $10.06, reflecting the inclusion of $2.757 billion in acquired IPR&D and milestones expense for the year. This also includes the $0.88 per share impact from the fourth quarter.
- The acquired IPR&D and milestones expense stems from collaborations, licensing agreements, and other asset acquisitions. AbbVie does not forecast these expenses due to their uncertain timing and occurrence.
- The guidance reflects a downward adjustment from previously announced figures, which excluded these expenses.
Earnings Report
AbbVie Inc. has released its earnings guidance for the fourth quarter and full year of 2024, incorporating the impact of acquired in-process research and development (IPR&D) and milestones expense. Below are the key highlights:
Fourth Quarter 2024 Guidance
Full-Year 2024 Guidance
Significant Trends
This update provides insight into AbbVie's financial performance and the impact of strategic investments in research and development. The final results for Q4 2024 are still subject to financial statement closing procedures and may differ from these preliminary estimates.
Corporate Leadership
Leadership Change
Kevin K. Buckbee is leaving his role as Senior Vice President, Controller at AbbVie, planning to retire effective March 1, 2025. David R. Purdue will step up as the new Senior Vice President, Controller on the same date. Purdue has been with AbbVie since 2003 and has held various finance roles .