The article paragraph is about the introductory remarks of an AbbVie First Quarter 2025 Earnings Conference Call. The call begins with the operator introducing Ms. Liz Shea, the Senior Vice President of Investor Relations, and other key executives, including CEO Rob Michael. Liz Shea mentions that the call will include forward-looking statements subject to risks and uncertainties, and notes the use of non-GAAP financial measures to explain AbbVie's performance. Rob Michael then highlights that AbbVie had an excellent start to the year, exceeding expectations in various therapeutic areas and advancing both internal and external growth opportunities. After prepared statements, a Q&A session will follow.

In the first quarter, the company exceeded expectations with adjusted earnings per share of $2.46 and net revenues over $13.3 billion, driven by strong sales growth in its ex-Humira platform, particularly in immunology, neuroscience, oncology, and anesthetics. As a result, the company raised its full-year adjusted EPS guidance. Potential impacts from future tariffs have not been factored into these estimates. The company plans significant U.S. investments to support growth, particularly in new areas like obesity. The company is also progressing with several promising pipeline programs in immunology and oncology, and continues to enhance its pipeline through strategic transactions for future growth.

The paragraph discusses AbbVie's recent strategic moves and commercial performance. The company acquired Nimble Therapeutics to enhance its immunology offerings with oral peptides and entered a license agreement with Gubra to develop an amylin analog for obesity treatment. AbbVie is optimistic about the potential of this program, given the global health concern of obesity. The company plans to invest further in this area and its other key growth sectors, projecting robust business fundamentals and high revenue growth through 2029. Jeff Stewart reports that AbbVie's immunology portfolio, particularly Skyrizi and Rinvoq, exceeded expectations with over $6.2 billion in quarterly revenue, driven by strong sales in the inflammatory bowel disease market, securing significant market shares domestically and internationally.

The paragraph discusses the strong market performance of AbbVie's medications Skyrizi and Rinvoq, which are capturing a significant share of patients in various therapeutic areas such as ulcerative colitis, dermatology, and rheumatology. Skyrizi leads in psoriatic disease markets, while Rinvoq shows increased global demand, especially in atopic dermatitis and upcoming expansions into giant cell arteritis. Despite this success, Humira's sales have significantly dropped due to increased competition and biosimilar erosion, leading to a downward revision of its sales forecast. Meanwhile, AbbVie's oncology sector surpasses expectations, with Venclexta revenue growing due to strong performance in chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML), though Imbruvica's sales decline due to competition.

The paragraph discusses the company's commercial portfolio in solid tumors and aesthetics. In solid tumors, the company highlights its leading ADC, Elahere, for ovarian cancer and anticipates U.S. regulatory approval for Teliso-V, a new treatment for non-small cell lung cancer. In aesthetics, global sales declined due to economic challenges, impacting products like BOTOX Cosmetic and Juvederm. Despite short-term challenges, the company remains optimistic about the long-term growth potential in facial injectables, driven by high consumer interest. They also mention the recent U.S. regulatory submission of BoNT/E, a fast-acting toxin for glabellar lines, expected to commercialize next year. Additionally, the neuroscience segment saw significant revenue growth, exceeding expectations.

The paragraph reports on the financial performance of several pharmaceutical products, highlighting substantial growth in sales for VRAYLAR, BOTOX Therapeutic, UBRELVY, and QLIPTA. It notes VRAYLAR's increasing market share in treating Bipolar I disorder and adjunctive major depression and mentions strong performances in their migraine therapy portfolio. Additionally, VYALEV's sales reflect strong uptake in Japan and Europe with a promising US launch. The development of Tavapadon for Parkinson's disease shows potential for commercial release in 2026. Overall, there is optimism about the company's portfolio momentum. Lastly, European approval for Rinvoq in GCA was received, with FDA approval anticipated soon.

The article paragraph discusses ongoing developments and upcoming milestones in immunology and oncology for a pharmaceutical company. In immunology, it mentions the progress of clinical trials, including Phase III data for Rinvoq in alopecia areata and vitiligo, and various studies for Skyrizi in combination therapies. In oncology, the company anticipates accelerated approval for Teliso-V, a c-Met directed ADC for non-small cell lung cancer, as well as progress with tmAb A, another c-Met ADC with ongoing and planned studies in lung cancer and colorectal cancer. Additionally, ABBV-706, an ADC for small cell lung cancer, is highlighted for its use of specific warhead and linker technology.

The paragraph discusses various phases and advancements in clinical trials across different therapeutic areas. In oncology, a Phase 1 study for a treatment named 706 showed promising results in patients with relapsed or refractory small cell lung cancer, and future trials are planned. Additionally, progress is being made in multiple myeloma with the BCMA CD3 bispecific ABBV-383, and future data from combination studies are anticipated. There is also an ongoing Phase 3 trial for VENCLEXTA in MDS, with regulatory submissions expected if outcomes are positive. A submission for PIVEC in BPDCN is planned as well. In neuroscience, interim data for Tavapadon in Parkinson's disease show a strong benefit-risk profile, maintaining efficacy and safety, with low rates of adverse events. A regulatory application for Tavapadon is planned for later this year.

The paragraph discusses recent developments and financial results for a company. In aesthetics, they submitted a regulatory application for a rapid onset, short-acting toxin BoNT/E and started a clinical program to evaluate its co-administration with BOTOX, which could lead to a novel product. In obesity, their partner Gubra reported positive interim results from a study on the amylin analog ABBV-295, which showed dose-dependent weight loss and a good tolerability profile. The study is ongoing, with full data expected next year. Financially, the company reported better-than-expected first-quarter earnings with adjusted earnings per share of $2.46 and total net revenues exceeding $13.3 billion, driven by strong operational growth. Adjusted gross margin was reported at 84.1% of sales, with R&D and SG&A expenses at 15.4% and 24.6% of sales, respectively.

The company has adjusted its financial outlook, raising its full-year adjusted earnings per share guidance to $12.09-$12.29, excluding future IPR&D expenses. Total net revenues are projected at $59.7 billion, a $700 million increase, despite a 0.6% adverse impact from foreign exchange. Key product revenue forecasts include increased sales for Skyrizi, Rinvoq, BOTOX Therapeutic, oral CGRP, Imbruvica, and Venclexta, while US Humira sales are expected to decrease due to biosimilar competition. Aesthetics global sales are projected at $5.1 billion, with lower guidance for BOTOX and Juvederm. Net interest expense is $627 million, and the adjusted tax rate is 14.2%.

The paragraph outlines AbbVie's financial expectations for 2025, projecting an adjusted gross margin of 84% of sales, adjusted SG&A expenses of $13.2 billion, and adjusted R&D expenses of $8.9 billion to support its pipeline growth. The adjusted operating margin is expected to be 46.5% of sales, accounting for a 0.4% impact from acquired expenses in the first quarter. For the second quarter, net revenues are forecasted at approximately $15 billion with a 0.3% negative impact from foreign exchange, while adjusted earnings per share are anticipated to be between $3.26 and $3.30. The guidance excludes potential impacts from new trade policies or tariffs, although mitigation strategies are being prepared. AbbVie emphasizes its significant U.S. manufacturing presence and plans for expansion, highlighting the influence of tax policies in encouraging domestic production growth.

In the paragraph, Scott and Jeff are providing an update on their company's performance during an earnings call, highlighting a strong start to the year with significant momentum. Scott mentions an increase in revenue guidance for their drugs Skyrizi and Rinvoq, attributing the growth to various indications, particularly in psoriatic, IBD, rheumatology, and dermatology. Chris Schott from JPMorgan asks about the competitive landscape, including the launch of Tremfya in IBD, and inquires about the future outlook for Humira in the face of current erosion.

The paragraph highlights the strong performance and market growth of Skyrizi and Rinvoq in the immunology sector, despite increasing competition. It notes the significant expansion of the IL-23 class since its early days, particularly in conditions like psoriasis, and expresses confidence in the potential impact on inflammatory bowel disease (IBD), citing Skyrizi’s recent launches in Crohn's and ulcerative colitis (UC). While acknowledging the ongoing erosion of Humira due to biosimilars, it suggests that this is expected and being monitored, asserting that the decline is not significantly affecting the company's overall growth.

In the paragraph, Terence Flynn from Morgan Stanley asks about strategies related to tariffs and updates on an amylin program. Rob Michael addresses the first question by explaining AbbVie's robust manufacturing network, emphasizing their ability to maintain supply during disruptions like the COVID pandemic. He highlights the importance of their US manufacturing presence, which employs over 6,000 workers across 11 sites, producing a variety of pharmaceutical products. Michael notes plans for significant future investments in US manufacturing, particularly to support growth in areas like obesity treatment. Roopal will address the second question about the amylin program.

The paragraph discusses potential strategies for mitigating the impact of tariffs and other challenges on the company. In the short term, inventory management and alternate API sources are considered, along with cost efficiencies and productivity initiatives. Passing tariff costs to customers is viewed as unviable due to penalties and existing contracts. In the long term, the company plans to invest over $10 billion to expand US manufacturing capacity by 2025 and focus on supply chain actions and cost efficiencies. Despite challenges, the company is confident about its business momentum and has raised its guidance for the year. The discussion also touches on intellectual property (IP) and tax rates, indicating the company's strong US presence and alignment with industry peers, suggesting no significant impact from tariffs on its overall profile.

The paragraph discusses Allergan's redomiciliation to the U.S. and its similarities in IP and tax profiles with the author's company. The 2017 tax reform is highlighted as beneficial for U.S. companies, encouraging long-term investment and manufacturing. Roopal Thakkar then shifts to discussing a multiple ascending dose study for a drug, noting the potential to test higher doses and longer durations beyond six weeks, with plans for a formal Phase 2b study next year. The current study may have larger sample sizes and aims to explore dose titration, with appetite suppression as the only reported adverse effect.

The paragraph discusses a study involving dose titration and evaluation of effects on muscle and bone, with data expected next year to inform a Phase 2b study design. Carter Gould from Cantor raises concerns about drug pricing, especially regarding international reference pricing. Rob Michael responds, emphasizing a balanced approach that addresses affordability while promoting innovation. He notes the importance of valuing innovation in the EU and hopes the administration considers potential negative impacts of international reference pricing on the US healthcare industry and future innovation. Jeff is set to address a related commercial question about the co-administration of BoNT/E and BOTOX.

The paragraph discusses the impact of policy, particularly tax reform, on investment in the pharmaceutical industry. It highlights that price controls and higher taxes could reduce investment in innovative medicines. However, the administration's efforts to address the "pill penalty" in the IRA are seen as positive for long-term innovation. The European push to value innovation and supportive policies are also welcomed. The speaker cites AbbVie's $5 billion investment since the 2017 tax reform as an example, which included infrastructure and capability expansions in the US, as well as the acquisition of Allergan. This investment led to increased R&D, even through Humira's loss of exclusivity. Overall, the paragraph argues that tax reform has provided incentives to invest in US innovation. Additionally, Jeff Stewart gives a brief update on BoNT/E and its dual-level operation.

The paragraph discusses a new market opportunity for a short-acting toxin, BoNT/E, which works in 8.5 hours and lasts 2.5 weeks, making it appealing to consumers hesitant about long-lasting toxins like BOTOX. The potential for BoNT/E to stimulate market engagement and offer a complementary or superior alternative to traditional BOTOX is highlighted. The paragraph also addresses the potential impact of combining BoNT/E with BOTOX, suggesting a significant shift in the market due to the rapid efficacy of BoNT/E. Following this, Courtney Breen from Bernstein inquires about inventory levels for products like Rinvoq, Botox, Vraylar, and Humira in the U.S. for the current and upcoming years, as well as further clarification on the BoNT/E topic.

Rob Michael and Jeff Stewart address questions about pricing strategy in the tester market and the impact of tariffs. Rob emphasizes that the company will not speculate on tariff impacts without detailed policies, referencing their previous approach to Part D benefit redesign as an example of their transparent communication once details are known. Jeff discusses the pricing analysis for an upcoming product, noting the importance of the lifetime value of new patients in aesthetic practices and the potential implications for pricing due to the product's shorter duration. The company plans to carefully evaluate these considerations as part of their launch readiness process.

In the paragraph, Mohit Bansal asks about the strategy behind using Gubra, particularly in relation to amylin as a standalone agent and its potential as a monotherapy for patients who cannot tolerate GLP-1. Roopal Thakkar responds by emphasizing the importance of tolerability, noting a significant dropout rate with current treatments due to this issue. She mentions that a tolerable monotherapy could offer meaningful weight loss and other benefits, such as muscle preservation. This new treatment could be a follow-on option for patients who have discontinued current therapies. Additionally, the neutral pH formulation of Gubra allows for potential combination with other mechanisms.

The paragraph discusses AbbVie's strategic interests and plans in two areas: the potential development of emraclidine for schizophrenia treatment and the company's operational footprint, particularly in Ireland. AbbVie sees potential in emraclidine and plans to explore further dosing studies despite past challenges. Additionally, the company is evaluating its global operations, balancing between maintaining its presence outside the U.S. and investing domestically, amidst uncertainties about future U.S. administration policies.

The paragraph discusses a strategic plan for drug development and manufacturing. The speaker outlines a phased approach to drug trials, starting with higher doses and progressing through Phase 2 and Phase 3 depending on the trial results, focusing on opportunities in neurodegeneration psychosis. Rob Michael then addresses AbbVie's manufacturing strategy, emphasizing the importance of ensuring supply, especially during challenges like the global pandemic. He highlights that key products like Skyrizi are manufactured in the US, and discusses the impact of tax policy on the supply chain structure. Additionally, he notes that AbbVie is expanding its manufacturing capacity to meet increasing demand, influenced by the strong performance of products like Skyrizi and Rinvoq. The commercial team challenges operations to keep pace, but operations ensures they invest appropriately to meet demand.

The paragraph discusses a pharmaceutical company's strategic investment in the US, focusing on areas such as peptide manufacturing, especially as they expand into the obesity market. It also addresses the challenges posed by US government actions affecting the biopharma industry, including potential FDA disruptions, tariff threats, and pricing pressures from past and current administrations. The company is actively engaging with Washington leadership through its government affairs organization to address these issues, with a focus on tax reform and aligning with key industry associations, despite not being a member of any pharma association. Additionally, it notes that their guidance does not account for potential shifts in trade policy, such as sector-specific tariffs.

The paragraph discusses recent developments in the biopharma industry, including Congressional recommendations to redefine a patient in the 340B program, seen as a positive step to address program abuse. It also mentions efforts to eliminate the "pill penalty" to encourage innovation. The company's teams are actively engaging with the FDA and have not encountered delays, despite an uncertain environment. Scott Reents clarifies the discussion on potential pharmaceutical sector tariffs, noting that current tariffs exclude pharmaceutical products. Vamil Divan from Guggenheim Securities inquires about tariffs on aesthetic products like breast implants and Juvederm and questions why these aren't accounted for in the company's new guidance.

The paragraph discusses the impact of tariffs on aesthetic products and market share dynamics in the pharmaceutical industry. Scott Reents explains that while pharmaceuticals are largely exempt from tariffs, some aesthetic products are affected, but the financial impact is modest at around $30 million, which has been accounted for in their guidance. Jeff Stewart then discusses market share in the US and China, highlighting a market share loss in toxins in the US during the fourth quarter, but noting a recovery with a one-point gain in the first quarter due to reengagement with the Alley program. However, they still need to regain more share to return to pre-Alley change levels. In fillers, their market share remains stable in the US.

The paragraph discusses the business performance of BOTOX and Juvederm in China, highlighting positive momentum and share growth, particularly due to recent approvals for BOTOX in the masseter area and Juvederm's VOLUX. Despite market pressure in the filler sector, there's a focus on recovering market share in the U.S. toxin space. The conversation then shifts to Skyrizi and Rinvoq, with questions about their long-term growth and combination trials. Early data from these trials is expected next year, and the company is excited about combinations like alpha-4 beta-7 and Lutikizumab, which show promise for patients with IBD who have failed other advanced therapies.

The paragraph discusses potential combinations and advancements in immunology treatments, specifically focusing on TREM1 and a longer-acting TL1A agent that might be effective with IL-23, similar to Skyrizi. The company is exploring biomarker segmentation for patient treatment, similar to oncology. There's strong demand for Skyrizi and Rinvoq, leading to a $900 million guidance increase for the year, and they anticipate continued growth through 2027, with Rinvoq expected to have new indications by the end of the decade. The company aims to elevate the standard of care in immunology, using the next eight years to develop and enhance treatment options.

The paragraph discusses the growth strategy of a company with a focus on expanding beyond their current immunology products, Skyrizi and Rinvoq. They identify five key growth areas with confidence and have recently entered the obesity space as an additional opportunity. The company is positioned to grow over the next eight years and beyond. James Shin from Deutsche Bank asks about pricing and volume dynamics, particularly the impact on Humira, Skyrizi, and Rinvoq. Scott Reents responds, noting that Skyrizi and Rinvoq experienced strong demand in the first quarter, with slight pricing favorability due to effective co-pay utilization management and earlier-than-anticipated channel mix changes. Despite this, they still expect negative pricing impacts over the full year.

The paragraph discusses a decrease in the volume of Humira due to market share erosion and changes in pricing dynamics, including rebating changes as the company enters a new contract year. Geoff Meacham from Citibank asks about the potential for pharmacy benefit manager (PBM) reform and its impact, as well as the company's focus on business development (BD) and potential therapeutic areas to expand into, such as neuroscience and metabolic diseases. Jeff Stewart expresses support for reforms that enhance patient affordability and emphasizes AbbVie's commitment to its current five key growth areas, highlighting strong performance in their migraine and Parkinson's franchises.

The paragraph discusses a company's strategic focus on expanding its presence in the neuroscience field, with an emphasis on psychiatric disorders, migraines, Parkinson's disease, and neurodegeneration. It highlights recent business activities, including collaborations and acquisitions in psychiatry and Alzheimer's research. The company is also broadening its portfolio by entering the obesity market, recognizing its growth potential and alignment with their existing business in aesthetics. The overall strategy is to address unmet medical needs and elevate standards of care across these therapeutic areas.

The paragraph discusses opportunities within the obesity market, particularly focusing on the amylin class as an attractive non-GLP-1 mechanism. The speaker believes this, along with other investments, will drive long-term growth. It then pivots to a question about drug advertising, noting AbbVie's significant investment and potential changes in advertising regulations. Despite the possibility of regulatory changes, the speaker emphasizes support for First Amendment rights to advertise and mentions that the company is prepared to adapt its marketing strategy if needed. The conversation also touches on the potential interest in long-acting GLP options within the obesity treatment portfolio.

The paragraph discusses a company's strategic ability to adapt to changes in market dynamics, emphasizing the competitiveness of their brands. Roopal Thakkar highlights opportunities for monotherapy and combination mechanisms, noting their current formulation's neutral pH as conducive for combinations. Trung Huynh from UBS raises questions about the pricing dynamics of Skyrizi and Rinvoq, asking if their performance included onetime effects like inventory changes or pull-forward effects. He also inquired about the impact of China's reciprocal tariffs on the company's aesthetics business. Scott Reents responds, pointing out strong demand for Skyrizi and Rinvoq, and highlights that retailer destocking, rather than inventory buildup, contributed to the quarterly growth.

The paragraph discusses financial and operational performance aspects of certain products and markets. It mentions the modest impact of retail destocking and tariffs on overall growth. The growth globally was largely operational and minimal from destocking. The paragraph also touches on the China market, noting no significant change in demand over the last 30 days, although there are positive developments like share growth from recent approvals in China. Additionally, it highlights two products, Vyalev and Elahere, which performed better than expected outside of the I&I business, particularly in Japan and Europe. Jeff Stewart emphasizes Vyalev's significance and its potential to continue surpassing expectations.

The paragraph discusses the progress and potential of certain products and strategies in the company's portfolio. It highlights the success and promising market feedback of a new product for sleep and movement disorders, noting its advantages over existing treatments like Duopa. They are preparing to expand into the Parkinson's treatment category with Tavapadon and have seen significant uptake of Elahere, particularly due to its non-chemotherapy attributes and international launch strategy. Rob Michael emphasizes the success of Elahere following the acquisition of ImmunoGen and the combined antibody-drug conjugate (ADC) capabilities that are fueling their oncology pipeline. The paragraph concludes by mentioning promising developments in multiple myeloma treatment as part of AbbVie's growing oncology focus.

The paragraph is part of the conclusion of AbbVie's first quarter 2025 earnings conference call. Liz Shea appreciates a specific question about Elahere and informs listeners that a replay of the call is available on their website. The operator thanks participants for joining and ends the conference, wishing everyone a good day.

This summary was generated with AI and may contain some inaccuracies.