AbbVie Highlights SKYRIZI, RINVOQ Growth and Pipeline Catalysts at Wells Fargo Conference

Key Points

• SKYRIZI and RINVOQ remain AbbVie’s main growth drivers, with additional opportunities in inflammatory bowel disease, vitiligo, alopecia and hidradenitis suppurativa. The company expects a subcutaneous SKYRIZI induction approval for Crohn’s disease in the fourth quarter and plans further combination-therapy data.
• AbbVie is advancing a broad pipeline, including the BCMA-directed cancer therapy etentamig, which showed strong early multiple-myeloma results and could support a rapid regulatory filing. Neuroscience programs such as bretisilocin for depression are also expected to deliver additional data this year.
• The company is taking a selective approach to acquisitions and partnerships, having invested about $20 billion in roughly 30 transactions while increasing annual R&D spending toward $10 billion. Management maintained its outlook for high-single-digit annual revenue growth through the decade.

AbbVie NYSE: ABBV executives outlined growth plans across immunology, oncology and neuroscience at a Wells Fargo conference, emphasizing continued momentum for its SKYRIZI and RINVOQ franchises, a pipeline of combination therapies and an approach to business development focused on assets that fit its long-term strategy.

Jeff Stewart, AbbVie’s executive vice president and chief commercial officer, said the company remains encouraged by the growth outlook for immunology markets including inflammatory bowel disease, atopic dermatitis and psoriatic arthritis. He said these markets are expanding as new therapies support earlier treatment and broader use across lines of therapy.

Stewart said SKYRIZI and RINVOQ, now in their eighth year of growth, continue to have opportunities for market-share gains. He pointed to planned or ongoing development in additional indications, including vitiligo, alopecia and hidradenitis suppurativa, or HS. AbbVie previously raised its long-term outlook for the vitiligo and alopecia opportunities to more than $3 billion, he said.

Immunology pipeline and Crohn’s disease plans

In inflammatory bowel disease, Stewart said AbbVie expects approval of a subcutaneous induction regimen for SKYRIZI in Crohn’s disease during the fourth quarter. The company expects to release additional data from the AFFIRM study later in the quarter. He said topline findings showed strong endoscopic healing results and that the company views the regimen as a potential catalyst for its IBD position.

Roopal Thakkar, AbbVie’s executive vice president, head of research and chief scientific officer, discussed the company’s combination-therapy platform. In early data, a combination of SKYRIZI and AbbVie’s proprietary alpha-4 beta-7 therapy showed a doubling in endoscopic remission versus SKYRIZI monotherapy within the same study, according to Thakkar.

AbbVie plans to present additional data at gastrointestinal conferences later this year, representing about 80% of patient data, followed by a full dataset next year. The company is also enrolling a larger platform study evaluating SKYRIZI, its alpha-4 beta-7 therapy and an extended-duration TL1A therapy in Crohn’s disease and ulcerative colitis.

Thakkar said the company will evaluate whether higher dosing of the alpha-4 beta-7 treatment can further improve endoscopic outcomes. Stewart said transformational efficacy and convenient administration would be key commercial requirements for any combination product, including potentially using an on-body device or a simple injection.

AbbVie also expects data later this year from Phase III studies of lutikizumab and RINVOQ in HS. Thakkar said lutikizumab is being studied in patients who have not previously received biologics as well as patients who have failed them, while the RINVOQ study is enrolling patients who have failed biologic therapies. He said the trial designs accounted for potentially variable placebo responses in HS and included site training on lesion identification and counting.

Business development and investment priorities

Scott Reents, AbbVie’s chief financial officer, said the company has completed roughly 30 transactions and spent about $20 billion over the past several years. About half of that amount related to the Apogee transaction, he said, while the remaining investments involved smaller and earlier-stage opportunities.

Reents said AbbVie has increased annual research and development spending by roughly $3.5 billion since 2022 and expects R&D spending to approach $10 billion this year. He said the company’s approach combines internal development with external innovation, particularly assets that complement existing franchises.

While AbbVie has the financial capacity to consider early-stage, late-stage and marketed assets, Reents said it does not need to pursue revenue simply for the sake of adding revenue. He said management will continue to evaluate opportunities in the company’s core therapeutic areas and adjacent categories through what he described as a measured and methodical process.

Reents reiterated AbbVie’s previously discussed high-single-digit compound annual revenue growth outlook through the decade and said the company’s first loss of exclusivity after its current major products is not expected until VRAYLAR in 2030.

Oncology and neuroscience developments

In oncology, Thakkar highlighted AbbVie’s BCMA-directed T-cell engager etentamig for multiple myeloma. He said the therapy was designed with high affinity for BCMA and lower affinity for CD3, an approach intended to support efficacy while improving tolerability and convenience.

According to Thakkar, a study was stopped early at the request of the data monitoring committee after a median follow-up of 11 months. He said the results showed high response rates, progression-free survival and an overall-survival trend, with both hazard ratios below 0.5. The regimen involved one step-up dose and 13 injections annually because it is administered monthly.

AbbVie has dosed about 100 patients in outpatient settings across the development program, Thakkar said. The company plans discussions with regulators regarding labeling, including potential requirements for risk evaluation and mitigation and hospitalization. Stewart said AbbVie is preparing for a rapid filing and market entry.

Thakkar also described a solid-tumor pipeline including telisotuzumab vedotin, ABBV-901, ABBV-969, a KRAS program, DLL3-directed therapies and a partnership with RemeGen involving a PD-1/VEGF program. He said data from the PD-1/VEGF program were expected to be presented at the World Lung meeting.

In neuroscience, Thakkar said AbbVie is developing bretisilocin for major depressive disorder and plans another readout this year. He said early data showed deep and durable remission, while the treatment experience lasted about two hours. AbbVie is planning an acute Phase III study, a Phase II study to evaluate dose and durability, and a Phase II study in post-traumatic stress disorder.

Looking ahead, Thakkar said a successful year would include continued commercial execution in immunology, favorable HS results, advancement of oncology programs into Phase III, progress in psychiatry and rapid execution of atopic dermatitis studies involving zumilokibart from Apogee.

About AbbVie (NYSE:ABBV)

AbbVie Inc NYSE: ABBV is a global biopharmaceutical company that discovers, develops and commercializes medicines across immunology, oncology, neuroscience, eye care, aesthetics and other specialty areas. The company was established in 2013 after separating from Abbott Laboratories, which retained Abbott's diversified medical products and diagnostics businesses while AbbVie focused on research-based pharmaceuticals.

AbbVie's immunology portfolio includes Skyrizi (risankizumab) and Rinvoq (upadacitinib), which are used to treat several inflammatory conditions.

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