AbbVie (ABBV) Company Report

The FDA approved EPKINLY® (epcoritamab-bysp) combined with rituximab and lenalidomide (R2) as the first bispecific antibody combination therapy for adult patients with relapsed/refractory follicular lymphoma after ≥1 prior systemic therapy.
In the Phase 3 EPCORE FL-1 trial, EPKINLY + R2 reduced the risk of disease progression or death by 79% (HR 0.21; 95% CI: 0.13–0.33; p<0.0001) and achieved an 89% overall response rate (vs 74% for R2 alone).
Among patients receiving EPKINLY + R2, 74% attained a complete response (vs 43% with R2), and median progression-free survival was not reached vs 11.2 months for R2.
This approval represents EPKINLY’s third indication and converts its accelerated approval granted in June 2024 into full approval; the safety profile was consistent with known regimen effects.

5 days ago

Press Release

Xilio Therapeutics presents Phase 2 vilastobart data in MSS mCRC

ABBV

Presented 40% objective response rate (ORR) in heavily pre-treated MSS mCRC patients without liver metastases and high plasma TMB, with statistically significant correlation (p = 0.05) between TMB status and response.
As of May 12, 2025, 44 patients were treated with vilastobart plus atezolizumab (100 mg Q6W and 1200 mg Q3W), including 27 without liver metastases and 24 evaluable for plasma TMB.
Approximately 55% of non-MSI-H CRC patients were plasma TMB-high (≥10 mutations/Mb), highlighting the potential of plasma-based TMB assays over traditional tissue-based tests.
Combination therapy was generally well-tolerated, with most treatment-related adverse events Grade 1–2, a 5% discontinuation rate and 7% incidence of colitis.

Nov 7, 2025, 2:05 PM

Press Release

Xilio presents masked immunotherapy data at SITC 40th Annual Meeting

ABBV

Xilio’s masked T cell engager programs leveraging ATACR and SEECR formats demonstrated potent preclinical anti-tumor activity with reduced systemic toxicity, supporting a best-in-class potential across multiple targets.
Efarindodekin alfa (XTX301) Phase 1 monotherapy in 62 advanced solid tumor patients showed generally well-tolerated safety up to the RP2D and two partial responses, including a confirmed PR with a 33% tumor reduction.
In Phase 2 for vilastobart plus atezolizumab in MSS mCRC, deep ctDNA reductions (≥75%) correlated with radiographic responses, and two patients achieved endoscopic complete responses with undetectable ctDNA.
Xilio nominated its PSMA ATACR candidate in Q3 2025 and plans to nominate CLDN18.2 (Q4 2025) and STEAP1 SEECR (H1 2026) candidates, with at least two IND filings anticipated in 2027.
Data were presented at SITC (Nov 5–9, 2025), including posters on masked engagers (Abstract 972), XTX301 PD data (Abstract 567), ctDNA biomarker analysis (Abstract 541) and pTMB enrichment (Abstract 1315).

Nov 7, 2025, 2:01 PM

Press Release

AbbVie to Showcase Epcoritamab Data at ASH 2025

ABBV

Genmab and AbbVie will present over 20 epcoritamab abstracts, including seven oral presentations, at the ASH Annual Meeting (Dec 6–9).
Data highlight epcoritamab’s potential in first- and second-line follicular lymphoma and first-line diffuse large B-cell lymphoma.
Phase 3 EPCORE FL-1 trial results (epcoritamab + rituximab + lenalidomide) in relapsed/refractory FL accepted for an oral presentation.
Genmab will host a 2025 R&D Update and ASH Data Review webcast on December 11.

Nov 3, 2025, 2:05 PM

Press Release

AbbVie reports Q3 2025 results and raises full-year outlook

ABBV

Earnings

Guidance Update

M&A

AbbVie delivered adjusted EPS of $1.86 and net revenues of $15.8 billion in Q3, up 8.4% operationally, beating guidance; raised 2025 EPS to $10.61–$10.65 and sales to $60.9 billion, with Q4 revenue and EPS guidance at $16.3 billion+ and $3.32–$3.36
Immunology revenues grew 11.2% to $7.9 billion, led by SKYRIZI ($4.7 billion, +46% op) and RINVOQ ($2.2 billion, +34.1% op), offsetting HUMIRA’s 55.7% decline to $993 million; neuroscience sales rose 19.6% to $2.8 billion, with VYALEV up 40% to $138 million
Invested $84 billion in R&D since 2013, plans $9 billion of 2025 R&D expense, and maintains ~90 pipeline programs; key upcoming catalysts include tavapadon, PVEK approvals, expanded indications for RINVOQ/EPKINLY/QULIPTA/UBRELVY, and late-stage data for lutikizumab and Temab-A
Generated $13 billion of free cash flow YTD Q3 (cash $5.6 billion), increased quarterly dividend by 5.5% to $1.73 (payable Feb 2026), and acquired Gilgamesh (bretisilocin) and Capstan to expand immunology and psychiatry pipelines

Oct 31, 2025, 1:00 PM

Transcript

AbbVie reports Q3 2025 results

ABBV

Earnings

Guidance Update

Dividends

AbbVie delivered adjusted EPS of $1.86, $0.10 above guidance, with net revenues of $15.8 billion (+8.4% operationally), driven by strong immunology and neuroscience performance.
Immunology revenues reached $7.9 billion (+11.2%), led by SKYRIZI $4.7 billion (+46%) and RINVOQ $2.2 billion (+34.1%), while Humira sales declined 55.7% to $993 million.
Raised full-year 2025 guidance to $10.61–$10.65 adjusted EPS and $60.9 billion net revenues, reflecting upgraded forecasts for SKYRIZI and neuroscience.
Increased quarterly dividend 5.5% to $1.73 per share (payable Feb 2026), supported by $13 billion free cash flow and planned $10 billion U.S. capital investment over 10 years.
Advanced pipeline with positive phase 3 RINVOQ data in alopecia areata and vitiligo, FDA submission for PVEC in BPDCN, and acquisitions of Capstan’s CAR-T platform and Gilgamesh’s bredacillicin.

Oct 31, 2025, 1:00 PM

Transcript

AbbVie raises 2025 outlook as Q3 revenues beat expectations

ABBV

Earnings

Guidance Update

Dividends

AbbVie reported Q3 adjusted EPS of $1.86, $0.10 above guidance, on total net revenues of $15.8 billion, up 8.4% operationally; raised full-year 2025 adjusted EPS guidance to $10.61–$10.65 and sales guidance to $60.9 billion.
Immunology sales reached $7.9 billion (+11.2% op), led by SKYRIZI at $4.7 billion (+46%) and RINVOQ at $2.2 billion (+34.1%); neuroscience grew 19.6% to $2.8 billion, oncology was flat at $1.7 billion, and aesthetics declined 4.2% to $1.2 billion.
Investing $9 billion in R&D for 2025 to support ~90 pipeline programs; announced positive phase 3 RINVOQ results in alopecia areata and vitiligo, submitted PVEC for BPDCN, and advancing novel ADCs and in vivo CAR-T platforms.
Increased the quarterly dividend by 5.5% to $1.73 per share starting February 2026; generated ~$13 billion free cash flow YTD and targets a net leverage ratio of two times by end-2026.

Oct 31, 2025, 1:00 PM

Transcript

AbbVie reports Q3 2025 results

ABBV

Earnings

Guidance Update

Dividends

AbbVie delivered third-quarter net revenues of $15.776 B, up 9.1% reported and 8.4% operationally.
GAAP diluted EPS was $0.10, an 88.6% decrease, and adjusted diluted EPS was $1.86, down 38.0%.
Immunology portfolio net revenues grew 11.9% reported to $7.885 B (11.2% operational); neuroscience portfolio net revenues increased 20.2% reported to $2.841 B (19.6% operational).
Raised full-year 2025 adjusted diluted EPS guidance to $10.61–$10.65, from $10.38–$10.58.
Declared a 5.5% dividend increase to $1.73 per share, beginning February 17, 2026.

Oct 31, 2025, 11:51 AM

8-K

AbbVie reports Q3 2025 financial results

ABBV

Earnings

Guidance Update

Dividends

AbbVie delivered third-quarter net revenues of $15.776 billion, up 9.1 percent reported (8.4 percent operational) versus prior year.
GAAP diluted EPS was $0.10, down 88.6 percent, and adjusted diluted EPS was $1.86, down 38.0 percent, reflecting a $1.50 per-share impact from acquired IPR&D and milestones expense.
The company raised its full-year 2025 adjusted diluted EPS guidance to $10.61–$10.65, up from $10.38–$10.58.
AbbVie declared a 5.5 percent dividend increase, raising the quarterly payout from $1.64 to $1.73 per share, effective with the February 17, 2026 payment.

Oct 31, 2025, 11:49 AM

Press Release

AbbVie reports positive Phase 3 results for RINVOQ in vitiligo

ABBV

Product Launch

In two replicate Phase 3 studies, upadacitinib (RINVOQ 15 mg QD) achieved both co-primary endpoints—≥50% reduction in total vitiligo (T-VASI 50) and ≥75% reduction on the face (F-VASI 75) at week 48 vs placebo in adult and adolescent NSV patients.
Study 1 outcomes: T-VASI 50 was 19.4% vs 5.9% and F-VASI 75 was 25.2% vs 5.9%; Study 2: T-VASI 50 was 21.5% vs 5.9% and F-VASI 75 was 23.4% vs 6.9% for upadacitinib vs placebo.
Safety profile aligned with approved indications; most frequent TEAEs were upper respiratory tract infection, acne and nasopharyngitis, with no new safety signals, MACE or VTE reported.
These results address a high unmet need—no approved systemic therapies exist for vitiligo—and support AbbVie’s expansion in immunology.

Oct 29, 2025, 12:11 PM

Press Release

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