ABBVIE INC. - ABBV STOCK NEWS

AbbVie (NYSE: ABBV) announced that the European Commission has approved SKYRIZI® (risankizumab) for treating adult patients with moderately to severely active ulcerative colitis (UC). This marks SKYRIZI's fourth approved indication in the European Union. The approval is based on data from two Phase 3 trials: INSPIRE (induction) and COMMAND (maintenance).

Key findings include:

• In INSPIRE, 20% of patients achieved clinical remission at week 12 with SKYRIZI vs 6% with placebo
• In COMMAND, 40% and 38% of patients achieved clinical remission at week 52 with SKYRIZI 180mg and 360mg, respectively, vs 25% in the control group
• Significant improvements in mucosal healing were observed, especially in patients without previous biologic or JAK inhibitor failure

The safety profile was consistent with previous trials, with no new safety risks identified.

AbbVie (NYSE:ABBV) reported Q2 2024 financial results with net revenues of $14.462 billion, up 4.3% on a reported basis. Diluted EPS was $0.77 on a GAAP basis, down 32.5%, while adjusted diluted EPS was $2.65, down 8.9%. Key highlights include:

- Immunology portfolio revenues: $6.971 billion, up 2.3%
- Oncology portfolio revenues: $1.634 billion, up 10.5%
- Neuroscience portfolio revenues: $2.162 billion, up 14.7%
- Aesthetics portfolio revenues: $1.390 billion, up 0.5%

AbbVie raised its 2024 adjusted diluted EPS guidance to $10.71 - $10.91. The company also announced leadership changes, with Robert A. Michael assuming the role of CEO effective July 1, 2024.

AbbVie has submitted regulatory applications to the FDA and EMA for upadacitinib (RINVOQ®) to treat giant cell arteritis (GCA). This autoimmune disease affects medium and large arteries, causing symptoms such as headaches, jaw pain, and vision changes, potentially leading to permanent vision loss. The applications are backed by Phase 3 SELECT-GCA study results, showing that upadacitinib (15 mg once daily) with a 26-week steroid taper regimen achieved sustained remission from week 12 through 52. The safety profile was consistent with existing conditions treated by upadacitinib.

AbbVie (NYSE:ABBV) has appointed Roopal Thakkar, M.D., as Executive Vice President, Research & Development, and Chief Scientific Officer. Thakkar, who is currently the Senior Vice President and Chief Medical Officer, Global Therapeutics, will now lead AbbVie's global R&D division, encompassing over 14,000 members across all discovery and development stages, including therapeutics and aesthetics. CEO Rob Michael highlighted Thakkar's robust track record in forging strategic partnerships and advancing clinical programs. Thomas J. Hudson, M.D., who served as Chief Scientific Officer since 2019, will retire. Hudson has been instrumental in shaping AbbVie's early-stage science and precision medicine capabilities since joining in 2016.

AbbVie (NYSE: ABBV) is set to release its second-quarter 2024 financial results on Thursday, July 25, 2024, before the market opens. The company will hold a live webcast of the earnings conference call at 8 a.m. Central time, accessible through its Investor Relations website. Additionally, an archived edition of the session will be made available later the same day.

AbbVie announced that Robert A. Michael has assumed the role of Chief Executive Officer (CEO) and joined the Board of Directors effective July 1, 2024. Michael succeeds Richard A. Gonzalez, who will now serve as Executive Chairman. Michael, with over 31 years of experience, previously held roles including President and Chief Operating Officer, Vice Chairman, and Chief Financial Officer. He will lead AbbVie with a focus on innovation and growth.

Gonzalez expressed confidence in Michael's leadership, highlighting a strong leadership team and a solid financial foundation for AbbVie's future. Michael emphasized his commitment to AbbVie's mission and thanked Gonzalez for his leadership.

AbbVie has received a positive opinion from the European Medicines Agency's CHMP for epcoritamab (TEPKINLY®), a bispecific antibody for treating adults with relapsed/refractory follicular lymphoma (R/R FL) after two or more prior therapies. If approved, it will be the first bispecific antibody conditionally approved for both R/R FL and R/R diffuse large B-cell lymphoma (DLBCL) in the EU. This recommendation is based on results from the Phase 1/2 EPCORE® NHL-1 study, which showed significant overall and complete response rates. The European Commission's decision is expected later this year. Follicular lymphoma accounts for 20-30% of all non-Hodgkin's lymphoma cases, with about 13,000 cases in Western Europe in 2023. The collaboration between AbbVie and Genmab aims to secure additional international regulatory approvals.

AbbVie (NYSE: ABBV) announced the acquisition of Celsius Therapeutics, a biotechnology company focused on inflammatory diseases. This $250 million cash deal includes adjustments and aims to advance Celsius' leading investigational asset, CEL383, an anti-TREM1 antibody for treating inflammatory bowel disease (IBD). CEL383 has completed Phase 1 clinical trials and targets TREM1, a gene linked to inflammation in IBD. AbbVie believes CEL383 could help more IBD patients achieve remission, reflecting the company's commitment to expanding its immunology portfolio.

Allergan Aesthetics, an AbbVie company (NYSE: ABBV), has launched Allē Payment Plans, allowing patients to pay for aesthetic treatments over time without hard credit checks. This initiative aims to make treatments like BOTOX® Cosmetic and JUVÉDERM® more accessible. Market research indicates that while over 50 million Americans are interested in facial injectables, cost remains a major barrier, with only a fraction seeking treatment annually. The pilot program showed that 54% of transactions were from new patients, and 34% included multiple brands. The national rollout of the payment plans begins today, with full availability expected in the coming months. The plans are offered at no cost to aesthetic providers for Allergan Aesthetics products, enhancing their ability to attract new patients.