On April 26. 2024 AbbVie (NYSE:ABBV) reported financial results for the first quarter ended March 31, 2024 (Press release, AbbVie, APR 26, 2024, View Source [SID1234642384]).
"We continue to demonstrate outstanding operational execution and delivered another quarter of strong results," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "I couldn’t be more proud of the organization we have built over the past 11 years. We’ve established an exemplary company culture, developed a productive R&D engine, delivered top-tier financial performance and made a remarkable impact on patients and the communities we serve."
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"I want to thank Rick for his exceptional leadership since AbbVie’s inception and I am deeply honored to serve as the company’s next CEO," said Robert A. Michael, president and chief operating officer, AbbVie. "First quarter results were well ahead of our expectations, driven by excellent performance from our ex-Humira growth platform. Based on our strong results and significant momentum, we are raising our full-year outlook."
First-Quarter Results
•Worldwide net revenues were $12.310 billion, an increase of 0.7 percent on a reported basis, or 1.6 percent on an operational basis.
•Global net revenues from the immunology portfolio were $5.371 billion, a decrease of 3.9 percent on a reported basis, or 3.1 percent on an operational basis, due to Humira biosimilar competition.
◦Global Humira net revenues of $2.270 billion decreased 35.9 percent on a reported basis, or 35.2 percent on an operational basis. U.S. Humira net revenues were $1.771 billion, a decrease of 39.9 percent. Internationally, Humira net revenues were $499 million, a decrease of 15.8 percent on a reported basis, or 11.6 percent on an operational basis.
◦Global Skyrizi net revenues were $2.008 billion, an increase of 47.6 percent on a reported basis, or 48.0 percent on an operational basis.
◦Global Rinvoq net revenues were $1.093 billion, an increase of 59.3 percent on a reported basis, or 61.9 percent on an operational basis.
•Global net revenues from the oncology portfolio were $1.543 billion, an increase of 9.0 percent on a reported basis, or 9.8 percent on an operational basis.
◦Global Imbruvica net revenues were $838 million, a decrease of 4.5 percent, with U.S. net revenues of $610 million and international profit sharing of $228 million.
◦Global Venclexta net revenues were $614 million, an increase of 14.2 percent on a reported basis, or 16.3 percent on an operational basis.
◦Global Elahere net revenues were $64 million, reflecting a partial quarter of sales based on the February 12, 2024 close date of the ImmunoGen acquisition.
•Global net revenues from the neuroscience portfolio were $1.965 billion, an increase of 15.9 percent on a reported basis, or 16.0 percent on an operational basis.
◦Global Botox Therapeutic net revenues were $748 million, an increase of 4.1 percent on a reported basis, or 4.5 percent on an operational basis.
◦Global Vraylar net revenues were $694 million, an increase of 23.6 percent.
◦Global Ubrelvy net revenues were $203 million, an increase of 33.8 percent.
◦Global Qulipta net revenues were $131 million, an increase of 97.7 percent.
•Global net revenues from the aesthetics portfolio were $1.249 billion, a decrease of 4.0 percent on a reported basis, or 2.5 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $633 million, a decrease of 3.9 percent on a reported basis, or 2.6 percent on an operational basis.
◦Global Juvederm net revenues were $297 million, a decrease of 16.4 percent on a reported basis, or 13.7 percent on an operational basis.
•On a GAAP basis, the gross margin ratio in the first quarter was 66.7 percent. The adjusted gross margin ratio was 82.9 percent.
•On a GAAP basis, selling, general and administrative (SG&A) expense was 26.9 percent of net revenues. The adjusted SG&A expense was 24.6 percent of net revenues.
•On a GAAP basis, research and development (R&D) expense was 15.8 percent of net revenues. The adjusted R&D expense was 14.7 percent of net revenues.
•Acquired IPR&D and milestones expense was 1.3 percent of net revenues.
•On a GAAP basis, the operating margin in the first quarter was 22.7 percent. The adjusted operating margin was 42.2 percent.
•On a GAAP basis, net interest expense was $453 million. The adjusted net interest expense was $429 million.
•On a GAAP basis, the tax rate in the quarter was 21.8 percent. The adjusted tax rate was 14.8 percent.
•Diluted EPS in the first quarter was $0.77 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.31. These results include an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense.
Recent Events
•AbbVie announced that its board of directors unanimously selected Robert A. Michael, AbbVie’s current president and chief operating officer, to succeed Richard A. Gonzalez as the company’s chief executive officer (CEO). Mr. Gonzalez, who has served as CEO since AbbVie’s formation in 2013, will retire from the role of CEO and become executive chairman of the board of directors, effective July 1, 2024. Additionally, the board has appointed Mr. Michael as a member of the board of directors effective July 1, 2024.
•AbbVie announced that it completed its acquisition of ImmunoGen. This transaction added ImmunoGen’s flagship antibody-drug conjugate (ADC), Elahere (mirvetuximab soravtansine-gynx), for folate receptor-alpha (FRα)-positive platinum-resistant ovarian cancer (PROC), to AbbVie’s portfolio. Late-stage development programs for Elahere provide opportunity to expand into additional patient populations. The transaction also included a pipeline of ADCs that further build on AbbVie’s existing oncology pipeline of novel targeted therapies and next-generation immuno-oncology assets, which have the potential to create new treatment possibilities across multiple solid tumors and hematologic malignancies.
•AbbVie announced that the U.S. Food and Drug Administration (FDA) granted full approval for Elahere for the treatment of FRα-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies. The full approval of Elahere was based on the confirmatory MIRASOL Phase 3 trial in which data showed that Elahere treatment resulted in an overall survival (OS) benefit and reduced the risk of cancer progression by 35%.
•AbbVie announced that the FDA granted Priority Review of the supplemental Biologics License Application (sBLA) for Epkinly (epcoritamab), for the treatment of adult relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of therapy. If approved, Epkinly will be the only subcutaneous bispecific antibody to treat adults with R/R FL after two lines of prior therapy, marking its second indication following FDA and European Medicines Agency (EMA) approval of R/R third-line diffuse large B-cell lymphoma (DLBCL) treatment. The FDA had previously granted this investigational indication Breakthrough Therapy Designation (BTD). The sBLA is supported by data from the Phase 1/2 EPCORE NHL-1 clinical trial. Epkinly is being co-developed by AbbVie and Genmab.
•AbbVie announced positive top-line results from the Phase 3 SELECT-GCA study, showing Rinvoq (upadacitinib, 15 mg, once daily) in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remission from week 12 through week 52 in adults with giant cell arteritis (GCA). In this study, 46 percent of patients receiving Rinvoq in combination with a 26-week steroid taper regimen achieved sustained remission compared to 29 percent of patients receiving placebo in combination with a 52-week steroid taper regimen. Rinvoq’s safety profile in GCA was generally consistent with that in approved indications, and no new safety signals were identified.
•AbbVie announced positive topline results from the Phase 3b/4 LEVEL UP study, that evaluated the efficacy and safety of Rinvoq (15 mg, once daily starting dose and dose-adjusted based on clinical response) versus Dupixent (dupilumab) in adults and adolescents with moderate to severe atopic dermatitis (AD) who had inadequate response to systemic therapy or when use of those therapies was inadvisable. Rinvoq demonstrated superiority versus Dupixent in the primary endpoint of simultaneous achievement of near complete skin clearance (Eczema Area and Severity Index 90) and no to little itch (Worst Pruritus Numerical Rating Scale of 0 or 1) at Week 16. Rinvoq also showed superiority versus Dupixent for all ranked secondary endpoints, including the rapid onset of achieving near complete skin clearance and no to little itch. The safety profile of Rinvoq was consistent with the profile in previous AD studies with no new safety signals identified during the 16-week period.
•At the Congress of European Crohn’s and Colitis Organisation (ECCO), AbbVie presented 17 abstracts, including nine oral presentations and eight posters, from a range of studies across its inflammatory bowel disease (IBD) portfolio. Oral presentations included new post-hoc analysis of clinical and endoscopic outcomes from the Phase 3 SEQUENCE trial comparing Skyrizi (risankizumab) versus Stelara (ustekinumab) in patients with moderate to severe Crohn’s disease (CD), results from the Phase 3 COMMAND study of Skyrizi as a maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC), and long-term safety results from the Phase 3 U-ENDURE trial of Rinvoq in adult patients with moderately to severely active CD. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
•At the 2024 American Academy of Dermatology (AAD) Annual Meeting, AbbVie presented 29 abstracts including three late-breaking presentations. The presented data across AbbVie and Allergan Aesthetics’ extensive portfolios reinforce the companies’ ongoing commitment to developing transformative medical dermatology and aesthetic treatments to advance and redefine the standard of care for patients.
•Allergan Aesthetics announced the FDA approval of Juvederm Voluma XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21. Juvederm Voluma XC is the first and only hyaluronic acid (HA) dermal filler to receive FDA approval for the improvement of moderate to severe temple hollowing with results lasting up to 13 months with optimal treatment.
•At the American Academy of Neurology (AAN) Annual Meeting, AbbVie announced an interim analysis of an ongoing 156-week extension study that supports the long-term safety, tolerability and efficacy of Qulipta (atogepant) to prevent chronic and episodic migraine. The overall long-term safety results were consistent with the known safety profile of Qulipta in chronic and episodic migraine, and no new safety signals were identified. These results also support improvements in key efficacy outcomes, including reduction in monthly acute medication use days.
•AbbVie and Landos Biopharma announced a definitive agreement under which AbbVie will acquire Landos, a clinical stage biopharmaceutical company focused on the development of novel, oral therapeutics for patients with autoimmune diseases. Landos’ lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist in Phase 2 for the treatment of UC.
•AbbVie and OSE Immunotherapeutics, a clinical-stage immunotherapy company, announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to resolve chronic and severe inflammation, currently in the pre-clinical development stage.
•AbbVie and Tentarix Biotherapeutics announced a multi-year collaboration focused on the discovery and development of conditionally-active, multi-specific biologic candidates in oncology and immunology. The collaboration will leverage AbbVie’s therapeutic area expertise and Tentarix’s Tentacles platform.
Full-Year 2024 Outlook
AbbVie is raising its adjusted diluted EPS guidance for the full year 2024 from $10.97 – $11.17 to $11.13 – $11.33, which includes an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense incurred during the first quarter 2024. The company’s 2024 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2024, as both cannot be reliably forecasted.