On July 29, 2022 AbbVie (NYSE:ABBV) reported that financial results for the second quarter ended June 30, 2022 (Press release, AbbVie, JUL 29, 2022, View Source [SID1234617122]).
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"We delivered another strong quarter with substantial progress for our new products and indications. Importantly, Skyrizi and Rinvoq continued their impressive ramps and are on pace to deliver approximately $7.5 billion in combined annual sales, underscoring their significant potential," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "The momentum of our business, combined with advances across our pipeline continue to support AbbVie’s promising long-term outlook."
Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.
1 Beginning in the first quarter 2022, AbbVie includes the impact of upfront and milestone payments related to collaborations, licensing agreements and other asset acquisitions in its reported non-GAAP financial measures.
Second-Quarter Results
Worldwide net revenues were $14.583 billion, an increase of 4.5 percent on a GAAP basis, or 6.1 percent on an operational basis.
Global net revenues from the immunology portfolio were $7.207 billion, an increase of 17.8 percent on a reported basis, or 19.2 percent on an operational basis.
Global Humira net revenues of $5.363 billion increased 5.8 percent on a reported basis, or 6.8 percent on an operational basis. U.S. Humira net revenues were $4.664 billion, an increase of 9.6 percent. Internationally, Humira net revenues were $699 million, a decrease of 13.8 percent on a reported basis, or 7.3 percent on an operational basis, due to biosimilar competition.
Global Skyrizi net revenues were $1.252 billion, an increase of 85.9 percent on a reported basis, or 88.3 percent on an operational basis.
Global Rinvoq net revenues were $592 million, an increase of 56.3 percent on a reported basis, or 60.7 percent on an operational basis.
Combined global Skyrizi and Rinvoq net revenues were $1.844 billion.
Global net revenues from the hematologic oncology portfolio were $1.650 billion, a decrease of 9.1 percent on a reported basis, or 7.9 percent on an operational basis.
Global Imbruvica net revenues were $1.145 billion, a decrease of 17.1 percent, with U.S. net revenues of $862 million and international profit sharing of $283 million.
Global Venclexta net revenues were $505 million, an increase of 16.2 percent on a reported basis, or 21.2 percent on an operational basis.
Global net revenues from the neuroscience portfolio were $1.658 billion, an increase of 13.7 percent on a reported basis, or 15.2 percent on an operational basis.
Global Botox Therapeutic net revenues were $678 million, an increase of 12.6 percent on a reported basis, or 14.5 percent on an operational basis.
Vraylar net revenues were $492 million, an increase of 13.9 percent.
Global Ubrelvy net revenues were $185 million.
Global net revenues from the aesthetics portfolio were $1.371 billion, a decrease of 4.4 percent on a reported basis, or 2.1 percent on an operational basis.
Global Botox Cosmetic net revenues were $695 million, an increase of 18.9 percent on a reported basis, or 21.2 percent on an operational basis.
Global Juvederm net revenues were $344 million, a decrease of 19.5 percent on a reported basis, or 15.7 percent on an operational basis, unfavorably impacted by COVID-19 restrictions in China and suspension of aesthetics operations in Russia.
On a GAAP basis, the gross margin ratio in the second quarter was 71.4 percent. The adjusted gross margin ratio was 84.7 percent.
On a GAAP basis, selling, general and administrative expense was 37.1 percent of net revenues. The adjusted SG&A expense was 20.8 percent of net revenues.
Research and development expense was 11.0 percent of net revenues on both a GAAP and Non-GAAP adjusted basis.
Acquired IPR&D and milestones expense was 1.8 percent of net revenues.
On a GAAP basis, the operating margin in the second quarter was 22.6 percent. The adjusted operating margin was 51.0 percent, which includes an unfavorable 180 basis point impact from acquired IPR&D and milestones expense.
Net interest expense was $532 million.
On a GAAP basis, the tax rate in the quarter was 21.6 percent. The adjusted tax rate was 13.4 percent.
Diluted EPS in the second quarter was $0.51 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.37. These results include an unfavorable impact of $0.14 per share related to acquired IPR&D and milestones expense.
Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.
Recent Events
AbbVie announced that the U.S. Food and Drug Administration (FDA) approved Skyrizi (risankizumab) as the first and only specific interleukin-23 inhibitor for the treatment of adults with moderately to severely active Crohn’s disease (CD). The approval is supported by three pivotal Phase 3 studies in which Skyrizi demonstrated significant improvements in clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. This marks Skyrizi’s third FDA approved indication. Skyrizi is a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
AbbVie announced that the FDA approved Rinvoq (upadacitinib, 15 mg, once daily) for the treatment of adults with active ankylosing spondylitis (AS) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The approval is supported by data from two pivotal clinical trials in which Rinvoq delivered rapid and meaningful disease control. This approval marks the fifth FDA approved indication for Rinvoq in chronic immune-mediated diseases.
AbbVie announced the European Commission (EC) approved Rinvoq (45 mg (induction dose) and 15 mg and 30 mg (maintenance doses)) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). The approval is based on results from two Phase 3 induction studies and one maintenance study in which significantly more patients treated with Rinvoq achieved the primary and all secondary endpoints compared to placebo.
AbbVie announced the EC approved Rinvoq (15 mg, once daily) for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-Axial SpA). The approval is based on results from the Phase 3 SELECT-AXIS 2 study in which Rinvoq met the primary endpoint and 12 of 14 ranked secondary endpoints.
AbbVie announced that it submitted applications for a new indication to the FDA and European Medicines Agency (EMA) for Rinvoq (45 mg (induction dose) and 15 mg and 30 mg (maintenance doses)) for the treatment of adult patients with moderately to severely active CD. The submissions are supported by three Phase 3 clinical trials demonstrating Rinvoq achieved the co-primary endpoints of clinical remission and endoscopic response as induction and maintenance treatment.
AbbVie announced positive top-line results from the Phase 3 maintenance study, U-ENDURE, evaluating Rinvoq in adult patients with moderate to severe CD. The results showed Rinvoq (15 mg or 30 mg, once daily) achieved the co-primary endpoints of endoscopic response and clinical remission, as well as the secondary endpoint of endoscopic remission, at one year (week 52) compared to placebo. The safety results in this study were generally consistent with the known profile of Rinvoq, with no new safety risks observed. Full results from the study will be presented at upcoming medical conferences and published in a peer-reviewed journal.
At the Digestive Disease Week (DDW) Annual Meeting, AbbVie presented 27 abstracts that reinforced its leadership in advancing research and the standards of care across multiple gastroenterological conditions. Presentations included further analyses of Phase 3 clinical study programs for Rinvoq in moderately to severely active UC and investigational use of Skyrizi in moderately to severely active CD.
At the European Alliance of Associations for Rheumatology (EULAR) 2022 Congress, AbbVie showcased its leadership in rheumatology research with new data across multiple inflammatory joint diseases. Key data presented included SELECT-AXIS 2 trial results evaluating the efficacy and safety of Rinvoq in patients with nr-Axial SpA, and in patients with AS; two-year data from the SELECT-PsA 1 and SELECT-PsA 2 studies of Rinvoq in patients with psoriatic arthritis (PsA); and results of the one-year data evaluating the efficacy and safety of Skyrizi in patients with active PsA in the KEEPsAKE 1 and KEEPsAKE 2 clinical trials.
At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and European Hematology Association (EHA) (Free EHA Whitepaper) Congress, AbbVie presented 46 abstracts for six investigational and approved medicines across eight cancer types. Highlights included new data that showed Venclexta (venetoclax) plus obinutuzumab demonstrated sustained progression-free survival (PFS) in chronic lymphocytic leukemia (CLL) patients after four years off treatment; results from a Phase 2 trial of epcoritamab which showed clinically meaningful efficacy in challenging-to-treat, highly refractory, large B-cell lymphoma (LBCL) patients; and new data from the Phase 2 REFINE study of investigational navitoclax in combination with ruxolitinib that is supportive of early intervention in myelofibrosis (MF) to achieve improved clinical outcomes in spleen volume reduction (SVR), symptom score and bone marrow fibrosis (BMF). Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Epcoritamab is being co-developed by AbbVie and Genmab.
AbbVie announced that it submitted a New Drug Application (NDA) to the FDA for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson’s disease (PD). The submission is based on results from a Phase 3, head-to-head, randomized and controlled clinical trial demonstrating statistically significant improvement in "On" time without troublesome dyskinesia compared to oral immediate-release carbidopa/levodopa (CD/LD). If approved, ABBV-951 will offer patients the first continuous subcutaneous delivery of CD/LD prodrugs.
AbbVie announced that it submitted a supplemental NDA to the FDA for Qulipta (atogepant) to support label expansion for the preventive treatment of migraine in adult patients with chronic migraine. AbbVie also submitted a marketing authorization application for Qulipta with the EMA for the preventive treatment of migraine in adult patients who have at least four migraine days per month.
At the American Headache Society (AHS) Annual Scientific Meeting, AbbVie presented 29 abstracts that covered a wide range of studies across AbbVie’s migraine portfolio. Presentations highlighted positive results from the Phase 3 PROGRESS trial investigating Qulipta for the preventive treatment of migraine in patients with chronic migraine, clinical trial results evaluating Ubrelvy (ubrogepant) for acute treatment of migraine and data evaluating Botox (onabotulinumtoxinA) for the preventive treatment of migraine in patient with chronic migraine.
At the American Psychiatric Association (APA) Annual Meeting, AbbVie presented positive data from a Phase 3 trial of Vraylar (cariprazine, 1.5 mg/day) for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to ongoing antidepressant therapy. The study met its primary endpoint of statistically significant improvement using the Montgomery-Åsberg Depression Rating Scale (MADRS) total score in patients compared with placebo. Vraylar’s safety profile was consistent with that of previous studies across indications in the treatment of adults with depressive episodes associated with bipolar I disorder, the acute treatment of manic or mixed episodes associated with bipolar I disorder and schizophrenia. Vraylar is being co-developed by AbbVie and Gedeon Richter Plc.
At the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, AbbVie presented new data from its leading portfolio of eye care treatments. Highlights included new data on Vuity (pilocarpine HCl ophthalmic solution) 1.25%, the first and only FDA-approved eye drop for the treatment of presbyopia (age-related blurry near vision) in adults, and Durysta (bimatoprost intracameral implant), a first-of-its-kind biodegradable implant to lower eye pressure for glaucoma patients.
AbbVie and Cugene Inc., a clinical-stage biotechnology company focused on developing next-generation precision immunology and oncology medicines to treat autoimmune disease and cancer, announced an exclusive worldwide license option agreement for CUG252, a potential best-in-class Treg-selective IL-2 mutein, as well as other novel IL-2 muteins, for the potential treatment of autoimmune and inflammatory diseases.
AbbVie and iSTAR Medical announced a strategic transaction to further develop and commercialize iSTAR Medical’s MINIject device, a next-generation minimally invasive glaucoma surgical (MIGS) device for patients with glaucoma. This alliance accelerates iSTAR Medical’s goal to bring MINIject to more patients globally and provides an opportunity for AbbVie to further expand its diverse eye care portfolio.
Full-Year 2022 Outlook
AbbVie is confirming its adjusted diluted EPS guidance range for the full-year 2022 of $13.78 – $13.98 which includes an unfavorable impact of $0.23 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2022. The company’s 2022 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2022, as both cannot be reliably forecasted.