On April 30, 2021 AbbVie (NYSE:ABBV) reported financial results for the first quarter ended March 31, 2021 (Press release, AbbVie, APR 30, 2021, View Source [SID1234578893]).
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"We are off to an excellent start to 2021, with strong performance across our core therapeutic areas and first quarter revenue and earnings results ahead of our expectations," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "Our new products are delivering impressive performance and we are on the cusp of potential commercial approvals for more than a dozen new products or indications over the next two years – including five expected approvals in 2021."
First-Quarter Results
Worldwide GAAP net revenues were $13.010 billion, an increase of 51.0 percent on a reported basis. Worldwide adjusted net revenues of $12.935 billion increased 5.2 percent on a comparable operational basis.
Global net revenues from the immunology portfolio were $5.744 billion, an increase of 12.9 percent on a reported basis, or 11.8 percent on an operational basis.
Global Humira net revenues of $4.867 billion increased 3.5 percent on a reported basis, or 2.6 percent on an operational basis. U.S. Humira net revenues were $3.907 billion, an increase of 6.9 percent. Internationally, Humira net revenues were $960 million, a decrease of 8.3 percent on a reported basis, or 12.6 percent on an operational basis, due to biosimilar competition.
Global Skyrizi net revenues were $574 million.
Global Rinvoq net revenues were $303 million.
Global net revenues from the hematologic oncology portfolio were $1.673 billion, an increase of 8.0 percent on a reported basis, or 7.3 percent on an operational basis.
Global Imbruvica net revenues were $1.268 billion, an increase of 2.9 percent, with U.S. net revenues of $999 million and international profit sharing of $269 million.
Global Venclexta net revenues were $405 million, an increase of 27.9 percent on a reported basis, or 24.5 percent on an operational basis.
Global net revenues from the aesthetics portfolio were $1.141 billion, an increase of 34.9 percent on a comparable operational basis.
Global Botox Cosmetic net revenues were $477 million, an increase of 44.7 percent on a comparable operational basis.
Global net revenues from the neuroscience portfolio were $1.248 billion, an increase of over 100.0 percent on a reported basis, or 10.9 percent on a comparable operational basis.
Global Botox Therapeutic net revenues were $532 million, an increase of 7.0 percent on a comparable operational basis.
Global Vraylar net revenues were $346 million, an increase of 21.2 percent on a comparable operational basis.
Global Ubrelvy net revenues were $81 million.
On a GAAP basis, the gross margin ratio in the first quarter was 67.6 percent. The adjusted gross margin ratio was 83.9 percent.
On a GAAP basis, selling, general and administrative expense was 21.8 percent of net revenues. The adjusted SG&A expense was 21.2 percent of net revenues.
On a GAAP basis, research and development expense was 13.7 percent of net revenues. The adjusted R&D expense was 11.6 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
On a GAAP basis, the operating margin in the first quarter was 31.5 percent. The adjusted operating margin was 51.0 percent.
On a GAAP basis, net interest expense was $622 million.
On a GAAP basis, the tax rate in the quarter was 8.1 percent. The adjusted tax rate was 12.3 percent.
Diluted EPS in the first quarter was $1.99 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.95.
Note: "Comparable Operational" comparisons include full-quarter current year and prior year results for Allergan, which was acquired on May 8, 2020, as if the acquisition closed on January 1, 2019, and are presented at constant currency rates and reflect comparative local currency net revenues at the prior year’s foreign exchange rates. Refer to the Key Product Revenues schedules for further details. "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year’s foreign exchange rates.
Recent Events
AbbVie announced that it submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for Skyrizi (risankizumab, 150 mg) for the treatment of adults with active psoriatic arthritis (PsA). The applications are supported by two Phase 3 studies in which Skyrizi demonstrated improved skin and joint symptoms and physical function, with a greater proportion of patients achieving minimal disease activity versus placebo. The safety profile of Skyrizi in these studies was generally consistent with the safety profile of Skyrizi in plaque psoriasis, with no new safety risks observed. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
AbbVie announced positive results from the Phase 3 induction study, U-ACCOMPLISH, which showed Rinvoq (upadacitinib, 45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 8 in adult patients with moderate to severe ulcerative colitis (UC). Additionally, all ranked secondary endpoints, including clinical, endoscopic and histologic outcomes, were met. U-ACCOMPLISH is the second of two Phase 3 induction studies to evaluate the safety and efficacy of Rinvoq in adults with moderate to severe UC and the results were consistent with findings from the first Phase 3 induction study, U-ACHIEVE. Safety results were also consistent with the previous Phase 3 induction study and the known profile of Rinvoq, with no new safety risks observed. Full results from the study will be presented at a future medical meeting and submitted for publication in a peer-reviewed journal. Results from the Phase 3 maintenance study and regulatory submissions are expected in 2H 2021.
AbbVie announced that the FDA extended the review period for the supplemental New Drug Applications (sNDA) for Rinvoq in the treatment of adult patients with active PsA as well as in the treatment of adults and adolescents with moderate to severe atopic dermatitis (AD). AbbVie received information requests from the FDA for an updated assessment of the benefit-risk profile for Rinvoq in both indications. AbbVie responded to the requests and the FDA will require additional time for a full review of the submissions. The updated Prescription Drug User Fee Act (PDUFA) action dates have been extended three months to late 2Q 2021 for PsA and early 3Q 2021 for AD.
AbbVie announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion for Venclyxto (venetoclax) in combination with hypomethylating agents for the treatment of adult patients with newly-diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The positive CHMP opinion is based on data from the VIALE-A and M14-358 trials and represents the third positive CHMP opinion for an extension of indications for Venclyxto. If approved by the European Commission (EC), Venclyxto in combination with hypomethylating agents would be a new regimen for patients with AML. The EC is expected to deliver its final decision on Venclyxto combination therapy for use in AML in 2Q 2021. 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.
AbbVie announced the FDA accepted its New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine in adults who meet criteria for episodic migraine. The NDA is supported by data from a clinical program evaluating the efficacy, safety and tolerability of orally administered atogepant in nearly 2,500 patients who experience 4-14 migraine days per month, including data from the pivotal Phase 3 ADVANCE study in which all active treatment arms of atogepant met their primary endpoint and the 30 and 60 mg doses met all six secondary endpoints with statistical significance. If approved, atogepant will be the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine. AbbVie anticipates a regulatory decision in late 3Q 2021.
At the 2021 American Academy of Neurology (AAN) Annual Meeting, AbbVie presented data across its neuroscience portfolio. A total of 33 abstracts, including 4 oral presentations, were shared from a broad range of studies across the spectrum of migraine, advanced Parkinson’s disease (PD) and spasticity. Researchers presented migraine related data from the Phase 3 ADVANCE trial results on the safety and efficacy of atogepant in the preventive treatment of migraine, real-world data on the role of Botox (onabotulinumtoxinA) in combination with CGRP monoclonal antibodies (mAbs) for chronic migraine prevention, as well as data evaluating the efficacy and safety of Botox and Ubrelvy (ubrogepant). In addition, investigators presented the study design of the Phase 3 study assessing the efficacy and safety of the investigational treatment ABBV-951 (foslevodopa/foscarbidopa), a levodopa/carbidopa prodrug administered as a 24-hour continuous subcutaneous infusion, in people with advanced PD.
AbbVie announced that it submitted a NDA to the FDA for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. Presbyopia is a common, progressive condition that reduces the aging eye’s ability to focus on near objects and affects nearly half of the adult U.S. population. The application is primarily based on data from two pivotal Phase 3 studies involving 750 patients. In both studies AGN-190584 met the primary endpoint reaching statistical significance in improvement in near vision without a loss of distance vision. If approved, AGN-190584 is expected to be the first eye drop to treat presbyopia and the FDA is expected to act on the NDA by the end of 2021.
AbbVie announced the launch of Refresh Digital lubricant eye drops, a new lubricant eye drop formulated to specifically relieve dryness and irritation that may occur from prolonged screen time. Refresh Digital features proprietary HydroCell technology that supports all three layers of the tear film to keep eyes hydrated.
Allergan Aesthetics announced the launch of SkinMedica Neck Correct Cream, the first product from the professional-grade skincare line formulated to address the specific biology of the skin on the neck and décolleté area. SkinMedica Neck Correct Cream was designed to prevent the early signs as well as treat the visible appearance of moderate to severe neck aging. It is clinically proven to firm and tighten the look of crepey skin, prevent and reduce the look of sagging, smooth deep lines and wrinkles and enhance skin tone evenness.
AbbVie and Caribou Biosciences, Inc., a leading clinical-stage CRISPR genome editing biotechnology company, announced that they have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR)-T cell therapeutics. Under the multi-year agreement, AbbVie will utilize Caribou’s next-generation Cas12a CRISPR hybrid RNA-DNA genome editing and cell therapy technologies to research and develop two new CAR-T cell therapies directed to targets specified by AbbVie.
Full-Year 2021 Outlook
AbbVie is raising its GAAP diluted EPS guidance for the full-year 2021 from $6.69 to $6.89 to $7.27 to $7.47. AbbVie is raising its adjusted diluted EPS for the full-year 2021 from $12.32 to $12.52 to $12.37 to $12.57. The company’s 2021 adjusted diluted EPS guidance excludes $5.10 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.
Conference Call
AbbVie will host an investor conference call today at 8:00 a.m. Central time to discuss our first-quarter performance. The call will be webcast through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central time.
Non-GAAP Financial Results
Financial results for 2021 and 2020 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie’s management believes non-GAAP financial measures provide useful information to investors regarding AbbVie’s results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. The company’s 2021 financial guidance is also being provided on both a reported and a non-GAAP basis.