Year Established: 2013
Revenues: $45,804 (+38%)
Net Income: $4,616 (-41%)
R&D: $6,557 (+2%)
TOP SELLING DRUGS
|Imbruvica||chronic lymphocytic leukemia||$5,314||14%|
|Botox||Therapeutic neuromuscular blocking agent||$1,387||>100%|
|Venclexta||Leukaemia, chronic lymphocytic (CLL)||$1,337||69%|
|Vraylar||schizophrenia, Bipolar I||$951||n/m|
Moving up the ranks to #4, in May 2020 AbbVie completed its $63 billion acquisition of Allergan, significantly adding scale and cash flow for further investment in R&D and business development. The two companies bring together $45.8 billion in global sales, with Allergan’s aesthetics portfolio significantly diversifying AbbVie’s revenue base. Having invested $5.8 billion in R&D last year to support its pipeline across key therapeutic areas, AbbVie picked up several key approvals and anticipates the approval of more than a dozen new products or indications over the next two years.
Second only to Humira, top seller IMBRUVICA (ibrutinib) was recently approved by the FDA in combination with rituximab for the treatment of previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), marking the 11th FDA approved indication for IMBRUVICA since it was first approved in 2013, and the sixth in CLL, the most common form of leukemia in adults.
A testament to its success in hematologic oncology, results from long-term, integrated analysis of two Phase III studies evaluating IMBRUVICA-based therapies for the first-line treatment of CLL/SLL up to 6.5 years of follow-up, showed similar progression-free survival (PFS) and overall response rates. Additionally, pooled analysis across four trials with up to eight years of follow-up showed that first-line treatment with IMBRUVICA-based therapies resulted in sustained, long-term efficacy with high four-year PFS rates in high-risk CLL patients.
While the 38% growth in 2020 includes Allergan product revenues from the date of the acquisition May 8, 2020, and acquisition and integration costs are reflected in earnings, AbbVie’s comparable operational results showed significant growth across its immunology, oncology and neuroscience franchises.
The company’s flagship immunology portfolio sales were up 13% for the year to $22.2 billion, with Humira sales up 3.5% to $19.8 billion, despite biosimilar competition, and newer products Skyrizi and Rinvoq revenues reached $1.6 billion and $731 million, respectively. Hematologic oncology portfolio sales were up an impressive 22% to $6.7 billion, with Imbruvica sales of $5.3 billion, up 14%, and Venclexta sales of $1.3 billion. Also pulling its weight, the neuroscience portfolio had sales of $3.5 billion with Botox Therapeutic sales reaching $1.4 billion and Vraylar revenues of $951 million.
Of note, full-year revenues from the acquired aesthetics portfolio contributed $2.6 billion, with Botox Cosmetic accounting for $1.1 billion. During the course of the year, Allergan Aesthetics, an AbbVie company, expanded its portfolio of toxins and dermal fillers, plastics and regenerative medicine, body contouring and skincare products, which hold market-leading positions in the U.S. and other key markets.
Key assets advancing within AbbVie’s pipeline include post-Humira hopefuls Rinvoq and Skyrizi, and migraine candidate atogepant, all of which are filed and pending approval for new or expanded indications. The following also highlights recent progress among other late stage programs.
Rinvoq (upadacitinib), a selective and reversible JAK inhibitor, is being studied in several immune-mediated inflammatory diseases and shows a lot promise. Recent results from a Phase III study show that Rinvoq achieved superiority to Sanofi’s Dupixent in treating Eczema for the primary endpoint, the proportion of patients with at least a 75 percent improvement in Eczema in adults with moderate to severe atopic dermatitis. Rinvoq also showed superiority versus Dupixent for all ranked secondary endpoints.
Also, results from a Phase III induction study showed Rinvoq met the primary endpoint of clinical remission in adults with moderate to severe ulcerative colitis, along with all ranked secondary endpoints. Results from the Phase III maintenance study and regulatory submissions are expected in 2H21.
First approved in April 2019 for moderate to severe plaque psoriasis, Skyrizi is among AbbVie’s fastest growing immunology products. Recent Phase III studies evaluating interleukin-23 inhibitor Skyrizi (risankizumab), in moderate to severe Crohn's disease (CD), met the co-primary endpoints of clinical remission and endoscopic response, demonstrating superiority versus placebo. Additionally, key secondary endpoints showed significant clinical and endoscopic outcomes with symptom improvement. Additionally, Phase III studies evaluating Skyrizi in Active Psoriatic Arthritis (PsA) demonstrated strong levels of response on both joint and skin endpoints, with significantly more patients treated with Skyrizi achieving the primary endpoint.
Another key asset, Atogepant, is among AbbVie’s migraine therapeutics projected to be worth of $766 million in 2026 following FDA approval. Atogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist, a class of potent vasodilators, particularly in the cerebral circulation. A Phase III trial evaluating atogepant met its primary endpoint of statistically significant reduction in mean monthly migraine days, compared to placebo, for all doses evaluated across a 12-week treatment period. The trial also demonstrated statistically significant improvements in all six secondary endpoints. Regulatory submissions are pending in the U.S. and other countries.
In other late stage news, Phase III results evaluating Allergan’s AGN-190584 (pilocarpine) ophthalmic solution for the treatment of symptoms associated with presbyopia, met the primary efficacy endpoint. Presbyopia is a common, progressive condition that reduces the aging eye's ability to focus on near objects and affects nearly four out of 10 people in the U.S.
Several significant investments in early stage asset alliances aim to overcome challenges associated with antibodies and cell therapies. AbbVie will pay Genmab $750 million upfront, and a potential for up to $3.15 billion in additional milestones, to jointly develop and commercialize Genmab's next-gen bispecific antibody programs, epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4 in hematological cancers.
The alliance will combine antibodies from both companies along with Genmab's DuoBody technology and AbbVie's payload and ADC technology to select and develop up to four additional differentiated next-gen antibody-based product candidates, potentially across both solid tumors and hematological malignancies. In an effort to provide a more targeted, less toxic treatment approach, Genmab's DuoBody-CD3 technology engages and directs cytotoxic T cells selectively to tumors and AbbVie's ADC technology allows the delivery of therapeutic toxin directly to cancer cells while sparing healthy cells.
In another global research alliance, AbbVie will pay $180 million upfront and as much as $1.74 billion in milestones to advance I-Mab’s lemzoparlimab (TJC4), an anti-CD47 monoclonal antibody for the treatment of multiple cancers. Lemzoparlimab is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in potentially differentiating lemzoparlimab from other antibodies of the same class currently in development.
An equity investment in Caribou Biosciences will leverage Caribou's next-gen Cas12a CRISPR hybrid RNA-DNA (chRDNA) genome editing and cell therapy technologies to develop two new chimeric antigen receptor (CAR)-T cell therapies directed to targets specified by AbbVie in exchange for $40 million upfront and up to $300 million in future milestones. While allogeneic, "off-the-shelf" CAR-T cell therapies have shown early promise in some cancer patients, this alliance aims to overcome the rejection of allogeneic CAR-T cells by the host immune system, a key challenge to their broader development.
Additionally, a global collaboration with Jacobio Pharmaceuticals aims to develop and commercialize SHP2 inhibitors targeting a key node in cancer and immune cells. Many tumors have genetic mutations, driving abnormal cancer cell growth which relies on SHP2 activity.
SHP2 also plays a key role in controlling cytokine production and immune cell response. Inhibition of SHP2 is believed to potentially reduce cancer cell growth and modulate immune responses to generate anti-tumor activities. AbbVie has an exclusive license to Jacobio's early clinical stage SHP2 assets, JAB-3068 and JAB-3312, oral small molecules designed to specifically inhibit SHP2activity.
Finally, AbbVie and Frontier Medicines Corp., a precision medicine company drugging challenging protein targets, partnered to develop and commercialize a pipeline of small molecule therapeutics against high-interest, difficult-to-drug protein targets using Frontier's chemoproteomics platform to identify small molecules for programs directed to novel E3 ligases and certain oncology and immunology targets.