AL-002

iStock, Michael Vi AbbVie’s Humira missed Wall Street’s expectations in the third quarter but Skyrizi and Rinvoq’s continuing outperformance demonstrated the overall strength of its immunology franchise. Despite the continued biosimilar erosion on Humira sales, AbbVie exceeded analyst expectations in its third-quarter earnings report on Wednesday, buoyed by the strong growth of its other immunology assets. AbbVie’s revenue jumped 3.8% in Q3 bringing in $14.46 billion, which was 1% ahead of the consensus forecast of $14.3 billion. The company reported adjusted diluted earnings-per-share (EPS) of $3, which also beat Wall Street’s projection of $2.94. AbbVie’s Q3 beat comes despite the steep decline in Humira sales, which cratered 37% year-over-year and dropped to $2.23 billion, compared to $3.55 billion during the same period last year. In an investor call on Wednesday, CCO Jeffrey Stuart attributed the company’s shrinking Humira business to its loss of exclusivity and “biosimilar competition,” particularly in the U.S. Still, company executives were optimistic about its immunology unit on the call, with AbbVie CEO Robert Michael saying that he is “extremely pleased” with the performance of the ex-Humira platform. “AbbVie’s diversified portfolio delivered sales that were $260 million above our expectations, Michael said, noting that “our ex-Humira platform drove this overachievement.” Skyrizi, indicated for plaque psoriasis and psoriatic arthritis and which AbbVie has positioned as a successor to Humira, surged 50.8% in Q3 with $3.2 billion in net revenue—surpassing both the analyst consensus. Rinvoq, an oral JAK inhibitor approved for ulcerative colitis, Crohn’s disease and other immune-mediated diseases, grew 45.3% in the quarter with $1.17 billion in sales. William Blair analyst Myles Minter in an investor note wrote that AbbVie’s Q3 beat “was mainly driven by continued strength of Skyrizi and Rinvoq,” adding that AbbVIe is likely looking at “strong and durable growth pro the coming years thanks to its strong growth platform.” Regarding the biosimilar challenge to Humira, Minter noted that “AbbVie has managed the erosion well,” which in turn will give investors “enough visibility to get comfortable with the strong growth outlook for AbbVie over the near and long term.” Guggenheim Partners analyst Vamil Divan pointed to AbbVie’s cancer products Imbruvica and Venclexta, which “performed better than the Street expected.” Venclexta saw nearly 15% year-over-year growth and brought in $677 million in Q3, while Imbruvica—despite earning $828 million—was hit with an 8.8% decline in sales. Looking at AbbVie’s pipeline, Leerink Partners analyst David Risinger flagged an upcoming readout for emraclidine, a potentially best-in-class next-generation anti-psychotic drug being developed for schizophrenia. Data from two Phase II studies—EMPOWER-1 and EMPOWER-2—are expected by the end of the year . Risinger also called out two “Alzheimer’s wildcards,” ABBV-552 and AL002, both of which are in Phase II.

Alzheimer’s disease medicines commercialized in the past two years validated amyloid beta as a drug target, but these antibody therapies still have a hard time penetrating the membrane that covers blood vessels supplying the brain. AbbVie aims to best those drugs through its acquisition of Aliada Therapeutics, a clinical-stage biotech whose technology enables large molecules such as antibodies to cross this protective barrier. AbbVie announced Monday it is paying $1.4 billion in cash to acquire Aliada, a biotech that just entered the clinic earlier this year. Boston-based Aliada gets drugs across the blood-brain barrier (BBB) by leveraging receptors that transport substances into the brain. Lead Aliada program ALIA-1758 is an antibody engineered with binders for transferrin, which transports iron into the brain, and CD98, which transports certain amino acids. The drug comes from a platform technology called Modular Delivery, or MODEL. presented by Health IT Accelerating Claim Processing: Strategies to Shorten the Life of a Claim These strategies and practices can significantly shorten the life cycle of claims, leading to quicker resolutions and improved financial outcomes. By Greenway Health “We’re essentially taking advantage of normal physiological brain transport processes, and if you like, we’re hijacking those by attaching therapeutic cargos to our delivery modules to allow brain delivery,” Aliada Chief Scientific Officer John Dunlop explained in an interview during the BIO Conference in June. Aliada licensed MODEL from Johnson & Johnson subsidiary Janssen, which had used the technology to develop ALIA-1758. Aliada co-founder Danielle Feldman, who is senior director of corporate development for the company, was with RA Capital Management when her search for new technologies led her to Johnson & Johnson Innovation—JJDC, Dunlop said. Those discussions led both parties to conclude that the best way for the MODEL technology to realize its value was as a standalone company undistracted by the goings-on of a big pharmaceutical company. Aliada was formed at the end of 2021, with seed financing from RA Capital and J&J. OrbiMed and Sanofi Ventures later joined an extension of the financing. Dunlop declined to disclose how much was invested, but securities filings show the company raised $1 million in 2021, followed by nearly $32 million in late 2022. Dunlop did say Aliada had enough capital to support the lead program through Phase 1b proof-of-concept testing in Alzheimer’s. Clinical trial records show a Phase 1 trial began in May with a targeted enrollment of 52 healthy adults. According to Dunlop, ALIA-1758’s affinity for its target receptors means that more drug can get into the brain per dose, which should translate to needing a lower dosage level to achieve the desired therapeutic effect. A lower dose could reduce the adverse effects associated with amyloid-reducing drugs. Eisai’s Leqembi, which won full FDA approval last year, and Eli Lilly’s Kisunla, approved in July, carry warnings on their labels for risks of bleeding and swelling complications. presented by Sponsored Post The Promise of Value-Based Care and MedTech Innovation Monica Vajani, Executive Director for mHUB’s MedTech Accelerator, discusses how mHUB is helping innovators transition healthcare towards value-based care. By Monica Vajani - mHUB AbbVie has been spreading its bets in Alzheimer’s drug R&D. The company earlier this year reportedly discontinued development of ABBV-916 as a monotherapy, but is still leaving the door open for applications of the antibody as part of combination treatments. An Alzheimer’s partnership with Alector began in 2017. Two years ago, AbbVie terminated one program that had reached Phase 1 testing, opting to focus the alliance’s efforts on a second Alector program, AL002. This drug is an antibody designed to modulate the TREM2 receptor as a way of enhancing the activity of microglia, immune cells found in the central nervous system (CNS). Alector is responsible for Phase 1 and 2 testing, after which AbbVie has the option to license the drug. AbbVie’s pipeline currently shows AL002 is still in Phase 2 testing. In 2022, AbbVie paid $130 million up front to acquire Syndesi Therapeutics, developer of small molecule drugs that modulate synaptic transmission. Syndesi’s most advanced program, renamed ABBV-552, targets synaptic vesicle protein 2A (SV2A). AbbVie’s pipeline currently shows this program is in Phase 2 testing. AbbVie said it expect to close the Aliada acquisition by the end of this year. In the company’s announcement of the deal, Roopal Thakkar, executive vice president, research and development and chief scientific officer, AbbVie, said neuroscience is one of the company’s key growth areas. “This acquisition immediately positions us to advance ALIA-1758, a potentially best-in-class disease-modifying therapy for Alzheimer’s disease,” he said. “In addition, Aliada’s novel BBB-crossing technology strengthens our R&D capabilities to accelerate the development of next-generation therapies for neurological disorders and other diseases where enhanced delivery of therapeutics into the CNS is beneficial.”