AnaptysBio(ANAB) - 2025 Q4 - Annual Results

Financial Performance - As of year-end 2025, the company has approximately $310 million in cash, including a one-time $75 million milestone from GSK due to Jemperli achieving $1 billion in worldwide net sales in November 2025[6]. - Jemperli generated $303 million in Q3 2025, reflecting a greater than 16% quarter-over-quarter growth rate, with an annualized run rate exceeding $1.2 billion[14]. - The company expects to receive over $390 million annually in Jemperli royalties at GSK's peak sales guidance of over $2.7 billion, anticipated to be achieved before 2031[14]. - Jemperli's revenue forecasts indicate a steep growth trajectory, with projected sales reaching over $2 billion by 2031[16]. Corporate Strategy - The company plans to separate into two independent publicly traded entities by Q2 2026 to maximize shareholder value[6]. - The anticipated paydown of financial obligations to Sagard is projected between Q2 2027 and Q1 2028, based on Jemperli's continued strong growth[14]. - The company anticipates minimal infrastructure and staff requirements post-separation, focusing on protecting and returning value from royalty assets[6]. - The company is focused on expanding its market presence and enhancing its product pipeline through ongoing clinical trials and research[116]. Clinical Trials and Drug Development - The company is initiating a Phase 1b clinical trial for ANB033 in Eosinophilic Esophagitis in Q1 2026, with top-line data from the Phase 1b trial in Celiac Disease expected in Q4 2026[8]. - Imsidolimab has received FDA BLA submission for generalized pustular psoriasis (GPP) in December 2025, with potential approval as early as mid-2026[14]. - The ongoing Phase 1b trial in Celiac Disease (CeD) anticipates top-line data in Q4 2026, with a focus on mucosal healing and prevention of mucosal damage[56]. - The ongoing Phase 1b trial for ANB033 is set to initiate in Q1 2026, focusing on its efficacy in treating eosinophilic esophagitis[66]. - The Phase 1a trial of ANB033 in healthy volunteers showed no serious adverse events (SAEs) or severe adverse events (AEs), indicating favorable safety and tolerability[36]. - The Phase 2b trial for ulcerative colitis showed a favorable safety and tolerability profile, but the lack of efficacy at Week 12 led to the decision to discontinue further development in this indication[126]. Drug Mechanism and Efficacy - ANB033 demonstrated a statistically significant survival benefit in a GvHD mouse model compared to isotype control (P<0.0001) and Belatacept (P=0.003) with a 60-day study showing body weight loss was also significantly reduced (P<0.001)[32]. - ANB033 exhibited a favorable pharmacokinetic (PK) profile with a half-life of 2 to 3 weeks and full receptor occupancy maintained for over 30 days[36]. - The drug's mechanism of action targets excessive IL-15 and IL-2 production, which are key drivers of CeD inflammation[42]. - ANB033 treatment preserved villus height and crypt depth in a CeD mouse model, indicating improved histological outcomes[46]. - ANB033 significantly reduced CD122+ NK cells by over 50% with a return towards baseline within 3 months, demonstrating its potential in CeD treatment[40]. - Rosnilimab shows a best-in-disease profile in rheumatoid arthritis (RA) with a market potential of approximately $20 billion in the U.S., the first new mechanism approved since 2012[88]. - Rosnilimab demonstrated JAK-like efficacy with comparable response rates across more stringent endpoints regardless of prior therapy type, including JAKs[100]. Market Potential and Demographics - The U.S. market for patients non-responsive to a gluten-free diet is projected to be $4-5 billion, with an initial target population of approximately 1.1 million diagnosed patients[62]. - There are about 340,000 diagnosed U.S. patients with eosinophilic esophagitis (EoE), with 170,000 being biologic-eligible and around 30,000 currently treated with Dupixent[74]. - The prevalence of EoE is increasing at a compound annual growth rate (CAGR) of over 8%, with anticipated U.S. sales exceeding $5 billion by 2030[74]. - The target population for rheumatoid arthritis (RA) in the US generated approximately $10 billion in 2021, with over $1 billion in sales from Rituxan and biosimilars in the third-line treatment despite infection risks[124]. - The prevalence of RA in the US is around 1.8 million, with approximately 1 million treated with biologics and JAK inhibitors, and about 500,000 in the second-line treatment category[124]. Safety and Tolerability - Rosnilimab's safety and tolerability were favorable compared to standard of care, with strict continuation criteria preventing patients with improvement at 3 months from continuing in the trial[88]. - Serious adverse events (SAEs) were low across treatment groups, with only one ischemic stroke reported in the 100 mg group[122]. - The company observed a 90% depletion of pathogenic T cells in the Phase 2 trial for RA, indicating expected pharmacological activity[126]. - Rosnilimab demonstrated a well-tolerated safety profile with a dropout rate of less than 2% due to adverse events (AEs) over six months, with only one dropout attributed to a moderate headache[122]. Competitive Landscape - The incidence of serious adverse events (SAEs) in commercial products with black box warnings has not hindered their sales, with RA sales reaching $4.5 billion for one product[120]. - Rosnilimab's competitive landscape shows it as a best-in-class T cell depleter, outperforming competitors in pathogenic T cell depletion[116]. - The market for RA treatments remains fragmented, with no clear treatment of choice after anti-TNF failures, presenting an opportunity for new biologics[124].