AnaptysBio(ANAB)
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AnaptysBio(ANAB) - 2025 Q4 - Annual Results
2026-01-09 22:17
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].
AnaptysBio seeks partial dismissal in GSK oncology unit dispute over drug royalty
Reuters· 2026-01-09 00:09
Core Viewpoint - AnaptysBio has filed a partial motion to dismiss a claim from GSK's oncology unit regarding a breach of contract related to royalties from the cancer drug Jemperli [1] Group 1 - AnaptysBio is currently involved in a legal dispute with GSK's oncology unit [1] - The dispute centers around allegations that AnaptysBio breached their contract [1] - The claim involves royalties tied to the sales of the cancer drug Jemperli [1]
Anaptys Files Motion to Dismiss Tesaro's Claim of Anticipatory Breach of Contract in Ongoing Litigation Against Tesaro, a GSK subsidiary
Globenewswire· 2026-01-08 23:00
Core Viewpoint - AnaptysBio is engaged in a legal dispute with Tesaro and GSK regarding a Collaboration and Exclusive License Agreement, with a trial scheduled for July 14-17, 2026, to resolve all claims [1]. Group 1: Legal Proceedings - Anaptys filed a partial motion to dismiss Tesaro's anticipatory breach of contract claim in Delaware Chancery Court [1]. - Tesaro initiated a lawsuit against Anaptys on November 20, 2025, claiming Anaptys had repudiated the Collaboration Agreement [2]. - Anaptys responded with its own complaint, asserting that Tesaro materially breached the Collaboration Agreement and that GSK tortiously interfered with it [3]. Group 2: Motion to Dismiss - Anaptys filed a Motion to Dismiss Tesaro's claim on December 30, 2025, arguing that it has not repudiated the Collaboration Agreement and is merely asserting its contract rights [4]. - The motion also invokes Delaware's anti-SLAPP law, which aims to prevent lawsuits that deter good-faith legal rights assertions [4]. - Tesaro and GSK argue that Anaptys' Motion to Dismiss should stay all discovery, which Anaptys opposes as they prepare for the upcoming trial [5]. Group 3: Collaboration Agreement Details - The Collaboration Agreement, established in March 2014, allows Anaptys to receive royalties from Jemperli sales, structured as follows: 8% for net sales below $1 billion, 12% for sales between $1 billion and $1.5 billion, 20% for sales between $1.5 billion and $2.5 billion, and 25% for sales above $2.5 billion [6][7]. - The royalty term extends until at least the expiration of composition of matter coverage, which is set to expire in 2035 in the U.S. and 2036 in the EU [7]. Group 4: Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [8]. - The company's pipeline includes several candidates, such as rosnilimab for rheumatoid arthritis and ANB033 for celiac disease [8]. - Anaptys plans to separate its biopharma operations from its royalty assets by the end of 2026 to better align with investor interests [9].
Anaptys Files Motion to Dismiss Tesaro’s Claim of Anticipatory Breach of Contract in Ongoing Litigation Against Tesaro, a GSK subsidiary
Globenewswire· 2026-01-08 23:00
Core Viewpoint - AnaptysBio is engaged in a legal dispute with Tesaro and GSK regarding a Collaboration and Exclusive License Agreement, with a trial scheduled for July 14-17, 2026 [1][5]. Group 1: Legal Proceedings - Anaptys filed a partial motion to dismiss Tesaro's anticipatory breach of contract claim in Delaware Chancery Court [1]. - Tesaro initiated a lawsuit against Anaptys on November 20, 2025, claiming Anaptys had repudiated the Collaboration Agreement [2]. - Anaptys responded with its own complaint, asserting that Tesaro materially breached the Collaboration Agreement and that GSK tortiously interfered with it [3]. Group 2: Collaboration Agreement Details - The Collaboration Agreement, established in March 2014, allows Anaptys to receive royalties from sales of Jemperli, with rates of 8% for net sales below $1 billion, 12% for sales between $1 billion and $1.5 billion, 20% for sales between $1.5 billion and $2.5 billion, and 25% for sales above $2.5 billion [6][7]. - The royalty term extends at least until the expiration of composition of matter coverage in 2035 in the U.S. and 2036 in the EU [7]. Group 3: Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [8]. - The company's pipeline includes several candidates, such as rosnilimab for rheumatoid arthritis and ANB033 for celiac disease [8]. - Anaptys plans to separate its biopharma operations from its royalty assets by the end of 2026 to better align with investor interests [9].
Anaptys to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-06 21:15
Company Overview - AnaptysBio, Inc. is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases [3] - The company's pipeline includes rosnilimab, a pathogenic T cell depleter, which has completed a Phase 2b trial for rheumatoid arthritis; ANB033, a CD122 antagonist, currently in a Phase 1b trial for celiac disease; and ANB101, a BDCA2 modulator, in a Phase 1a trial [3] - Anaptys has discovered and out-licensed multiple therapeutic antibodies, including a PD-1 antagonist (Jemperli) to GSK and an IL-36R antagonist (imsidolimab) to Vanda Pharmaceuticals [3] Upcoming Events - Daniel Faga, president and CEO of Anaptys, will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, at 4:30 PM PT / 7:30 PM ET [1] - A live webcast of the presentation will be available on the investor section of the Anaptys website, with a replay accessible for at least 30 days following the event [2] Strategic Developments - Anaptys recently announced plans to separate its biopharma operations from its substantial royalty assets by year-end 2026, allowing investors to align their investment philosophies and portfolio allocation with the strategic opportunities and financial objectives of each company [4]
This Biotech Stock Has More Than Tripled in 2025, but Red Flags Are Waving
Yahoo Finance· 2025-12-19 17:05
Core Viewpoint - AnaptysBio (ANAB) is a biotechnology company focused on therapeutic antibodies for inflammation and immuno-oncology, currently valued at $1.32 billion [1]. Group 1: Stock Performance - AnaptysBio has surged 227% over the past year, reaching a 5-year high of $49.52 on December 19 [6][4]. - The stock gained 32.5% since the Trend Seeker issued a "Buy" signal on November 18 [2]. - The stock has a Weighted Alpha of +194.83 and a Relative Strength Index (RSI) of 75.79, indicating strong technical momentum [7]. Group 2: Market Sentiment - AnaptysBio has a 100% "Buy" opinion from Barchart, reflecting strong analyst and investor sentiment [6][7]. - Despite the positive sentiment, Wall Street anticipates a decline in earnings and revenue next year [6]. - More than 30% of the float is sold short, suggesting caution among investors [6]. Group 3: Financial Projections - Revenue is expected to grow by 124.23% this year but is projected to decrease by 37.71% next year [7]. - Earnings are estimated to increase by 71.91% this year but are expected to decline by 181.57% next year [7].
AnaptysBio (NasdaqGS:ANAB) FY Conference Transcript
2025-12-03 13:57
Summary of AnaptysBio FY Conference Call (December 03, 2025) Company Overview - **Company**: AnaptysBio (NasdaqGS:ANAB) - **Industry**: Biopharmaceuticals Key Points Business Segments and Developments - **Biopharma Operations**: - **ANB033**: A CD122 antagonist, initiated a trial for celiac disease in 2025, with data expected in Q4 2026. A second trial for eosinophilic esophagitis (EOE) is planned for 2026 [4][19]. - **Rosnilimab**: Advanced program for rheumatoid arthritis (RA) with positive phase 2b data from a study involving 424 patients. Plans to move into phase 3 development in 2026 with external funding [4][12]. - **Royalty Management**: - **Jemperli**: Expected to generate $1.4 billion in sales at GSK, with significant royalty rights. The company plans to separate the royalty management business from biopharma assets in 2026 [5][31]. Clinical Trials and Efficacy - **Rosnilimab**: - Phase 2 trial in ulcerative colitis (UC) showed good safety but insufficient efficacy to continue. The focus will be on RA with a phase 3 design that includes placebo-controlled trials [6][8]. - 69% of patients achieved low disease activity (CDAI) by week 14, with a placebo-adjusted delta over 20% [11]. - Safety profile was unremarkable, with no malignancies or serious infections reported [15]. - **ANB033**: - Targeting celiac disease with a focus on mucosal healing, measuring villus height to crypt depth ratio. The phase 1B trial will assess both gluten challenge and patients with severe mucosal injury [20][22]. - The market for celiac disease treatment is estimated to be multi-billion dollars, with over 250,000 patients in the U.S. not well controlled on a gluten-free diet [26]. Financial and Strategic Considerations - The company anticipates ending 2025 with $300 million in cash, including $75 million milestone from GSK upon Jemperli exceeding $1 billion in sales [36]. - Plans to separate the biopharma and royalty management businesses in 2026, ensuring each can operate independently and maintain value [29][35]. - The royalty management business is projected to become cash flow positive by Q2 2027 [31][37]. Legal and Regulatory Issues - Ongoing litigation with GSK regarding Jemperli, with AnaptysBio contending that GSK is in breach of obligations related to the asset's development [33][34]. - The separation plans are independent of the litigation, ensuring that the biopharma operations can execute their strategy regardless of the trial outcome [35]. Market Outlook - The biopharma segment is expected to capture significant value post-separation, with potential for growth in both ANB033 and Rosnilimab [40]. - The company believes there is substantial upside in the biopharma business that is currently undervalued by the market [40]. Additional Insights - The company is exploring strategic partnerships for RA development while protecting its royalty stream [9][16]. - There is a focus on broadening the ANB033 program with potential for multiple indications, including EOE [39]. This summary encapsulates the critical developments and strategic outlook for AnaptysBio as discussed in the conference call, highlighting both opportunities and challenges within the biopharmaceutical landscape.
AnaptysBio (NasdaqGS:ANAB) FY Conference Transcript
2025-12-02 19:32
Summary of AnaptysBio Conference Call Company Overview - **Company**: AnaptysBio - **Industry**: Biopharmaceuticals Key Points Business Separation - AnaptysBio is planning to split its operations into two distinct entities: a royalty management business and a biopharma business by the end of 2026 [1][2] - The rationale for the split is to allow investors to focus on different asset portfolios, as the royalty business (including Jemperli, LIMS, and Dolomap) is substantial enough to operate independently [2][3] - The separation aims to protect and return value to shareholders, with expectations of significant upside for both businesses [3] Operational Timeline - The separation process includes regulatory approvals, financial audits, and logistical arrangements, with a potential update on rosnilimab expected in the first half of the year [4][5] - AnaptysBio anticipates ending the year with $300 million in cash, which will support the biopharma business post-separation [12] Rosnilimab and Celiac Disease Programs - Rosnilimab is being advanced for rheumatoid arthritis (RA), with positive phase 2b data indicating sustained low disease activity and remission rates [37] - The company is preparing for an end-of-phase 2 meeting with the FDA to discuss the next steps for Rosnilimab [38] - AnaptysBio is also conducting a phase 1b trial for AMB-033, a CD122 antagonist targeting celiac disease, with two cohorts designed to assess the drug's efficacy [20][21] Clinical Trial Insights - The phase 1b trial for AMB-033 includes a gluten challenge for one cohort and a focus on inflammation in the second cohort, aiming to demonstrate healing of the mucosal injury [22][24] - The target population for AMB-033 includes over two million patients with celiac disease, with a focus on statistically significant healing compared to placebo [27][31] Market Potential - The biopharma business is expected to have at least two years of capital to operate post-separation, ensuring a solid financial foundation [12] - The company is exploring strategic and financial collaborations to support the phase 3 program for Rosnilimab [39] - AnaptysBio is positioned to be the first approved drug for celiac disease, which currently has no approved treatments [31] Future Developments - Multiple catalysts are expected in the coming year, including updates on Rosnilimab, AMB-033, and ongoing growth in Jemperli's monotherapy indications [41] - The company is committed to maintaining a streamlined infrastructure for the royalty business post-separation [7][9] Additional Important Information - The litigation with GSK and Tesaro is deemed independent of the biopharma business's optimization efforts, with no expected impact on timelines [10][11] - The company is focused on minimizing operational complexity while maximizing shareholder value through the separation [7][8]
Anaptys Announces Participation in December Investor Conferences
Globenewswire· 2025-11-25 21:15
Group 1 - AnaptysBio, Inc. is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [2] - The company's pipeline includes rosnilimab, ANB033, and ANB101, with various stages of clinical trials [2] - Anaptys plans to separate its biopharma operations from its royalty assets by year-end 2026 to better align with investor interests [3] Group 2 - Upcoming investor conferences include the Piper Sandler 37th Annual Healthcare Conference and the Evercore 8th Annual Healthcare Conference [1] - Live webcasts of the events will be available on the Anaptys investor website, with replays accessible for at least 30 days [1] - The company is engaging in fireside chats and one-on-one investor meetings on specific dates in December 2025 [4]
美股减肥药概念股涨跌各异
Ge Long Hui A P P· 2025-11-24 15:00
Group 1 - ANAB stock increased by 4.7% in early trading [1] - Hims & Hers saw a rise of 4.3% [1] - Biogen (BIIB) shares rose by 2.7% [1] Group 2 - Eli Lilly experienced a slight decline [1] - Abbott's stock fell by over 0.6% [1] - Novo Nordisk ADR dropped by over 9% [1]