AnaptysBio(ANAB) - 2025 Q2 - Quarterly Results

Executive Summary & Q2 2025 Business Update AnaptysBio reported positive Phase 2b data for rosnilimab in RA, completed enrollment for its UC trial, announced celiac disease as the initial indication for ANB033, and anticipates a $75 million milestone from GSK Q2 2025 Business Highlights AnaptysBio reported positive Phase 2b data for rosnilimab in RA, completed enrollment for its UC trial, announced celiac disease as the initial indication for ANB033 with a Phase 1b cohort planned, and anticipates a $75 million milestone from GSK for Jemperli - AnaptysBio, Inc. (Nasdaq: ANAB) is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reporting Q2 2025 financial results and business update[2] - Rosnilimab's Phase 2b data in rheumatoid arthritis (RA) delivered a compelling safety and tolerability profile and JAK-like efficacy[3] - Enrollment completed in the Phase 2 ulcerative colitis (UC) trial, with top-line data through Week 12 expected in Q4 2025[3][5] - Initial indication for CD122 antagonist, ANB033, is celiac disease (CeD), with a Phase 1b cohort planned to initiate by Q4 2025[3][5] - Anticipate triggering a $75 million commercial sales milestone from GSK in 2025 once Jemperli achieves $1 billion in worldwide net sales[5] Portfolio Updates Provides updates on clinical programs including rosnilimab for RA and UC, ANB033 for celiac disease, and ANB101, all progressing through clinical trials Rosnilimab (Pathogenic T Cell Depleter) Rosnilimab's Phase 2b RA trial showed compelling safety and JAK-like efficacy with durable responses, supporting potential for extended maintenance dosing. Enrollment for the Phase 2 UC trial is complete, with top-line data expected in Q4 2025 Rheumatoid Arthritis (RA) Program Positive Phase 2b data for rosnilimab in RA demonstrated compelling efficacy and a favorable safety profile, supporting extended maintenance dosing - Positive data through Week 38 from 424-patient Phase 2b RA trial, demonstrating best-in-disease profile with JAK-like efficacy and monthly (Q4W) dosing[5][6] - Favorable safety and tolerability profile, particularly compared to standard of care biologics or JAK inhibitors[6] - CDAI LDA responders at Week 28 showed durable responses for at least 12-14 weeks off drug through Week 38, supporting potential for extended maintenance dosing (e.g., Q8W or Q12W)[6] Ulcerative Colitis (UC) Program Enrollment is complete for the Phase 2 UC trial, assessing rosnilimab's efficacy and safety with top-line data expected in Q4 2025 - Enrollment complete for global Phase 2 trial in moderate-to-severe UC (N=136, ~50% advanced therapy experienced)[5][9] - Assessing Q2W and Q4W dose levels of subcutaneously administered rosnilimab vs. placebo[9] - Top-line data through Week 12, including primary and key secondary endpoints, on track for Q4 2025[5][9] - Blinded surveillance data suggests a favorable safety and tolerability profile consistent with prior rosnilimab trials[9] ANB033 (CD122 Antagonist) ANB033 is in Phase 1, with celiac disease announced as its initial indication. A Phase 1b cohort is planned for Q4 2025, leveraging its MoA to inhibit IL-2 and IL-15 signaling for CeD - Phase 1 trial ongoing in healthy volunteers[5][7] - Initial indication for ANB033 is celiac disease (CeD), affecting over 2.1 million people in the U.S. with no approved therapies[3][5][9] - ANB033's MoA, inhibiting both IL-2 and IL-15 signaling, is believed to be well-suited to target multiple pathogenic drivers of CeD[3] - Plan to initiate a Phase 1b cohort for ANB033 in celiac disease by Q4 2025[3][5][9] ANB101 (BDCA2 Modulator) ANB101 is currently in an ongoing Phase 1 trial in healthy volunteers - Phase 1 trial ongoing in healthy volunteers[5][7] Collaboration Updates Details updates on collaborations with GSK for Jemperli, anticipating a $75 million milestone, and Vanda for imsidolimab, with an upcoming BLA submission and potential milestones GSK Immuno-Oncology Financial Collaboration (Jemperli) GSK reported strong Q2 2025 sales for Jemperli, leading Anaptys to anticipate a $75 million milestone payment in 2025 upon Jemperli reaching $1 billion in worldwide net sales. GSK is also advancing Jemperli in multiple pivotal trials for various cancer indications - GSK announced strong commercial performance for Jemperli with $262 million in Q2 2025 sales and $482 million in 1H 2025 sales, showing >19% USD and >12% GBP quarter-over-quarter growth[9] - Anaptys anticipates triggering a one-time $75 million commercial sales milestone from GSK in 2025 once Jemperli achieves $1 billion in worldwide net sales in a calendar year[5][9] - GSK is investing in additional indications for Jemperli monotherapy and combinations, including pivotal Phase 2 and 3 trials for various colorectal and head and neck cancers[9] Vanda Imsidolimab Financial Collaboration Vanda anticipates FDA BLA submission for imsidolimab in GPP in 2H 2025. Anaptys is eligible for up to $35 million in regulatory and sales milestones, plus a 10% royalty on net sales - Vanda anticipates FDA BLA submission for generalized pustular psoriasis (GPP) in 2H 2025[11] - Anaptys is eligible to receive up to $35 million for future regulatory approval (including a $5 million milestone upon U.S. FDA approval) and sales milestones, plus a 10% royalty on net sales[11] Financial Performance Summarizes Q2 and 1H 2025 financial results, including collaboration revenue, operating expenses, net loss, cash position, and stock repurchase activities Second Quarter 2025 Financial Results Summary AnaptysBio reported significant increases in collaboration revenue, managed operating expenses with a slight R&D decrease and G&A increase, and a reduced net loss for Q2 and 1H 2025 compared to the prior year Collaboration Revenue Collaboration revenue significantly increased in Q2 and 1H 2025, driven by higher Jemperli royalties and revenue from the Vanda license agreement | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | YoY Change (Q2) | 1H 2025 (in thousands) | 1H 2024 (in thousands) | YoY Change (1H) | | :------------------- | :--------------------- | :--------------------- | :---------------- | :--------------------- | :--------------------- | :---------------- | | Collaboration Revenue | $22,263 | $10,971 | +102.9% | $50,034 | $18,150 | +175.7% | - Increase primarily due to Jemperli royalties increasing by $11.0 million (Q2) and $22.1 million (1H), and $9.7 million in revenue recognized for the Vanda license agreement[11] Operating Expenses Operating expenses were managed, with a decrease in R&D primarily due to lower development costs, and an increase in G&A due to transaction costs | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | YoY Change (Q2) | 1H 2025 (in thousands) | 1H 2024 (in thousands) | YoY Change (1H) | | :-------------------- | :--------------------- | :--------------------- | :---------------- | :--------------------- | :--------------------- | :---------------- | | Research and development | $37,824 | $41,997 | -10.0% | $79,004 | $79,039 | -0.04% | | General and administrative | $10,609 | $9,295 | +14.1% | $24,739 | $21,633 | +14.4% | - R&D decrease in Q2 2025 primarily due to lower development costs for ANB032 and imsidolimab, offset by higher costs for rosnilimab RA/UC Phase 2 trials and ANB033/ANB101 Phase 1 trials[11] - G&A increase primarily due to transaction costs associated with the Vanda Pharmaceuticals license agreement[11] Net Loss and EPS Net loss and loss per share significantly reduced in Q2 and 1H 2025, reflecting improved financial performance | Metric | Q2 2025 | Q2 2024 | YoY Change (Q2) | 1H 2025 | 1H 2024 | YoY Change (1H) | | :-------------------- | :-------- | :-------- | :---------------- | :-------- | :-------- | :---------------- | | Net Loss (in thousands) | $(38,630)$ | $(46,660)$ | +17.2% (reduced loss) | $(77,959)$ | $(90,596)$ | +14.0% (reduced loss) | | Net Loss Per Share | $(1.34)$ | $(1.71)$ | +21.6% (improved) | $(2.62)$ | $(3.35)$ | +21.8% (improved) | Cash Position and Runway Cash and investments decreased to $293.7 million by June 30, 2025, primarily due to operating activities and share repurchases, but the company maintains a cash runway through year-end 2027 | Metric | June 30, 2025 (in millions) | December 31, 2024 (in millions) | Change (in millions) | | :-------------------- | :-------------------------- | :----------------------------- | :------------------- | | Cash and Investments | $293.7 | $420.8 | $(127.1)$ | - Decrease primarily due to operating activities and $55.5 million in shares repurchased, offset by $15.0 million received from Vanda Pharmaceuticals[11] - Reiterating cash runway through year-end 2027[11] Stock Repurchase Program AnaptysBio has repurchased 9.3% of its outstanding shares for $55.5 million under its $75.0 million program as of June 30, 2025 - Repurchased 2,853,836 shares (9.3% shares outstanding) with $55.5 million as of June 30, 2025, from its $75.0 million Stock Repurchase Program[11] About Anaptys Anaptys is a clinical-stage biotechnology company focused on developing innovative immunology therapeutics for autoimmune and inflammatory diseases - Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases[12] - Lead program rosnilimab is in Phase 2b for RA and Phase 2 for UC. Pipeline also includes ANB033 (celiac disease) and ANB101 (both in Phase 1 trials)[12] - Out-licensed therapeutic antibodies include Jemperli (PD-1 antagonist) to GSK and imsidolimab (IL-36R antagonist) to Vanda Pharmaceuticals[12] Consolidated Financial Statements Presents the company's consolidated balance sheets and statements of operations, detailing assets, liabilities, equity, revenue, and expenses for the reported periods Consolidated Balance Sheets The balance sheet shows a significant decrease in total assets and a shift to a stockholders' deficit as of June 30, 2025, compared to December 31, 2024, primarily due to reductions in cash, investments, and receivables | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :-------------------------- | :----------------------------- | :-------------------- | | Total Assets | $335,250 | $483,834 | $(148,584)$ | | Total Current Assets | $291,906 | $431,876 | $(139,970)$ | | Cash and cash equivalents | $44,298 | $123,080 | $(78,782)$ | | Short-term investments | $221,412 | $262,293 | $(40,881)$ | | Total Liabilities | $379,983 | $412,966 | $(32,983)$ | | Total Stockholders' (Deficit) Equity | $(44,733)$ | $70,868 | $(115,601)$ | Consolidated Statements of Operations and Comprehensive Loss The statement details the company's financial performance for Q2 and 1H 2025, highlighting increased collaboration revenue, managed operating expenses, and a reduced net loss, alongside a notable increase in non-cash interest expense | Metric (in thousands) | Q2 2025 | Q2 2024 | 1H 2025 | 1H 2024 | | :------------------------------------------ | :-------- | :-------- | :-------- | :-------- | | Collaboration revenue | $22,263 | $10,971 | $50,034 | $18,150 | | Research and development | $37,824 | $41,997 | $79,004 | $79,039 | | General and administrative | $10,609 | $9,295 | $24,739 | $21,633 | | Loss from operations | $(26,170)$ | $(40,321)$ | $(53,709)$ | $(82,522)$ | | Non-cash interest expense for sale of future royalties | $(19,606)$ | $(10,953)$ | $(37,667)$ | $(17,270)$ | | Net loss | $(38,630)$ | $(46,660)$ | $(77,959)$ | $(90,596)$ | | Basic and diluted net loss per common share | $(1.34)$ | $(1.71)$ | $(2.62)$ | $(3.35)$ | Legal & Contact Information Contains important disclosures regarding forward-looking statements and provides contact information for investor relations Forward-Looking Statements This section advises that the press release contains forward-looking statements regarding future events, which are subject to inherent risks and uncertainties that could cause actual results to differ from projections - The press release contains forward-looking statements regarding clinical trial data release timing (rosnilimab UC, ANB033 CeD), potential milestone payments from Vanda and GSK, and projected cash runway[13] - These statements involve risks and uncertainties, including the ability to advance product candidates, obtain regulatory approval, fund development, and protect intellectual property[13] Contact Information Provides contact details for investor relations inquiries - Contact: Nick Montemarano, Executive Director, Investor Relations, 858.732.0178, investors@anaptysbio.com[14]