Core Viewpoint - Companies are involved in a dispute over a licensing agreement for Jemperli, a drug indicated for certain types of endometrial cancer [1] Group 1 - The drug Jemperli is utilized for the treatment of specific forms of endometrial cancer [1] - The companies are accusing each other of violating the terms of the licensing agreement related to Jemperli [1]

This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Anaptysbio and its partner GSK are suing each other, claiming breach of contract over the big drugmaker’s license to market the likely blockbuster cancer immunotherapy Jemperli. A California-based developer of immune-modulating antibody drugs, Anaptysbio claimed in a Delaware court that GSK violated the terms of its decade-old deal by testing some of its experi ...

Core Viewpoint - AnaptysBio has filed a Verified Complaint against Tesaro and GSK, alleging material breaches of their Collaboration Agreement and seeking legal remedies [1][2]. Group 1: Legal Dispute - The Complaint asserts that Tesaro breached the Collaboration Agreement by engaging in clinical trials with competing PD-1 antagonists, including Keytruda, and failed to use reasonable efforts to maximize commercial returns for Jemperli [2]. - Anaptys previously filed a complaint against GSK in 2020 for similar breaches related to GSK's clinical trial of Zejula in combination with Keytruda, which resulted in a settlement that included cash payments and increased royalties on Jemperli [3]. - Tesaro has initiated its own lawsuit against Anaptys, claiming that Anaptys has breached the Collaboration Agreement, which Anaptys contends is without merit [4]. Group 2: Collaboration Agreement Details - The Collaboration Agreement, established in March 2014, involves Tesaro developing Jemperli for various solid tumor indications [6]. - Anaptys is entitled to royalties from Jemperli sales, structured as 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 [7]. - A one-time $75 million commercial sales milestone is anticipated once Jemperli achieves $1 billion in worldwide net sales [7]. Group 3: Financial Implications - The royalty term under the Collaboration Agreement extends until the expiration of composition of matter coverage, which is set to expire in 2035 in the U.S. and 2036 in the EU [8]. - Anaptys estimates that Sagard will have accrued $250 million in royalties and sales milestones through the end of 2025, with full paydown of $600 million expected between Q2 2027 and Q2 2028 [9]. Group 4: Future Developments - The parties have agreed to an expedited schedule with the Delaware Chancery Court, with a trial anticipated in July 2026 [5]. - Milestone and royalty payment obligations to Anaptys will continue during the legal proceedings [5].

Summary of GSK Conference Call Company Overview - **Company**: GSK (GlaxoSmithKline) - **Focus**: Research and Development (R&D) strategy, particularly in oncology, respiratory diseases, HIV, and infectious diseases Key Points R&D Strategy - GSK's R&D strategy emphasizes the science of the immune system and the application of technologies, focusing on both organic and inorganic growth opportunities [4][5] - The company has transitioned into marketed assets, with a focus on "bolt-on deals" to enhance its portfolio [5] - A clear lens on capital allocation is maintained, comparing internal and external opportunities to optimize R&D investments [6] Oncology Focus - GSK is concentrating on oncology, with notable assets like momelotinib and the B7H3 and B7H4 ADCs [7][8] - The strategy involves pivoting towards assets with apparent efficacy in monotherapy during phase one trials, avoiding the complexities of combination therapies [8] - Significant data capabilities have been built through collaborations and acquisitions, enhancing decision-making for external acquisitions [9][10] Respiratory Disease Developments - GSK is well-positioned in lung disease, particularly with Nucala for COPD, targeting a market of 300 million individuals [12][13] - The company is advancing long-acting monoclonal therapies and has pivotal studies planned for 2027-2028 [13] - There is a focus on addressing fibrosis in liver, kidney, and lung tissues, with ongoing studies in these areas [14] HIV and Infectious Diseases - GSK is developing long-acting treatments for HIV, with a focus on Q4M regimens expected to launch in 2028 [26][27] - The company is addressing the challenges posed by generic competition in the HIV market, particularly with the impending loss of exclusivity for Dolutegravir [25][26] - In infectious diseases, GSK is focusing on hepatitis B and vaccine innovations, with significant data expected by the end of the year [15] Pipeline and Portfolio Management - GSK's pipeline is characterized by a focus on major blockbusters, with a rigorous culling of non-promising assets [17] - The company has achieved 13 successful phase three studies last year, indicating strong operational capabilities [18] - Upcoming catalysts include bepirovirsen for chronic hepatitis B and Canlapixent for respiratory conditions, with significant market potential [19][20] Decision-Making in Acquisitions - GSK's acquisition strategy is driven by the need for effective clinical outcomes and scalability, as seen in the EFI deal for fibrosis treatment [30][31] - The company prioritizes assets that can integrate well into existing studies and have favorable manufacturing profiles [32] Budget and Resource Allocation - GSK's R&D budget is optimized to ensure that any new assets must justify their inclusion by providing significant value [33][34] - The focus remains on enhancing R&D effectiveness through technology and strategic investments [34] Additional Insights - GSK's approach to R&D is characterized by a blend of internal development and strategic acquisitions, aiming to create a robust pipeline that addresses significant medical needs [17][18] - The company is actively working to dispel perceptions of a weak pipeline by highlighting the strategic rationale behind its asset selection and development focus [16]

Summary of AnaptysBio Conference Call Company Overview - **Company**: AnaptysBio (NasdaqGS:ANAB) - **Focus**: Development of biologics or antibodies for autoimmune diseases - **Clinical Programs**: Three clinical stage programs including Rosnilimab, AMV033, and AMV101 [1][2] Key Clinical Programs Rosnilimab - **Type**: Selective and potent depleter of pathogenic T cells - **Recent Development**: Positive phase 2b trial readout in arthritis with plans to advance into phase 3 trials for rheumatoid arthritis (RA) [1][24] - **Trial Details**: Robust study with 424 patients, showing high tolerability and sustained responses off-drug [24][30] AMV033 - **Type**: CD122 antagonist blocking IL-15 and IL-2 signaling - **Current Status**: Phase 1b trial initiated for celiac disease, with plans for a second indication in 2026 [1][2][7] - **Mechanism**: Designed to target autoimmune cells, particularly CD8 T cells in diseases like celiac disease and eosinophilic esophagitis (EOE) [8][20] AMV101 - **Current Status**: In phase 1a trials with results expected next year [1][32] Royalty Management Business - **Separation Announcement**: Company plans to separate into two businesses: biopharma operations and royalty management [2] - **Key Products**: - **Jemperli**: PD-1 antagonist with expected run rate of $1.4 billion to $1.5 billion; AnaptysBio anticipates substantial royalties based on sales tiers [3][4] - **Imsidolimab**: IL-36 receptor antagonist partnered with Vanda Pharmaceuticals, expected approval next year [6] Financial Overview - **Cash Position**: Expected $300 million cash at the end of the year [2] - **Royalty Structure**: Royalties range from 8% to 25% based on sales thresholds, with potential for significant revenue [4][6] Market Opportunity - **Celiac Disease**: Estimated 2 million patients in the US, with 250,000 potentially eligible for biologics by the 2030s [19] - **EOE Market**: Dupilumab, the only approved therapy, has generated $2 billion in sales, indicating a growing market for new therapies [20][23] Competitive Landscape - **Competitors**: Other companies like Novartis and Teva are also developing therapies targeting similar pathways in autoimmune diseases [9][10] - **Differentiation**: AnaptysBio's approach targets both inflammation and the underlying autoimmune response, which may provide advantages over existing therapies [15][22] Conclusion - **Future Plans**: AnaptysBio aims to advance AMV033 into further trials and move Rosnilimab into phase 3 next year, with a focus on addressing significant unmet needs in autoimmune diseases [31][32]

Summary of AnaptysBio Conference Call Company Overview - **Company**: AnaptysBio - **Core Areas**: Biopharma business and drug development focusing on rosnilimab, ANB033, and a royalty business from GSK's Jemperli [2][3] Key Points on Drug Development - **Rosnilimab**: - A PD-1 pathogenic T-cell depleter aimed at treating arthritis, with plans to advance into phase three trials [2] - Recent trial in ulcerative colitis (UC) did not meet criteria for progression; the drug was found ineffective for UC despite being safe [4][5] - High bar for remission was not met, leading to a focus on rheumatoid arthritis (RA) instead [7][11] - Data from a 424-patient trial in RA showed 85% of patients maintained low disease activity or remission after 14 weeks off the drug [12] - Market opportunity in RA is significant, with a second-line plus market valued at $10 billion in the U.S. alone [15] - **ANB033**: - Currently enrolling patients in initial celiac disease trials, with data expected by the end of Q4 next year [2][14] - The company is exploring additional indications for this drug, including eosinophilic esophagitis (EOE) [30] Royalty Business - **Jemperli Royalties**: - Expected to generate significant revenue, with GSK guiding for over $2.7 billion in sales, translating to approximately $390 million in royalty value for AnaptysBio [33] - The royalty business is being separated to highlight its value, which is expected to exceed the current market cap of AnaptysBio [32][36] - The separation aims to provide clarity and attract investors focused on growth opportunities [36] Market Dynamics and Competitive Landscape - **Market Opportunity**: - There are 500,000 patients cycling off TNF therapies, with 150,000 having no other treatment options, indicating a substantial unmet need [15] - The competitive landscape includes other companies like Teva and Novartis, which are also pursuing treatments for celiac disease and other indications [28][29] - **Safety and Efficacy Concerns**: - Comparisons were made with Lilly's PD-1 agonist, which faced efficacy issues, suggesting that AnaptysBio's drug has a better safety profile [18][19] - The company emphasizes that the class of drugs does not have inherent safety issues, but rather operational challenges in other trials [20] Future Plans and Financial Position - **Separation Timeline**: - The split into two companies is expected by the end of next year, with flexibility on timing based on regulatory processes [39][40] - AnaptysBio is well-funded with $300 million in cash, which will support ongoing and future trials [42] - **Strategic Focus**: - The company is committed to advancing rosnilimab in RA while also exploring other indications for ANB033 [14][45] - The royalty business will operate with a low cost of capital, focusing on returning value to shareholders [33][41] Conclusion - AnaptysBio is strategically positioning itself for growth through the advancement of its drug candidates and the separation of its royalty business, which is expected to provide significant revenue potential. The focus remains on addressing unmet medical needs in autoimmune diseases while ensuring a strong financial foundation for future developments.

Summary of AnaptysBio Conference Call Company Overview - **Company**: AnaptysBio - **Industry**: Biotechnology Key Points and Arguments 1. Business Split Announcement - AnaptysBio plans to split into two entities: a royalty-focused company and a biopharma company, aimed at enhancing shareholder value and focusing on distinct investor interests [6][9][10] 2. Rosnilimab Development - Rosnilimab, a selective T cell depleter, completed a phase 2b trial in arthritis with 424 patients, showing significant efficacy and safety, with statistically significant results at week 12 [2][3] - The drug demonstrated low disease activity and remission rates that improved over six months and persisted for nine months post-treatment [2][3][18] 3. ANB033 Development - ANB033, a CD122 receptor antagonist, is currently in a phase 1b trial for celiac disease, with plans to announce a second indication in 2026 [4][30] - The trial design includes two cohorts: one undergoing a gluten challenge and another with significant mucosal damage not receiving gluten [28][29] 4. Jemperli Royalty Stream - AnaptysBio has a significant royalty stream from Jemperli, projected to reach a $1.5 billion run rate by year-end, with potential royalties of $390 million when GSK achieves peak sales of over $2.7 billion [4][5][11] - Jemperli is positioned as a market leader in frontline endometrial cancer, with expectations for substantial growth [7][12] 5. Market Expectations and Consensus - There is a notable discrepancy between GSK's sales guidance for Jemperli and Wall Street consensus, with GSK projecting far greater sales than the consensus estimate of $1.9 billion [10][11] - AnaptysBio believes the royalty from Jemperli alone is worth significantly more than its current market cap [12] 6. Future Plans and Funding - AnaptysBio plans to meet with the FDA to discuss the phase 3 program for Rosnilimab and explore various funding options for the RA program [19][20] - The company is considering strategic collaborations to support the development of its pipeline [20] 7. Safety and Efficacy in Trials - The safety profile of Rosnilimab is favorable, with less than 2% of patients discontinuing due to adverse events [18][23] - The company remains confident in the RA program despite a recent setback in ulcerative colitis trials, citing strong translational data supporting the drug's mechanism of action [21][22][24] 8. Market Opportunity in Arthritis - There is a significant market opportunity in the arthritis space, with over 500,000 patients in the U.S. on biologics and many progressing beyond TNFs [15][16] - Rosnilimab is expected to perform well in patients who have previously undergone multiple therapies [16][17] 9. Upcoming Data and Milestones - Data from the ANB033 trial is expected next year, which will provide insights into its efficacy and potential for future development [30] Additional Important Information - The company is well-capitalized, anticipating over $300 million in cash by year-end, including milestone payments from GSK [5]

Core Insights - AnaptysBio Inc. announced data from the Phase 2 trial of rosnilimab for moderate-to-severe ulcerative colitis, indicating that the drug did not meet its primary or key secondary endpoints [2][5]. Trial Results - Rosnilimab was found to be safe and well-tolerated, but it performed no better than placebo at Week 12, with clinical remission rates of 7% for patients receiving 400mg Q4W and 800mg Q2W, compared to 5% and 4% for endoscopic remission [2][5]. - The placebo rates in the trial were within expected historical ranges [2]. - Preliminary data suggested an increase in remission rates between Week 12 and Week 24, but these rates did not meet the six-month target product profile [5]. Financial Implications - The company will discontinue the ulcerative colitis trial, resulting in at least $10 million in savings [3]. Future Plans - AnaptysBio remains optimistic about the potential of rosnilimab in rheumatoid arthritis (RA) and plans to provide an update in H1 2026, including funding strategies that do not dilute royalties [4]. - The company is also conducting a Phase 1b study for ANB033 for celiac disease and plans to announce another Phase 1b study in a different inflammatory disease in 2026 [7]. Market Reaction - Following the announcement, AnaptysBio shares fell by 13.63%, trading at $34.24 [8]. Strategic Moves - AnaptysBio reiterated its intention to separate biopharma assets from substantial royalty assets in 2026, including expected royalties of over $390 million per year from Jemperli at GSK's peak sales guidance of over $2.7 billion [8].

Core Insights - AnaptysBio, Inc. reported strong financial results for Q3 2025, with a net income of $15.1 million for the quarter, marking a significant improvement compared to a net loss of $32.9 million in Q3 2024 [14][23]. - The company announced its intent to separate its biopharma operations from its royalty assets by the end of 2026, aiming to unlock potential value for investors [5][16]. Financial Performance - Collaboration revenue for Q3 2025 was $76.3 million, up from $30.0 million in Q3 2024, driven primarily by Jemperli sales exceeding $750 million [17][23]. - Research and development expenses decreased to $31.4 million in Q3 2025 from $42.2 million in Q3 2024, while general and administrative expenses remained relatively stable [17][23]. - Cash and investments totaled $256.7 million as of September 30, 2025, down from $420.8 million at the end of 2024, primarily due to operating activities and share repurchases [17][20]. Business Updates - Jemperli sales grew to $785 million year-to-date in 2025, with a quarter-over-quarter growth of over 16% [5][6]. - Anaptys anticipates a one-time $75 million commercial sales milestone in Q4 2025 from GSK once Jemperli achieves $1 billion in worldwide net sales [5][6]. - The company is on track to report top-line Phase 2 data for rosnilimab in ulcerative colitis in November or December 2025 [5][13]. Strategic Initiatives - The planned separation will create two independent publicly traded companies, allowing investors to align their portfolios with distinct business objectives [6][16]. - The biopharma operations will focus on innovative immunology therapeutics, including rosnilimab, ANB033, and ANB101, while the royalty management company will handle royalties and milestone payments [6][16]. Clinical Development - Rosnilimab's Phase 2b data in rheumatoid arthritis was presented at ACR Convergence 2025, showing promising response rates [13]. - A Phase 1b trial for ANB033 in celiac disease has been initiated, with top-line data expected in Q4 2026 [5][13].

Core Insights - GSK plc reported third-quarter 2025 core earnings of $1.48 per American depositary share (ADS), exceeding the Zacks Consensus Estimate of $1.26, with core earnings increasing 11% year over year on a reported basis and 14% at a constant exchange rate (CER) [1][10] - Quarterly revenues rose 7% on a reported basis and 8% at CER to $11.52 billion (£8.55 billion), driven by rising sales across all business segments, particularly in HIV, oncology, and respiratory medicines, surpassing the Zacks Consensus Estimate of $11.16 billion [2][10] Segment Performance - GSK operates under three segments: General Medicines, Specialty Medicines, and Vaccines. Specialty Medicines sales increased by 16%, General Medicines rose by 4%, and Vaccine sales were up by 2% [3] - HIV sales rose 12% during the quarter, driven by increased demand for Dovato and long-acting medications like Apretude and Cabenuva, with Dovato sales increasing by 24% [4][5] - Oncology sales surged by 39%, led by strong demand for Jemperli, which saw a 79% increase due to expanded treatment indications [6][7] - Respiratory drug Nucala sales increased by 14%, while Benlysta sales rose by 17%, reflecting strong demand across markets [9] Financial Guidance - GSK raised its 2025 guidance, now expecting sales growth of 6-7%, up from a previous forecast of 3-5%, and core EPS growth of 10-12% [10][17][19] - Specialty Medicines are now expected to grow at a mid-teens percentage at CER, while General Medicines are anticipated to remain stable [18] - The company reiterated its guidance for R&D and SG&A expenses, with R&D expected to grow slightly faster than sales [20] Long-term Strategy - GSK is focusing on HIV, immunology/respiratory, and oncology therapeutic areas, with 80 assets in clinical development, including 16 in late-stage development or under regulatory review [24] - The company plans to launch five new products/line extensions this year, with four already approved by the FDA [25] - GSK aims to launch 15 new drugs between 2025 and 2031, each with peak sales potential exceeding £2 billion [26]