AbbVie Conference Call Summary Company Overview - **Company**: AbbVie (NYSE: ABBV) - **Date**: February 13, 2026 - **Focus**: Discussion on drug development, particularly lutikizumab and RINVOQ for hidradenitis suppurativa (HS) and inflammatory bowel disease (IBD) Key Points Drug Development and Differentiation - **Lutikizumab and RINVOQ**: Targeting HS with a distinct mechanism involving IL-1 alpha and IL-1 beta, aiming for clinical differentiation from HUMIRA and Cosentyx [1][2] - **Clinical Data**: Phase II data shows strong efficacy in both biologic-experienced and naive patients, indicating potential for differentiation in treatment outcomes [13][21] - **Combination Therapies**: AbbVie is exploring co-formulations and combinations with other assets to enhance treatment efficacy [7][9] Clinical Insights - **Neutrophil Role in HS**: Lutikizumab's bispecific approach targets both IL-1 alpha and beta, which play crucial roles in HS pathology [11][43] - **Efficacy Expectations**: Conventional wisdom suggests biologic-naive patients may show higher efficacy, but AbbVie has observed clinically meaningful effects in TNF-failure populations [17][21] Competitive Landscape - **Other Compounds**: AbbVie is aware of competitors like Sanofi's OX40 bispecific and their implications in HS treatment, particularly regarding immunosuppression risks [23][28] - **Immunogenicity Concerns**: Challenges with anti-TNF bispecifics have been noted, leading AbbVie to focus on novel mechanisms rather than traditional anti-TNFs [34][36] IBD Development - **SKYRIZI and Combinations**: AbbVie is excited about the potential of SKYRIZI in IBD, particularly with combinations involving lutikizumab and TL1A-directed treatments [45][49] - **TREM1 Mechanism**: TREM1 is being evaluated as a novel mechanism for IBD, with potential applications in other fibrotic diseases [60][78] Future Directions - **Biomarker Research**: AbbVie is investigating biomarkers to enhance individualized treatment approaches in IBD, aiming for more targeted therapies [69][70] - **TL1A in Fibrotic Diseases**: The potential for TL1A as an anti-fibrotic agent is being explored, with interest in diseases like rheumatoid arthritis and systemic sclerosis [78][80] Oral IL-23 Development - **Next-Generation Oral Treatments**: AbbVie is developing an oral IL-23 treatment, focusing on higher potency and longer half-life to improve patient adherence compared to existing therapies [81][83] Unique Compounds - **ADC Targeting CD19**: AbbVie is excited about a unique ADC targeting CD19 with a steroid payload, which may offer rapid and durable B-cell depletion [86][91] Additional Insights - **Market Positioning**: AbbVie aims to position its products effectively in the market, leveraging data from ongoing studies to enhance treatment options for patients [68][86] - **Long-Term Strategy**: The company is focused on developing innovative therapies that address unmet medical needs in both HS and IBD, with a strong emphasis on combination therapies and novel mechanisms [56][60]

Group 1 - Halozyme Therapeutics Inc. is identified as a promising mid-cap growth stock, with TD Cowen raising its price target from $79 to $90 while maintaining a Buy rating [1] - Investor sentiment is shifting positively ahead of Q4 2025 earnings, with 2026 guidance being crucial for positioning in a sector-wide recovery [1][3] - A global collaboration and exclusive license agreement was announced between Takeda and Halozyme, granting Takeda access to Halozyme's ENHANZE drug-delivery technology for vedolizumab [2][3] Group 2 - The agreement allows Takeda to utilize Halozyme's recombinant human hyaluronidase PH20 enzyme to enhance the subcutaneous delivery of vedolizumab, aiming to improve treatment flexibility and reduce therapy management time [3] - Halozyme is a biopharmaceutical company focused on researching, developing, and commercializing proprietary enzymes and devices both in the US and internationally [4]

Core Insights - Samsung Epis Holdings is entering a significant phase in 2026, announcing six new candidates in its biosimilar pipeline, aiming for a total of 20 biosimilars by 2030 [1][4] - The company has received IND clearance for its first novel therapeutic candidate, SBE303, and plans to advance its clinical program this year [1][4] - Samsung Bioepis is expanding its portfolio beyond biosimilars, focusing on antibody-drug conjugates (ADCs) to address unmet medical needs [1][4] Biosimilar Pipeline - Samsung Bioepis currently has 11 biosimilars approved and launched in over 40 countries, covering 10 unique biological molecules [4] - The new biosimilar candidates include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab [4][6] - The company has launched several biosimilars, including adalimumab (Humira), etanercept (Enbrel), infliximab (Remicade), trastuzumab (Herceptin), and bevacizumab (Avastin) [3][5] Novel Therapeutics Development - SBE303 is Samsung Bioepis' first novel ADC targeting Nectin-4, with a Phase 1 clinical trial set to begin this year [4] - The company aims to introduce one novel therapeutic candidate into clinical studies each year [4] - Epis NexLab, a new subsidiary, is focused on developing a peptide-based drug delivery platform [4][9] Company Overview - Samsung Epis Holdings is dedicated to biopharmaceuticals and biotechnology, aiming to maximize corporate and shareholder value through R&D and strategic investments [7] - Samsung Bioepis, established in 2012, focuses on making healthcare accessible through innovative product development across various therapeutic areas [8] - Epis NexLab, established in 2025, is committed to driving innovation in next-generation biotechnology platforms [9]

Core Insights - Halozyme Therapeutics has entered into a global collaboration and exclusive license agreement with Takeda for the use of its ENHANZE drug delivery technology with vedolizumab, marketed as ENTYVIO [1][2] - The collaboration aims to enhance patient experience by providing flexible treatment options for those with inflammatory bowel disease (IBD), specifically Crohn's disease and ulcerative colitis [2][3] Company Overview - Halozyme is a biopharmaceutical company focused on innovative solutions to improve patient experiences and outcomes, particularly through its ENHANZE drug delivery technology, which utilizes the proprietary enzyme rHuPH20 [5] - The ENHANZE technology has been validated commercially, impacting over one million patients through ten products across more than 100 global markets [5] - Halozyme is also developing Hyperconâ™, a microparticle technology aimed at reducing injection volume while expanding the range of therapeutics that can be delivered subcutaneously [6] Industry Context - Crohn's disease and ulcerative colitis are significant forms of IBD, with an estimated 10 million people expected to be living with IBD globally within the next decade, indicating a growing healthcare burden [3] - Vedolizumab (ENTYVIO) is a biologic therapy approved for both intravenous and subcutaneous administration for adults with moderately to severely active IBD [4]

Core Insights - HEALWELL AI's DARWEN™ AI Platform is one of the first to generate regulatory-grade real-world data (RWD) to enhance patient access and advance the pharmaceutical industry [3][4][6] - The collaboration with Takeda Pharmaceutical showcased the platform's ability to improve remission outcomes in ulcerative colitis and Crohn's disease through vedolizumab dose escalation [4][6] - HEALWELL's unique AI-driven RWD generation capability is expected to significantly impact clinical and commercial value in healthcare [3][6] Company Overview - HEALWELL AI Inc. focuses on preventative care using artificial intelligence to improve healthcare outcomes through early disease detection [9] - The company is publicly traded on the Toronto Stock Exchange under the symbol "AIDX" and on the OTC Exchange under "HWAIF" [9] - HEALWELL has been recognized for its leadership in healthcare AI, being named a finalist in Newsweek's AI Impact Awards 2025 [7][8] Industry Impact - The use of AI in generating RWD is a transformative approach that can lead to more precise and effective patient-centered care [5][6] - The platform's ability to extract clinically meaningful insights from electronic health records positions HEALWELL at the forefront of healthcare AI innovation [5][6] - The advancements in RWD generation are expected to facilitate faster and more accurate development of pharmaceutical products, ultimately improving patient outcomes [5][6]