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]

Summary of Avalo Therapeutics Conference Call Company Overview - **Company**: Avalo Therapeutics (NasdaqCM:AVTX) - **Event**: 2026 Conference on February 11, 2026 - **Focus**: Discussion on the upcoming phase 2b data from the LOTUS trial for AVTX-009, a monoclonal antibody targeting IL-1 beta Key Points Industry and Product Insights - **Product**: AVTX-009, a high-affinity anti-IL-1 beta monoclonal antibody - **Trial**: LOTUS trial, over 250 patients, placebo-controlled, focusing on moderate to severe hidradenitis suppurativa (HS) [2][36] - **Expected Data Release**: Phase 2b data anticipated in Q2 2026 [2][60] Mechanism of Action - **IL-1 Beta Role**: Principal driver of inflammation in HS, with higher concentrations than other inflammatory markers [6][14] - **Comparison with Other Drugs**: IL-1 beta is considered more effective than IL-1 alpha in treating HS, as evidenced by the failure of anti-IL-1 alpha drugs like bermekimab [13][14] Trial Design and Execution - **Trial Structure**: Three-arm study comparing two dosing regimens of AVTX-009 against placebo [34][35] - **Patient Population**: Over 250 patients enrolled, including a significant number of biologically experienced patients [37][42] - **Placebo Response**: Historical placebo response rates in HS trials range from 13% to 18% [35] Safety and Efficacy Considerations - **Safety Profile**: Expected increase in bacterial infections and potential for neutropenia, but generally manageable [47] - **Efficacy Expectations**: Aiming for a response rate of 20% or higher beyond placebo, with a potential "home run" at 25% [49][50] Future Directions - **Next Steps**: Plans for two pivotal phase III trials following the LOTUS study data [52] - **Potential Indications**: Interest in expanding into dermatology, rheumatology, and gastrointestinal diseases due to the potency of AVTX-009 [53] Financial Position - **Cash Reserves**: $100 million reported at the end of the previous year, with a burn rate of $50 million [68] Additional Considerations - **Quality of Life Metrics**: Focus on pain relief and quality of life improvements as key endpoints in the trial [54][55] - **Data Release Timeline**: Complete data set expected to include a 6-week safety follow-up, with final patient visits concluding in March 2026 [62][64] This summary encapsulates the critical insights from the Avalo Therapeutics conference call, highlighting the company's strategic focus, product development, and market positioning within the biotech industry.

Core Insights - Novartis AG reported fourth-quarter 2025 net sales of $13.34 billion, a 1% year-over-year increase, but below Wall Street's estimate of $13.78 billion [1] - On a constant-currency basis, sales decreased by 1% [1] - The company faced a significant negative impact from generic competition, which reduced sales by 15 percentage points, including a 3 percentage point impact from revenue deduction adjustments in the U.S. related to Entresto and Promacta [1] Financial Performance - Pricing pressures negatively impacted sales by 4 percentage points, while currency fluctuations had a positive impact of 2 percentage points [2] - Core operating income increased by 1% to $4.93 billion, with a core operating income margin of 37.0%, reflecting a slight increase of 0.1 percentage points [2] - The growth in core operating income was supported by higher government grant income and lower selling, general, and administrative (SG&A) expenses, although this was partially offset by increased research and development (R&D) expenses [2] Product Performance - Strong demand for key therapies contributed to growth, with Kisqali sales rising 44% to $1.32 billion, Kesimpta increasing 27% to $1.23 billion, and Cosentyx revenue up 11% to $1.81 billion [3] - Scemblix saw an 87% increase to $391 million, while Pluvicto advanced 70% to $605 million [3] Future Outlook - For fiscal 2026, Novartis anticipates low single-digit growth in net sales, while core operating income is expected to decrease in the low single digits [5] - The incoming CFO indicated that adjusted operating income is projected to grow significantly in the second half of 2026, which is expected to positively impact 2027 and beyond [5] - Novartis shares rose 1.79% to $152.54, reaching a new 52-week high [5]

Core Insights - Novartis AG reported fourth-quarter core earnings per share of $2.03, exceeding the Zacks Consensus Estimate of $1.99 and up from $1.98 a year ago [1][7] - Core net income decreased by 1% to $3.9 billion, while revenues of $13.3 billion fell short of the Zacks Consensus Estimate of $13.7 billion, despite a 1% year-over-year increase [2][7] - The company faced revenue pressure from generic competition for key drugs Entresto and Promacta, leading to a 1% decline in sales on a constant currency basis [2][26] Financial Performance - Core operating income improved by 1% to $4.9 billion, supported by higher government grant income and lower SG&A expenses, although offset by increased R&D expenses [19] - For 2025, Novartis reported sales growth of 8% to $54.53 billion, surpassing the Zacks Consensus Estimate, with core EPS increasing by 17% to $8.98 [20] - Guidance for 2026 indicates low single-digit growth in net sales on a constant currency basis, with core operating income expected to decline in low single digits [21] Drug Performance - Cosentyx sales rose 11% to $1.8 billion, driven by strong demand across all regions [5] - Kisqali sales surged 44% to $1.32 billion, although it missed estimates, with underlying global growth at 54% [6][8] - Entresto sales plummeted 45% to $1.2 billion due to generic competition, while Promacta sales fell 63% to $226 million [8][13] - Pluvicto sales increased by 70% to $605 million, driven by strong demand following recent approvals [11] - Kesimpta sales grew 27% to $1.2 billion, while Jakavi sales increased by 8% to $555 million [10][12] Strategic Updates - Novartis announced plans to acquire Avidity Biosciences for $12 billion to enhance its late-stage neuroscience pipeline [22][23] - The acquisition aims to strengthen the company's position in addressing genetic neuromuscular diseases [28] - A collaboration agreement with the U.S. government was established to reduce drug prices while supporting ongoing investments in manufacturing and R&D [25] Market Position - Novartis shares have gained 42.1% over the past year, outperforming the industry growth of 19% [2] - The company is navigating significant patent expirations, with a focus on key growth drivers such as Kisqali, Kesimpta, Pluvicto, and Scemblix [26][27]

Novartis (NYSE:NVS) Q4 2025 Earnings call February 04, 2026 08:00 AM ET Company ParticipantsGraham Parry - Managing DirectorHarry Kirsch - CFOJames Gordon - DirectorJames Quigley - Executive DirectorMatthew Weston - Managing Director of Pharmaceutical ResearchMichael Leuchten - Managing DirectorMukul Mehta - CFO DesignatePeter Vardult - Managing Director of Pharmaceuticals Equity ResearchRichard Vosser - Managing DirectorSachin Jain - VPSeamus Fernandez - Senior Managing DirectorSimon Baker - Partner and He ...

Financial Data and Key Metrics Changes - Novartis achieved 8% sales growth and 14% core operating income growth for the full year 2025, with a core margin of 40.1%, reached two years ahead of plan [5][34][36] - For Q4, sales declined by 1%, while core operating income increased by 1%, with underlying growth of 3% when excluding one-time adjustments [6][38] - Core EPS rose 17% to $8.98, and free cash flow reached an all-time high of CHF 17.6 billion, growing 8% [34][39] Business Line Data and Key Metrics Changes - Kisqali sales grew 57% to CHF 4.8 billion for the year, with Q4 growth at 44% [7][8] - Kesimpta grew 36% to $4.4 billion, with a 27% growth in Q4 [10][11] - Pluvicto reached $2 billion in sales, showing 42% constant currency growth [12] - Leqvio achieved blockbuster status with 57% growth for the year [14] - Scemblix also reached blockbuster status with 87% growth in Q4 [15] Market Data and Key Metrics Changes - Novartis reported strong growth in key markets, with Kisqali leading in early breast cancer settings in Germany with over 80% NBRX share [8] - Kesimpta is leading in 9 out of 10 major markets outside the U.S. [11] - Pluvicto has secured approvals in Japan and China, contributing to strong growth outside the U.S. [12] Company Strategy and Development Direction - Novartis aims to grow through the largest patent expiry in its history, focusing on key growth brands and pipeline replacement power [7] - The company is committed to maintaining a strong pipeline with seven pivotal readouts expected in 2026 [31][49] - Novartis plans to continue investing in R&D, with over $10 billion allocated in 2025 [39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a 5%-6% sales CAGR from 2025 to 2030, despite anticipated generic impacts [42][48] - The company expects to return to a core margin of over 40% by 2029 [43] - Management highlighted the importance of pipeline assets in driving future growth [49] Other Important Information - The company completed a CHF 15 billion share buyback program and proposed a dividend increase of 6% [40][27] - The transition of CFO from Harry Kirsch to Mukul Mehta was noted, with Kirsch acknowledging the company's transformation during his tenure [41] Q&A Session Questions and Answers Question: Insights on remibrutinib and FDA conversations - Management confirmed that remibrutinib has an approved label without liver safety discussions, and they plan to advocate for limited liver monitoring based on FDA feedback [54][56] Question: Commercial opportunities for remibrutinib in MS - Management indicated that while B-cell monoclonal antibodies will remain dominant, there is a significant market for oral options, especially for patients preferring non-injectable therapies [61] Question: Risks associated with Pelacarsen's event-based study - Management expressed confidence in the study's design and powering assumptions, despite lower than expected event rates [63]

Financial Data and Key Metrics Changes - Novartis achieved high single-digit growth with an 8% increase in sales and a 14% rise in core operating income for the full year 2025, reaching a core margin of 40.1% [4][35] - For Q4, sales declined by 1%, while core operating income increased by 1%, with core EPS rising 2% to $2.03 [5][38] - Free cash flow reached an all-time high of CHF 17.6 billion, growing 8% year-over-year [35][39] Business Line Data and Key Metrics Changes - Kisqali sales grew 57% year-over-year to CHF 4.8 billion, with Q4 growth at 44% [6][7] - Kesimpta saw a 36% increase to $4.4 billion, with a 27% growth in Q4 [10] - Pluvicto achieved $2 billion in global sales, with a 75% increase in the U.S. [12] - Leqvio reached blockbuster status with 57% growth for the year [14] - Scemblix also reached blockbuster status with 87% growth in Q4 [15] Market Data and Key Metrics Changes - Kisqali's U.S. sales growth was 62%, with over 80% NBRX share in Germany for early breast cancer [7][9] - Kesimpta is leading in NBRX share in 9 out of 10 major markets outside the U.S. [10] - Pluvicto secured approvals in Japan and China, contributing to strong growth outside the U.S. [12] - Scemblix has a 41% NBRX share in the U.S. and 72% in the third-line setting across major markets [17] Company Strategy and Development Direction - Novartis aims to grow through the largest patent expiry in its history, focusing on key growth brands and pipeline replacement [6] - The company plans to continue investing in R&D while managing productivity improvements [43][44] - Novartis is committed to maintaining a 5%-6% sales CAGR from 2025 to 2030 [44][49] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving mid-single-digit sales growth in 2026 despite anticipated challenges from generic entries [43][44] - The company expects to return to a core margin of over 40% by 2029 [44] - Management highlighted the importance of pipeline advancements and upcoming pivotal readouts in 2026 [32][50] Other Important Information - Novartis has completed its CHF 15 billion share buyback program and initiated a new CHF 10 billion program [41] - The proposed dividend for 2025 is CHF 3.70 per share, marking a 6% increase [41][42] Q&A Session Questions and Answers Question: Insights on remibrutinib and FDA conversations - Management noted that remibrutinib has an approved label without liver safety discussions, and they plan to advocate for limited liver monitoring based on FDA feedback [53][54] Question: Commercial opportunities for remibrutinib in MS - Management indicated that the commercial opportunity will depend on data-driven results, with a significant market for oral options in MS [60][61] Question: Thoughts on Pelacarsen's event-based study risks - Management expressed confidence in the study's design and powering assumptions, despite lower than expected event rates [62][63] Question: Launch plans for Rhapsido and Ianalumab in an MFN world - Management acknowledged the importance of adjusting launch strategies for significant assets like Rhapsido and Ianalumab in the ex-U.S. market [73]

Content Click below to navigate through the document Company overview 2025 financial review 2026 guidance Conclusions Appendix References Q4 2025 Results Investor presentation February 4, 2025 Novartis Q4 Results | February 4, 2026 1 Content Click below to navigate through the document Company overview 2025 financial review 2026 guidance Conclusions This presentation contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, that can general ...

Core Insights - Novartis reported strong performance in 2025 with high single-digit sales growth and core margin expansion despite facing significant US generic competition [3] - Key growth drivers included Kisqali, Kesimpta, Pluvicto, Scemblix, and Cosentyx, which continued their strong trajectory [3] - The company advanced several potential multi-blockbusters in its pipeline with FDA approvals and positive Phase III readouts [3] - Novartis expects to grow through the largest patent expiry in its history in 2026, indicating the strength of its business [3] Financial Performance - Q4 2025 net sales reached USD 13.3 billion, a 1% increase year-over-year, while full-year net sales were USD 54.5 billion, reflecting an 8% increase [4][13] - Operating income for Q4 was USD 3.6 billion, up 2%, and for the full year, it was USD 17.6 billion, a 21% increase [10][13] - Net income for Q4 was USD 2.4 billion, down 15%, while full-year net income was USD 14.0 billion, up 17% [10][14] - Core operating income for Q4 was USD 4.9 billion, a 1% increase, and for the full year, it was USD 21.9 billion, a 12% increase [11][16] - Free cash flow for Q4 was USD 1.7 billion, down 54%, while for the full year, it was USD 17.6 billion, an 8% increase [12][17] Key Growth Drivers - Priority brands showed strong performance in Q4, with Kisqali sales growing 44%, Kesimpta 27%, Pluvicto 70%, Scemblix 87%, and Cosentyx 11% [18] - The top 20 brands contributed to a total of USD 10.8 billion in Q4 sales, with a slight increase of 2% year-over-year [19] R&D and Innovation - Novartis received FDA approval for Itvisma, the first gene replacement therapy for a broad SMA population, and expanded indications for Scemblix [21] - Pluvicto's FDA submission for metastatic hormone-sensitive prostate cancer was completed based on Phase III data [22] - Ongoing trials for ianalumab showed significant benefits in Sjögren's disease and primary immune thrombocytopenia [23][24] Strategic Initiatives - Novartis announced a proposed acquisition of Avidity Biosciences, expected to close in the first half of 2026, enhancing its pipeline in neuroscience [25] - The company reached an agreement with the US government to lower drug prices, which will impact its 2026 guidance [32] Capital Structure - Novartis repurchased 77.6 million shares for USD 8.9 billion in 2025, reducing the total number of shares outstanding by 66.9 million [27] - Net debt increased to USD 21.9 billion by the end of 2025, primarily due to cash outflows for share repurchases and dividends [28] 2026 Guidance - For 2026, Novartis expects low single-digit growth in net sales and a decline in core operating income [30]

Group 1: Company Overview and Financial Outlook - Novartis AG is considered one of the most profitable healthcare stocks, with a Buy rating initiated by Citi and a price target of CHF 133, indicating strong momentum and a sales growth guidance of 5%-6% annually through 2030 [1] - The company is headquartered in Basel, Switzerland, and was incorporated in 1996, offering products such as Entresto, Cosentyx, and Kisqali [4] Group 2: Trade and Tariff Protection - Novartis expects to be protected from U.S. tariffs by mid-2026, with plans to produce in the U.S. for the U.S. market, supported by existing inventory [2] - The company's agreement with the U.S. government is anticipated to exclude it from tariffs, amidst broader tariff plans affecting several European countries [3]