AnaptysBio, Inc. (NASDAQ:ANAB) announced on Tuesday that it plans to explore separating its business into two independent, publicly traded companies.Referred to as “Royalty Management Co” and “Biopharma Co,” the two companies’ different business models enable investors to align their investment philosophies and portfolio allocation with each company’s strategic opportunities and financial objectives.“Anaptys is strategically positioned with multiple attractive, high-potential assets…,” said Daniel Faga, pre ...

PresentationI will now hand the conference over to your speaker host, Dan Faga, President and CEO of Anaptys. Please go ahead, sir.Good day. Thank you for standing by. Welcome to the Anaptys conference call. [Operator Instructions] Please note that today's conference may be recorded.Daniel FagaPresident, CEO & Director Good afternoon and thank you for joining us today. We are excited to discuss today the further evolution of Anaptys with our intention to separate our biopharma operations from our substantia ...

PresentationI will now hand the conference over to your speaker host, Dan Faga, President and CEO of Anaptys. Please go ahead, sir.Good day. Thank you for standing by. Welcome to the Anaptys conference call. [Operator Instructions] Please note that today's conference may be recorded.Daniel FagaPresident, CEO & Director Good afternoon and thank you for joining us today. We are excited to discuss today the further evolution of Anaptys with our intention to separate our biopharma operations from our substantia ...

Strategic Separation to Maximize Shareholder Value Sept. 29, 2025 Safe harbor statement This presentation and any accompanying oral presentation contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from the Company's clinical trials, including initial data for rosnilimab's Phase 2 clinical trial in ulcerative colitis; expectations regarding the structure ...

Designed to unlock potential value by creating two independent, publicly traded companies with different business objectives and opportunitiesUpon completion, the royalty management company will manage royalties and milestone payments from financial collaborations, including Jemperli with GSK and imsidolimab with Vanda, with a focus on protecting and returning their valueUpon completion, the biopharma operations company will focus on development and potential commercialization of innovative immunology thera ...

Summary of AnaptysBio Conference Call Company Overview - AnaptysBio is focused on developing antibodies that modulate overexpressed or disease-driving immune cells to restore immune homeostasis in patients with autoimmune inflammatory diseases [4][6] - The company has three development-stage antibodies: rosnilimab, ANB033, and ANB101 [4][5] Key Programs and Developments Rosnilimab - Rosnilimab is a selective and potent depleter of pathogenic T cells, with recent Phase IIb arthritis study results showing remission rates surpassing best-in-class medicines [4][5][9] - The drug demonstrated over 90% depletion of specific T cells in both the periphery and synovium, with a tolerability profile showing less than 2% dropout due to adverse events [9][10] - Initial data from an ulcerative colitis trial is expected in Q4 of this year [5][11] ANB033 - ANB033 is a CD122 antagonist targeting celiac disease, with the Phase Ib trial starting imminently [5][39] - The drug is designed to block both IL-15 and IL-2, providing a dual mechanism of action [41][42] ANB101 - ANB101 is a BDCA2 modulator currently in Phase IA trials with healthy volunteers [5] Financial Position - AnaptysBio has over $300 million in capital, sufficient to fund operations through year-end 2027 [6][50] Market Dynamics - The ulcerative colitis market is seen as an attractive opportunity, with a potential $6 billion market size in the U.S. [25][26] - The company anticipates a different market uptake in ulcerative colitis compared to rheumatoid arthritis, which is more mature and competitive [24][25] Competitive Landscape - AnaptysBio believes its rosnilimab has a differentiated mechanism compared to competitors like J&J, which faced challenges in dosing and efficacy [33][34][35] - The company is optimistic about the potential for class cycling in ulcerative colitis, similar to trends seen in rheumatoid arthritis [25][26] Future Expectations - The company is focused on achieving maximum remission rates in ulcerative colitis, with a significant readout expected in six months [27][29] - The royalty stream from Jemperli, a drug discovered by AnaptysBio, is projected to be a significant asset, with potential revenues exceeding the company's current market cap [49][50] Conclusion - AnaptysBio is positioned for growth with multiple promising drug candidates and a strong financial foundation, targeting significant unmet needs in autoimmune diseases [6][50]

Core Insights - GSK stock has increased by 6.4% over the past month, adding nearly $5 billion to its market value, driven by strong performance in the Specialty Medicines unit and a positive long-term outlook despite challenges in the Vaccines unit and economic pressures [1][9]. Group 1: Specialty Medicines Performance - The Specialty Medicines unit is experiencing significant sales growth, with a 16% increase in the first half of 2025, attributed to successful launches in Oncology and long-acting HIV medicines [3][9]. - Key products driving growth include Nucala, Dovato, Cabenuva, Apretude, Jemperli, and Ojjaara, with expectations for low teens percentage growth in sales for this segment in 2025 [4][9]. - Specialty Medicines currently account for approximately 40% of GSK's sales and are projected to exceed 50% of total revenues by 2031 [4]. Group 2: Promising Pipeline and R&D - GSK is increasing its R&D investment in long-acting and specialty medicines across various therapeutic areas, including Respiratory, Immunology & Inflammation, Oncology, and HIV [5]. - Recent approvals include the pentavalent MenABCWY meningococcal vaccine and Blujepa/gepotidacin for uncomplicated urinary tract infections, with additional regulatory applications under review [6][7]. - GSK plans to launch five new products/line extensions in 2025, including Blenrep and depemokimab, which are already approved in the U.S. [7]. Group 3: Vaccine Sales Challenges - Vaccine sales in the U.S. are declining, particularly for the shingles vaccine Shingrix and the RSV vaccine Arexvy, with total vaccine sales down 11% at CER in the first half of 2025 [8][11]. - Revised recommendations for RSV vaccinations have negatively impacted sales of Arexvy, particularly among adults aged 60-74 [10][11]. - GSK anticipates a low single-digit percentage decrease in vaccine sales for 2025, reflecting broader challenges in this segment [11]. Group 4: Stock Performance and Valuation - GSK stock has outperformed the industry and the S&P 500, rising 21.2% year-to-date compared to a 1.4% increase for the industry [12]. - The stock is trading at a forward price/earnings ratio of 8.58, significantly lower than the industry average of 14.78, indicating attractive valuation [14]. - Analysts have raised the earnings consensus estimate for 2025 from $4.34 to $4.37 per share, reflecting optimism around profit growth [18]. Group 5: Future Growth Expectations - GSK expects over 7% sales growth and more than 11% core operating profit growth on a CAGR basis from 2022 to 2026, driven by the Specialty Medicines segment [21]. - The growth in Specialty Medicines is expected to offset the slowdown in the Vaccines unit, with General Medicines also contributing to overall sales growth [21].

Core Insights - GSK plc reported second-quarter 2025 core earnings of $1.23 per American depositary share (ADS), exceeding the Zacks Consensus Estimate of $1.12, with a year-over-year increase of 7% on a reported basis and 15% at a constant exchange rate (CER) [1][9] - Quarterly revenues rose 1% on a reported basis and 6% at CER to $10.67 billion (£7.99 billion), driven by increased sales of HIV, oncology, and vaccine products, surpassing the Zacks Consensus Estimate of $10.33 billion [2][9] Segment Performance - GSK operates under three segments: General Medicines, Specialty Medicines, and Vaccines. Specialty Medicines sales increased by 15%, while Vaccine sales rose by 9%. General Medicines experienced a decline of 6% [3][9] - HIV sales grew by 12%, supported by increased demand for Dovato and long-acting medications Apretude and Cabenuva, with Apretude and Cabenuva sales rising by 50% and 46%, respectively [4][6] - Oncology sales surged by 42%, driven by strong demand for Jemperli and Ojjaara/Omjjara, with Jemperli sales increasing by 91% [6][7] - Vaccine sales were bolstered by increased uptake of meningitis and shingles vaccines, with Shingrix sales rising by 6% [12] Financial Guidance - GSK raised its 2025 sales and profit guidance, now expecting sales to increase toward the top end of the previously issued range of 3-5%, with Specialty Medicines projected to grow at a low teens percentage at CER [15][16] - The company anticipates core operating profit and core EPS to grow toward the top end of the previously issued guided range of 6-8% [16][17] Long-term Strategy - GSK has prioritized focus on HIV, immunology/respiratory, and oncology therapeutic areas, with 84 assets in clinical development, including 16 candidates in late-stage development or under regulatory review [24] - The company plans to launch five new products/line extensions in 2025, with three already approved in the first half of the year [25][26]

Core Insights - GSK's Specialty Medicines segment is a significant contributor to its sales, accounting for nearly 40% of total revenue and expected to exceed 50% by 2031 [6] Sales Growth - The Specialty Medicines unit has experienced a 17% sales increase in Q1 2025, driven by successful launches in Oncology and long-acting HIV medicines [2][10] - Key products such as Nucala and Dovato are major revenue drivers, alongside new long-acting HIV treatments like Cabenuva and Apretude, and oncology drugs Jemperli and Ojjaara [3] Research and Development - GSK is increasing R&D investments in long-acting and specialty medicines across various therapeutic areas, including Respiratory, Immunology & Inflammation, Oncology, and HIV [4] - The approval of Blujepa for uncomplicated urinary tract infections and Nucala for chronic obstructive pulmonary disease (COPD) supports the growth trajectory [4][10] Regulatory Approvals - Regulatory applications for Blenrep combinations for multiple myeloma and depemokimab for chronic rhinosinusitis and asthma are under review, with FDA decisions expected in 2025 [5] Competitive Landscape - GSK faces significant competition in the Specialty Medicines segment from major pharmaceutical companies such as AstraZeneca, Merck, and Pfizer [7][8] Stock Performance and Valuation - GSK's stock has increased by 16.3% year-to-date, outperforming the industry average of 0.3% [9] - The company's shares are trading at a forward price/earnings ratio of 8.34, which is lower than the industry average of 14.93 and below its 5-year mean of 10.21 [12] Earnings Estimates - The Zacks Consensus Estimate for GSK's earnings per share has risen from $4.38 to $4.41 for 2025, while the estimate for 2026 has slightly declined [14]

Rosnilimab (PD-1 depleter and agonist) in Rheumatoid Arthritis (RA) - Rosnilimab is well-positioned for the ~$20 billion U S RA market, which hasn't had a new mechanism approved since 2012[14] - In b/tsDMARD-naïve patients, Rosnilimab shows JAK-like efficacy, with 64% achieving CDAI LDA, 48% achieving ACR50, and 23% achieving ACR70[28] - In b/tsDMARD-experienced patients, Rosnilimab surpassed the 6-month Target Product Profile (TPP) and is comparable at mid/high dose to JAKs in all-active H2H study[30] - 83% of Week 28 CDAI LDA responders were still in response at Week 34, demonstrating durable responses for at least 2-months off-drug[33] - Synovial biopsies show ~90% reduction of PD-1+ T cells in the target issue with 400mg/600mg doses[39, 40] Rosnilimab in Ulcerative Colitis (UC) - Initial Phase 2 data for Rosnilimab in Ulcerative Colitis is expected in Q4 2025[2, 78] - Enrollment is ongoing in the Phase 2 trial for moderate-to-severe UC, with interim 6-month data expected in Q4 2025[60] - The primary endpoint of the UC trial is the change in modified Mayo score (mMS) vs placebo at Week 12[62] ANB033 (CD122 antagonist) - Phase 1 trial of ANB033 in healthy volunteers has been initiated, with an R&D event planned for H2 2025[63, 78] - ANB033 is designed to reduce pathogenic T cells and NK Cells by potently inhibiting IL-15 and IL-2 biology[63, 65, 66] Financial Position - The company has a strong capital position with ~$383 million in cash as of Q1 2025, expected to provide a cash runway through YE 2027[7, 69, 76]