Financial Data and Key Metrics Changes - Revenue for the nine-month period was just over JPY 3.4 trillion, a decrease of 3.3% or -2.8% at constant exchange rate [10] - Core Operating Profit was JPY 971.6 billion, a year-on-year decrease of 3.4% at both actual effects and constant exchange rate [10] - Reported operating profit was JPY 422.4 billion, an increase of 1.2% [11] - Core EPS was JPY 428, and reported EPS was JPY 137 [11] - Adjusted free cash flow was JPY 625.9 billion, even after a $1.2 billion upfront payment to Innovent Biologics [11] Business Line Data and Key Metrics Changes - Growth and launch products represented over 50% of total revenue and grew 6.7% at constant exchange rate [11] - In GI, Entyvio grew 7.4% at constant exchange rate, with strong growth in Q3 due to a one-time gross-to-net drop [12] - Rare diseases product Takhzyro slowed to 2.4% growth at constant exchange rate, impacted by new competing products in the US [12] - Immunoglobulin growth was 4.3% year to date, driven by subcutaneous IG products [13] - Qdenga growth accelerated to 22.1%, primarily driven by Brazil [13] Market Data and Key Metrics Changes - Entyvio Pen is now on formulary with all three large pharmacy benefit managers, achieving commercial coverage of more than 80% [12] - Takhzyro's growth is being offset by new competitors and the impact of Medicare Part D redesign in the U.S. [13] - Albumin has returned to growth of 1.3%, but slower than expected due to softening demand in China [13] Company Strategy and Development Direction - The company is preparing for significant new product launches, focusing on Oveporexin, rusfertide, and zasocitinib, expected to launch over the next 18 months [5][6] - The late-stage pipeline includes eight programs with potential to transform the standard of care [8] - The company is committed to maintaining operational efficiency while investing in R&D for future growth [15] Management's Comments on Operating Environment and Future Outlook - Management revised revenue guidance to low single-digit decline at constant exchange rate due to stronger than anticipated Vyvanse generic erosion [16] - The company maintains full-year guidance for core operating profit and core EPS [16] - Management emphasized the importance of cost discipline while preparing for new product launches [15] Other Important Information - The transition of leadership to Julie Kim, CEO-elect, is underway, with operational responsibilities being handed over [28][30] - The company is focusing on simplifying processes and adopting advanced technologies [31] Q&A Session Summary Question: Thoughts on next fiscal year and dividend policy - Management indicated it is too early to provide guidance for the next fiscal year, with the budget being finalized [39] - Emphasis on maintaining a progressive dividend policy, with decisions based on core EPS and cash flow [43] Question: Zasocitinib phase 2 outcomes and safety data - Data from UC and Crohn's disease phase 2 studies expected this year, with ongoing studies on dosing [45] - Safety profile consistent with previous studies, with more data to be presented at an upcoming medical conference [46] Question: Impact of MFN on U.S. policy - Management does not support MFN, emphasizing that price controls could impact future innovation [52] - Organizational changes aim to enhance competitiveness and speed in U.S. marketing [54] Question: Entyvio sales performance and IRA impact - Q3 sales were robust, with improved coverage in the U.S. [59] - Anticipation of price negotiations under IRA, with uncertainty on the extent of potential price cuts [61] Question: Takhzyro growth trends and competitive impact - Takhzyro remains the gold standard, but growth is impacted by new competitors and Medicare Part D redesign [66] - Long-term efficacy data supports Takhzyro's position in the market [66] Question: PDT clinical progress and outlook - Demand slowdown noted, particularly in albumin due to regulatory changes in China [81] - Overall outlook for PDT remains mid-single-digit growth for the year [81] Question: Zasocitinib phase III data presentation - Presentation at AAD is a possibility, with focus on fast onset of action and clear skin [87] - Competitive advantages include ease of administration and strong safety profile [88]

TSE: 4502 Committed to Growth & Shareholder Returns FY2025 Q3 Earnings Announcement The companies in which Takeda directly and indirectly owns investments are separate entities. In this presentation, "Takeda" is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words "we", "us" and "our" are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifyi ...

Protagonist Therapeutics FY Conference Summary Company Overview - **Company**: Protagonist Therapeutics (NasdaqGM:PTGX) - **Event**: FY Conference at the 44th J.P. Morgan Healthcare Conference - **Date**: January 13, 2026 Key Points Industry and Market Context - Protagonist is positioned in the biopharmaceutical industry, focusing on innovative therapies for unmet medical needs, particularly in the areas of immunology and rare diseases [2][26] Core Assets and Development Pipeline - **Icotrokinra (Ico)**: - Partnered with Johnson & Johnson (J&J) - Aims to set a new standard of care in psoriasis and other IL-23-mediated indications - First and only oral IL-23 pathway blocker in late-stage development - Potential market opportunity exceeding $80 billion across four indications: psoriasis, psoriatic arthritis, ulcerative colitis (UC), and Crohn's disease [4][5][6] - Anticipated peak sales of over $10 billion [6] - **Rusfertide**: - Partnered with Takeda - A synthetic peptide mimetic of hepcidin, targeting polycythemia vera (PV) - Phase 3 VERIFY study results deemed practice-changing, with potential peak revenue of $1-$2 billion [10][11] - Fast-track status and breakthrough therapy designation expected to expedite approval [12] - **Emerging Assets**: - **PN-881**: An oral IL-17 antagonist, expected to enter Phase I studies [13][15] - **PN-8047**: An oral hepcidin functional mimetic, complementing Rusfertide, with Phase I initiation expected by year-end [16][17] - **PN-477**: A novel oral triple agonist for obesity, with IND-enabling studies ongoing [18][19] - **PN-458**: A new dual GLP-1/GIP agonist for obesity, enhancing the obesity portfolio [20] Financial Position - Protagonist ended Q3 2025 with approximately $679 million in cash, sufficient to fund operations through 2028 [21][22] - Revenue potential from partnered assets: - Icotide: Eligible for $600 million in future milestones and 6%-10% royalty range, averaging around 7.25% [22][23] - Rusfertide: Potential opt-out fee of $400 million, with royalties ranging from 14%-29% based on sales [24][25] Strategic Vision - Protagonist aims to maximize shareholder value while expanding its discovery pipeline, with aspirations to grow its market cap from $5 billion to $10-$20 billion [33] - The company emphasizes the importance of partnerships with pharmaceutical companies for scaling and expertise, particularly in the obesity space [34][46] Upcoming Catalysts - Anticipated commercial launches for Icotide and Rusfertide within the year [26] - Completion of pivotal studies and initiation of Phase II studies for emerging assets [26] Additional Insights - The company is focused on maintaining a balance between funding internal R&D and returning capital to shareholders through potential stock buybacks and dividends [34][35] - Protagonist is committed to expanding its pipeline with a focus on high-priority targets in immunology, including IL-4 [53] Conclusion Protagonist Therapeutics is at a pivotal growth stage, with a robust pipeline of innovative therapies and a strong financial position, poised for significant market impact in the coming years. The strategic partnerships and upcoming product launches are expected to drive value creation and enhance shareholder returns.

Core Viewpoint - Johnson & Johnson (NYSE: JNJ) is in acquisition talks with Protagonist Therapeutics (NASDAQ: PTGX), which has led to a significant increase in Protagonist's stock price, closing at $8.7, a rise of approximately 30% with a market capitalization of $540 million [2]. Group 1: Acquisition Details - The details of the potential acquisition are not finalized, and the terms under discussion may not be guaranteed [5]. - The expected deal would significantly exceed Protagonist's market value, including a premium, and would enhance Johnson & Johnson's portfolio in immunology and oncology through two experimental drugs [5]. Group 2: Collaboration and Product Development - Johnson & Johnson and Protagonist are collaborating on the oral IL-23 inhibitor, Icotrokinra, which is aimed at treating immune diseases such as plaque psoriasis and ulcerative colitis, with Johnson & Johnson holding exclusive commercialization rights [6][8]. - Johnson & Johnson has already submitted a new drug application to the FDA for Icotrokinra to treat plaque psoriasis, following the loss of patent exclusivity for its product Stelara [8]. Group 3: Financial Aspects and Milestones - The collaboration includes potential financial milestones, with an upfront payment and milestone achievements totaling $337.5 million, alongside royalties of 6% to 10% on net sales exceeding $4 billion [6]. - Upcoming potential milestones through 2028 include various payments for marketing approvals and NDA filing acceptances, totaling an estimated $155 million [6]. Group 4: Market Performance - Protagonist's stock has more than doubled this year, with a notable 45% increase in March due to encouraging results from late-stage trials of Rusfertide, a treatment for polycythemia vera [12].

Core Viewpoint - Johnson & Johnson is in talks to acquire Protagonist Therapeutics, which could strengthen its product line amid competition from low-cost generics for its key immunotherapy drug Stelara [1] Group 1: Company Developments - Johnson & Johnson is currently collaborating with Protagonist Therapeutics on the development of immunology drugs [1] - Protagonist is also working with Takeda Pharmaceutical on a drug called Rusfertide, aimed at treating rare blood cancers [1] Group 2: Market Implications - The potential acquisition would help Johnson & Johnson consolidate its product offerings as it faces competition from generic versions of Stelara [1]

Core Thesis - Protagonist Therapeutics, Inc. (PTGX) presents a compelling investment opportunity due to strong clinical progress and underappreciated fundamentals, with a market cap of $3.6 billion and $615 million in net cash as of June 2025 [2][4] Clinical Assets - PTGX's most valuable asset, Icotrokinra (Ico), is an oral IL-23R peptide antagonist partnered with JNJ, nearing FDA approval with robust Phase 2/3 data for multiple indications including psoriasis and Crohn's disease [2][3] - Ico's efficacy rivals or potentially surpasses injectable treatments like Skyrizi and Tremfya, positioning PTGX to capture significant market share in a $25 billion IL-23 class [3] Financial Projections - PTGX is projected to earn $400–$900 million in annual royalties from Ico, with additional upside from sales milestones and market expansion, leading to a plausible base-case DCF value of $3–4 billion [3][5] - Rusfertide, another asset partnered with Takeda, targets polycythemia vera and is expected to generate $100–$200 million in annual cash flow, along with a $400 million opt-out payment [3][4] Strategic Positioning - PTGX's platform includes oral IL-17, oral hepcidin, and obesity drug candidates, providing high optionality and potential for significant future upside [4] - The company has a strong balance sheet with minimal burn relative to upcoming catalysts, and management incentives are aligned with shareholder value [4] Market Catalysts - Multiple catalysts exist, including Ico approval and Rusfertide commercialization decisions, which the market has yet to fully price in [4][5] - The potential for strategic transactions, such as royalty sales or platform acquisitions, could further unlock value for PTGX [5]

Core Viewpoint - Protagonist Therapeutics has selected PN-477 as its primary development candidate for obesity treatment, which is a triple agonist peptide targeting GLP-1, GIP, and glucagon (GCG) receptors, offering both efficacy and convenience through oral or subcutaneous administration [2][4]. Group 1: Drug Development and Efficacy - PN-477 has completed extensive preclinical evaluations, demonstrating positive effects in various animal models of obesity and blood glucose control, including diet-induced obese mice, normal dogs, and crab-eating macaques [4]. - The drug exhibits strong activation of GLP-1, GIP, and GCG receptors in vitro, indicating its potential effectiveness [4]. - PN-477's pharmacodynamic properties and overall performance make it suitable for parallel development as both a daily oral medication (PN-477o) and a weekly injection (PN-477sc) [4]. Group 2: Clinical Trials and Future Plans - The Investigational New Drug (IND) application is currently underway, with the first phase of clinical trials expected to start in the second quarter of 2026 [4]. - Protagonist Therapeutics plans to submit a New Drug Application (NDA) for its other candidates in 2025, indicating a robust pipeline [6][7]. Group 3: Market Position and Competitive Advantage - Despite the dominance of GLP-1 receptor agonists in the market, there is room for improvement, and a triple agonist like PN-477 could provide a significant breakthrough in obesity treatment by offering an oral option alongside injectable therapies [6]. - PN-477 is anticipated to reduce fat mass while preserving lean body mass and improving tolerability and comorbidities, positioning it as a potential blockbuster product for the company [6]. Group 4: Company Overview - Protagonist Therapeutics is an integrated biopharmaceutical company focused on drug discovery and late-stage development, with two novel candidates in Phase III clinical trials and plans for NDA submissions in 2025 [6][7]. - The company is also advancing several preclinical peptide drug development projects, including PN-881 and oral hepcidin [7].