Zasocitinib IR Event Phase 3 Psoriasis Data Presented at AAD March 28th, 2026 ET / March 29th, 2026 JST Photo: IFPA | All the Colors We Are This material is prepared and distributed solely for the purpose of providing information about Takeda's management or busine ss to shareholders, investors, and analysts, and is not intended to induce purchase or prescription of any specific drugs and other products. This material is not intended for healthcare professionals, patients, or other persons other than those ...

Protagonist Therapeutics Conference Call Summary Company Overview - **Company**: Protagonist Therapeutics (NasdaqGM:PTGX) - **Industry**: Biotechnology, specifically focused on peptide technology for drug development Key Points and Arguments 2026 Outlook - Protagonist Therapeutics is anticipating a significant year in 2026 with two potential FDA approvals for partnered products and ongoing data from its early pipeline [3][4] - The company has a strong financial position, funding new efforts with its own resources and maintaining a surplus cash balance, which will be used to maximize shareholder value [4] Product Pipeline - **IL-23 Receptor Antagonist**: Partnered with Johnson & Johnson (J&J), NDA filed in July 2025, with expected approval in Q3 2026 [4][5] - **Rusfertide (Hepcidin Mimetic)**: Partnered with Takeda, received priority review with NDA filed by the end of 2025, also expected approval in Q3 2026 [5][6] - The partnership with Takeda is structured as a 50-50 co-development and co-commercialization agreement, with an option for Protagonist to opt-in for a $400 million milestone payment [6][28] Market Potential - The oral IL-23 blocker is the first of its kind, with significant market potential as J&J's research indicates that over 75% of patients currently on injectables would switch to an oral option [14][15] - The company believes that the oral formulation could not only capture market share from injectables but also create a new market segment [15] Clinical Data and Efficacy - The company reported a 30% clinical remission rate in ulcerative colitis from phase two studies, indicating strong efficacy [17] - The mechanism of action targets the IL-23 receptor, which is overexpressed in gastrointestinal tissues, potentially leading to better outcomes in inflammatory bowel disease compared to existing treatments [19][20] Future Developments - Protagonist is advancing multiple assets, including oral IL-17 and oral hepcidin candidates, with phase one studies expected to yield important data [7][8][36] - The oral IL-17 candidate (PN-881) aims to achieve high potency and specificity, with a focus on both A and F isoforms, which is critical for efficacy in treating conditions like psoriasis [38][39] Strategic Considerations - The company is considering the balance between opting out of the rusfertide partnership for a substantial upfront payment versus co-promoting the drug, weighing the benefits of financial security against potential long-term gains [28][30] - Protagonist is also exploring the development of a franchise around IL-17 compounds, with a focus on psoriasis and potentially other indications [50][52] Competitive Landscape - The company acknowledges the competitive nature of the obesity and metabolic disease space, with plans to differentiate its oral triple G agonist from existing injectable options [54][55] - Protagonist aims to achieve both significant weight loss and improved safety profiles, positioning its products as versatile options for patients [59][60] Additional Important Insights - The company is committed to maintaining confidentiality around clinical data until strategic decisions are made, with plans to share findings at medical conferences rather than immediately [43] - Protagonist's approach to drug development emphasizes the advantages of peptides over small molecules, particularly in terms of potency and specificity [49] This summary encapsulates the key insights from the Protagonist Therapeutics conference call, highlighting the company's strategic direction, product pipeline, and market potential within the biotechnology sector.

Investment Rating - The report maintains a "Positive" outlook for the pharmaceutical and biotechnology industry [5] Core Viewpoints - Short-term fluctuations do not change the long-term growth trajectory of the innovative drug sector. Despite recent market volatility, the underlying logic for medium to long-term growth remains intact, driven by globalization, technological breakthroughs, and industry upgrades [8][12] - The focus has shifted from "can we go global" to "what progress has been made after going global," emphasizing the importance of overseas clinical deployment and milestone achievements for innovative drugs [13][14] - Breakthroughs in frontier technologies, particularly in small nucleic acids and CAR-T therapies, position Chinese companies to become core global assets [18][20] - The commercialization of innovative drugs is expected to lead to a profitability inflection point, with key companies entering a positive cycle of product volume growth and reinvestment in R&D [22] Summary by Sections 1. Short-term Fluctuations, Long-term Growth - The innovative drug sector has experienced significant volatility due to concentrated expectations and emotions, but the long-term growth trend remains unchanged [8][12] - The valuation of leading companies has reached reasonable levels, suggesting potential investment opportunities as market sentiment stabilizes [12] 1.1 Focus on Globalization Progress - The emphasis has shifted to the progress of products in overseas clinical trials, with a focus on key data readouts and milestone achievements [13][14] - Domestic bispecific antibodies are accelerating their global clinical trials, becoming core trading assets in the context of expiring patents for PD-(L)1 products [13] 1.2 Breakthroughs in Frontier Technologies - Chinese companies are leading in small nucleic acids and CAR-T therapies, with significant advancements in delivery technologies expanding treatment options beyond rare diseases [18] - In vivo CAR-T therapies have shown preliminary clinical effectiveness, with a growing number of transactions indicating a shift towards mainstream adoption [20] 1.3 Commercialization Driving Profitability - Leading innovative drug companies are entering a cycle of product volume growth that supports R&D reinvestment, with expectations for exceeding market performance in 2023 [22] - The upcoming earnings period in March-April 2026 is seen as a critical validation point for the sector [22] 2. Global New Drugs: Highlights in Autoimmunity and Oncology - The report highlights the approval of the world's first PD-L1/TGF-β bispecific antibody, showcasing the R&D capabilities of domestic companies [26][27] - The successful launch of innovative drugs in critical therapeutic areas reflects the growing strength of domestic pharmaceutical companies in addressing unmet medical needs [26][27]

Investment Rating - The report maintains a "Positive" outlook for the innovative pharmaceutical sector in China [5]. Core Viewpoints - Short-term fluctuations do not alter long-term growth prospects. The innovative drug sector has experienced increased volatility due to external factors, but the underlying logic for medium to long-term growth remains intact. The report suggests focusing on investment opportunities once market volatility stabilizes [8][12]. - Key investment themes include "outbound execution," "breakthroughs in cutting-edge technologies," and "profitability inflection points" [3][8]. Summary by Sections 1. Short-term Fluctuations, Long-term Growth - The innovative drug sector has been experiencing significant fluctuations since the beginning of the year, driven by investor sentiment and market adjustments. However, the long-term trends of globalization, technological breakthroughs, and industrial upgrades remain unchanged [12]. - The focus has shifted from "can we go abroad" to "what progress is made after going abroad," emphasizing the importance of clinical deployment and milestone achievements in overseas markets [13][14]. 1.1 Outbound Execution Becomes Key - The report highlights that the focus on outbound strategies has transitioned to the progress of products in overseas clinical trials. The performance of domestic dual antibodies in global clinical trials is becoming a focal point for the industry [13][14]. 1.2 Breakthroughs in Cutting-edge Technologies - Chinese companies are making significant advancements in small nucleic acids and cell therapies, positioning themselves as core assets in global transactions. The report notes that small nucleic acids are expanding beyond rare diseases and metabolic disorders, with breakthroughs in delivery technologies [18][19]. - In vivo CAR-T therapies are showing promising initial clinical results, with a growing number of transactions in this area, indicating a shift towards more mainstream applications [20][21]. 1.3 Commercialization Drives Profitability Inflection Points - Leading innovative pharmaceutical companies are entering a positive cycle of product commercialization and reinvestment in R&D. The report anticipates that 2026 will be a critical year for profitability, with key performance periods in March and April serving as important validation points [22][23]. 2. Global New Drugs: Highlights in Autoimmunity and Oncology - The report discusses the approval of the world's first PD-L1/TGF-β dual antibody, highlighting the strength of domestic R&D capabilities. This drug, approved for advanced gastric cancer, showcases the potential for domestic companies to achieve significant milestones in drug development [26][27].

Company Overview - Protagonist Therapeutics, Inc. (NASDAQ:PTGX) was founded on August 22, 2006, and is headquartered in Newark, California. The company focuses on developing peptide-based therapies targeting rare diseases, hematology, and immunology [4]. Recent Developments - H.C. Wainwright raised its price target on Protagonist Therapeutics to $117 from $80, reiterating a Buy rating based on the company's drug development track record and probability-of-success assumptions across multiple programs, including PN-8047 and obesity assets [1]. - A company director sold 20,000 shares valued at approximately $1.7 million, an event that investors are monitoring alongside ongoing pipeline developments [3]. - Protagonist Therapeutics reported two potential late-stage assets, Icotrokinra and Rusfertide, with New Drug Applications (NDAs) submitted for plaque psoriasis and polycythemia vera expected in 2025 [3]. Pipeline and Partnerships - The company anticipates multiple Phase 2 and Phase 3 readouts across immunology, hematology, and obesity indications [3]. - Existing partnerships with Johnson & Johnson and Takeda include milestone and royalty structures that support non-dilutive funding [3].

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]

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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]