Takeda Pharmaceutical Company (NYSE:TAK) Update / briefing March 28, 2026 08:30 PM ET Company ParticipantsChinwe Ukomadu - Head of Gastrointestinal and Inflammation Therapeutic Area UnitElizabeth Borgeson - Investor Relations OfficerHidemaru Yamaguchi - Managing DirectorHiroyuki Matsubara - Equity Research Senior AssociateJulie Kim - CEO-ElectRhonda Pacheco - President of U.S. Business UnitTony Ren - Head of Asia Healthcare ResearchConference Call ParticipantsSeiji Wakao - Executive Director and Senior Anal ...

Summary of Protagonist Therapeutics Conference Call Company Overview - **Company**: Protagonist Therapeutics (NasdaqGM:PTGX) - **Key Product**: ICOTYDE, an oral peptide-targeted therapy for moderate-to-severe plaque psoriasis Key Industry and Company Insights FDA Approval Announcement - Protagonist announced FDA approval of ICOTYDE for treating moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 and older who weigh at least 40 kg [2][4] - ICOTYDE is the first oral peptide-targeted therapy that blocks the IL-23 pathway by targeting the IL-23 receptor, contrasting with existing injectable antibodies that target the IL-23 ligand [4][6] Clinical Development and Efficacy - The approval was supported by a comprehensive phase 3 program involving approximately 2,500 patients across four studies, meeting all primary endpoints and demonstrating a favorable safety profile [7][9] - ICOTYDE has a broad label based on studies in both adults and adolescents, including head-to-head studies showing superiority to the active comparator, Sotyktu [8] Financial Implications - The approval triggers a $50 million milestone payment from Johnson & Johnson (J&J) and initiates a royalty-based revenue stream [10] - Protagonist has earned a total of $387 million in milestone payments since the collaboration with J&J began in 2017, with an additional $580 million in potential future milestones [10][11] - The royalty structure includes tiered royalties ranging from 6% to 10% on global net sales, with a weighted average of 7.25% at $4 billion in annual sales [12] Strategic Partnerships - Protagonist emphasizes the importance of its collaboration with J&J, which is responsible for commercialization and ongoing clinical trials of ICOTYDE [13] - The partnership has been described as a win-win, highlighting the potential blockbuster category of ICOTYDE [13] Pipeline and Future Developments Additional Assets - Protagonist is expecting FDA approval for rusfertide, a hepcidin mimetic for polycythemia vera, in the third quarter of the year [14][15] - The company is developing new R&D assets, including an oral IL-17 peptide antagonist (PN881) and an oral triple GLP GIP GCG agonist (PN477) for obesity [16][17] Financial Position and Shareholder Value - Protagonist aims to fund its R&D programs without equity offerings, focusing on returning capital to shareholders through potential share buybacks [19][20] - The company is exploring partnerships for its IL-17 and obesity programs, with ongoing dialogues with multiple parties [107] Market Position and Competitive Landscape - Protagonist believes ICOTYDE can capture market share from existing injectables and attract patients currently not on treatment due to aversion to injections [53][54] - The company is focused on differentiating its products in a competitive landscape, particularly in the obesity space where unmet needs exist [77][96] Conclusion - The approval of ICOTYDE marks a significant milestone for Protagonist, validating its peptide technology platform and setting the stage for future growth and product-driven cycles [20][22] - The company is well-positioned financially and strategically to expand its pipeline and enhance shareholder value through innovative therapies and partnerships.

US FDA Approval of ICOTYDETM (Icotrokinra) For Treatment of Moderate -to - Severe Plaque Psoriasis Dinesh V. Patel, Ph.D. President & CEO Conference Call March 18, 2026 1 Legal Disclaimer This presentation and any accompanying oral presentation contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act. All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements regarding: the timing a ...

Protagonist Therapeutics FY Conference Summary Company Overview - Protagonist Therapeutics focuses on innovation through novel peptides, with expertise in both injectable and oral peptides since 2008, a time when peptides were largely overlooked [8][9] - The company went public in 2016 with the assistance of Barclays [4] Key Assets and Developments - **Icotrokinra**: An oral IL-23 blocker, the first of its kind, with phase 3 data showing promise. Approval is sought for psoriasis, with additional studies in psoriatic arthritis, ulcerative colitis, and Crohn's disease [9][10][12] - **Rusfertide**: A weekly injectable mimetic of hepcidin, targeting polycythemia vera, with a partnership with Takeda established in January 2024. Priority review has been granted, potentially accelerating approval [14][15][16] - Both drugs are expected to be approved in Q3 2026, marking significant milestones for the company [15] Future Pipeline - Protagonist is developing an oral IL-17 program and has preclinical studies in IL-4, aiming to create a portfolio of oral peptides to differentiate from existing injectable options [19][22][27] - The company is also working on an oral triple GLP-GIP-GCG for obesity, with clinical studies expected to begin in the second half of the year [25][131] Clinical Strategy and Evaluation - The company emphasizes rigorous preclinical evaluation to ensure oral bioavailability and efficacy, taking longer than typical assessments to select the right candidates [36][38] - For icotrokinra, J&J is leading the launch strategy, leveraging extensive data from head-to-head studies against competitors [41][45] Competitive Landscape - Protagonist acknowledges competition in the hepcidin space but believes their approach of creating a mimetic offers a distinct advantage over others enhancing endogenous hepcidin production [62][66][70] - The company is confident in its market position due to its early development stage and unique drug mechanisms [78] Business Development and Partnerships - Protagonist plans to take assets to clinical proof of concept before seeking partnerships for larger indications, while considering retaining more backend economics through creative cost-sharing arrangements [102][123] - The company aims to avoid external fundraising, focusing on internal funding for studies [125] Obesity Market Insights - The obesity treatment landscape is seen as a significant opportunity, with Protagonist aiming to differentiate through oral peptides in a crowded market [128][131] - The company is developing both weekly subcutaneous and daily oral formulations, with a focus on creating a diverse portfolio to address various patient needs [133][137] Conclusion - Protagonist Therapeutics is positioned to leverage its innovative peptide technology and strategic partnerships to address unmet medical needs in various therapeutic areas, particularly in immunology and obesity, while maintaining a strong focus on clinical efficacy and market differentiation [131][140]

Protagonist Therapeutics Conference Call Summary Company Overview - **Company**: Protagonist Therapeutics (NasdaqGM:PTGX) - **Focus**: Peptide therapeutics, with a history of development since 2008, aiming to address unmet medical needs through innovative oral peptide solutions [5][6] Key Points and Arguments Product Pipeline and Development - **Late-Stage Assets**: Protagonist has two late-stage partnered assets expected to receive approval in 2026, with outstanding Phase 3 data [5][6] - **Partnerships**: Collaborations with big pharma, such as Takeda and Johnson & Johnson, provide financial flexibility and support for R&D [6][27] - **Rusfertide**: Targeting polycythemia vera, with a priority review received, aiming for approval in Q3 2026. The disease affects approximately 100,000 patients in the U.S. [14][15][18] - **Icotrokinra**: Partnered with J&J, targeting psoriasis with promising Phase 3 data and an NDA filed in July 2025, expected approval in Q3 2026 [29][30] Market Opportunities - **Rusfertide**: Addresses uncontrolled hematocrit levels in polycythemia vera, a significant unmet need in treatment options [17][18] - **Icotrokinra**: Positioned as the first oral IL-23 antagonist, with a large market opportunity as 75%-90% of injectable patients may switch to an oral option [34][35] - **Obesity Market**: Protagonist is developing oral triple agonists, which could treat billions of patients, differentiating from existing injectable options [77][78] Financial Aspects - **Royalty Structure**: For rusfertide, a 21% royalty on the first $1.5 billion in sales, increasing to 29% thereafter. This structure supports the decision to opt-out of full partnership with Takeda [20][21][23] - **Sales Milestones**: Expected sales milestones for icotrokinra and rusfertide combined are projected at $1.2 billion, with achievable targets [31][32] Future Developments - **PN-881**: Currently in Phase 1 studies, targeting IL-17 blockers, with data expected in Q3 2026 to determine further development [60][63] - **Anti-Obesity Candidates**: Development of both oral and subcutaneous triple agonists, with clinical proof of concept expected soon [78][83] - **Financial Stability**: The company has a strong balance sheet, allowing for continued investment in its pipeline without the need for shareholder dilution [92] Additional Important Insights - **Differentiation Strategy**: Protagonist aims to create unique solutions in crowded markets by focusing on oral formulations and addressing specific unmet needs [8][12] - **Safety and Efficacy**: Emphasis on the safety profile of new drugs, particularly for chronic conditions where long-term treatment is necessary [49][50] - **Market Dynamics**: The company is aware of the competitive landscape and is strategically positioning its products to capture market share from existing therapies [41][42] This summary encapsulates the key insights from the Protagonist Therapeutics conference call, highlighting the company's strategic direction, product pipeline, market opportunities, and financial outlook.

Core Insights - Takeda Pharmaceutical Company Limited (NYSE:TAK) is recognized as a promising stock under $20, particularly following the FDA's acceptance of the New Drug Application for rusfertide, a first-in-class hepcidin mimetic aimed at treating polycythemia vera, a rare blood cancer [1][4] Regulatory Developments - The FDA has granted Priority Review for rusfertide, with a Prescription Drug User Fee Act action date set for Q3 2026, indicating the drug's potential to meet significant unmet medical needs [2] - The regulatory submission is backed by data from the Phase 3 VERIFY study and long-term results from Phase 2 REVIVE and THRIVE trials, which demonstrated that rusfertide significantly improved response rates when added to standard care [2] Clinical Efficacy - Clinical findings revealed that rusfertide more than doubled response rates compared to standard treatments alone, with key benefits including sustained control of hematocrit levels below 45%, reduced need for phlebotomy procedures, and improvements in patient-reported symptoms like fatigue [2][3] Collaboration and Commercialization - Under a 2024 collaboration agreement, Takeda is responsible for the regulatory strategy and global filings, while Protagonist Therapeutics retains an option to co-commercialize rusfertide in the US through a profit-sharing model [3] - Rusfertide functions by mimicking the hormone hepcidin to regulate iron homeostasis, targeting the disease's underlying mechanism, and if approved, it will offer a novel subcutaneous treatment option for patients [3]

Core Insights - Takeda had a successful year in 2025, with three new molecular entities (NMEs) achieving positive Phase III readouts: rusfertide, oveporexton, and zasocitinib [2] - The company is preparing for the launch of these drugs and is also experiencing a maturing in-line portfolio [2] - A new CEO is set to join in June, prompting discussions on the future direction of the company [2]

Protagonist Therapeutics FY Conference Summary Company Overview - **Company**: Protagonist Therapeutics (NasdaqGM:PTGX) - **Focus**: Peptide therapeutics with a transition from a platform company to commercialization through partnerships with J&J and Takeda [3][4] Key Points Current Position and Strategy - Protagonist has achieved financial independence, allowing it to fund future efforts without diluting shareholders [4] - The company emphasizes differentiation in its drug development, focusing on unmet needs [4] Product Pipeline - **Iko (oral IL-23 blocker)**: - First-in-class oral IL-23 blocker with a strong safety profile, described as having placebo-like safety [6][7] - Expected to dominate the psoriasis market due to its unique oral formulation and proven efficacy [7][10] - Clinical data shows over 70% of patients achieving significant skin clearance in 16 weeks [9] - Market research indicates a potential shift from injectables to oral options, with 75%-90% of injectable patients willing to switch [10] - Estimated market potential for Iko is around $10 billion to $12 billion, with competitors like Skyrizi moving towards $20 billion [14] - **Psoriatic Arthritis**: - Market size is smaller compared to psoriasis and IBD, estimated at 10%-15% of the total market [16] - Success in psoriasis is expected to translate to psoriatic arthritis, with a 100% success rate observed in IL-23 blockers [15] - **Inflammatory Bowel Disease (IBD)**: - Phase II data shows 30% clinical remission in ulcerative colitis (UC) patients, indicating strong potential [17][18] - The drug targets overexpressed receptors in GI tissues, which may enhance efficacy [18] - The company plans to include both biologic-naive and experienced patients in Phase III studies [19] - **Rusfertide**: - A first-in-class treatment for polycythemia vera (PV), with priority review status expected to lead to potential approvals [28] - Estimated peak sales opportunity of $1 billion to $2 billion, with a focus on addressing uncontrolled hematocrit levels [30][33] - The U.S. prevalence of PV is around 150,000-160,000 patients, with 80,000-100,000 currently on treatment [33] Financial Considerations - Protagonist has opted out of certain partnership agreements to retain a higher percentage of revenue, with a royalty structure of 21% up to $1.5 billion in net sales and 29% beyond that [41][42] - The company is considering share buybacks to return value to shareholders, emphasizing its strong cash flow and R&D pipeline [53] Future Directions - Protagonist is open to exploring partnerships for larger indications while maintaining independence for smaller ones [46] - The company is expanding its research capabilities beyond peptides, including small molecules and oligonucleotides, to address unmet needs [57] Additional Insights - The company believes that the current market dynamics and its innovative pipeline position it well for future growth, despite market volatility [53] - Protagonist's strategy includes leveraging partnerships for commercialization while focusing on its core competencies in drug development [46][47]

Core Viewpoint - Takeda and Protagonist Therapeutics announced that the FDA accepted the New Drug Application for rusfertide and granted it Priority Review, marking a significant step for this investigational treatment for polycythemia vera [1] Company Summary - Takeda is collaborating with Protagonist Therapeutics on rusfertide, which is a first-in-class hepcidin mimetic peptide therapeutic [1] - The FDA's acceptance of the NDA indicates a positive regulatory outlook for the drug, which targets a specific patient population [1] Industry Summary - The acceptance of rusfertide by the FDA highlights ongoing innovation in the treatment of polycythemia vera, a condition that currently has limited therapeutic options [1] - The Priority Review designation suggests that the FDA recognizes the potential significance of rusfertide in addressing unmet medical needs in this therapeutic area [1]

Core Insights - The company has submitted a New Drug Application (NDA) for rusfertide to the US Food and Drug Administration (FDA), with potential approval and launch expected within the year [1] - The company plans to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window anticipated to open in Q2 [1] - A U.S. regulatory decision for ICOTYDETM (icotrokinra) is expected in 2026, with a potential launch also anticipated this year [1] - Completion of Phase 1 for PN-881 is expected by mid-2026 [1] - The pre-clinical pipeline has been expanded with novel wholly-owned candidates, including PN-477, which is an oral and subcutaneous formulation [1]