Core Insights - Innovent Biologics showcased pre-clinical study results for IBI3011 and IBI3034 at the ACR Annual Meeting 2025, highlighting their potential in treating inflammatory and autoimmune diseases [1][2][5]. Group 1: IBI3011 - IBI3011 is a humanized monoclonal antibody that inhibits IL1, IL33, and IL36, effectively alleviating conditions like gout and arthritis in animal models [2][3]. - The drug demonstrates favorable pharmacokinetic properties and safety in monkeys, with a high concentration formulation developed for subcutaneous administration [3][4]. - IBI3011 has received IND approval from China's National Medical Products Administration for acute gouty arthritis, positioning it as a best-in-class therapy with improved response depth and convenience compared to existing treatments [4][7]. Group 2: IBI3034 - IBI3034 is a TACI/BCMA chimeric fusion protein that modulates B lymphocytes and serum immunoglobulin, showing promise for treating B cell-related autoimmune diseases [5][6]. - The drug features half-life extension technology, allowing for a longer dosing interval compared to current therapies, and is well tolerated in monkeys at a dosage of 200 mg/kg [5][6]. - Ongoing IND-enabling studies for IBI3034 aim to further establish its efficacy and safety profile in various autoimmune conditions [6][7]. Group 3: Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for oncology, autoimmune, cardiovascular, and metabolic diseases [8][9]. - The company has launched 16 products and has multiple assets in various stages of clinical trials, indicating a robust pipeline and commitment to addressing unmet medical needs [9].

Financial Data and Key Metrics Changes - Revenue from continuing operations is projected to be in the range of $170-$174 million for fiscal year 2025, reflecting an 8%-11% growth over the prior year [12] - Adjusted EBITDA loss in Q3 was $600,000, showing significant improvement with a positive cash flow from operating activities of approximately $2.2 million for the quarter [31][32] Business Line Data and Key Metrics Changes - Revenue from Life Sciences Services increased by 16% year-over-year, accounting for 55% of total revenue, with biostorage bioservices revenue up by 21% [6][12] - Revenue from commercial cell and gene therapy support grew 36% year-over-year to $8.3 million, driven by the global adoption of these therapies [5][12] - Life Sciences Products revenue grew 15% year-over-year, supported by improved demand for cryogenic systems [6][12] Market Data and Key Metrics Changes - The company supports the largest portfolio of clinical and commercial gene therapies globally, with 745 global clinical trials, including 83 in phase three [11] - Despite macroeconomic challenges, the regenerative therapies market remains resilient, indicating strong future growth potential [5][10] Company Strategy and Development Direction - The company is focused on expanding its product portfolio and enhancing its service offerings, including the launch of new cryogenic shippers and condition monitoring solutions [7][8] - A strategic partnership with DHL Group aims to enhance the company's positioning in the APAC and EMEA regions, leveraging DHL's global scale [10] - The company is advancing its Global Supply Chain Centers in Paris and California to optimize operations and client support [9] Management's Comments on Operating Environment and Future Outlook - Management acknowledges macro uncertainties, including the government shutdown and tariff landscape, but remains optimistic about long-term growth in the cell and gene therapy market [17][18] - The company anticipates continued growth in commercial therapies and clinical trials, with expectations for additional application filings and therapy approvals [11][18] Other Important Information - The company has received ISO certification for handling cell therapy-based materials, reinforcing its position as a best-in-class provider [66][68] - The company is not expecting growth in China for 2026 but is working on strategies for future growth in that region [72] Q&A Session Summary Question: Concerns about sequential revenue decline despite positive momentum - Management explained that guidance reflects macro uncertainties, balancing growth momentum with cautious outlook due to government shutdown and tariffs [17][18] Question: Impact of recent FDA draft guidance on clinical trials - Management noted that new FDA guidance could drive more activity in biologics approvals, positively impacting the company [22][24] Question: EBITDA guidance and profitability expectations - Management indicated strong progress towards positive adjusted EBITDA, with expectations to reach it by year-end [31][33] Question: Trends in gene therapy and cell therapy markets - Management highlighted ongoing investment in gene therapy despite some financing challenges, with strong activity in cell therapy [26][45] Question: Impact of government shutdown on operations - Management stated that the shutdown has caused delays in filing activities but has not significantly impacted service demand [50][51] Question: Updates on IntegriCell and revenue generation - Management confirmed that revenue is being generated from IntegriCell facilities, with expectations for significant growth post-2026 [90]

Financial Performance - Q3 2025 revenues were $16.7 billion, a 7% decrease compared to Q3 2024, primarily due to a decline in COVID-19 product revenues[37] - Adjusted diluted EPS for Q3 2025 was $0.87, a 16% decrease compared to $1.06 in Q3 2024, impacted by a $1.35 billion Acquired In-Process R&D charge related to the 3SBio licensing agreement[37] - The company reaffirms its 2025 revenue guidance of $61.0 to $64.0 billion and raises and narrows its adjusted diluted EPS range to $3.00 to $3.15[47] Strategic Initiatives - The company reached an agreement with the U S Government to provide greater clarity and reduce uncertainty around tariffs and pricing[7, 8] - The company proposed acquisition of Metsera to accelerate and expand presence in obesity with highly differentiated medicines[7, 8] - The company closed of 3SBio Licensing Agreement, which is a potential foundational backbone in the company's Oncology portfolio[7, 8] Pipeline Development - PADCEV + pembro significantly and meaningfully improved overall and event-free survival vs surgery alone[11] - Single Arm Phase 2 PHAROS Trial OS showed 67% at 49 months, 54% at 47 months, 49% at 45 months[13] - XTANDI + Leuprolide showed HR (95% CI): 0.597 (0.444-0.804) P = 0.0006[17] Cost Management - The company expects $7.2 billion in total net cost savings by the end of 2027 while also reinvesting $500 million to strengthen R&D productivity[43]

Financial Data and Key Metrics Changes - The company reported record royalty revenue of $236 million, a 52% increase year over year, contributing to total revenue of $354 million, which reflects a 22% growth year over year [4][27] - Adjusted EBITDA grew by 35% to $248 million, outpacing top-line growth, showcasing the strength of the royalty-based business model [4][30] - The company raised its full-year 2025 guidance, projecting total revenue of $1.3 billion to $1.375 billion, representing 28% to 35% growth over 2024 [7][31] Business Line Data and Key Metrics Changes - Darzalex Subcutaneous sales increased by 20% to $3.7 billion, with a significant market share gain of approximately 5.7 percentage points across all therapy lines [10][11] - Fesgo generated revenue of approximately $2.3 billion, reflecting a 54% year-over-year increase, with conversion from intravenous therapies reaching 51% [13] - Vyvgart Hytrulo saw total sales increase by 96% year-over-year to $1.13 billion, driven by the subcutaneous formulation enabling self-injection [14][16] Market Data and Key Metrics Changes - The company achieved 13 out of 15 growth catalysts year to date, including new product approvals and expanded indications [5] - The approval of Darzalex Subcutaneous for smoldering multiple myeloma in Europe is expected to expand its market reach significantly [6] - The subcutaneous formulation of Ocrevus is projected to represent an incremental $2 billion opportunity, with analysts estimating total brand sales to reach $10 billion by 2028 [18][19] Company Strategy and Development Direction - The acquisition of Electrovive aims to enhance at-home administration of biologic therapies, expanding the portfolio of drug delivery technologies [8] - The company is focused on patient-centric drug delivery solutions, leveraging its ENHANZE technology alongside new innovations like HyperCon [9] - The strategic goal is to maintain strong momentum in transforming the subcutaneous delivery landscape, with a robust pipeline of future royalty streams [24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued strength of the core ENHANZE business and the accelerating momentum across the partner portfolio [34] - The company anticipates sustained royalty contributions from all products through at least 2030, ensuring a robust revenue stream [24] - Management highlighted the importance of ongoing discussions for new ENHANZE agreements, indicating strong interest from potential partners [48] Other Important Information - The company reported a strong balance sheet with cash and marketable securities of $702 million as of September 30, 2025, up from $596.1 million at the end of 2024 [28] - The net debt-to-EBITDA ratio was 0.9 times at the end of the third quarter, indicating a solid financial position [28] Q&A Session Summary Question: Thoughts on capital allocation and debt management - Management indicated a balanced approach to capital allocation, with plans to pay down debt while considering share repurchases and new acquisition opportunities [35][36] Question: Awareness of Electrovive technology among partners - Management noted that there is good awareness of the HyperCon technology among current partners, with strong support for potential collaboration [39] Question: Market growth sources for products - Management highlighted that market growth is coming from both share gains from other therapies and earlier use in treatment [40] Question: Future M&A opportunities - Management stated that while they are actively looking for new opportunities, it is unlikely there will be another acquisition this year following the Electrovive deal [42][43] Question: Updates on pipeline products - Management confirmed that there have not been any public updates from ViiV or Acumen recently, but they are awaiting further information [57]

Core Insights - Takeda Pharmaceutical Company Limited reported a second-quarter 2025 adjusted net profit of 201.6 billion Japanese yen (approximately $1.31 billion), with earnings per American Depositary Share (EPADS) of 43 cents, missing analyst expectations of 44 cents [1][2] - Total sales for the quarter were $7.52 billion (1.18 trillion yen), falling short of consensus estimates of $8.08 billion [1][3] Financial Performance - First half 2025 sales decreased by 6.9% (-3.9% at constant currency) to 2.22 trillion yen, while core operating profit dropped 11.2% to 639.2 billion yen [3] - Neuroscience revenue significantly impacted the decline, with second quarter Neuroscience sales falling 33% to 97.5 billion yen [3] - Vaccine sales decreased by 21.1% to 20.2 billion yen, while cancer drug sales increased by 4.3% to 149.1 billion yen [3] Segment Performance - Gastrointestinal sales rose by 2% to 353.5 billion yen, while revenue from rare diseases fell by 2.7% to 184.1 billion yen [4] Outlook - Takeda updated its full-year 2025 outlook, revising core revenue guidance from 4.53 trillion yen to 4.50 trillion yen [5] - The company expects core operating profit of 1.13 trillion yen, down from prior guidance of 1.14 trillion yen, and core earnings of 479 yen, reduced from previous guidance of 485 yen [5] Stock Performance - Following the earnings report, TAK stock was trading 2.25% lower at $13.46 in premarket trading [6]

Financial Data and Key Metrics Changes - Revenue in H1 was just over JPY 2,200 billion, a decrease of 6.9% or 3.9% at constant exchange rates [11] - Core operating profit was JPY 639.2 billion, a year-on-year decrease of 11.2% at actual FX or 8.8% at constant rates [11] - Reported operating profit declined by 27.7% due to larger impairment losses this fiscal year [11] - Core EPS was JPY 279 and reported EPS was JPY 72, reflecting a 40% decline in reported net profit [11] Business Line Data and Key Metrics Changes - Growth on launch products grew 5.3% at constant exchange rates, representing over 50% of revenue [12] - ENTYVIO grew at 5.1% at constant rates, with a revision of full year forecast for NTDO to 6% at constant exchange rates [12][13] - TAKHZYRO grew steadily with 5.9% growth at constant rates [13] - Immunoglobulin and albumin are expected to grow at high single digits [15] Market Data and Key Metrics Changes - The U.S. market for ENTYVIO is seeing increased active pen patients, but revenue growth has been slightly below expectations [12][13] - The impact of Medicare Part D redesign is affecting several products in the U.S. [14] - The strength of the euro against the Brazilian real is impacting QDenga sales [16] Company Strategy and Development Direction - The company is entering a new business cycle with the Vyvanse generic impact mainly behind it, with potential launches for three new products [7] - The partnership with Innovent Biologics is expected to enhance the oncology pipeline significantly [8][34] - The company is focused on leveraging technology and AI to transform operations [7] Management's Comments on Operating Environment and Future Outlook - Management expects better growth rates for the full fiscal year despite H1 being impacted by loss of exclusivity [22] - The company is committed to maintaining cost discipline while investing for future growth [22] - Management acknowledges the challenges posed by foreign exchange fluctuations, particularly the euro's strength [20][68] Other Important Information - The company has revised its full year guidance for corporate profits and core EPS to reflect unfavorable changes in product mix and transaction FX dynamics [20] - The dividend outlook remains at JPY 200 per share for the full year [21] Q&A Session All Questions and Answers Question: Regarding the Innovent deal and R&D spending - Management emphasized commitment to investment in oncology while managing R&D expenses effectively, with a focus on achieving mid to long-term margins driven by top-line growth [64][66] Question: About the growth rate of ENTYVIO and competitive pressures - Management noted that ENTYVIO remains a market leader but faces intensified competition, particularly in Crohn's disease, impacting growth expectations [93][94] Question: On the gross margin trend and revised guidance - Management explained that the gross margin decline is primarily due to transaction effects and product mix changes, with expectations for lower gross margins in the second half [82][84] Question: About the Innovent partnership and data replicability - Management expressed confidence in the data from the Innovent partnership, noting significant due diligence was conducted to ensure data applicability in global trials [96]

Financial Performance - FY2025 H1 revenue decreased by 69% to JPY 22195 billion[21], a 39% decrease at CER[21] - FY2025 H1 core operating profit decreased by 112% to JPY 6392 billion[21], an 88% decrease at CER[21] - FY2025 H1 adjusted free cash flow increased by 1123% to JPY 5254 billion[21] - Growth & Launch Products increased by 53% at CER in H1[18, 24] - The company maintains broadly flat revenue guidance at CER[18, 36] Pipeline Update - Rusfertide and oveporexton are on track to file within FY2025[18] - Zasocitinib Ph3 psoriasis data is expected in H2[18] - Mezagitamab Ph1b IgAN data show durable eGFR over 18 months[18] - A partnership with Innovent Biologics to bolster the oncology pipeline[18] Oncology Partnership - Takeda entered into a license and collaboration agreement with Innovent Biologics for rights to IBI343 and IBI363, and an exclusive option to license rights to IBI3001, in each case worldwide outside of mainland China, Hong Kong, Macau and Taiwan[12] - IBI363 has demonstrated encouraging data across multiple solid tumor types, with a confirmed objective response rate (cORR) of 367% in sqNSCLC (IO-Refractory) and a median overall survival (mOS) of 153 months at 1/15 mg/kg[80] - IBI343 has shown robust monotherapy activity and a favorable safety profile, with a cORR of ~30% in 2L Pancreatic Cancer (CLDN182 1+/2+/3+ ≥60% expression) and an mOS of 121 months[94]

Core Insights - Takeda announced earnings results for the first half of fiscal year 2025, which ended on September 30, 2025, and provided an updated full-year outlook [1] Financial Performance - The results for the first half are in line with expectations for core business progress during this transitional year focused on new product launches [1] Management Commentary - CEO Christophe Weber highlighted that the updated full-year outlook reflects impairment charges [1]

Core Insights - Phathom Pharmaceuticals announced the publication of additional analyses from its pivotal Phase 3 pHalcon-NERD-301 trial for VOQUEZNA (vonoprazan) in treating Non-Erosive Reflux Disease (NERD), highlighting its potential to alleviate nighttime GERD symptoms [1][8] Group 1: Clinical Findings - Nighttime GERD symptoms affect up to 80% of patients, leading to impaired sleep and increased health risks, yet many patients do not find relief with existing treatments [2][9] - The Phase 3 trial involved 772 patients, randomized to receive either VOQUEZNA (10 mg or 20 mg) or placebo, with significant findings on symptom relief [3][5] - VOQUEZNA demonstrated rapid and sustained relief of nighttime GERD symptoms, with heartburn-free nights increasing significantly after the first dose and maintained through 24 weeks [5][6] Group 2: Efficacy Data - At week 4, patients on VOQUEZNA 10 mg and 20 mg reported heartburn-free nights of 59.9% and 56.4%, respectively, compared to 43.3% for placebo [6] - Improvements in nocturnal symptom severity and sleep-related impacts were sustained throughout the treatment period, with median heartburn-free nights remaining above 70% [5][6] - VOQUEZNA was generally well tolerated, with common adverse events being mild and occurring in less than 5% of patients [6][7] Group 3: Product Information - VOQUEZNA is a potassium-competitive acid blocker (PCAB) approved for treating Erosive and Non-Erosive GERD, as well as H. pylori infection [10][30] - Approximately 38 million U.S. adults suffer from Non-Erosive GERD, with around 15 million receiving prescription treatment annually [9]

PresentationZhengwei SongDirector of IR & Financial Strategy Okay. So good evening, and good morning, dear investors and analysts. So thank you all for joining Innovent Investor call today. Earlier today, we just announced a significant global strategic collaborations with Takeda. So we are hosting this call to share details and to discuss the strategic importance with us. So before we begin, I'm very honored to introduce a special guest from our partner Dr. P.K. Morrow, the Head of Oncology Therapeutic Are ...