®Agreement provides Takeda with exclusive access to ENHANZE drug delivery technology for vedolizumab ® SAN DIEGO, Jan. 8, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) today announced the Company entered into a global collaboration and exclusive license agreement with Takeda in December 2025. The agreement provides Takeda with access to Halozyme's ENHANZE drug delivery technology, the leading proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20), for use with vedolizumab. Vedol ...

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 Q1 revenue was JPY 1,1067 billion, a decrease of 84% compared to FY2024 Q1[16] - FY2025 Q1 core operating profit was JPY 3218 billion, a decrease of 158% compared to FY2024 Q1[16] - FY2025 Q1 reported operating profit increased by 110% to JPY 1846 billion, primarily due to lower impairment and restructuring expenses[16, 28] - Adjusted free cash flow for FY2025 Q1 was JPY 1901 billion, a significant increase of 7036% compared to FY2024 Q1[16] - Takeda maintains its FY2025 forecast with revenue of JPY 4,5300 billion, a decrease of 11%[34] Portfolio Performance - Growth & Launch Products increased by 50% at CER in Q1[18] - Growth & Launch Products accounted for JPY 5581 billion (USD 39 billion), representing 50% of total revenue[19] - VYVANSE revenue is expected to decline by JPY 1096 billion (-30% at CER) in FY2025[34] Pipeline and Milestones - Oveporexton (TAK-861) Phase 3 met all primary and secondary endpoints, showing transformative potential in NT1[40] - Zasocitinib is in Phase 3 for Psoriasis with a head-to-head start vs deucravacitinib[46, 49] - Rusfertide is targeting US filing for Polycythemia Vera in H1 FY25[49]