他曾任 Shire PLC (“Shire”) 特殊药品业务部前总裁，拥有超过 30 年涵盖神经科学、罕见疾病及特殊药品领域的丰富经验，并曾在 Astra-Merck 与 AstraZeneca PLC 担任高管职务作为领导者，他在中枢神经系统 (“CNS”) 领域项目中，于晚期临床研发、全球商业化及资本筹集方面拥有公认的成功经验此次任命正值 Helus Pharma 推动研发管线迈向关键临床里程碑，包括预计本季度发布的 HLP004 II 期数据与预计今年晚些时候发布的 HLP003 III 期顶线数据 本新闻稿构成该公司于 2025 年 12 月 30 日发布的补充招股书中所指的“指定新闻稿”；该补充招股书作为公司 2025 年 9 月 17 日发布的简式基础储架招股说明书的补充，已于 2025 年 12 月 19 日完成修订。 波士顿和多伦多, Feb. 11, 2026 (GLOBE NEWSWIRE) -- Helus PharmaTM (“Helus”) (Nasdaq: HELP) (Cboe CA: HELP) 是一家临床阶段制药公司，致力于通过开发新型血清素能激动剂 (“NSAs”) 推动心 ...

Former President of Shire PLC’s (“Shire”) Specialty Pharmaceutical business, with more than 30 years of experience across neuroscience, rare disease, and specialty pharmaceuticals, including senior leadership roles at Astra-Merck and AstraZeneca PLCProven leader in late-stage clinical development, global commercialization, and capital formation across central nervous system (“CNS”) programsAppointed as Helus Pharma advances its pipeline toward key clinical milestones, including expected Phase 2 data for HLP ...

Core Insights - Takeda Pharmaceutical revised its full-year revenue guidance downward to JPY 4.53 trillion, reflecting a low single-digit decline at constant exchange rates due to stronger-than-anticipated erosion of Vyvanse generics in the U.S. [1][7] - The company maintained its full-year guidance for core operating profit at JPY 1.15 trillion and core EPS at JPY 486, supported by disciplined cost management [1][7] - Takeda reported adjusted free cash flow of JPY 625.9 billion for the period, indicating strong cash generation despite a $1.2 billion upfront payment to Innovent Biologics [2][7] Financial Performance - For the nine-month period, Takeda's revenue was just over JPY 3.4 trillion, down 3.3% year over year (down 2.8% at constant exchange rates) [3] - Core operating profit decreased by 3.4% year over year to JPY 971.6 billion, while reported operating profit rose by 1.2% to JPY 422.4 billion [3] - Core EPS was reported at JPY 428, with reported EPS at JPY 137 [3] Growth Drivers - Growth-and-launch products accounted for over 50% of total revenue, growing 6.7% year to date, driven by Entyvio and vaccines [5][8] - Entyvio experienced a growth of 7.4% at constant exchange rates, attributed to strong third-quarter performance and formulary wins [9] - Qdenga vaccine growth accelerated to 22.1%, primarily driven by demand in Brazil [10] Pipeline Developments - Takeda is preparing for several late-stage product launches, with three key pipeline assets—oveporexton, rusfertide, and zasocitinib—expected to shape future growth [4][11] - Positive phase III readouts for oveporexton and rusfertide have led to NDA filings, with launches planned within the current calendar year [6][11] - Zasocitinib showed significant efficacy in psoriasis treatment, with a summer submission target and a potential launch in 2027 [14] Leadership Transition - CEO Christophe Weber announced his transition from the main presenter role, with Julie Kim set to take over leadership in June [17]

Takeda Pharmaceutical Company (NYSE:TAK) Q3 2026 Earnings call January 29, 2026 05:30 AM ET Company ParticipantsAndrew Plump - President of Research & DevelopmentChristophe Weber - CEOChristopher O'Reilly - Head of Investor RelationsJulie Kim - CEO-electMilano Furuta - CFOConference Call ParticipantsHidemaru Yamaguchi - AnalystHiroyuki Matsubara - AnalystMike Nedelcovych - AnalystSeiji Wakao - AnalystShinichiro Muraoka - AnalystSteve Barker - AnalystTony Ren - AnalystChristopher O'ReillyThank you for taking ...

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]

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 Data and Key Metrics Changes - Revenue in Q1 2025 was just over JPY 1,100 billion, a decrease of 8.4% or 3.7% at constant exchange rates [11] - Core operating profit decreased by 15.8% at actual FX or 11.9% at constant exchange rates, amounting to JPY 321.8 billion [11] - Reported operating profit increased by 11% to JPY 184.6 billion, mainly due to lower impairments and restructuring expenses [11][17] - Adjusted free cash flow was strong at JPY 190.1 billion [11] Business Line Data and Key Metrics Changes - Launch products, which represent 50% of revenue, grew by 5% at constant exchange rates [12] - In the GI segment, Entyvio grew by 4.9% at constant rates, with a 30% increase in active EntyvioPen patients in the U.S. [12][13] - TAKHZYRO continues to grow as a market leader in HAE prophylaxis, while the PDT portfolio experienced fluctuations typical of quarterly results [13] - QDenga was impacted by shipment timing and currency effects, but volume is increasing with expectations for strong growth [14] Market Data and Key Metrics Changes - The U.S. market saw a significant impact from Vyvanse's generic erosion, which was a main driver of the revenue decline [15][16] - The generic supply situation in the U.S. improved, leading to expectations of less headwind from Vyvanse in future quarters [15] - The appreciation of the Japanese yen against major currencies also posed a headwind this quarter [16] Company Strategy and Development Direction - The company views FY 2025 as pivotal due to a rapidly progressing late-stage pipeline, with positive results from pivotal Phase III studies of oviporexant [8][20] - The focus remains on late-stage development activities, with ambitions to file for up to five additional indications through FY 2029 [36] - The company is committed to maintaining a strong manufacturing presence in the U.S. and is exploring direct-to-consumer models for certain products [59][63] Management's Comments on Operating Environment and Future Outlook - Management anticipates that FY 2025 will be the last year of significant impact from Vyvanse erosion, with expectations for revenue growth to moderate in subsequent quarters [7][20] - The company is well-positioned to manage potential impacts from tariffs and is actively preparing for price negotiations related to Medicare [20][110] - Management remains confident in achieving full-year guidance despite the challenges faced in Q1 [42][46] Other Important Information - The company executed two leverage-neutral bond issuances to streamline its maturity profile [18] - The company plans to file for U.S. approval of oviporexant later this year, with regional filings to follow [27] - The company is exploring the potential of orexin agonists in various disorders beyond narcolepsy, including sleep-wake cycle disruptions and metabolism [77] Q&A Session Summary Question: Expectations for recovery in sales of specific products - Management acknowledged that Q1 was soft but does not reflect the underlying dynamics, expecting recovery as market access improves [42][44] Question: Additional benefits of new molecules in the pipeline - Management indicated that the new orexin agonist has potential for broader applications beyond narcolepsy, with ongoing development in various disorders [47][49] Question: Competitive landscape for narcolepsy treatments - Management expressed confidence in the competitive positioning of oviporexant, highlighting significant improvements in key symptoms [57][58] Question: Investment strategies in the U.S. market - Management confirmed ongoing investments in U.S. manufacturing and R&D, emphasizing the importance of the U.S. market for future growth [59][60] Question: Dynamics affecting Entyvio's market performance - Management noted challenges in transitioning patients to the pen formulation but expects improvements as access issues are addressed [86][88] Question: R&D spending outlook - Management clarified that Q1 spending was in line with plans, with expectations for increased R&D activities as new trials commence [72][106] Question: Most Favored Nation drug pricing policy discussions - Management is preparing for potential negotiations related to the MFN policy but has not yet been contacted for direct discussions [109][110] Question: Preparations for the launch of oviporexant - Management is focusing on building a sales team and utilizing digital technology for diagnostics leading up to the launch [113]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was just over JPY 1,100 billion, a decrease of 8.4% or 3.7% at constant exchange rates [9] - Core operating profit decreased by 15.8% at actual FX or 11.9% at constant exchange rates, amounting to JPY 321.8 billion [9] - Reported operating profit increased by 11% to JPY 184.6 billion [9] - Adjusted free cash flow was strong at JPY 190.1 billion [9] Business Line Data and Key Metrics Changes - Launch products, which represent 50% of revenue, grew by 5% at constant exchange rates [10] - In the GI segment, Entyvio grew by 4.9% at constant rates, with a 30% increase in active patients [10][11] - TAKHZYRO continues to grow as a market leader in HAE prophylaxis [11] - In oncology, prazacla is expanding with global launches [12] - QDenga was impacted by shipment timing and currency effects but is expected to deliver strong growth for the full year [12] Market Data and Key Metrics Changes - The U.S. market saw a significant impact from Vyvanse's generic erosion, which was a main driver of the revenue decline [13][14] - The generic supply situation in the U.S. improved, leading to expectations of less headwind from Vyvanse in future quarters [14] - The appreciation of the Japanese yen against major currencies also posed a headwind this quarter [14] Company Strategy and Development Direction - The company views FY 2025 as pivotal due to its rapidly progressing late-stage pipeline, including positive results from pivotal studies of oviporexton [6][7] - The focus remains on expanding the orexin franchise and exploring additional indications for orexin agonists [29][35] - The company plans to file for U.S. approval of oviporexton later this year, with regional filings to follow [25] Management's Comments on Operating Environment and Future Outlook - Management anticipates that the impact from Vyvanse's generic erosion will moderate in future quarters, with no change to the full-year outlook [6][18] - The company is well-positioned to manage potential tariff impacts and is actively preparing for future negotiations regarding drug pricing policies in the U.S. [18][110] Other Important Information - The company executed two leverage-neutral bond issuances to streamline its maturity profile [16] - The average annual maturity over the next three years is approximately JPY 220 billion, which is considered manageable [17] Q&A Session Summary Question: Expectations for recovery in sales of Entyvio, IG, Vyvanse, and QDenga - Management believes Q1 performance does not reflect underlying product dynamics and expects recovery as market access improves [43][45] Question: Additional benefits of new molecules in the pipeline - The company is exploring multiple indications for orexin agonists, with ongoing Phase IIb programs and plans for new molecules [48][49] Question: Competitive landscape for narcolepsy treatments - Management believes oviporexton is potentially best in class, with significant benefits across all symptoms of narcolepsy type one [57] Question: Investment strategy in the U.S. market - The company is highly invested in U.S. manufacturing and R&D, with plans to continue this trend [59][60] Question: Dynamics affecting Entyvio's market access - Management is addressing local access issues and expects improvements to drive growth for the Entyvio pen [86] Question: R&D spending outlook - R&D spending is expected to ramp up as new trials begin, with management maintaining full-year guidance [72][107] Question: Most favored nation drug pricing policy discussions - The company is preparing for potential negotiations related to the IRA Medicare price negotiations but has not been contacted directly yet [110]