Takeda Pharmaceutical Q3 Earnings Call Highlights

Takeda Pharmaceutical (NYSE:TAK) reported fiscal 2025 third-quarter results that executives said reflected “the strength of Takeda fundamentals,” supported by disciplined cost management as the company prepares for several late-stage product launches. Management emphasized that fiscal 2025 is a “pivotal year,” with three key pipeline assets—oveporexton, rusfertide, and zasocitinib—expected to shape the next phase of growth.

Financial performance and updated outlook

Chief Financial Officer Milano Furuta said the company continues to manage the “significant impact” from Vyvanse generic erosion, but noted the headwind has been “steadily tapering off” quarter by quarter. For the nine-month period, Takeda posted revenue of just over JPY 3.4 trillion, down 3.3% year over year (down 2.8% at constant exchange rates). Core operating profit was JPY 971.6 billion, down 3.4% year over year, while reported operating profit rose 1.2% to JPY 422.4 billion. Core EPS was JPY 428 and reported EPS was JPY 137.

Furuta highlighted strong cash generation, reporting adjusted free cash flow of JPY 625.9 billion for the period, even after a $1.2 billion upfront payment to Innovent Biologics made in December.

Management updated its full-year guidance by revising revenue expectations downward at constant exchange rates, citing stronger-than-anticipated Vyvanse generic erosion in the U.S. Furuta said Takeda is “revising only revenue guidance to low single-digit decline at CER,” while maintaining full-year guidance for core operating profit and core EPS due to ongoing operating expense discipline. Based on revised FX assumptions, Takeda forecast full-year revenue of JPY 4.53 trillion, core operating profit of JPY 1.15 trillion, and core EPS of JPY 486. The company also upgraded its adjusted free cash flow forecast.

Growth drivers: Entyvio, vaccines, and portfolio trends

Takeda’s growth and launch products represented more than 50% of total revenue and grew 6.7% at constant exchange rates year to date, improving from the 5% growth rate reported in the first two quarters.

• Gastrointestinal (GI): Entyvio grew 7.4% at constant exchange rates. Furuta said the third-quarter growth was “particularly strong,” in part due to a prior-year one-time gross-to-net impact. Management cited Entyvio Pen as a key driver and said it is now on the formulary with all three large pharmacy benefit managers, with commercial coverage above 80%.
• Rare diseases: Takhzyro growth slowed to 2.4% at constant exchange rates. Executives attributed pressure in the U.S. to new competitors, partially offset by international uptake. CEO-elect Julie Kim also said the market is maturing with high diagnosis and prophylaxis penetration, and noted an impact from Medicare Part D redesign.
• Plasma-derived therapies (PDT): Furuta said revenue growth improved versus the first half but pointed to headwinds in albumin. Albumin returned to 1.3% growth but was slower than expected due to softening demand in China and supply reallocation effects. Kim said China’s utilization guidelines have impacted demand and that growth could take time to return. Management said immunoglobulin (IG) grew 4.3% year to date, driven by double-digit growth in subcutaneous IG; IVIG was impacted by Medicare Part D redesign, which Takeda expects to normalize in the fourth quarter.
• Vaccines: Qdenga growth accelerated to 22.1%, driven primarily by Brazil.

On Entyvio’s outlook, CEO Christophe Weber said Takeda is not projecting Entyvio to gain share but aims for it to remain stable and “grow at market pace,” with a long-term goal of a 50/50 split between IV and pen. In Q&A, executives also addressed Entyvio’s selection for a future U.S. IRA price negotiation cycle. Kim said the outcome is too early to quantify and that Takeda will submit an evidence package; she noted that prior cohorts saw varying levels of price cuts and the company will update expectations once pricing is known. She also said Takeda expects Entyvio Pen to be included in the negotiation process.

Late-stage pipeline: three phase III wins and launch preparation

Weber and President of R&D Andrew Plump said Takeda delivered positive phase III readouts for all three late-stage programs highlighted during the call. Weber said the company has filed NDAs with the FDA for oveporexton and rusfertide and is awaiting formal acceptance.

Plump described oveporexton as an orexin 2 receptor agonist for narcolepsy type 1 and said both phase III studies met clinically and statistically significant improvements across all 14 primary and secondary endpoints. He added that approximately 85% of patients in the trials saw measurable improvement bringing them into the normative range on the Epworth Sleepiness Scale. Takeda said it is working to launch oveporexton in the current calendar year.

For rusfertide, a hepcidin mimetic for polycythemia vera, Plump emphasized phase III results showing hematocrit control below 45% through 52 weeks, with quality-of-life improvements on fatigue and symptom scales and reduced need for phlebotomy. Takeda said it is working to launch rusfertide in PV in the current calendar year.

Takeda also highlighted zasocitinib, a highly selective TYK2 inhibitor for psoriasis. Plump said phase III studies showed significant PASI 75 improvement within four weeks, with more than half of patients achieving PASI 90 at week 16 and approximately 30% achieving PASI 100, with continued improvement through week 24. Management said full data will be presented at a medical conference in the near future, and executives pointed to “fast onset,” “clear skin,” and once-daily oral dosing with no food interactions as key features. Takeda expects a summer regulatory submission timeframe, noting that the overall filing timeline depends on completion of the phase III package, accumulation of one-year safety data in roughly 1,000 patients on active drug, and CMC readiness. The company continues to expect a psoriasis launch in calendar 2027.

Partnerships, pipeline expansion, and leadership transition

Plump highlighted additional pipeline updates, including a fully enrolled head-to-head zasocitinib study versus deucravacitinib expected to read out in 2026. He also referenced proof-of-concept IgA nephropathy data for mezagitamab that suggested durable kidney function benefits lasting about two years after an initial treatment period. Takeda also discussed a second orexin 2 agonist program (TAK-360) enrolling in phase II for narcolepsy type 2 and idiopathic hypersomnia, with data expected this year to inform phase III development.

In oncology, Plump discussed elritercept data in myelofibrosis and detailed two licensed Innovent assets now called TAK-928 and TAK-921. He said Takeda and Innovent have a 60/40 shared investment structure for TAK-928, with phase III decisions starting as soon as 2026 into 2027.

Weber said the call marked his last earnings call as the main presenter, noting he will participate in the full-year call in a supportive role as Kim takes the lead ahead of a formal handover in June. Kim said organizational changes effective April 1 are intended to improve competitiveness, growth, and speed ahead of multiple launches, including efforts to redesign processes and adopt AI and other technologies.

About Takeda Pharmaceutical (NYSE:TAK)

Takeda Pharmaceutical Company Limited (NYSE: TAK) is a Tokyo-based, multinational biopharmaceutical company with roots dating back to 1781. The company researches, develops, manufactures and commercializes pharmaceutical and biopharmaceutical products for patients worldwide. Takeda is publicly listed and operates as a fully integrated R&D-driven healthcare company focused on delivering specialty medicines and therapies across a range of therapeutic areas.

Takeda’s main business activities encompass discovery and development of prescription medicines, clinical development and regulatory affairs, manufacturing of small molecules and biologics, and global commercial operations.