Oveporexton

OSAKA, Japan--(BUSINESS WIRE)--Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the first quarter of fiscal year 2025 (three months ended June 30, 2025), with generic erosion of VYVANSE significantly impacting revenue and Core Operating Profit in line with company expectations for the quarter. The company expects these impacts to moderate in future quarters. Takeda also achieved several important milestones in its R&D pipeline, reinforcing its long-term growth trajectory and underscoring its commitment to delivering sustainable value through innovation. Most notably, both Phase 3 studies of oveporexton successfully met all primary and secondary endpoints, demonstrating statistically significant improvements across doses. These results reinforce the potential of oveporexton to transform the standard of care in narcolepsy type 1. In addition, Takeda received U.S. FDA approval for GAMMAGARD® LIQUID ERC and European Commission (EC) approval for ADCETRIS® in new indications and presented promising clinical data for rusfertide at the 61st American Society of Clinical Oncology (ASCO) Annual Meeting Plenary Session. These developments underscore the strength of Takeda’s late-stage pipeline and its potential to drive future growth. Takeda chief financial officer, Milano Furuta, commented: “The impact of VYVANSE generic erosion on Takeda’s FY2025 Q1 results was very significant, but consistent with our expectations, and there is no change to our full-year outlook announced in May. “Our late-stage pipeline continues to advance with the announcement in July of positive results from two pivotal Phase 3 studies for oveporexton in narcolepsy type 1, with both studies meeting all primary and secondary endpoints. These results represent a significant scientific milestone, and we are very excited about the potential for our late-stage pipeline to deliver value to the patients we serve and to position Takeda for sustainable growth.” FINANCIAL HIGHLIGHTS for FY2025 Q1 Ended June 30, 2025 (Billion yen, except percentages and per share amounts) FY2025 Q1 FY2024 Q1 vs. PRIOR YEAR (Actual % change) Revenue 1,106.7 1,208.0 -8.4% Operating Profit 184.6 166.3 +11.0% Net Profit 124.2 95.2 +30.4% EPS (Yen) 79 61 +30.8% Operating Cash Flow 215.4 170.3 +26.5% Adjusted Free Cash Flow (Non-IFRS) 190.1 23.7 +703.6% Core (Non-IFRS) (Billion yen, except percentages and per share amounts) FY2025 Q1 FY2024 Q1 vs. PRIOR YEAR (Actual % change) vs. PRIOR YEAR (CER % change) Revenue 1,106.7 1,208.0 -8.4% -3.7% Operating Profit 321.8 382.3 -15.8 % -11.9% Margin 29.1% 31.6% -2.6 pp ― Net Profit 237.0 276.8 -14.4% -10.3% EPS (Yen) 151 176 -14.1% -10.0% FY2025 Outlook (unchanged from May 2025) (Billion yen, except percentages and per share amounts) FY2025 FORECAST FY2025 MANAGEMENT GUIDANCE Core Change at CER (Non-IFRS) Revenue 4,530.0 --- Core Revenue (Non-IFRS) 4,530.0 Broadly flat Operating Profit 475.0 --- Core Operating Profit (Non-IFRS) 1,140.0 Broadly flat Net Profit 228.0 --- EPS (Yen) 145 --- Core EPS (Yen) (Non-IFRS) 485 Broadly flat Adjusted Free Cash Flow (Non-IFRS) 750.0-850.0 --- Annual Dividend per Share (Yen) 200 --- Additional Information About Takeda’s FY2025 Q1 Results For more details about Takeda’s FY2025 Q1 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2025 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2025 Q1 investor presentation (available at https://www.takeda.com/investors/financial-results/quarterly-results/). About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com. 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Alkermes’ narcolepsy therapy improved the ability of patients in a mid-stage trial to stay awake, the company said Monday. And while a Phase 3 program is on the cards, it said this might not happen in the immediate timeframe. The pill, named alixorexton, met the Phase 2 trial’s primary endpoint, with narcolepsy patients who took the drug once a day for six weeks having statistically significant, clinically meaningful and dose-dependent improvements from baseline in mean sleep latency over placebo (p<0.0001 at all doses). The study, called Vibrance-1, signed up 92 subjects with the type 1 form of narcolepsy (NT1). Patients with both types of narcolepsy struggle to stay awake during the day, but NT1 patients also have sudden bouts of muscle weakness, called cataplexy. Around 20% of narcolepsy cases are type 1. Sleep latency was measured using a process called the Maintenance of Wakefulness Test (MWT). Patients lie down in a dark, quiet room every two hours for eight hours, and the time it takes for them to fall asleep is measured. Healthy people can stay awake for at least 20 minutes on average; narcolepsy patients are out for less than five. NT1 patients given alixorexton, previously referred to as ALKS 2680, achieved “normative wakefulness,” meaning they were able to stay awake for those 20 minutes. The actual figures for the patients’ time remaining awake, split by dose, have not yet been released. All doses beat placebo on excessive daytime sleepiness, as measured on the Epworth Sleepiness Scale. When it came to testing alixorexton’s effects on muscle weakness, however, only the middle 6 mg dose improved weekly cataplexy rates to a statistically significant degree. “We think that’s more of a methodological issue in Phase 2, because typically cataplexy rates would correlate with all these other positive directions,” Alkermes CEO Richard Pops told Endpoints News . He said the company would focus on “tuning out” this variability in Phase 3 trials. Improvements in narcolepsy symptom severity, cognitive complaints and fatigue were also seen in Vibrance-1, and there were no serious treatment-emergent adverse events. Full data from the trial will come at the World Sleep meeting in Singapore in September, Alkermes said. Alixorexton is an orexin 2 receptor agonist and shares its mechanism with Takeda’s oveporexton, which last week became the first drug in this class to succeed in a Phase 3 test. Analysts are predicting that Takeda could have a blockbuster on its hands. Pops said that Alkermes was planning a three-month-long Phase 3 trial in NT1, similar to what the FDA had requested for Takeda’s Phase 3 trial of oveporexton. But pivotal trials will not start yet, Pops said. Alixorexton is also in Phase 2 studies in narcolepsy type 2 and another type of sleeping disorder called idiopathic hypersomnia. Alkermes will wait for the NT2 trial to read out this autumn. “Then we’ll sit down with FDA with those data and finalize the design of Phase 3. So it’s a little too early to say when we’ll launch Phase 3, but we’ll be moving as fast as we can now with these data,” he said. Pops says he is encouraged by Takeda’s success. “Our overall view is that both we and Takeda are blazing new ground here,” he said. “We’re quite excited to see Takeda’s positive data, reinforcing the idea that orexin 2 receptor agonists can be used safely on a consistent basis, and really drive profound clinical effects for patients with narcolepsy — that’s a really good thing.” He said that the two meds were “quite different, and have been from the outset.” Takeda’s pill is given twice a day, while Alkermes’ is once a day. He said Takeda was mainly focused on NT1, whereas Alkermes is looking at NT2 and idiopathic hypersomnia. (Takeda is investigating other orexin 2 receptor agonists for idiopathic hypersomnia and narcolepsy type 2.) “We feel like they’re an effective pioneer in the space. We’re right behind with a drug with a bit broader spectrum of potential activity,” Pops said.