FX-322

Headline results for the fourth quarter: Revenue: JPY 354.3 billion ($2.6 billion), up 16.6% Loss: JPY 46.1 billion ($345 million)Note: All changes are versus the prior-year period unless otherwise statedWhat the company said:Astellas noted that sales of its main products including Xtandi, Padcev, Xospata showed "steady growth" during the fourth quarter, while revenue from Evenity in Japan also increased.The company explained that the loss in the three-month period was due to an impairment loss of JPY 60.3 billion. Astellas said earlier this month that "considering the sales situation" for Evrenzo in Japan and Europe, it will book an impairment loss of approximately JPY 45 billion, as well as JPY 8.6 billion after terminating the development of FX-322 and JPY 4.7 billion for ending an agreement with Adaptimmune Therapeutics.Other results: Xtandi: JPY 149.3 billion, up 21.6% Betanis, Myrbetriq and Betmiga: JPY 47.5 billion, up 4.8% Prograf: JPY 47.1 billion, up 6.5% Padcev: JPY 11.4 billion, up 58.6% Xospata: JPY 10.3 billion, up 23% Vesicare: JPY 3.5 billion, down 12.7% Evrenzo: JPY 800 million, up 58.5% Full-year revenue: JPY 1.52 trillion, up 17.2% Full-year profit: JPY 98.7 billion, down 20.4%Looking ahead:Astellas expects revenue for fiscal year 2023 of JPY 1.52 trillion ($11.4 billion), broadly in line with the prior 12-month period, with sales of Xtandi reaching nearly JPY 670 billion ($5 billion), up from JPY 661.1 billion ($4.9 billion). Meanwhile, core profit is seen growing 1.5% to JPY 228 billion ($1.7 billion).Pipeline updates:Astellas disclosed that it ended Phase I development of ASP9801 and ASP0739 for cancer, while it also discontinued mid-stage work on ASP7517 in acute myeloid leukaemia and myelodysplastic syndrome, as well as early-stage investigation in solid tumours. The drugmaker added that it also halted Phase I development of ASP8731/ML-0207 for sickle cell disease.($1 = JPY 133.727)

Astellas said that it will book impairment charges totalling JPY 58 billion ($434 million) in the fourth quarter of fiscal year 2022 after terminating a deal and a pipeline candidate, as well as recording lower than expected sales of its key drug Evrenzo.The company noted that "considering the sales situation" for Evrenzo in Japan and Europe, it will book an impairment loss of approximately JPY 45 billion ($336 million). The product, which is partnered with FibroGen and used to treat anaemia of chronic kidney disease, generated revenue of JPY 900 million ($7 million) in the third quarter. Astellas now expects peak sales of Evrenzo of under JPY 50 billion ($376 million), down from an earlier range of between JPY 50 billion and JPY 100 billion ($752 million).Analysts at Credit Suisse explained that the market for HIF-PH inhibitors, such as Evrenzo, has "not developed as much as initially expected," adding that it had seen a probable revision to forecasts for Astellas' product at some point.The drugmaker noted that the impairment charges include JPY 8.6 billion ($65 million) after the termination of development of FX-322 for the treatment of sensorineural hearing loss. Partner Frequency Therapeutics disclosed earlier this year that a Phase IIb study of the drug failed to achieve its primary endpoint, prompting the firm to slash over 50% of its staff.Astellas added that the impairment charges also comprise JPY 4.7 billion ($35 million) after it ended an agreement with Adaptimmune Therapeutics focused on stem-cell derived allogeneic T-cell therapies. Under the deal signed in 2020, Astellas and Adaptimmune agreed to develop T-cell therapy candidates directed to up to three cancer targets, with the latter receiving an upfront payment of $50 million, as well as being eligible for up to $897.5 million in further payments.