Business
Ionis reports second quarter 2024 financial results
WAINUATM U.S. launch progressing well; approved in Canada; EU approval decision expected this year Olezarsen PDUFA December 19, 2024 for FCS Positive Phase 3
About this update from Ionis Pharmaceuticals, Inc.
[{"type":"text","content":"WAINUATM U.S. launch progressing well; approved in Canada; EU approval decision expected this year\nOlezarsen PDUFA December 19, 2024 for FCS\nPositive Phase 3 donidalorsen data for HAE; preparing U.S. and EU regulatory submissions \nOn track to achieve 2024 financial guidance\nCARLSBAD, Calif., Aug. 1, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) (the \"Company\"), today reported financial results for the second quarter of 2024.\n\n \n \n \n \n \n \n\n \n\"Over the first half of this year, we continued to deliver on our goal to bring a steady cadence of medicines to people with serious diseases. The WAINUA launch for hereditary ATTR polyneuropathy (ATTRv-PN) continues to progress well with AstraZeneca. QALSODY is now approved in the EU, expanding the number of patients who can benefit from the first approved treatment for a genetic form of ALS. And we are well positioned for our first independent launch with olezarsen, which was accepted for Priority Review with a December FDA action date for people with familial chylomicronemia syndrome (FCS), a serious and rare disease with no approved treatments in the U.S. Additionally, we completed enrollment in our Phase 3 olezarsen program for the much larger severe hypertriglyceridemia (sHTG) patient population, keeping us on track for data in the second half of next year. And based on recent positive Phase 3 results, we believe donidalorsen, our second planned independent U.S. launch, is positioned to be a preferred choice for people with hereditary angioedema (HAE),\" said Brett P. Monia, Ph.D., chief executive officer of Ionis. \"We also advanced our next wave of potentially transformational medicines, including announcing plans to independently advance ION582 into a Phase 3 study next year, based on positive data in Angelman syndrome; this program is poised to become the cornerstone of our robust wholly owned neurology pipeline. Our recent achievements, together with multiple upcoming catalysts, position Ionis to deliver next-level value for all stakeholders.\"\nSecond Quarter 2024 Summary Financial Results(1):\nThree months ended\nJune 30,\nSix months ended\nJune 30,\n2024\n2023\n2024\n2023\n(amounts in millions)\nTotal revenue\n$225\n$188\n$345\n$319\nOperating expenses\n$291\n$279\n$560\n$523\nOperating expenses on a non-GAAP basis\n$260\n$252\n$498\n$469\nLoss...