Tag: IONS

Ionis Q1 2020 financial results and business updates

Ionis Pharmaceuticals, Inc. () today reported its financial results for Q1 2020 and shared the achievements of the first quarter that set the company up to achieve their strategic objectives for the year. Spinraza royalties contributed nearly half of the company’s revenue.
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  • Growing commercial revenues combined with a substantial base of R&D revenues
    • Commercial revenue from SPINRAZA® (nusinersen) royalties increased by more than 10 percent to $66 million compared to Q1 2019
    • Product sales from TEGSEDI® (inotersen) and WAYLIVRA® (volanesorsen) more than doubled to $15 million compared to Q1 2019
    • R&D revenue of $49 million included over $25 million from Ionis’ neurology disease franchise and $15 million from its cardiometabolic franchise
  • First quarter results in line with projections to be meaningfully profitable this year
    • Operating loss and net loss of $61 million and $48 million, respectively, on a GAAP basis
    • Non-GAAP operating loss and net loss of $20 million and $15 million, respectively
  • Cash position of $2.4 billion provides substantial financial strength to continue executing on strategic goals
  • Roche completed enrollment in the global, GENERATION HD1 Phase 3 study in patients with Huntington’s disease
  • Initiated the CARDIO-TTRansform Phase 3 clinical trial for AKCEA-TTR-LRx in patients with TTR-mediated amyloid cardiomyopathy
  • Two medicines granted Fast Track Designation by the U.S. FDA
    • AKCEA-APO(a)-LRx for the treatment of cardiovascular disease due to elevated Lp(a) levels
    • IONIS-C9Rx for the treatment of C9orf72-ALS
  • Ionis generated more than $20 million as numerous partnered medicines advanced
    • $10 million from AstraZeneca for ION532, targeting APOL1 for the treatment of kidney disease
    • $7.5 million from Biogen for IONIS-MAPTRx for the treatment of Alzheimer’s disease
    • $5 million from Dynacure for IONIS-DNM2-2.5Rx for the treatment of centronuclear myopathies
  • Ionis and Akcea reported positive topline results for AKCEA-APOCIII-LRx and vupanorsen (AKCEA-ANGPTL3-LRx)
  • Results from the Phase 2 study of AKCEA-APO(a)-LRx in patients with Lp(a)-driven cardiovascular disease, highlighting the favorable safety and tolerability profile and the potential to address a major area of unmet need, were published in the New England Journal of Medicine
  • Initiated a Phase 1 study of ION224, an Ionis-owned medicine in development for the treatment of NASH
  • Initiate the Phase 3 study of AKCEA-APOCIII-LRx in patients with FCS
  • Refile WAYLIVRA new drug application for U.S. marketing authorization
  • File for WAYLIVRA marketing approval in Brazil with PTC Therapeutics
  • Report clinical proof-of-concept results for four or more programs
  • Initiate a first-in-human study of ION541 in patients with sporadic ALS, conducted by Biogen
  • Advance five or more new medicines into development, including several Ionis-owned medicines

https://ir.ionispharma.com/news-releases/news-release-details/ionis-reports-first-quarter-2020-financial-results-and-recent