Key Highlights

  • Product revenue, net, was USD 17.8 million, none a year earlier, and Cost of Goods Sold was USD 0.2 million.
  • R&D expense was USD 106.1 million versus 102.0 million, and SG&A expense was USD 37.5 million versus 35.5 million.
  • Operating loss was USD 126.8 million versus 137.4 million, and the voucher sale produced a USD 194.0 million gain.
  • Net income was USD 70.1 million versus a net loss of 126.9 million, and diluted EPS was USD 0.37.

Revenue and Operating Expenses

Denali Therapeutics Inc. (NASDAQ:DNLI), a biotechnology company whose approved product is AVLAYAH (tividenofusp alfa-eknm), filed its Quarterly Report for the period ended September 30, 2026. Product revenue, net, was USD 17,778 thousand, with no Revenue in the third quarter of 2025. For the nine months, product revenue, net, was USD 21,382 thousand. The company stated that one customer accounted for substantially all product revenue.

Cost of goods sold was USD 192 thousand. Research and Development expense was USD 106,102 thousand versus USD 101,950 thousand, and selling, general and administrative expense was USD 37,485 thousand versus USD 35,484 thousand. Intangible asset amortization was USD 750 thousand. Total operating expenses were USD 144,529 thousand versus USD 137,434 thousand.

The loss from operations was USD 126,751 thousand versus USD 137,434 thousand. For the nine months, the loss from operations was USD 394,649 thousand versus USD 417,977 thousand.

Analyst estimates were EPS of negative USD 0.27 against reported EPS of USD 0.37.

Net Income and Per Share Results

The gain on sale of a priority review voucher, net, was USD 194,000 thousand, and interest and other income, net, was USD 2,877 thousand versus USD 10,532 thousand. Total other income was USD 196,877 thousand versus USD 10,532 thousand.

Net income was USD 70,126 thousand versus a net loss of USD 126,902 thousand. Basic and diluted Net Income per share was USD 0.37 versus a net loss per share of USD 0.74, on 192,077,855 diluted weighted-average shares. For the nine months, the net loss was USD 185,874 thousand versus USD 383,991 thousand, or USD 0.99 per share versus USD 2.24.

Cash, Securities and Liabilities

Cash and cash equivalents were USD 102,870 thousand at September 30, 2026, compared with USD 205,326 thousand at December 31, 2025. Short-term marketable securities were USD 413,326 thousand versus USD 662,553 thousand. Accounts receivable, net, were USD 18,882 thousand, and inventory was USD 26,275 thousand.

Net cash used in Operating Activities for the nine months was USD 345,649 thousand versus USD 314,062 thousand. Purchases of marketable securities were USD 749,801 thousand, and maturities and sales were USD 602,655 thousand.

Total liabilities were USD 329,648 thousand versus USD 131,093 thousand, including a Liability related to the revenue participation right agreement of USD 209,661 thousand. The filing's risk discussion refers to the need to obtain additional funding to continue as a going concern, and to the risk that AVLAYAH may not achieve expected levels of market acceptance.

Items to Follow

Investors can follow AVLAYAH product revenue, which was USD 17,778 thousand in the quarter, Accounts Receivable concentrated in one customer, and inventory of USD 26,275 thousand.

Other items include research and development expense of USD 106,102 thousand, the revenue participation right liability of USD 209,661 thousand, and the balance of cash and marketable securities reported at quarter end.