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Ionis Pharmaceuticals Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 29 April 2026: press release. Guidance figures: 2 raised, 1 lowered, 2 new, 1 kept. The quarter’s numbers.

Key takeaways

  • Revenue rose 87% year over year: Total revenue was $246 million against $132 million a year earlier; management attributed the increase to continued commercial success. Source
  • R&D revenue included $95M milestones: R&D revenue was $138 million against $56 million, and about $95 million of it came from clinical and regulatory milestone payments across several partnerships. Source
  • TRYNGOLZA sales rose to $27M: U.S. net product sales of TRYNGOLZA were $27 million against $6 million a year earlier; management cited a decrease in net price as an offset. Source
  • Operating expenses rose on launches: GAAP operating expenses were $364 million against $278 million; non-GAAP were $321 million against $249 million, mainly from commercialization spend and launch preparations. Source
  • Olezarsen sHTG filing under priority review: The olezarsen sNDA for sHTG was accepted for Priority Review; the EMA accepted an indication extension application for sHTG in March. Source
  • Cash fell after note maturity: Cash and short-term investments were $1.9 billion, down from $2.7 billion at year end, mainly because $633 million was used to repay 0% convertible notes due April 1, 2026. Source

“Ionis’ strong performance in the first quarter of 2026 underscores the strength of our commercial and R&D engines.”

Brett P. Monia, Ph.D., chief executive officer of Ionis

Guidance

AreaPeriodFigureAgainst last quarter
Total revenue Sourcefull year 2026$875-900 millionRaised from $800-825 million
TRYNGOLZA product sales, net Sourcefull year 2026$100-110 millionNew
DAWNZERA product sales, net Sourcefull year 2026$110-120 millionNew
Operating loss on a non-GAAP basis Sourcefull year 2026$425-475 millionLowered from $500-550 million
Cash, cash equivalents and short-term investments Sourcefull year 2026>$1.6 billionKept
TRYNGOLZA peak net sales in sHTG Sourceannual peak>$3 billionRaised from >$2 billion

What changed from last quarter

  • Guidance raised: Total revenue guidance for 2026 raised to $875-900 million from $800-825 million. Source
  • Guidance lowered: Non-GAAP operating loss guidance for 2026 narrowed to $425-475 million from $500-550 million. Source
  • Guidance raised: Olezarsen peak net sales guidance for sHTG raised to more than $3 billion from more than $2 billion. Source
  • New guidance: Product-level 2026 guidance started for TRYNGOLZA and DAWNZERA net product sales, which the prior release said would come with first quarter results.
  • Guidance kept: Year-end cash, cash equivalents and short-term investments guidance was kept at more than $1.6 billion. Source
  • New: Olezarsen sNDA for sHTG was accepted by the FDA for Priority Review; the prior release only said it had been submitted. Source
  • New: Zilganersen NDA for Alexander disease was accepted for Priority Review; the prior release said it had been submitted. Source
  • New: High-dose SPINRAZA regimen is now approved and launched in the U.S. and EU; the prior release listed it as under U.S. review. Source
  • Ended: The 0% convertible notes due April 1, 2026 matured and were repaid from an escrow deposit. Source

Results and growth drivers

  • Revenue rose 87% year over year: Total revenue was $246 million against $132 million a year earlier; management attributed the increase to continued commercial success. Source
  • Operating loss narrowed sharply: GAAP loss from operations was $118 million against $146 million; on a non-GAAP basis the loss was $75 million against $117 million. Source
  • Net loss per share narrowed: Basic and diluted net loss per share was $0.56 against $0.93 a year earlier; GAAP net loss was $93 million against $147 million. Source

Revenue streams and milestones

  • Commercial revenue rose 42%: Commercial revenue was $108 million against $76 million, mainly from TRYNGOLZA and DAWNZERA product sales. Source
  • R&D revenue included $95M milestones: R&D revenue was $138 million against $56 million, and about $95 million of it came from clinical and regulatory milestone payments across several partnerships. Source
  • Royalty income slightly lower: SPINRAZA royalties were $44 million against $48 million; WAINUA royalties rose to $11 million from $9 million. Source

“Based on our strong year-to-date revenue performance, accelerating momentum and positive outlook for the rest of the year, we are improving our 2026 financial guidance.”

Elizabeth L. Hougen, chief financial officer of Ionis

Products and partnered sales

  • TRYNGOLZA sales rose to $27M: U.S. net product sales of TRYNGOLZA were $27 million against $6 million a year earlier; management cited a decrease in net price as an offset. Source
  • DAWNZERA sales reached $16M: U.S. net product sales of DAWNZERA were $16 million, up 125% from the fourth quarter of 2025, when they were $7 million. Source
  • SPINRAZA global sales of $374M: Partner SPINRAZA global sales were $374 million, producing $44 million of royalty revenue for Ionis. Source
  • WAINUA sales and launches expand: Partner WAINUA global sales were $51 million, producing $11 million of royalty revenue, with launches underway in numerous regions including the EU and China. Source

Operating costs and margins

  • Operating expenses rose on launches: GAAP operating expenses were $364 million against $278 million; non-GAAP were $321 million against $249 million, mainly from commercialization spend and launch preparations. Source
  • Selling and admin costs doubled: Selling, general and administrative expense was $151 million against $76 million; research, development and patent expense was $210 million against $201 million. Source
  • Equity compensation excluded from non-GAAP: Equity award compensation of $43 million, against $29 million, is excluded from non-GAAP figures; management describes it as non-cash. Source

“Our independent launches are increasingly contributing to revenue, driven by strong commercial execution”

Brett P. Monia, Ph.D., chief executive officer of Ionis

Regulatory and pipeline milestones

  • Olezarsen sHTG filing under priority review: The olezarsen sNDA for sHTG was accepted for Priority Review; the EMA accepted an indication extension application for sHTG in March. Source
  • Zilganersen filing accepted for priority review: The NDA for Alexander disease was accepted for Priority Review, which management described as the first independent launch from its neurology pipeline. Source
  • Bepirovirsen filing gets breakthrough status: The bepirovirsen NDA for chronic hepatitis B was accepted for Priority Review and granted Breakthrough Therapy designation; regulatory review is accepted in the EU, Japan and China. Source

Cash, debt and balance sheet

  • Cash fell after note maturity: Cash and short-term investments were $1.9 billion, down from $2.7 billion at year end, mainly because $633 million was used to repay 0% convertible notes due April 1, 2026. Source
  • Other convertible notes stay outstanding: The 0% convertible notes due 2030 and 1.75% convertible notes due 2028 remained on the balance sheet at $752 million and $569 million. Source

Strategy and launch plans

  • Independent launches drive the plan: Management said it is on track for two more independent launches in 2026: olezarsen for sHTG and zilganersen for Alexander disease. Source
  • Cash-flow breakeven goal kept at 2028: Management restated its goal of reaching cash-flow breakeven in 2028. Source
  • EU launches begun by partners: The TRYNGOLZA launch in the EU was initiated by Sobi, and the DAWNZERA EU launch was initiated by Otsuka. Source

Coming up, as management said on 29 April 2026

  • Olezarsen sHTG decision due June 30: FDA action date for olezarsen in sHTG; management said the drug is to launch this year, assuming approval. Source
  • Bepirovirsen data shown at EASL: Phase 3 bepirovirsen data in chronic hepatitis B are to be presented at EASL, which the CEO described as next month. Source
  • Zilganersen decision due September 22: FDA action date for zilganersen in Alexander disease, with launch expected this year assuming approval. Source
  • Bepirovirsen decision due October 26: FDA action date for bepirovirsen in chronic hepatitis B; management plans a 2026 launch assuming approval. Source
  • Pelacarsen and eplontersen readouts later: Results from the pelacarsen Lp(a) HORIZON and eplontersen CARDIO-TTRansform cardiovascular outcomes trials are expected later this year. Source

Figures management reported

FigureReported
TRYNGOLZA U.S. net product sales, first quarter 2026 Source$27 million
DAWNZERA U.S. net product sales, first quarter 2026 Source$16 million
SPINRAZA global sales, first quarter 2026 Source$374 million
WAINUA global sales, first quarter 2026 Source$51 million
Research, development and patent expense, GAAP Source$210 million
SPINRAZA high-dose regimen approval SourceApproved and launched in U.S. and EU
Zilganersen PDUFA target action date SourceSeptember 22, 2026

Risks management discussed

  • Regulatory: The olezarsen launch this year depends on FDA approval, which management describes as an assumption. Source
  • External: TRYNGOLZA sales grew on demand but were offset by a lower net price. Source
  • Operational: Key 2026 event timing is based on current assumptions and may change. Source

Earlier plans management reported on

  • On track: The sNDA was accepted for Priority Review and sHTG launch preparations are described as on track. Source
  • On track: Management says zilganersen is on track to launch this year, assuming approval. Source
  • On track: Management says bepirovirsen is on track for a 2026 launch, assuming approval. Source
  • Not stated: The prior release gave mid-year 2026 for pelacarsen HORIZON data; this release does not repeat that timing and management did not state a delay. Source
  • Not stated: The prior release said TRYNGOLZA and DAWNZERA product-level guidance would come with first quarter results; this release includes it.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.