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IONIS PHARMACEUTICALS INC (IONS)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 revenue of $157.0M rose 17% year over year and reflected a strong launch contribution from TRYNGOLZA and higher royalties; GAAP diluted EPS was a loss of $0.80, and management raised full-year revenue guidance to $875–$900M, TRYNGOLZA net sales to $85–$95M, and improved non-GAAP operating loss guidance to $275–$300M .
  • TRYNGOLZA net sales reached $32M in Q3, up nearly 70% sequentially, while DAWNZERA (donidalorsen) began its U.S. launch and is “off to an encouraging start” following August approval for HAE .
  • Olezarsen in sHTG delivered topline Phase 3 results showing up to 72% placebo-adjusted fasting triglyceride reduction and 85% reduction in acute pancreatitis events; sNDA filing is planned by year-end and full data will be presented at AHA Nov 8—key near-term catalysts for the stock .
  • Management reiterated a path to cash flow breakeven in 2028, supported by accelerating product revenue and partner royalties; cash and short-term investments were $2.2B at quarter-end, providing strategic flexibility .

What Went Well and What Went Wrong

  • What Went Well

    • “Watershed moment” quarter: advancing Ionis-owned medicines with two independent launches underway and two more anticipated in 2026, supporting raised FY25 guidance .
    • Commercial execution: TRYNGOLZA net sales of $32M (+~70% QoQ) with strong prescriber breadth and favorable coverage; royalties from SPINRAZA ($56M) and WAINUA ($13M) added meaningful revenue .
    • Pipeline momentum: Olezarsen Phase 3 CORE/CORE2 topline successes with planned sNDA by year-end, plus positive pivotal zilganersen in AxD positioning first independent neurology launch in 2026 .

  • What Went Wrong

    • GAAP losses persist: Q3 GAAP net loss of $129M and loss from operations of $160M reflect higher SG&A tied to multiple launches, partly offset by lower R&D as late-stage studies concluded .
    • Q4 pacing caution: Management flagged a shorter 10-week quarter and potential seasonality, tempering near-term sequential growth expectations for TRYNGOLZA .
    • Pricing/European payer complexity: sHTG pricing work remains ongoing, and EU reimbursement breadth could hinge on outcomes data focus for high-risk subgroups (e.g., ≥880 mg/dL or ≥500 mg/dL with AP history) .

Financial Results

Quarterly GAAP headline metrics

MetricQ3 2024Q1 2025Q2 2025Q3 2025
Revenue ($USD)$134.0M $131.6M $452.0M $157.0M
GAAP Diluted EPS ($)$(0.95) $(0.93) $0.70 $(0.80)
Loss from Operations ($USD)$(148.0)M $(146.0)M $140.0M $(160.0)M

Revenue breakdown (commercial vs R&D)

Revenue Component ($USD)Q3 2024Q2 2025Q3 2025
Product sales (TRYNGOLZA)$0M $19M $32M
Royalty revenue (SPINRAZA)$57M $54M $56M
Royalty revenue (WAINUA)$5M $10M $13M
Other royalties$5M $6M $7M
Other commercial revenue$9M $14M $8M
Collaborative agreement revenue$45M $337M $31M
WAINUA joint development revenue$13M $12M $10M
Total revenue$134M $452M $157M

KPI table (products and royalties)

KPIQ1 2025Q2 2025Q3 2025
TRYNGOLZA net sales ($USD)$6M $19M $32M
SPINRAZA royalties ($USD)$48M $54M $56M
WAINUA royalties ($USD)$9M $10M $13M

Non-GAAP operating profile

Metric ($USD)Q3 2024Q1 2025Q2 2025Q3 2025
Non-GAAP Operating Expenses$250M $249M $282M $286M
Non-GAAP Loss from Operations$(116)M $(117)M $170M $(129)M
Non-GAAP Net Loss$(108)M $(118)M $154M $(98)M

Q3 vs Wall Street consensus (S&P Global)

MetricQ1 2025Q2 2025Q3 2025
Revenue Actual ($USD)$131.6M*$452.0M*$156.7M*
Revenue Consensus Mean ($USD)$122.5M*$299.0M*$130.5M*
EPS Actual ($)$(0.9245)*$0.8462*$(0.6125)*
Primary EPS Consensus Mean ($)$(1.0317)*$0.1643*$(1.0525)*
# of Estimates (Revenue / EPS)17 / 6*20 / 7*19 / 8*

Values marked with * retrieved from S&P Global.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenueFY 2025$825–$850M $875–$900M Raised
TRYNGOLZA Product Sales, netFY 2025$75–$80M $85–$95M Raised
Operating Loss (Non-GAAP)FY 2025$300–$325M $275–$300M Improved (lower loss)
Cash, Cash Equivalents & ST InvestmentsFY 2025~$2.0B >$2.1B Raised

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Product performance (TRYNGOLZA)Q1: $6M first full quarter; favorable access; prescriber mix . Q2: $19M (+3x QoQ), citing strong patient identification and positive payer dynamics .$32M (+~70% QoQ); breadth/depth of prescribers; strong coverage (60% commercial/40% government) .Accelerating growth
DAWNZERA (donidalorsen) launchQ2: preparing for FDA decision; launch readiness and switch data positioning .Approved Aug 21; early adoption with switches, treatment-naïve starts; supportive patient programs .Early momentum building
Olezarsen sHTGQ1: CORE/CORE2 timing; strong TG lowering expected; AP secondary endpoint design . Q2: topline timing refined to Sept; AP combined analysis at 12 months .Topline positive (up to 72% TG↓; 85% AP↓); AHA late-breaker Nov 8; sNDA by YE25 .Major de-risking; regulatory path imminent
Regulatory/macroQ1: FDA/tariffs monitoring; no impacts; supply chain redundancies . Q2: convertibles refinancing plan .EU TRYNGOLZA approval and Sobi launch planned; EU sHTG reimbursement may focus on high-risk subgroups .Execution steady; EU pricing nuanced
Financial postureQ1: revenue guidance to $725–$750M; cash ~$1.9B . Q2: guidance to $825–$850M; licensing drove upside .Guidance raised again; cash $2.2B at Q3; CFO reiterates breakeven in 2028 .Improving outlook

Management Commentary

  • CEO: “The third quarter was a watershed moment… With two independent launches now underway, and two more anticipated in 2026, we are delivering on our goal to bring a steady cadence of new medicines…” .
  • CFO: “TRYNGOLZA’s nearly 70% increase over the prior quarter… we are increasing our financial guidance again for 2025… anticipate cash flow breakeven in 2028” .
  • Product strategy lead: For sHTG, initial outreach to ~20,000 HCPs covering ~360,000 patients, building on TRYNGOLZA prescriber base and scaling field force to ~200 reps ahead of launch .
  • Development: Olezarsen demonstrated unprecedented AP risk reduction; sNDA on track by year-end with AHA late-breaker Nov 8 .

Q&A Highlights

  • sHTG launch ramp: Expect strong uptake from high-risk patients not at goal on current therapies; plan to expand HCP coverage from ~3,000 to ~20,000 ahead of launch .
  • AP outcomes: Detailed data will highlight rapid and durable protection; combined CORE/CORE2 analysis at 12 months maximizes powering .
  • Pricing: sHTG pricing research ongoing; early payer signals suggest specialty range ($10k–$20k) for highly prevalent indications; final pricing at approval .
  • HAE market dynamics: Estimated ~7,000 U.S. patients; significant annual switching; early DAWNZERA feedback positive with repeat prescribers .
  • Q4 seasonality: Shorter quarter (~10 weeks) and first year launch dynamics prompted conservative near-term expectations .

Estimates Context

  • Q3 delivered a revenue beat vs consensus ($156.7M* actual vs $130.5M* estimate) and an EPS beat (GAAP primary EPS $(0.6125)* vs $(1.0525)* estimate), aided by TRYNGOLZA’s sequential growth and royalty strength; Q2’s outsized beat was driven by the $280M Ono upfront .
  • With FY25 guidance raised (revenue $875–$900M; TRYNGOLZA $85–$95M), consensus models likely need upward revisions for FY25 top-line and marginal improvement in non-GAAP operating loss .

Values marked with * retrieved from S&P Global.

Key Takeaways for Investors

  • Strong execution and guidance raise: Q3 showed durable commercial momentum and pipeline de-risking; FY25 revenue guidance up $50M with improved non-GAAP loss outlook—constructive for estimate revisions .
  • Near-term catalysts: AHA late-breaker for olezarsen (Nov 8) and sNDA filing by year-end could further support sentiment ahead of the anticipated 2026 sHTG approval .
  • Commercial flywheel: TRYNGOLZA’s prescriber base and access foundation should accelerate sHTG launch leverage; DAWNZERA’s early traction in a switch-heavy HAE market supports 2026 revenue build .
  • Balance sheet strength: ~$2.2B in cash and ST investments provides flexibility to fund launches and pipeline; convertibles refinancing strategy discussed in Q2 maintains optionality .
  • Watch pricing and EU reimbursement: sHTG pricing outcomes and EU payer focus on high-risk subsegments are key variables for peak revenue trajectory .
  • Long-term setup: Management targets cash flow breakeven by 2028 with >$5B combined peak revenue potential from independent products and partner royalties, highlighting favorable multi-year risk/reward .