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IONIS PHARMACEUTICALS INC (IONS)·Q2 2025 Earnings Summary

Executive Summary

  • Strong beat and guide raise: Q2 revenue $452.0M vs S&P consensus $299.0M; GAAP diluted EPS $0.70; S&P “Primary EPS” actual $0.85 vs $0.16 consensus, driven by $280M sapablursen license, accelerating TRYNGOLZA sales ($19M) and higher royalties. Guidance raised: FY25 revenue to $825–$850M (from $725–$750M); TRYNGOLZA FY25 sales introduced at $75–$80M; narrower non-GAAP operating loss ($300–$325M) and YE cash ~ $2.0B . EPS/Revenue estimates from S&P Global*. *
  • Commercial momentum: TRYNGOLZA net sales tripled sequentially to $19M; WAINUA and SPINRAZA royalties contributed $10M and $54M, respectively. EU CHMP positive opinion for TRYNGOLZA expands runway .
  • Near-term catalysts: FDA decision for donidalorsen (HAE) due Aug 21, 2025; CORE/CORE2 phase 3 readout for olezarsen in sHTG in September (management will include an AP statement in topline) .
  • Cash and operating leverage: Q2 non-GAAP net income $154M; non-GAAP opex +8% YoY amid launch investments. Company targeting sustained growth and positive cash flow “in the next few years”; considering refinancing 2026 converts .

What Went Well and What Went Wrong

What Went Well

  • Significant top- and bottom-line beat; revenue doubled YoY to $452M with non-GAAP net income $154M, enabling a sizable FY25 guide raise .
  • TRYNGOLZA execution: “Trengo[l]za exceeded revenue expectations… underscoring its strong therapeutic profile [and] well-executed commercial strategy” (CEO Brett Monia). $19M in Q2 net sales; >90% of patients paid $0 out of pocket; coverage mix ~60% commercial/40% government (Kyle Jenne) .
  • Pipeline/regulatory momentum: Positive CHMP opinion for TRYNGOLZA in EU FCS; donidalorsen PDUFA Aug 21; sHTG phase 3 CORE/CORE2 readout in September; CFO reiterated “significantly raising” FY25 guidance on strong performance .

What Went Wrong

  • Operating spend rising with commercialization; SG&A elevated for TRYNGOLZA/WAINUA and donidalorsen launch prep, though partially offset by lower R&D as late-stage studies ended .
  • Visibility into pancreatitis outcomes remains limited pre-CORE/CORE2; company will offer only a topline AP statement initially; investors must wait for full presentation/publication later in 2H25 .
  • Pricing strategy uncertainty for olezarsen in sHTG: management still evaluating price points and the transition dynamics from FCS-only pricing to broader SHTG label; payer testing ongoing .

Financial Results

Headline metrics vs prior periods and S&P Global consensus

MetricQ2 2024Q1 2025Q2 2025 ActualQ2 2025 Consensus*
Revenue ($M)$225 $132 $452 $299.0*
GAAP Diluted EPS ($)-$0.45 -$0.93 $0.70 $0.16 (Primary EPS)*
EBITDA ($M)——$142.7*$55.0*

Notes: S&P Global estimates/actuals denoted with asterisk*. Values retrieved from S&P Global.

Income statement bridge and profitability

Metric ($M)Q2 2024Q1 2025Q2 2025
Total Revenue225 132 452
Total Operating Expenses (GAAP)291 278 312
Income (Loss) from Operations (GAAP)-66 -146 140
Non-GAAP Operating Expenses260 249 282
Non-GAAP Income (Loss) from Operations-35 -117 170
GAAP Net Income (Loss)-66 -147 124
Non-GAAP Net Income (Loss)-35 -118 154

Revenue composition

Revenue line ($M)Q2 2024Q1 2025Q2 2025
Product sales – TRYNGOLZA (net)— 6 19
Royalty revenue – SPINRAZA57 48 54
Royalty revenue – WAINUA4 9 10
Other royalties3 7 6
TEGSEDI & WAYLIVRA (net)8 6 14
Collaborative agreement revenue141 46 337
WAINUA joint development revenue12 10 12
Total Revenue225 132 452

Product and royalty KPIs (operational)

KPIQ2 2025
TRYNGOLZA net sales$19M
WAINUA underlying sales (driving Ionis royalty)$44M; Ionis royalty $10M
SPINRAZA underlying sales (driving Ionis royalty)$393M; Ionis royalty $54M
TRYNGOLZA coverage mix~60% commercial / 40% government
TRYNGOLZA out-of-pocket>90% of patients paid $0

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenueFY 2025$725–$750M$825–$850MRaised
TRYNGOLZA Product Sales (net)FY 2025Not provided$75–$80MNew item
Operating Loss (Non-GAAP)FY 2025< $375M$300–$325MImproved (narrower loss)
Cash & ST InvestmentsFY 2025 YE~$1.9B~$2.0BRaised

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4’24, Q1’25)Current Period (Q2’25)Trend
Commercial execution – TRYNGOLZALaunch underway; initial revenue source added in 2024 . Early Q1’25 sales >$6M; raising FY25 revenue >$600M to $725–$750M on strength .$19M net sales; broadening prescriber base; favorable coverage; >90% $0 OOP; FY25 TRYNGOLZA $75–$80M .Accelerating growth; operational leverage improving.
Donidalorsen (HAE)PDUFA Aug 21, 2025 reiterated; positive OLE/PROs published .FDA decision next month; switch-study publication: 62% further attack-rate reduction; 84% patient preference; launch-ready organization .High readiness; positive switching narrative.
Olezarsen in sHTGH2’25 core data expected; Essence supportive .CORE/CORE2 topline set for September; management will include AP statement; Essence showed 58–61% TG reduction .Heightened anticipation; payer/pricing work ongoing.
Royalties (SPINRAZA/WAINUA)WAINUA EU approval; Spinraza higher-dose filing underway .SPINRAZA $393M sales; WAINUA $44M sales driving $54M/$10M royalties; higher-dose nusinersen PDUFA Sep 22, 2025 .Stable-to-improving royalty base; potential uplift.
Capital & cash runwayYE24 cash $2.3B; planned 2025 investments .YE25 cash guided to ~$2.0B; exploring 2026 converts refinance; aim for positive cash flow in next few years .Balanced growth investment with discipline.
Regulatory/EuropeEU momentum for WAINUA .TRYNGOLZA EU CHMP positive opinion (FCS) .Ex-US optionality expanding.

Management Commentary

  • CEO Brett Monia: “Tr[yn]golza exceeded revenue expectations during its second quarter on the market, underscoring its strong therapeutic profile, our well executed commercial strategy as well as the significant unmet need” .
  • CFO Elizabeth Hougen: “For the second time this year, we are significantly raising our 2025 financial guidance… The strong second quarter revenue we earned also enabled [us] to generate $154 million in non GAAP net income for the quarter” .
  • On sHTG data timing and AP disclosure: “We will provide a statement on AP in our top line press release… and present the full data set at a medical congress in the second half of this year” .
  • Commercial lead Kyle Jenne on TRYNGOLZA access: “Coverage mix… approximately 60% commercial and 40% government… over ninety percent of patients have paid $0 out of pocket since launch” .

Q&A Highlights

  • TRYNGOLZA ramp and H2 outlook: Sequential tripling in Q2 underpinned by expanding prescribers and fast reimbursement; continued focus on patient identification to reach an estimated up to 3,000 FCS patients in the U.S. .
  • sHTG CORE/CORE2 readout: Expect TG lowering similar to ESSENCE (≈58–62%); blinded AP events exceed those in FCS BALANCE; topline to include an AP statement; full data later in 2H25 .
  • Donidalorsen label and competition: On track for Aug 21 PDUFA; switch study provides strong evidence for safe transitions and patient preference; potential dosing monthly or every other month is a differentiator vs competitors .
  • Pricing strategy for sHTG: U.S. payer testing ongoing; broader population typically implies $10–$20K annual pricing bands, but Ionis will engage payers based on value and outcomes; transition dynamics from FCS to sHTG label being evaluated .
  • Capital planning: Company evaluating options to refinance 2026 converts; aims to minimize cost of capital and maintain flexibility .

Estimates Context

  • Q2 2025 vs S&P Global consensus: Revenue $452.0M vs $299.0M consensus (+$153.0M beat); “Primary EPS” $0.85 vs $0.16 (+$0.69); EBITDA $142.7M vs $55.0M (+$87.7M). Consensus counts: Revenue n=20; EPS n=7*.
  • Q1 2025 actuals: Revenue $131.6M vs $122.5M est; “Primary EPS” -$0.92 vs -$1.03 est*.
  • Implications: Street likely to lift FY25 revenue and EPS on stronger TRYNGOLZA trajectory, collaboration revenue uplift (Ono), and improved opex leverage; focus shifts to sustainability of R&D revenue and upcoming launch contributions*. Notes: S&P Global figures marked with asterisk*. Values retrieved from S&P Global.

Key Takeaways for Investors

  • High-quality beat with a material FY25 guide raise; breadth of revenue (product, royalties, collaborations) de-risks near term .
  • Commercial execution is working: TRYNGOLZA launch momentum is tangible, access favorable, and EU expansion on deck (CHMP positive) .
  • Near-term catalysts are stacked (donidalorsen PDUFA; CORE/CORE2 readout); topline AP disclosure should help frame payer/physician adoption for sHTG .
  • Watch pricing and label dynamics for olezarsen in sHTG; management intends to calibrate price via payer testing given large TAM and potential outcomes data .
  • Operating leverage is emerging; with multiple potential 2025–26 launches (independent and partnered), Ionis is positioned for sustained growth and a path to positive cash flow in the next few years .
  • Tactical setup: Post-earnings strength likely tied to the size of the beat and guide raise; the September CORE/CORE2 data and August donidalorsen outcome are the next major stock drivers .

Additional detail and sources:

  • Q2 2025 press release and financial tables (including guidance):
  • Form 8-K (Item 2.02) with Exhibit 99.1:
  • Q2 2025 earnings call transcript (prepared remarks + Q&A):
  • TRYNGOLZA EU CHMP positive opinion:
  • Donidalorsen OASISplus switch-study publication:
  • Q1 2025 results for trend comparison:
  • Q4 2024 results for trend comparison:

Footnote: *Values retrieved from S&P Global.