greeksoup/ stock research

Ionis Pharmaceuticals Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 29 July 2026: press release. Guidance figures: 3 kept. The quarter’s numbers.

Key takeaways

  • Revenue growth excluding prior-year payment: Second quarter total revenue was $268 million, against $452 million a year earlier. Excluding the one-time sapablursen upfront payment recognized in 2025, revenue grew 56% in the quarter and 69% in the first half. Source
  • Net loss versus prior-year profit: GAAP net loss was $115 million, or $0.69 per diluted share, against net income of $124 million, or $0.70 per diluted share, a year earlier. First-half net loss was $207 million. Source
  • TRYNGOLZA sales fell on lower price: TRYNGOLZA U.S. net product sales were $5 million in the second quarter, against $19 million a year earlier, and $32 million for the first half. Management cited a reduced net price effective April 1, 2026. Source
  • DAWNZERA sales rose 63% sequentially: DAWNZERA U.S. net product sales were $26 million in the second quarter and $42 million for the first half, with second-quarter sales up 63% from the first quarter of 2026. Source
  • Cash fell after note repayment: Cash, cash equivalents and short-term investments were $2.1 billion at June 30, 2026, down from $2.7 billion at December 31, 2025, mainly due to repaying the 0% convertible notes on April 1, 2026. Source
  • Zilganersen decision date September 22: The zilganersen NDA for Alexander disease is under FDA Priority Review with a target action date of September 22, 2026. The CEO said approval would position Ionis for its first independent launch from its neurology portfolio. Source
  • Bepirovirsen decision date October 26: Bepirovirsen for chronic hepatitis B is under regulatory review in the U.S., EU, Japan and China. The FDA granted Priority Review with a target action date of October 26, 2026. Source
  • CARDIO-TTRansform primary endpoint not met: Eplontersen's Phase 3 CARDIO-TTRansform study in ATTR-CM did not meet its primary composite endpoint in the overall population; nominal significance was shown in the pre-specified monotherapy population. Results will be presented at ESC in August 2026. Source

“With the approval of TRYNGOLZA in late June, Ionis is bringing the first and only treatment to reduce triglycerides and acute pancreatitis to people living with severe hypertriglyceridemia”

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

Guidance

AreaPeriodFigureAgainst last quarter
TRYNGOLZA product sales, net Sourcefull year 2026$100-110 millionKept
DAWNZERA product sales, net Sourcefull year 2026$110-120 millionKept
Cash-flow breakeven Source2028cash-flow breakeven in 2028Kept

What changed from last quarter

  • New: TRYNGOLZA was approved by the FDA to reduce triglycerides and acute pancreatitis risk in adults with severe hypertriglyceridemia (sHTG), adding an indication to the existing FCS approval. Source
  • New: Ionis entered a license agreement with Recordati to develop and commercialize zilganersen outside the U.S. Source
  • New: ION775 entered a Phase 2 study in people with sHTG and moderately elevated triglycerides, based on Phase 1 results. Source
  • New: Biogen plans to advance diranersen into Phase 3 development after Phase 2 CELIA data showed benefit in measures of cognition. Source

Results and revenue

  • Revenue growth excluding prior-year payment: Second quarter total revenue was $268 million, against $452 million a year earlier. Excluding the one-time sapablursen upfront payment recognized in 2025, revenue grew 56% in the quarter and 69% in the first half. Source
  • Net loss versus prior-year profit: GAAP net loss was $115 million, or $0.69 per diluted share, against net income of $124 million, or $0.70 per diluted share, a year earlier. First-half net loss was $207 million. Source
  • Operating loss on GAAP basis: GAAP loss from operations was $102 million, against income of $140 million a year earlier. On a non-GAAP basis the loss from operations was $57 million, compared with income of $170 million. Source

Wholly owned medicines

  • TRYNGOLZA sales fell on lower price: TRYNGOLZA U.S. net product sales were $5 million in the second quarter, against $19 million a year earlier, and $32 million for the first half. Management cited a reduced net price effective April 1, 2026. Source
  • SHTG approval and early launch: Management said the sHTG U.S. launch is showing early momentum after the June 2026 approval. A marketing application for sHTG is under review in the European Union. Source
  • DAWNZERA sales rose 63% sequentially: DAWNZERA U.S. net product sales were $26 million in the second quarter and $42 million for the first half, with second-quarter sales up 63% from the first quarter of 2026. Source
  • DAWNZERA launch outside U.S. underway: DAWNZERA launch outside the U.S. is underway, with new market approvals in the European Union. Source

“We are encouraged by the early launch momentum and look forward to accelerating growth from TRYNGOLZA and our other wholly owned medicines in the quarters and years to come”

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

Partnered medicines and R&D revenue

  • SPINRAZA global sales and royalties: SPINRAZA global sales were $402 million in the second quarter, resulting in royalty revenue of $54 million to Ionis. Source
  • WAINUA sales and royalties: WAINUA global sales were $70 million in the second quarter, with royalty revenue of $16 million. Management said global launches continue and additional submissions are in progress. Source
  • Collaboration revenue below prior-year upfront: Collaborative agreement revenue was $133 million, against $337 million a year earlier. The prior-year figure included a $280 million upfront payment for the global license of sapablursen to Ono. Source
  • Program payments under collaborations: Research and development revenue reflected multiple payments for programs advancing under Ionis's R&D collaborations, according to the company. Source

Operating expenses and non-GAAP

  • Operating expenses rose on launches: GAAP operating expenses were $370 million, against $312 million a year earlier. Management said the increase was primarily from commercial investment in TRYNGOLZA and DAWNZERA and launch preparation for zilganersen. Source
  • Selling, general and administrative expense rose: Selling, general and administrative expense was $150 million, against $91 million a year earlier. First-half selling, general and administrative expense was $301 million. Source
  • Equity compensation excluded from non-GAAP: Non-GAAP operating expenses were $325 million, excluding $45 million of equity compensation expense that the company described as non-cash. Source

“Our performance in the first half of this year reflects the strength and resilience of our business”

Elizabeth L. Hougen, chief financial officer of Ionis

Cash, debt and other income

  • Cash fell after note repayment: Cash, cash equivalents and short-term investments were $2.1 billion at June 30, 2026, down from $2.7 billion at December 31, 2025, mainly due to repaying the 0% convertible notes on April 1, 2026. Source
  • Royalty sale interest expense: Interest expense related to the sale of future royalties was $18 million in the second quarter, against $19 million a year earlier. Source
  • Other income rose in first half: Other income, net was $6 million in the second quarter and $49 million in the first half, against $3 million and $21 million a year earlier. Source

Pipeline and regulatory milestones

  • Zilganersen decision date September 22: The zilganersen NDA for Alexander disease is under FDA Priority Review with a target action date of September 22, 2026. The CEO said approval would position Ionis for its first independent launch from its neurology portfolio. Source
  • Bepirovirsen decision date October 26: Bepirovirsen for chronic hepatitis B is under regulatory review in the U.S., EU, Japan and China. The FDA granted Priority Review with a target action date of October 26, 2026. Source
  • CARDIO-TTRansform primary endpoint not met: Eplontersen's Phase 3 CARDIO-TTRansform study in ATTR-CM did not meet its primary composite endpoint in the overall population; nominal significance was shown in the pre-specified monotherapy population. Results will be presented at ESC in August 2026. Source
  • Phase 3 start and breakthrough designation: Salanersen entered Phase 3 development and received Breakthrough Therapy Designation from the FDA. Sapablursen also entered Phase 3, and ION775 entered Phase 2. Source

Coming up, as management said on 29 July 2026

  • Zilganersen FDA action and launch: Zilganersen has a target action date of September 22, 2026. Management said it is on track to launch this year, assuming approval. Source
  • Bepirovirsen global launch planned: The CEO said Ionis expects the global launch of bepirovirsen for chronic hepatitis B this year, with the FDA target action date of October 26, 2026. Source
  • Pelacarsen HORIZON results expected: The CEO said the company expects results from the pelacarsen Lp(a) HORIZON cardiovascular outcomes trial in the second half of 2026. Source
  • ESC Congress presentations in August: CORE and CORE2 open-label extension results for olezarsen will be presented at ESC in August 2026. ION775 Phase 1 and CARDIO-TTRansform results are also due at ESC that month. Source
  • European sHTG launch potentially 2027: The sHTG marketing application for olezarsen is under review in the EU, with a potential launch in 2027. Source
  • Obudanersen Phase 3 data timing: REVEAL enrollment for obudanersen in Angelman syndrome is complete, with data anticipated in the second half of 2027. Source

Figures management reported

FigureReported
TRYNGOLZA net product sales Source$5 million in Q2 2026; $32 million first half
DAWNZERA net product sales Source$26 million in Q2 2026; $42 million first half
SPINRAZA global sales Source$402 million in Q2 2026
WAINUA global sales Source$70 million in Q2 2026
Research, development and patent expense Source$217 million in Q2 2026 (GAAP)
Phase 3 trial readout Sourceprimary composite endpoint not met in overall population

Risks management discussed

  • Demand: The company cited a reduced net price for TRYNGOLZA effective April 1, 2026, which offset continued demand in FCS. Source

Earlier plans management reported on

  • On track: Management said the zilganersen launch is on track for this year, assuming FDA approval. Source
  • On track: Management said bepirovirsen is on track for global launch this year, with regulatory review under way in several countries. Source
  • Met: The company reported that enrollment in the Phase 3 REVEAL study is complete. Source
  • Met: The key 2026 events table lists the salanersen SMA Phase 3 initiation as achieved. Source
  • Met: The key 2026 events table lists the sapablursen polycythemia vera Phase 3 initiation as achieved. Source
  • Not stated: The key Phase 2 events table lists the tominersen Huntington's disease Phase 2 data milestone as Not Achieved. Source

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.