IONIS PHARMACEUTICALS (IONS) Company Report

Ionis Pharmaceuticals has been granted FDA Breakthrough Therapy designations for two investigational drugs: zilganersen for Alexander disease (AxD) and olezarsen for severe hypertriglyceridemia (sHTG).
Zilganersen is the first potential disease-modifying treatment for AxD, with a new drug application planned for early 2026.
Olezarsen demonstrated statistically significant reductions in triglyceride levels and acute pancreatitis events in Phase 3 studies, with a supplemental new drug application expected by year-end.
The company has shown strong market momentum, with a 129% total shareholder return over one year and a 138% increase in share price year-to-date.

4 days ago

Morningstar

Ionis Highlights Recent Product Launches, Strong Pipeline Progress, and Upcoming Approvals

IONS

Product Launch

New Projects/Investments

Guidance Update

Ionis successfully launched two independent medicines in the U.S. this year: Tryngolza for FCS (approved December last year) and Donidalorsen for hereditary angioedema (approved August this year), both showing excellent initial performance.
The company announced positive Phase 3 data for Olezarsen in severe hypertriglyceridemia (SHGG), demonstrating an 85% reduction in acute pancreatitis attacks and normalization of triglycerides in over 50% of cases, with approval anticipated in the second half of next year.
Ionis anticipates five Phase 3 readouts and two to three FDA approvals in the coming year, including for Alexander disease and Tryngolza for SHGG, and expects Phase 3 data for Eplontersen in TTR cardiomyopathy in the second half of next year.
A next-generation Spinraza product, offering once-per-year dosing and potentially greater efficacy, will enter a pivotal Phase 3 study in the first half of next year, with significantly more attractive royalty terms for Ionis (mid 20% range).

Nov 18, 2025, 1:30 PM

Transcript

Ionis Highlights Recent Product Launches, Upcoming Approvals, and Pipeline Progress at Jefferies Conference

IONS

Product Launch

Guidance Update

New Projects/Investments

Ionis successfully launched Tryngolza for familial chylomicronemia syndrome (FCS) and Donidalorsen for hereditary angioedema independently in the U.S. this year, with both launches off to excellent starts.
The company anticipates two FDA approvals next year for Alexander disease and Tryngolza for severe hypertriglyceridemia (SHGG), with a potential third approval for chronic HPV. Additionally, five Phase 3 readouts are expected next year.
Positive Phase 3 data for Olezarsen in severe hypertriglyceridemia demonstrated an 85% reduction in acute pancreatitis attacks and normalization of triglycerides in over 50% of cases, with physicians expressing eagerness to prescribe it.
A next-generation, once-per-year Spinraza is advancing to a Phase 3 study in the first half of next year, with significantly more attractive mid-20% royalty rates for Ionis compared to the current compound's mid-teens.

Nov 18, 2025, 1:30 PM

Transcript

Ionis Highlights Recent Product Launches and Anticipated 2026 Approvals and Pipeline Milestones

IONS

Product Launch

New Projects/Investments

Guidance Update

Ionis launched two medicines independently in the U.S. this year: Tryngolza for FCS (approved December last year) and DAWNZERA for hereditary angioedema (approved August this year), both of which are off to excellent starts.
The company announced positive Phase III data for severe hypertriglyceridemia (SHGG) from its CORE and CORE2 programs, demonstrating substantial reductions in triglycerides and acute pancreatitis, with approval anticipated in 2026. Positive Phase III data was also announced for a wholly-owned neurology drug for Alexander disease, with approval planned for 2026.
Ionis expects a significant year ahead with five Phase III readouts and two to three FDA approvals in 2026.
A next-generation, yearly dosed SPINRAZA product, licensed to Biogen, is expected to enter a pivotal Phase III study in the first half of 2026, offering significantly more attractive royalties in the mid-20% range compared to the current mid-teens.

Nov 18, 2025, 1:30 PM

Transcript

Ionis Pharmaceuticals Prices $770 Million Convertible Notes Offering to Refinance 2026 Notes

IONS

Debt Issuance

Convertible Preferred Issuance

Ionis Pharmaceuticals, Inc. (IONS) priced an offering of $700.0 million aggregate principal amount of 0.00% Convertible Senior Notes due 2030 in a private placement.
The initial purchasers exercised their option in full, increasing the total aggregate principal amount of notes to $770.0 million, with the sale expected to close on November 17, 2025.
The net proceeds from the offering, estimated at approximately $682.8 million (or approximately $751.2 million if the option was fully exercised), are expected to be used primarily to repurchase or repay its 0% Convertible Senior Notes due 2026.
Ionis expects to use approximately $267.6 million of the net proceeds to repurchase $200.0 million in aggregate principal amount of its 2026 notes concurrently with the offering.
The initial conversion price for the new notes is approximately $98.10 per share, representing a 35.0% premium over the last reported sale price of $72.67 per share on November 12, 2025.

Nov 17, 2025, 9:06 PM

8-K

Ionis Pharmaceuticals Updates on Commercial Performance, Pipeline, and Financial Outlook

IONS

Product Launch

Guidance Update

New Projects/Investments

Ionis Pharmaceuticals reported that Tryngolza, approved in December last year for FCS, has been beating expectations, with full-year guidance raised to $85-$95 million. The drug generated $57 million through the end of September.
Donidalorsen for HAE received on-time approval in August and is now on the market, with an expectation of greater than $500 million in peak sales and $8 million in sales by the end of this year.
The company announced "incredibly impressive" Phase 3 data for olezarsen (SHTG), projecting a potential billion-dollar opportunity and anticipating sNDA filing by year-end with approval in October next year. Additionally, impressive Phase 3 data for zilganersen (Alexander disease) was reported, with plans to bring it to market next year.
Ionis laid out a path to positive cash flow break-even in 2028. The company anticipates annual peak sales of $5 billion or more, comprising $3 billion from its wholly owned pipeline and greater than $2 billion in royalties from partnered programs.

Nov 13, 2025, 1:00 PM

Transcript

Ionis Provides Update on Commercial Launches, Pipeline Progress, and Financial Outlook

IONS

Product Launch

Guidance Update

Revenue Acceleration/Inflection

Ionis reported strong commercial execution for Tryngolza (FCS), with full-year guidance raised to $85-$95 million.
The company launched donidalorsen for HAE in August 2025, expecting peak sales greater than $500 million and a consensus of $8 million for the end of 2025.
Impressive Phase 3 data for olezarsen (SHTG) positions it as a potential billion-dollar opportunity, with an sNDA filing expected by year-end 2025 and anticipated approval in October 2026.
Ionis outlined a path to positive cash flow break-even by 2028, projecting annual peak sales of $5 billion or more from current and late-stage programs, including $3 billion from wholly owned pipeline and over $2 billion in royalties from partnered programs.

Nov 13, 2025, 1:00 PM

Transcript

Ionis Prices Convertible Notes Offering

IONS

Debt Issuance

Ionis Pharmaceuticals (IONS) priced an offering of $700.0 million aggregate principal amount of 0.00% Convertible Senior Notes due 2030.
The primary purpose of the offering is to refinance the company's existing 0% Convertible Senior Notes due 2026.
Ionis estimates net proceeds of approximately $682.8 million and plans to use $267.6 million to repurchase $200.0 million in aggregate principal amount of the 2026 notes.
The new notes, which mature on December 1, 2030, have an initial conversion price of approximately $98.10 per share, representing a 35.0% premium over the last reported sale price of $72.67 per share on November 12, 2025.

Nov 13, 2025, 5:39 AM

Press Release

Ionis Announces Proposed Convertible Note Offering to Refinance 2026 Notes

IONS

Debt Issuance

Ionis Pharmaceuticals announced a proposed private offering of $700.0 million aggregate principal amount of Convertible Senior Notes due 2030.
The company intends to grant the initial purchasers an option to purchase up to an additional $70.0 million principal amount of notes.
The primary use of proceeds from the offering is to refinance its 0% Convertible Senior Notes due 2026, through repurchases or repayment at maturity.

Nov 11, 2025, 9:05 PM

Press Release

Ionis Pharmaceuticals Announces Positive Phase 3 Results for Olezarsen in sHTG

IONS

New Projects/Investments

Ionis Pharmaceuticals, Inc. announced positive results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen for severe hypertriglyceridemia (sHTG) on November 8, 2025.
Olezarsen achieved a highly statistically significant placebo-adjusted mean reduction in fasting triglyceride levels of up to 72% at six months, with these reductions sustained through 12 months.
The studies also demonstrated a highly statistically significant 85% reduction in acute pancreatitis events at 12 months, marking the first time this has been achieved in sHTG, and 86% of treated patients reached triglyceride levels below 500 mg/dL.
Ionis is on track to submit a supplemental new drug application to the FDA by the end of 2025 for both 50 mg and 80 mg doses, with a Prescription Drug User Fee Act (PDUFA) target action date expected in 2026.

Nov 10, 2025, 11:04 AM

8-K

Earnings Transcripts

Quarterly earnings call transcripts for IONIS PHARMACEUTICALS.

Ask Fintool AI Agent

Get instant answers from SEC filings, earnings calls & more

What did Brett P. Monia say about margins?What are IONIS PHARMACEUTICALS's strategic priorities?How is IONIS PHARMACEUTICALS positioned vs competitors?How did IONIS PHARMACEUTICALS do last quarter?

Let Fintool AI Agent track IONIS PHARMACEUTICALS's earnings for you

Get instant analysis when filings drop