Ionis Pharmaceuticals NASDAQ: IONS lowered its 2026 sales forecast for TRYNGOLZA after a slower-than-expected launch in severe hypertriglyceridemia, while pushing its target for sustained positive cash flow back by a year.
The biotechnology company now expects approximately $50 million in full-year TRYNGOLZA net product sales. Chief Executive Officer Brett Monia said the rollout is taking longer than anticipated as physicians adopt a new approach to treating patients with high triglyceride levels.
Despite the reduced product forecast, Ionis reaffirmed its full-year revenue, non-GAAP operating loss and cash guidance. The company reported third-quarter revenue of $243 million, up 55% from a year earlier when excluding a $280 million one-time sapablursen payment received last year.
TRYNGOLZA launch faces a gradual ramp
TRYNGOLZA generated $9 million in third-quarter product sales and $41 million through the first nine months of 2026. The third quarter was its first full quarter following its June approval for severe hypertriglyceridemia, or sHTG. The medicine was already marketed for familial chylomicronemia syndrome, or FCS.
Monia said demand is increasing and patients are staying on treatment, but physicians need time to identify appropriate patients and gain experience with the medicine. Management maintained its belief that TRYNGOLZA can achieve more than $3 billion in peak annual sales, though it did not provide a timeline for reaching that level.
Chief Global Product Strategy Officer Kyle Jenne said approximately 1,500 prescribers had prescribed TRYNGOLZA between the sHTG approval and the end of September. About 24% had written more than one prescription. The company is seeking to expand its prescriber base, encourage repeat prescribing and make it easier for patients to obtain treatment.
A majority of prescriptions required a medical exception at this early stage of the launch, Jenne said. By the end of September, plans representing 33% of commercially insured lives had added the sHTG indication to their formularies. Ionis expects additional coverage policies to take effect this year and throughout 2027.
Jenne said factors that could affect fourth-quarter revenue include the company’s Quick Start program, which provides patients with free treatment while coverage is being secured, the time needed to navigate medical exceptions and seasonal limitations on office visits. He declined to provide further details about use of the program or the time patients spend on it.
Cash-flow target moves to 2029
Chief Financial Officer Beth Hougen said Ionis now expects to achieve sustained positive cash flow in 2029 rather than 2028. She attributed the shift to the slower TRYNGOLZA launch and recent phase III setbacks.
Monia later identified the setbacks as disappointments for eplontersen in ATTR cardiomyopathy and pelacarsen in Lp(a)-related cardiovascular disease. He said the cash-flow target will depend in large part on the TRYNGOLZA launch, as well as pipeline successes.
Ionis ended the third quarter with $1.9 billion in cash and investments and continues to project a year-end balance above $1.6 billion. Hougen said the company will remain in an investment period as its commercial products grow and will evaluate financing needs, with cost of capital and dilution among its considerations.
The company maintained its forecast for 2026 revenue of $875 million to $900 million and a non-GAAP operating loss of $425 million to $475 million. Hougen said Ionis plans to provide 2027 guidance at its February year-end earnings call.
DAWNZERA growth and pipeline progress
DAWNZERA, Ionis’ treatment for hereditary angioedema, generated $37 million in third-quarter product sales and $79 million for the first nine months of the year. Third-quarter sales increased approximately 40% from the prior quarter, Hougen said. Ionis reaffirmed its full-year DAWNZERA sales forecast of $110 million to $120 million.
Commercial revenue across the company reached $136 million in the third quarter, up 18% from the same period a year earlier. Ionis also recorded initial product revenue for ZANVASTRO, its recently approved treatment for Alexander disease, although it did not disclose a separate sales figure on the call. Jenne said the first patients have received commercial treatment.
Chief Development Officer Holly Kordasiewicz highlighted recent pipeline developments, including U.S. and Japan approvals for HIBSAGO, a chronic hepatitis B treatment partnered with GSK. Ionis earned a $30 million milestone payment following the U.S. approval and expects royalties as the global launch begins.
Kordasiewicz also cited positive phase III results for sefaxersen, partnered with Roche for IgA nephropathy, and ulefnersen, partnered with Otsuka for FUS-ALS. Roche plans to share the sefaxersen data with health authorities, with a potential U.S. approval next year, she said.
About Ionis Pharmaceuticals (NASDAQ:IONS)
Ionis Pharmaceuticals is a biotechnology company that discovers and develops RNA-targeted medicines, with a focus on antisense oligonucleotides. Its medicines are designed to act on RNA and change the production of proteins linked to disease. The company's research and development programs span neurological, cardiovascular, metabolic and rare diseases.
Ionis has developed medicines that it commercializes itself and products advanced or marketed with pharmaceutical partners. Its medicines and partnered products include treatments for conditions such as spinal muscular atrophy and transthyretin amyloidosis.
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