Ionis raises 2025 revenue guidance to $900M as TRYNGOLZA and DAWNZERA launches accelerate

Earnings Call Insights: Ionis Pharmaceuticals (IONS) Q3 2025

MANAGEMENT VIEW

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Brett Monia, CEO, stated the third quarter was a “watershed moment for Ionis as we made important progress advancing first and best-in-class medicines for several serious diseases, including in our core focus areas of neurology and cardiometabolic diseases.” He highlighted the strong momentum of TRYNGOLZA, the launch of DAWNZERA, and positive pivotal results from two Phase III programs. Monia announced, “we are raising our 2025 financial guidance, including TRYNGOLZA revenues.” He also emphasized recent European approval for TRYNGOLZA and anticipated launches for olezarsen and zilganersen next year.

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Richard S. Geary, Chief Development Officer, reported, “olezarsen demonstrated highly statistically significant and clinically meaningful mean reductions of up to 72% in placebo-adjusted fasting triglycerides at 6 months.” He added, “olezarsen also significantly reduced acute pancreatitis events, making it the first and only treatment to achieve this positive outcome in people with sHTG.” Geary confirmed upcoming data presentations and an sNDA submission for olezarsen by year-end, with further launches next year.

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Kyle Jenne, Chief Global Product Strategy Officer, detailed commercial progress: “TRYNGOLZA continued to exhibit strong momentum as we reported $32 million in net product sales, reflecting a nearly 70% increase in revenues quarter-over-quarter.” Jenne described expanding outreach to prescribers for the upcoming sHTG launch and strong early adoption of DAWNZERA, noting “patients switching from prior prophylactic or on-demand therapies as well as treatment-naive patients starting on DAWNZERA.”

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Elizabeth L. Hougen, CFO, said, “we generated $157 million in revenue, representing a 17% increase year-over-year.” She added, “we are once again increasing our 2025 financial guidance, our third consecutive increase this year.” Hougen provided updated revenue guidance and commented on Ionis’ “strong balance sheet that will support continued investment to drive accelerating growth.”

OUTLOOK

* Ionis raised its 2025 total revenue guidance to between $875 million and $900 million, an increase of $50 million versus prior guidance. Guidance for TRYNGOLZA product sales is now $85 million to $95 million for the full year, also an increase from prior guidance. Management anticipates “DAWNZERA will provide a modest revenue contribution this year with a greater impact beginning next year.” The company expects an operating loss between $275 million and $300 million for the full year and a year-end cash balance of more than $2.1 billion. Monia reiterated the goal of achieving cash flow breakeven by 2028.

FINANCIAL RESULTS

* Ionis reported $157 million in revenue for Q3 2025. TRYNGOLZA net product sales reached $32 million, a nearly 70% quarter-over-quarter increase. Royalty revenues were $76 million, up 13% from the previous quarter. For the first nine months of 2025, total revenue was $740 million, up 55% year-over-year. Year-to-date non-GAAP operating expenses increased 9%, with sales and marketing expenses rising due to launch activities, while R&D expenses decreased following the completion of late-stage studies. The company’s cash position at quarter-end exceeded $2.1 billion.

Q&A

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Jessica Fye, JPMorgan: Asked about the launch curve for olezarsen in sHTG and whether there is pent-up demand. Kyle Jenne responded that there is “strong interest” from healthcare providers and plans to expand the target HCP population from 3,000 to 20,000, covering approximately 360,000 sHTG patients. He expects “strong uptake based on the interest and what we've learned about the market thus far.”

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Huidong Wang, Barclays: Asked about any concerns in the CORE and CORE2 data and peak revenue potential for DAWNZERA, olezarsen, and Alexander disease. Monia stated there are “groundbreaking results” with olezarsen and no concerns regarding pancreatitis data. Jenne projected peak sales for DAWNZERA “greater than $500 million,” olezarsen “greater than $1 billion,” and Alexander disease “greater than $100 million.”

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Michael Ulz, Morgan Stanley: Inquired about pricing for olezarsen. Jenne said pricing research is ongoing and additional information will be provided next year upon approval.

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Gary Nachman, Raymond James: Queried about TRYNGOLZA patient sources and Q4 guidance. Jenne explained ongoing focus on patient identification, payer dynamics, and that Q4 guidance reflects a shorter quarter and potential seasonality.

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Additional questions addressed early DAWNZERA prescriptions, WAINUA revenue growth, capital allocation priorities, and sHTG trial retention rates, with management expressing confidence in product uptake, ongoing market research, and pipeline-driven internal investment.

SENTIMENT ANALYSIS

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Analysts largely expressed positive sentiment, congratulating management and focusing on launch trajectories, data quality, and peak sales potential. Queries reflected high expectations for new launches and product uptake.

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Management maintained a confident and upbeat tone, frequently highlighting “groundbreaking results,” “strong momentum,” and “confidence” in future launches. Monia stated, “With a deep pipeline, outstanding execution and a clear path to achieve cash flow breakeven in 2028, Ionis is well positioned to deliver transformative medicines for patients and accelerating value creation for shareholders.”

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Compared to the previous quarter, both analysts and management displayed increased confidence, with more specific discussions on launch execution and financial targets, and less focus on uncertainties.

QUARTER-OVER-QUARTER COMPARISON

* Ionis raised revenue guidance for the third consecutive quarter, reflecting accelerating commercial execution and stronger-than-expected sales from TRYNGOLZA. The previous quarter’s focus was on launch preparedness and initial momentum, while this quarter emphasized successful product launches and positive pivotal clinical data. Management’s tone was even more optimistic, citing concrete milestones and expanded guidance. Analysts shifted from questions on launch readiness and trial design to adoption curves, pricing, and peak sales projections, reflecting increased confidence in Ionis’ commercial trajectory. Strategic focus moved toward upcoming launches and maximizing commercial opportunities.

RISKS AND CONCERNS

* Management highlighted the importance of patient identification and payer dynamics for sustained TRYNGOLZA growth. Pricing for olezarsen in sHTG remains under evaluation, with management noting ongoing research and payer discussions. Analysts probed for potential concerns in pivotal trial data and drug retention rates, but management addressed these with assurances of data quality and product safety. No major new risks or operational disruptions were identified in the call.

FINAL TAKEAWAY

Ionis Pharmaceuticals emphasized breakthrough clinical results, stronger-than-expected commercial launches for TRYNGOLZA and DAWNZERA, and increased 2025 revenue guidance. With additional launches planned, a robust late-stage pipeline, and a strong balance sheet, the company is projecting continued growth, aiming for cash flow breakeven by 2028 and sustained value creation for shareholders.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/ions/earnings/transcripts]

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