This article first appeared on GuruFocus .
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Total Revenue:$45 million in Q3 2026; $159.9 million for first nine months of 2026.
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IBTROZI Net US Product Revenue:$27.5 million in Q3 2026, up 18% sequentially; $69.2 million for first nine months of 2026.
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Collaboration and License Revenue:$17.5 million in Q3 2026; $90.7 million for first nine months of 2026.
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Milestone and Royalty Payments:$7.7 million in Q3 2026 from Innovent Biologics (China) and Nippon Kayaku (Japan) partnerships.
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Gross-to-Net Deductions:Approximately 30% in Q3 2026; expected to remain generally stable.
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Total Operating Expenses:$75.2 million in Q3 2026.
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R&D Expenses:$32.7 million in Q3 2026; $98.4 million for first nine months of 2026.
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SG&A Expenses:$42.6 million in Q3 2026; $123.5 million for first nine months of 2026.
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Cash, Cash Equivalents and Marketable Securities:$663.4 million as of September 30, 2026, including all proceeds from summer convertible debt offerings.
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New Patient Starts:Approximately 160 new patients started IBTROZI treatment in Q3, about 65% in first-line setting; overall ROS1 TKI market new patient starts declined ~15% per IQVIA claims data.
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Market Share:Greater-than-60% share of first-line new patient starts; leading ROS1 TKI in total active patients across all lines of therapy.
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Anticipated Milestone:~$30 million payment expected upon potential European approval in first half of next year.
Release Date: November 04, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
Positive Points
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IBTROZI net US product revenue grew 18% sequentially to $27.5 million, driven by a growing active patient base.
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IBTROZI is now the leading ROS1 TKI in total active patients across all lines of therapy, with >60% share of first-line new patient starts.
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IBTROZI's clinical profile shows a 90% ORR, 50-month median DOR, and 50-month median PFS in TKI-naive patients, with no CNS warning in its label.
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Safusidenib received FDA Fast Track designation for IDH1-mutant glioma, with updated Phase 2 data showing ORR of 52% and 36-month PFS rate of 79%.
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Strong cash position of $663.4 million, sufficient to reach profitability, and IBTROZI is now self-sustaining on a standalone basis.
Negative Points
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Total new patient starts in the ROS1 TKI market declined 15% in Q3, with a 25% decline in lab partner testing alerts, creating revenue growth uncertainty.
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IBTROZI faces increasing competition from new entrants like repotrectinib and zidesamtinib, which could pressure future market share.
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The pool of patients available to switch from earlier-generation ROS1 TKIs is shrinking, making future growth more dependent on newly diagnosed patients.
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Safusidenib's pivotal PFS-based studies (SIGMA and Grade 2 study) will not generate data until 2029 or later, delaying potential regulatory submissions.
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Operating expenses remain high at $75.2 million for the quarter, with continued investments in R&D and SG&A, impacting near-term profitability.
Q & A Highlights
Q: Farzin Haque of Jefferies asked how to think about fourth-quarter IBTROZI revenue given the broader ROS1 market decline, and whether the $108 million consensus for the year is the right area. A: CEO Dr. David Hung said the softness in the last quarter reflects lumpiness rather than a trend, and the company anticipates growth continuing at around the same pace as seen in the past.
Q: Li Watsek of Cantor Fitzgerald asked which safusidenib endpoints could read out in 2027 and what would be impressive in the Grade 3 oligodendroglioma and post-vorasidenib settings. A: CEO Dr. David Hung said at least 20 patients are expected to be enrolled this year in the Grade 3 oligodendroglioma study, giving six to nine months of follow-up by June 2027, with responses generally seen in six to 12 months. He said the bar to beat is roughly a 20% response rate, citing Chimerix's approval on 11 responses in 50 patients (about 22%), and noted post-vorasidenib patients are easy to identify given the large pool progressing on vorasidenib.
Q: Robert Burns of HC Wainwright asked about the potential impact of zidesamtinib's front-line approval on IBTROZI's future revenue and how Nuvation would build out its commercial team for a glioma launch. A: CEO Dr. David Hung said IBTROZI's 90% response rate and 50-month duration of response will be hard to beat, noting zidesamtinib's second-line label carried unexpected CNS warnings and precautions, 42% peripheral edema and Grade 3 shortness of breath. CFO Philippe Sauvage said a glioma launch would leverage the existing commercial organization, requiring only a relatively small addition of about 17 reps given the limited number of treatment centers.
Q: Anish, on for Gregory Renza of Truist Securities, asked how IBTROZI is competing with repotrectinib in the first line, what drives physician choice, and whether the bigger opportunity is taking TKI share or expanding testing and conversion from chemo/IO. A: CEO Dr. David Hung said IBTROZI is doing very well against repotrectinib, having sold twice as much as all ROS1 agents combined in its first year, and cited unmatched efficacy and the unique absence of a CNS warning and precaution. Chief Commercial Officer Colleen Sjogren added that IBTROZI now has the largest number of patients actively receiving a ROS1 TKI across all lines, and that improving comprehensive RNA-based testing and incorporating molecular results into treatment decisions are the most meaningful opportunities.
Q: Priyanka Grover of JPMorgan asked whether discontinuation rates in the front and second line are still tracking with clinical trial data. A: CCO Colleen Sjogren said treatment-related adverse events from launch through September are tracking very closely to the TRUST trials. CFO Philippe Sauvage said time on therapy shows no difference from trials so far, though only 15 months of launch experience exists versus more than 50 months of trial observation. Sjogren noted early-launch patients were heavily pretreated, and adverse event-related discontinuations remain low and consistent with trials.
Q: Geoffrey Meacham of Citi asked about US nuances between community and academic settings and differences in the China and Japan partner launches. A: CEO Dr. David Hung said community settings show lower testing rates and more first-line chemotherapy use than academic centers. He said the China and Japan launches have exceeded expectations, partly because testing rates there are remarkably high.
Q: Stephen, on for Yaron Werber of TD Cowen, asked whether the Grade 3 oligodendroglioma study could read out faster than the post-vorasidenib study and how FDA acceptance of tumor growth rate could change the path to market. A: CEO Dr. David Hung said he is confident both studies will be positive but cannot say which reads out faster, though the post-vorasidenib study should accrue faster given more patients. He said tumor growth rate is not yet accepted by FDA and the company is not assuming acceptance, but will present the data alongside objective responses, noting a growing tumor cannot shrink without changing its slope.
Q: Mike, on for Mayank Mamtani of B. Riley, asked what gives confidence that IBTROZI follows the fivefold growth curve of LORBRENA and ALECENSA, and what to focus on in the SNO posters. A: CEO Dr. David Hung said IBTROZI's first five quarters are in the same $26 million to $30 million range as those ALK launches despite ROS1 incidence being half of ALK, and full revenue stacking from its long duration of response will not be visible for another three-plus years. CFO Philippe Sauvage noted ALK new patient starts fell 19% quarter over quarter yet the long-term trend remains up. Dr. Hung said the SNO posters will show more detail on the depth and durability of responses.
Q: Boris Peaker of JonesResearch asked about gross-to-net adjustments and how the SIGMA trial handles pseudo-progression after chemoradiation in its modified RANO assessment. A: CFO Philippe Sauvage said gross-to-net was stable at about 30% this quarter and should stay there until the next price increase. CEO Dr. David Hung said SIGMA is a placebo-controlled study with blinded independent committee review, and any pseudo-progression from radiation would occur in both arms, leaving the drug as the difference.
Q: Josh Werman, on for Silvan Turkcan of Citizens JMP, asked how consistent the roughly 3,000 annual ROS1 diagnoses have been and whether variability is year over year or quarter to quarter. A: CEO Dr. David Hung said the roughly 2% ROS1 incidence in non-small cell lung cancer is well supported by literature and the epidemiology is not off, but rare indications show quarter-to-quarter lumpiness, citing a recent 50% quarterly drop in ALK scripts. CFO Philippe Sauvage said the fluctuation is quarterly, not a yearly change.
Q: Xander, on for Leonid Timashev of RBC Capital Markets, asked about precedents for reusing a mechanism in the post-vorasidenib setting and how to frame responses there. A: CEO Dr. David Hung said safusidenib's response rate is more than double voras
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
