This article first appeared on GuruFocus .
Release Date: November 05, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
Positive Points
-
Net sales in Q3 2026 reached SEK 28.5 million, a 41% increase year-over-year, and first nine months sales grew 62% to SEK 84.9 million.
-
Trailing twelve-month sales exceeded SEK 100 million for the first time, reaching SEK 103.5 million.
-
Gross margin is approximately 98%, indicating highly attractive unit economics.
-
Positive CHMP opinion for label expansion into third-line treatment could double the addressable patient population and average treatment cycle length.
-
Cash position strengthened to SEK 117 million at quarter-end, plus approximately SEK 100 million from a directed share issue in October, funding glioblastoma development.
-
Operating expenses decreased 3% year-over-year, with G&A costs materially reduced, improving operating leverage.
-
Real-world studies from Spain and Italy accepted for ASH presentation, showing strong response rates and survival benefits.
-
Blood-brain barrier penetration confirmed in glioblastoma window-of-opportunity study, validating the PDC platform in CNS tumors.
-
Partnership progress in Central and Eastern Europe with list price secured in Slovenia, and ongoing partnership discussions in Japan.
-
Company remains on track to achieve positive cash flow for commercial operations during 2027.
Negative Points
-
Q3 sales were affected by the European summer vacation period, with softer demand in August and September.
-
Germany's overall market was flat in September, reflecting challenging market conditions.
-
Japan partnership delayed due to a previous partner's financial issues, pushing potential deal timing later than initially expected.
-
Q4 sales outlook uncertain, with management noting potential surprises and not providing specific guidance.
-
Glioblastoma clinical development timeline uncertain, pending regulatory interactions, with no clear path to market yet.
-
Commercial operations still not cash flow positive; breakeven requires revenue covering the current cost base.
-
Third-line expansion potential depends on European Commission approval, which is expected but not yet granted.
-
Competitive landscape evolving with bispecifics and CAR-T therapies moving to earlier lines, potentially impacting long-term positioning.
-
R&D spending of SEK 17.9 million continues, and advancing glioblastoma will generate additional costs in 2027.
-
Sales and marketing investment of SEK 36.5 million remains significant to support commercial activities in Germany, Spain, and Italy.
Q & A Highlights
-
Warning! GuruFocus has detected 4 Warning Signs with STU:OND.
-
Is STU:OND fairly valued? Test your thesis with our free DCF calculator.
Q: What sales trend should investors expect for Q4 2026 compared with Q3 and Q2, given the seasonal softness in Q3? A: CEO Sofia Hagis explained that Q3 is consistently an outlier due to the European summer vacation period, with softer demand in August and September. She noted that Q4 2025 was also an outlier because of a strike in Spain that caused sales to drop rapidly in December. Absent unexpected events, she expects the Q4 trend to be more similar to the 2024 pattern rather than the 2025 pattern, with Q4 commonly stronger than Q3 and the trend turning up.
Q: How should costs be viewed for the remainder of 2026 and for 2027? A: CFO Henrik Bergentoft said the previously guided cost base of just below SEK 300 million in total operating costs for 2025 remains a relevant benchmark for full-year 2026, though the company is currently running somewhat lower. For 2027, he expects the commercial part of Oncopeptides to run at more or less the same cost base, but added that advancing glioblastoma into the next clinical phase will generate additional costs. He stressed these are two different value drivers with separate investment cases and that the company will clearly communicate what is what.
Q: How long would clinical development in glioblastoma take in the base case, and when could the drug reach the market? A: CEO Sofia Hagis said the company needs to interact with regulatory authorities before giving a specific timeline. She reasoned that glioblastoma is very aggressive with high unmet need and rapid progression, so if clinical progress and evidence remain positive, there is an opportunity for regulatory mechanisms such as accelerated approval in the US, potentially faster approval in Europe, and likely orphan drug designation. She expects a glioblastoma development program to be much shorter than an average time to market, and the company will update on plans after gathering more INSULA data and engaging regulators.
Q: Does the target of positive cash flow from the commercial business during 2027 depend on a significant contribution from the third-line expansion, and what quarterly sales level is needed to break even? A: CFO Henrik Bergentoft said the company's current running-rate cost base is essentially the commercial operation, so that level of revenue would be required to be cash flow positive for the commercial part. He noted the cash flow positive target was expressed before the third-line expansion opportunity arose, but the expansion will certainly help reach it. CEO Sofia Hagis added that the market landscape is evolving rapidly as bispecifics move from fourth line to second line, which strengthens the third-line position, and she would not be surprised if the company gains a higher third-line market share than expected a year ago.
Q: What caused the delay in a Japan partnership, and have negotiations progressed to commercial terms with potential partners? A: CEO Sofia Hagis explained that discussions began in 2024 with multiple companies and progressed rapidly, but one partner was given exclusivity and then suffered delays and a financial issue after one of its products was withdrawn, putting licensing efforts on hold. That had nothing to do with Pepaxti specifically. The company has since initiated a new round of discussions with a new set of partners, and she has been to Japan twice this year to initiate discussions and conduct due diligence. Top Japanese KOLs are supportive and have promised to educate partners on Pepaxti, and the company is discussing with several companies.
Q: What patient subgroup and treatment line will be targeted in glioblastoma in the base case? A: CEO Sofia Hagis said it is too early to specify the exact subgroup, as the company must agree on a clinical development program and target population with regulators. Based on preclinical data, the drug appears able to kill tumor cells regardless of MGMT promoter mutation status, potentially overcoming resistance to alkylators such as temozolomide because DNA double-strand damage occurs in both mitochondria and the nucleus. Since about 60% of first-line patients have the mutation and limited efficacy from standard of care, the company will discuss with regulators whether a first-line population could be pursued fairly early, though the INSULA study and likely a Phase 1 dose-finding study would target recurrent glioblastoma first.
Q: How has the development of the facility been so far in Q4? A: CEO Sofia Hagis referred back to her earlier answer, saying the company does not comment on the current quarter. She noted Q3 showed encouraging year-over-year growth but was weaker than Q2 on a quarter-over-quarter basis, and Q4 is commonly stronger than Q3 with the trend turning up. She reiterated that last year's Q4 was disrupted by an unfortunate strike in Spain and slower development in Germany, and absent similar surprises she expects a trend more in line with 2024.
Q: What is the commercial and financial significance of a potential European Commission approval of the Type II variation expanding Pepaxti into third line? A: CEO Sofia Hagis said the label would expand to adult patients with at least two prior lines of therapy whose disease is refractory to lenalidomide and their last line, removing the triple-class refractory requirement. This acts as a multiplier across three dimensions: it could double the addressable European patient population and double average treatment cycles per patient in third line, unlocking potential well beyond the current SEK 1.5 billion estimate; German basket pricing would allow immediate launch while price negotiations proceed; and Pepaxti fills a growing gap for a non-immunotherapy mode of action after first- and second-line relapse.
Q: What is the timeline and launch plan following the positive CHMP opinion for the third-line label expansion? A: CEO Sofia Hagis said the company submitted to EMA this summer, received a positive CHMP opinion in September, and expects a formal European Commission decision in the coming weeks, no later than 60 days after the CHMP decision. The immediate priority after a positive decision is to submit a German reimbursement dossier within approximately one month, enabling an immediate third-line commercial launch in Germany. In parallel, the company is preparing third-line launches in Italy and Spain and stands ready to submit market access dossiers as soon as local procedures allow.
Q: What do the new real-world studies accepted for presentation at ASH show about Pepaxti's clinical utility? A: CEO Sofia Hagis highlighted two independent multicenter real-world studies from Spain and Italy covering 82 heavily pretreated patients. The Italian study of 42 patients showed a 48% overall response rate and 13.5-month median overall
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
