Sobi's Record Quarter: Growth, a CRL Setback, and a Pipeline That Keeps Delivering
Double-digit growth and a raised outlook mask a complex gout franchise, while Tryngolza and Gamifant move the needle forward.
SOBI.ST · Earnings Call · 2026-07-16
A Quarter of Exceptional Execution
Sobi's Q2 2026 results were hard to fault. Revenue grew 29% at constant exchange rates to just under SEK 7.8 billion, and adjusted EBITA margin came in at 35%—up from 34% a year ago. The company raised its full-year guidance for both revenue growth and margin, now expecting mid-to-high teens revenue growth (previously low double-digit) and a mid-to-high 30s EBITA margin (previously mid-30s). As CEO Guido Oelkers put it, “This performance was broad-based, driven by our strategic portfolio, supported across all regions, which again highlights the resilience and scalability of our business model.” — Guido Oelkers, CEO · 2026-07-16
Based on our strong performance in the first half of the year, we are increasing our full-year outlook.
Growth was diversified across products and geographies, with North America up 33%, international markets up 45%, and Europe up 23%. ALTUVOCT, Doptelet, and Gamifant remained the key growth drivers, while Aspaveli's rollout in nephrology continues to build patient momentum. CFO Henrik Stenqvist noted the quality of the growth: “We saw 26% growth at CER in H1, and we expect momentum to continue with ALTUVOCT, Doptelet, and Gamifant being the main growth drivers in full year 2026.”
The Gout Franchise: Two Steps Forward, One Step Back
The most significant development for the gout franchise was the Complete Response Letter (CRL) for NASP (pegsiticase). The FDA's letter, received in June, relates to manufacturing (CMC) issues at a contract facility—not clinical efficacy or safety. Management remains confident in a resubmission within 6-12 months. As Complete Response Letter and resubmission are central to near-term execution, the path forward is clear but will require careful execution. In contrast, the positive top-line results from the REDUCE 2 pivotal study of pozdeutinurad are a major de-risking event. Both doses met the primary endpoint, with 69% and 56.6% of patients achieving serum uric acid levels below 6 mg/dL at six months, versus 8% on placebo. Lydia Abad-Franch highlighted the strength of the data: “We reported positive top-line results from the pivotal phase III REDUCE 2 study. Both the 75 mg and 50 mg doses met the primary efficacy endpoint…” — Lydia Abad-Franch, Executive, likely Head of Clinical or Medical Affairs · 2026-07-16 The company expects REDUCE 1 to read out in Q4, and a filing is planned for 2027.
The contrast between the two assets is stark: NASP faces a manufacturing-linked delay, while pozdeutinurad looks increasingly likely to be a valuable addition to the market. This dichotomy is precisely why the gout franchise merits close attention.
Tryngolza: Data That Could Redefine the Market
New data for Tryngolza (olezarsen) presented at the EAS Congress provided potentially practice-changing evidence. In a pooled analysis of the CORE and CORE2 trials in patients with severe hypertriglyceridemia (TG ≥ 880 mg/dL), treatment with Tryngolza 80 mg led to an 85% relative risk reduction in acute pancreatitis events and a 66% placebo-adjusted reduction in TG levels. Notably, 85% of treated patients achieved TG levels below 880. Risk of acute pancreatitis is a critical clinical endpoint, and these data reinforce the product's value beyond simple biomarker reduction. As Guido Oelkers said, “We are the lead. We have very strong data on sHTG reduction… Then we have the data in AP reduction, which obviously the bar is super high.” The company is preparing for a launch in the broader indication early next year, with a CHMP opinion expected in H2 2026.
Gamifant and Aspaveli: Pipeline Progress Across the Board
The sepsis opportunity for Gamifant is advancing with the EMBRACE II registrational trial expected to initiate in H2 2026. The study will be conducted in collaboration with the Hellenic Institute for the Study of Sepsis, focusing on interferon-gamma driven Sepsis. Management is deliberately moving quickly, using a European pathway to speed access. “It's only driven by speed because we felt that the Emergency Task Force was understanding what we tried to achieve,” Guido explained.
Meanwhile, Aspaveli (pegcetacoplan) continues to gain traction in nephrology, with the enFuse device now approved in the EU, enabling home use. Patient numbers are tracking ahead of the 400-500 target for 2026, and the product is expected to benefit from accumulated patient acquisition. The company remains confident in the blockbuster potential of the renal franchise, despite some near-term sales fluctuations.
The quarter also saw strong contributions from ALTUVOCT, which is on track to reach SEK 10 billion in sales, and Doptelet, which continues to perform. All in, Sobi's Q2 2026 demonstrates that the company is executing well on its strategic portfolio while navigating the inevitable setbacks that come with drug development. The raised outlook for 2026 reflects both momentum and confidence, and the pipeline—from pozdeutinurad to Tryngolza to Gamifant—offers multiple catalysts that could redefine the company's trajectory over the next 12 months.