Interim report Q3 2026
Summary by AI BETAClose X
FDA approval of EMCITATE® (tiratricol) in the U.S. marks a transformative quarter for Egetis
Financial overview July-September
· Quarterly net revenue MSEK 21.5 (17.4), +24% at constant exchange rates (CER)
· Quarterly result MSEK -147.0 (-82.4)
· Cash flow for the quarter MSEK -111.9 (-57.2)
· Cash at the end of the quarter MSEK 266.5 (145.7)
· Earnings per share before and after dilution SEK ‑0.3 (-0.2)
Financial overview January-September
· Net revenue for the period MSEK 52.3 (44.6), +17% at CER
· Result for the period MSEK -350.4 (-222.8)
· Cash flow for the period MSEK 45.6 (-200.6)
· Cash at the end of the period MSEK 266.5 (145.7)
· Earnings per share before and after dilution SEK -0.8 (-0.6)
Significant events during the quarter
· FDA approved EMCITATE for treatment of peripheral thyrotoxicosis in patients with MCT8 deficiency in the U.S.
· Egetis RareLink™, the EMCITATE patient support program, was launched in partnership with PANTHERx® Rare
· A Rare Pediatric Disease Priority Review Voucher (PRV) was granted by FDA in connection with the approval of EMCITATE
· Tiratricol was granted Orphan Drug Designation for MCT8 deficiency in Japan
· Presented EMCITATE clinical data at the European Thyroid Association (ETA) and the European Society for Paediatric Endocrinology (ESPE) congresses, including data from the Triac Trial II and ReTRIACt studies
· Collaboration and supply agreement for EMCITATE signed with Orspec Pharma for Australia and New Zealand
Significant events after the quarter
· Largest retrospective study of tiratricol in RTH-beta, led by Erasmus Medical Center, was published, providing further scientific support for the continued development of tiratricol in this indication
· EMCITATE became commercially available in the U.S. for treatment of peripheral thyrotoxicosis in patients with MCT8 deficiency
· Egetis, and its subsidiary Rare Thyroid Therapeutics International AB (RTTI), entered into an agreement to sell the PRV for MUSD 190 (approximately MSEK 1,900). Former owners of RTTI are entitled to approximately 50 percent of net proceeds of the PRV
Comments from the CEO
FDA approval of EMCITATE® in the U.S.
The third quarter was a defining period for Egetis, culminating on September 28 with FDA´s approval of EMCITATE for the treatment of peripheral thyrotoxicosis in patients with MCT8 deficiency. EMCITATE is the first and only approved treatment for patients with MCT8 deficiency in the U.S.
This is an achievement which I am immensely proud of. Above all, the approval represents an important milestone for patients living with MCT8 deficiency and their families, who until now have had no approved treatment option in the U.S. It also represents a transformational milestone for Egetis and marks the beginning of a new chapter as we transition fully into a commercial-stage rare disease company in the world's largest pharmaceutical market.
MCT8 deficiency is a devastating and life-limiting genetic disorder. Patients experience severe neurodevelopmental impairment combined with persistent peripheral thyrotoxicosis, and a median life expectancy of approximately 35 years. This underlines both the severity of the disease and the substantial unmet medical need that has motivated our work with EMCITATE.
The U.S. approval was supported by a comprehensive clinical development program, including ReTRIACt, Triac Trial I, Triac Trial II, the Erasmus Medical Center (EMC) Cohort Study and Survival Study, and the U.S. Expanded Access Program. I would once again like to thank the patients and families who participated in these studies, as well as the investigators, healthcare professionals, patient advocacy organizations, our collaborators and, of course, the entire Egetis team whose commitment made this achievement possible.
U.S. commercial launch of EMCITATE
With approval secured, our immediate priority has been to make EMCITATE available to eligible patients in the U.S. as quickly and efficiently as possible.
I am proud to share that we initiated the U.S. launch on October 27, ahead of previously anticipated timelines. This achievement reflects the extensive commercial and operational preparations undertaken ahead of the FDA decision, enabling us to move rapidly following approval. We have already seen good traction among physicians for EMCITATE after the approval and the commercial availability announcements.
To support patients, caregivers and healthcare professionals from launch, we have implemented Egetis RareLink™, our dedicated patient support program for EMCITATE. Through Egetis RareLink, we have established the access infrastructure, including specialty distribution and dedicated support resources, designed to help patients, caregivers and healthcare professionals navigate the treatment journey. We have also partnered with PANTHERx® Rare to support medication access, education, care coordination and ongoing treatment services.
For an ultra-rare disease such as MCT8 deficiency, making a medicine commercially available is only one part of the challenge. Connecting diagnosed patients and their treating physicians with treatment and supporting them through the access process will be central to successful commercialization. Therefore,
our objective extends beyond launching a medicine, to building an infrastructure capable of supporting the MCT8 deficiency community over the long term.
The FDA approval also resulted in Egetis receiving a Rare Pediatric Disease Priority Review Voucher, or PRV. On November 4, we entered into an agreement to sell the PRV for USD 190 million (approximately SEK 1.900 million). Former owners of Rare Thyroid Therapeutics International AB are entitled to approximately 50 percent of net proceeds of the PRV, as an earnout following Egetis’ acquisition of EMCITATE® (tiratricol) in 2020.
Commercialization of EMCITATE in the EU and international markets
The revenue for EMCITATE during the third quarter was MSEK 21.5, a 24 percent increase at constant exchange rates (CER), compared with the same quarter in 2025. The majority of sales originate from Germany, the first and only country where we have concluded a national reimbursement process, with the German national statutory health insurers, GKV-Spitzenverband. In Spain, we had a first meeting with the Ministry of Health during the quarter, to discuss our submitted national pricing and reimbursement dossier for EMCITATE. In Italy and France, we await the publication of survival data for EMCITATE by Erasmus Medical Center, to strengthen our value dossiers.
Markets outside the U.S. and Europe
On August 31, we announced that our partner in Japan, Fujimoto Pharmaceutical Corporation, which holds an exclusive license to develop and commercialize EMCITATE for MCT8 deficiency in Japan, had been granted Orphan Drug Designation for tiratricol by Japan’s Ministry of Health, Labor and Welfare.
Among the benefits of this designation in Japan, a future marketing authorization application is eligible for Priority Review, reducing the review time from approximately twelve to nine months, and the market exclusivity period is extended to ten years. Tiratricol now holds Orphan Drug Designation for MCT8 deficiency in Japan, the U.S. and the EU. The NDA in Japan for EMCITATE is expected to be submitted in 2027.
Our distribution partner companies Er-Kim (Turkey, Central, Eastern, and Southeastern Europe) and taiba rare (Gulf region) are actively identifying patients in their respective territories and have initiated funded treatment to more patients. In the quarter we signed a collaboration and supply agreement with Orspec Pharma, to enable us to reach more patients with MCT8 deficiency in Australia and New Zealand.
Raising visibility of clinical evidence and awareness of MCT8 deficiency
We also continued to strengthen communication of the scientific evidence supporting tiratricol during the quarter. In September, clinical data relating to EMCITATE were presented at the 47th Annual Meeting of the European Thyroid Association (ETA) in Porto, Portugal, and the 64th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE) in Marseille, France. The presentations included data from Triac Trial II examining early treatment in young pediatric patients with MCT8 deficiency and results from the ReTRIACt study evaluating the effects of tiratricol treatment withdrawal.
The continued presentations and publications of clinical evidence are important as awareness of MCT8 deficiency grows internationally. They support the medical community in understanding the disease and the role of tiratricol and provide an important scientific foundation as we work to broaden access to EMCITATE globally.
Exploring the potential of tiratricol in RTH-beta
Our work is also increasingly focused on the longer-term potential of tiratricol beyond MCT8 deficiency. Resistance to thyroid hormone beta (RTH-beta) is a separate indication from MCT8 deficiency, with no overlap between the patient populations, and tiratricol already holds Orphan Drug Designation for RTH-beta in both the U.S. and the EU. In October, the largest retrospective cohort study to date evaluating tiratricol in patients with RTH-beta, was published in eBioMedicine, a journal in the Lancet family. The international multicenter study, led by Erasmus Medical Center, included 28 patients aged from 0.4 to 73 years with 18 different THRB mutations. Median treatment duration was approximately four years. In this retrospective analysis, tiratricol was associated with statistically significant reductions in free thyroxine, or FT4, of 37 percent and thyroid stimulating hormone, or TSH, of 43 percent, together with a reduction in heart rate of 10 beats per minute.
These results further strengthen the scientific rationale for investigating tiratricol as a potential treatment for RTH-beta, a rare inherited thyroid hormone disorder for which there are currently no approved therapies. Tiratricol is investigational in RTH-beta and has not been approved by any regulatory authority for this indication.
We are continuing our work to finalize the development plan for tiratricol in RTH-beta. Scientific advisory boards have been convened, and preparations for regulatory interactions are ongoing. While MCT8 deficiency remains our immediate commercial focus, RTH-beta represents an opportunity to apply our growing expertise in rare thyroid hormone disorders to another patient population with significant unmet medical need.
Cash
We report cash of MSEK 267 (MSEK 146) as of September 30, 2026. The sale of the PRV will provide a significant non-dilutive cash contribution, strengthening our financial flexibility as we accelerate the commercialization of EMCITATE in the U.S. and advance the RTH-beta program.
Outlook
2026 is a year marked by several important milestones for Egetis. Our team focuses on delivering three key priorities:
• Successfully launch EMCITATE in the U.S.
• Optimize pricing and reimbursement and continue launch of EMCITATE in Europe
• Finalize the development plan for tiratricol in RTH-beta.
Stockholm, Sweden, November 5, 2026
Nicklas Westerholm
CEO
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