Annual Report • Feb 26, 2025
Annual Report
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Year-End Report January-December 2024
and Prof. A. Rees presented on RTH-beta. Members of Egetis' management team highlighted the progress made toward market approvals for Emcitate, as well as the Company's strategic objectives. (Link to the Investor Day)
| 2024 Oct-Dec |
2023 Oct-Dec |
2024 Jan-Dec |
2023 Jan-Dec |
|
|---|---|---|---|---|
| Net revenue, MSEK | 10.8 | 32.6 | 46.1 | 57.6 |
| Result after tax, MSEK | -110.5 | -86.3 | -343.6 | -326.9 |
| Cash flow, MSEK | 218.1 | 223.6 | 41.8 | 180.4 |
| Cash, MSEK | 351.0 | 303.3 | 351.0 | 303.3 |
| Equity ratio % | 62 | 72 | 62 | 72 |
| Earnings per share, SEK | -0.3 | -0.3 | -1.1 | -1.3 |
| Earnings per share after dilution, SEK | -0.3 | -0.3 | -1.1 | -1.3 |
| Average number of employees | 40 | 30 | 35 | 27 |
On February 13, 2025, the European Commission (EC) approved Emcitate® (tiratricol) as the first and only treatment for patients with monocarboxylate transporter 8 (MCT8) deficiency in all 27 European Union member states, as well as Iceland, Norway, and Liechtenstein. I am very proud of the approval of Emcitate, which represents the single most important milestone in Egetis' history and a major step forward in building a sustainable rare disease company. We are delighted to bring this much needed new treatment to patients in the EU. I would like to thank all patients, parents, caregivers and investigators who have taken part in the comprehensive development program for Emcitate and all Egetis employees and collaborators for their dedicated and hard work, in particular the group of Prof. Dr. Edward Visser at the Erasmus University Medical Center, Rotterdam, The Netherlands.
We look forward to initiating pricing and reimbursement processes and discussions in Europe and expect to launch Emcitate in the first country, Germany, during the second quarter of 2025.
Following an agreement with the FDA, Egetis is conducting a pivotal, randomized, placebo-controlled study (ReTRIACt) in at least 16 evaluable patients with MCT8 deficiency to support the submission of a New Drug Application (NDA) in the USA. To increase the recruitment capacity in the study four additional clinical study sites have been opened in the USA in 2024: one each in Texas, Georgia, North Carolina and Florida. So far, 19 patients have been included, of which 11 patients have completed the randomized phase, 3 patients are in the run-in period and additional patients are being evaluated for screening. As previously communicated, we will update the market as soon as recruitment of the ReTRIACt trial is closed. At that time, we will also provide information on when to expect topline results and when we plan to submit the NDA application. More information about
the ReTRIACt study is available on clinicaltrials.gov under the code NCT05579327.
On February 24, Egetis participated in Behind the Mystery™, a TV show in the U.S. that airs during the morning program The Balancing Act®. This episode, sponsored by Egetis, aimed to raise awareness about MCT8 deficiency in connection with Rare Disease Day on February 28. The episode on MCT8 deficiency will also air on March 3, 2025. A replay can be viewed at TheBalancingAct.com/rare.
MCT8 deficiency is a rare genetic disease first described in 2004, and in the EU Emcitate is now the first and only approved therapy. Consequently, the general awareness of the disease and the diagnosis are very low, even among specialist physicians, and a large portion of patients remain misdiagnosed. Our medical affairs activities are focused on improving awareness of the disease and improving knowledge about its diagnosis, by participation and dialogues at scientific conferences, partnering with genetic testing companies, engaging with Key Opinion Leaders, advisory committees, and interactions with patient groups. During 2024, Egetis participated at over 30 scientific conferences on topics such as endocrinology, pediatrics, and neurology, where MCT8 deficiency has been presented.
For more information about MCT8 deficiency, please see https://www.mct8deficiency.com/
There is continued significant and growing interest from physicians worldwide in treating patients with MCT8 deficiency with Emcitate, which is already being prescribed as part of Managed Access Programs to patients in over 25 countries. Currently approximately 230 patients are being treated with Emcitate. At the request of the FDA, Egetis has implemented an Expanded Access Program (EAP) in the USA. Currently, 12 sites are open to enroll patients in the EAP and an
additional 8 hospitals are in the process of joining the program. The EAP program facilitates physicians in accessing tiratricol for their MCT8 deficiency patients who are ineligible for a clinical trial until the product receives market authorization. The program is also important for patients in the ReTRIACt study, so that they have the option to continue treatment with tiratricol after completing the study.
In December 2025, we announced that the Company has selected resistance to thyroid hormone beta (RTHβ) as the next potential indication for Emcitate. The company plans to support an investigatorinitiated Phase 2 multicenter study for patients with RTHβ in collaboration with academic research groups. RTHβ is a rare genetic disorder with a significant unmet medical need and currently has no approved treatments. The condition affects 1–2 individuals (both males and females) per 40,000 live births and is caused by mutations in the thyroid hormone receptor beta gene. Thyroid hormone is essential for development and metabolism in virtually all tissues and acts by binding to nuclear thyroid hormone receptors, leading to the transcription of hormone-sensitive genes. Recent studies have shown that patients with RTHβ have reduced survival and an increased risk of cardiovascular disease (Okosieme et al. 2023, Campi et al. 2024). RTHβ is a distinct indication, with no overlap in the patient population with MCT8 deficiency. In 2022, Egetis received Orphan Drug Designation (ODD) for RTHβ for Emcitate in both the U.S. and the EU.
On December 18, 2024, Egetis hosted an Investor Day in Stockholm. During the event, Professor Edward Visser from Erasmus University Medical Center gave a presentation on MCT8 deficiency and the unmet medical need, while Professor Aled Rees from Cardiff University spoke about RTHβ and the significant unmet medical need in this condition. Members of Egetis' leadership team highlighted the progress made toward marketing approvals for Emcitate, including a status update on the ReTRIACt
study, as well as plans for preparatory activities and commercialization, focusing on disease awareness, market access, and value proposition. Additionally, the Company's strategic short-term goals and longterm ambitions to build a sustainable orphan drug company were presented. (Link to Investor Day)
In October 2024 we carried out a directed share issue at a market price of SEK 4.50 per share, raising net proceeds of SEK 281 million. This new financing reflects investors' continued confidence in our assets, our team, and our work. The directed share issue was oversubscribed and included both existing and new international and Swedish institutional investors. The issuance was led by the U.S.-based life sciences investor Frazier Life Sciences with an investment of USD 10 million and was supported by international specialist investor Invus (USA/France), as well as Platinum Asset Management (Australia), Fjärde APfonden, Handelsbanken Fonder AB through the investment fund Hälsovård Tema, Unionen, HealthInvest Partners AB, and Cidro Förvaltning AB.
We report cash of approximately SEK 351 million as of December 31, 2024. Currently, the Company has an ongoing dialogue with BlackRock regarding the conditions and a prolongation of the Tranche B (EUR 15 million) draw down window of the loan facility.
2025 is a year marked by several important milestones for Egetis. Our team continues to focus on delivering four key priorities:
Egetis Therapeutics is an innovative and integrated pharmaceutical company, focusing on projects in latestage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment.
On February 13, 2025, the European Commission approved Emcitate as the first and only treatment for MCT8 deficiency in EU.
The Company's lead drug candidate Emcitate® (tiratricol) is under development for the treatment of patients with monocarboxylate transporter 8 (MCT8) deficiency, a highly debilitating rare disease with no available treatment. In previous studies (Triac Trial I and a long-term real-life study) tiratricol has shown highly significant and clinically relevant results on serum thyroid hormone T3 concentrations and secondary clinical endpoints. Triac Trial II investigated a potential treatment effect on neurocognitive development in young children under 30 months with MCT8 deficiency. The study did not show a statistically significant improvement compared to historical controls.
After a dialogue with the FDA, Egetis is conducting a randomized, placebo-controlled pivotal study in at least 16 evaluable patients to verify the results on T3 levels seen in previous clinical trials and publications. As previously communicated, the Company will update the market as soon as recruitment closes, and at that time, the Company will also provide
information on when to expect topline results and when the Company plans to submit the NDA application.
Tiratricol holds Orphan Drug Designation (ODD) for MCT8 deficiency and resistance to thyroid hormone type beta (RTH-beta) in the US and the EU. MCT8 deficiency and RTH-beta are two distinct indications, with no overlap in patient populations. Tiratricol has been granted Rare Pediatric Disease Designation (RPDD) which gives Egetis the opportunity to receive a Priority Review Voucher (PRV) in the US, after approval. This voucher can be transferred or sold to another sponsor.
The drug candidate Aladote® (calmangafodipir) is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol (acetaminophen) overdose. A proof of principle study has been successfully completed. The design of a pivotal Phase IIb/III study (Albatross), with the purpose of applying for market approval in the US and Europe, has been finalized following interactions with the FDA, EMA and MHRA. The development program for calmangafodipir has been parked until Emcitate marketing authorization submissions for MCT8 deficiency have been completed in the EU and the USA. Aladote has been granted ODD in the US and in the EU.
Egetis Therapeutics (Nasdaq Stockholm: EGTX) is listed on the Nasdaq Stockholm main market. For more information, see www.egetis.com

Emcitate is Egetis' lead drug candidate in clinical development and is being developed as a treatment of monocarboxylate transporter 8 (MCT8) deficiency, also known as Allan-Herndon-Dudley Syndrome (AHDS), a rare genetic disease that affects 1 in 70,000 men with high unmet medical need. Emcitate is the first and only approved treatment for MCT8 deficiency in the EU.
Thyroid hormones are crucial for the development and metabolic state of virtually all tissues. Thyroid hormone transport across the plasma membrane is required for the hormones' metabolism and intracellular action and is facilitated by thyroid hormone transporters, including MCT8. Mutations in the gene for MCT8 cause MCT8 deficiency. The gene is located on the X chromosome and mainly affects men.
The resulting dysfunction of MCT8 leads to impaired transport of thyroid hormone into certain cells and across the blood-brain-barrier and disruption of normal thyroid hormone regulation. Patients with MCT8 deficiency therefore have low concentrations of thyroid hormone in the central nervous system, which signals that the body should produce more thyroid hormone. This leads to increased levels of active thyroid hormone T3 in peripheral tissues, also called thyrotoxicosis. This leads to a complex pattern of symptoms with neurological developmental delay and intellectual disability, accompanied by severely elevated circulating thyroid hormone concentrations which are toxic for tissues including the heart, muscle, liver and kidney and results in symptoms such as failure to thrive, cardiovascular stress, insomnia and muscle wasting. Most patients will never develop the ability to walk or sit independently.
Tiratricol was granted Orphan Drug Designation for MCT8 deficiency in the EU in 2017 and the US in 2019. Tiratricol received US Rare Paediatric Disease Designation (RPDD) in 2020. Upon approval of the NDA, sponsors holding a RPDD and meeting the criteria specified can apply to receive a Priority Review Voucher (PRV). A PRV provides accelerated FDA review of a subsequent new drug application for any drug candidate, in any indication, shortening time to market in the US. The voucher may also be sold or transferred to another sponsor. During the last few years PRVs have been sold for between \$100-\$158 million.
A Phase 2b clinical trial (Triac Trial I) in MCT8 deficiency has been completed which showed significant and clinically relevant treatment effects on key aspects of the disease. In October 2021, data from long-term treatment in patients with MCT8 deficiency up to 6 years, with Emcitate was published. This was an investigator-initiated real-life cohort study at 33 sites conducted by the Erasmus University Medical
Center, Rotterdam, The Netherlands, where the efficacy and safety of Emcitate was investigated in 67 patients with MCT8 deficiency.
In December 2021, the EMA concluded that the clinical data from the Triac Trial I, together with the published data from long-term treatment, is sufficient for a regulatory submission of a Marketing Authorisation Application (MAA) to the EMA.
On February 13, 2025, the European Commission approved Emcitate as the first and only treatment for MCT8 deficiency in EU.
FDA acknowledges that a treatment effect on T3 levels and the manifestations of chronic thyrotoxicosis in MCT8- deficiency could provide a basis for marketing approval also in the US. Egetis is conducting a randomized study in at least 16 evaluable patients for up to 30 days to verify the T3 results, seen in previous clinical trials and publications. The design of this study (ReTRIACt) is available on clinicaltrials.gov under the code NCT055793. It is well established that the T3 levels in untreated MCT8 patients are significantly elevated, and data from previous studies suggest that tiratricol may normalize these levels rapidly and durably. So far 19 patients have been included, whereof 11 patients have completed the randomized phase. Recruitment will continue until at least 16 patients have completed the randomized phase. As previously communicated, the Company will update the market as soon as recruitment closes. At that time, the Company will also inform when to expect topline results and when the Company plans to submit the NDA application.
The Triac Trial II study included 22 young boys with MCT8 deficiency (<30 months old) and investigated the neurodevelopmental effects of early intervention with tiratricol. Top-line results were published in June-2024. The trial did not meet its primary endpoints, which were assessed by changes in the Gross Motor Function Measure (GMFM)-88 total score and the Bayley Scales for Infant and toddler Development (BSID)-III Gross Motor Skill domain, compared to natural history scores from the Triac Trial I. Among key secondary endpoints, total serum thyroid hormone T3 concentrations were reduced significantly and durably in all patients, thereby verifying tiratricol's ability to alleviate thyrotoxicosis in MCT8 deficiency patients.
The safety profile was similar to that seen in previous clinical studies, despite higher dosing per kg body weight compared to previous studies.
Emcitate is already supplied to approximately 230 patients in Managed Access Programs, following individual regulatory approvals from national regulatory agencies in over 25 countries, The most recent program to open is the Expanded Access Program (EAP) in the USA, requested by the FDA. Managed Access Programs allow early access to a medicine prior to regulatory marketing approval, granted to pharmaceuticals under development for conditions with high unmet medical needs and where no available treatment alternatives exist.
Emcitate has been granted orphan drug designation (ODD) for RTHβ in the USA and the EU. RTHβ is an additional indication, without overlap in patient populations, to the previously obtained ODD for MCT8 deficiency. The ODD for RTHβ is a direct result of Egetis' work to extend the indications for the Emcitate program to related but distinct conditions.
Calmangafodipir (Aladote®) is a first-in-class drug candidate with the potential to reduce the risk of acute liver failure associated with paracetamol/acetaminophen poisoning. Aladote has shown a beneficial effect in relevant preclinical models, even in the time-window when Nacetylcysteine (NAC) treatment no longer is effective (>8 hours). A proof of principle study in patients with paracetamol poisoning to prevent acute liver injury has been successfully completed. The study results provide preliminary evidence of the safety and tolerability of the combination of Aladote and NAC. Further, the results indicate that Aladote may reduce acute liver injury in this patient population.
Calmangafodipir has been granted Orphan Drug Designation (ODD) in the US and EU.
Paracetamol/acetaminophen is the most used drug in the world for the treatment of fever and pain, but
also one of the most overdosed drugs – intentionally or unintentionally. Paracetamol overdose is one of the most common methods in suicide attempts. When excessive amounts of paracetamol are metabolized in the liver, the harmful metabolite N-acetyl-p-benzoquinone imine (NAPQI) is formed, which can cause acute liver failure. The current standard of care for paracetamol poisoning, NAC, is effective if the patient receives medical care within eight hours of ingestion.
A pivotal Phase IIb/III study, Albatross, would be targeting patients with increased risk of liver injury, who arrive late at hospital, more than eight hours after a paracetamol overdose, for which current standard of care, NAC, is substantially less effective. The development program for calmangafodipir has been parked until tiratricol marketing authorization submissions for MCT8 deficiency have been completed in the EU and the USA.
Revenue amounted to MSEK 10.8 (32.6) during the quarter and MSEK 46.1 (57.6) for the period. Revenue consisted of 'Managed Access Program' Emcitate revenue of MSEK 10.8 (18.2) for the quarter and MSEK 46.1 (43.1) for the period. The corresponding quarter of the previous year also included license income from Fujimoto in Japan amounting to MSEK 14.5. The decrease in revenue during the quarter stems from less Emcitate being delivered to paying 'Managed Access Patients', due to regional variations in orders.
Cost of goods sold amounted to MSEK -2.3 (-4.7) for the quarter and MSEK -11.6 (-11.0) for the period and is entirely attributable to Emcitate. The costs were lower in the quarter due to regional variations in orders whilst higher in the period due to increased volumes of Emcitate.
Total operating expenses amounted to MSEK -113.2 (-111.0) for the quarter and MSEK -363.9 (-371.4) for the period.
Research and development expenses amounted to MSEK -41.0 (-56.7) for the quarter and MSEK -146.2 (-194.0) for the period. At the beginning of the corresponding period last year several cost items within R&D, such as costs related to production of Emcitate and nonclinical activities, coincided.
During the quarter, marketing and sales expenses amounted to MSEK -32.6 (-26.0) and for the period MSEK -109.7 (-86.6). The increase in costs compared to the same period of the previous year primarily stems from the expansion of the workforce and increased
activity in preparation for the planned commercialization of Emcitate.
Administrative expenses amounted to MSEK -37.4 (-27.7) during the quarter and MSEK -105.6 (-86.2) during the period. The increase in costs during the quarter and period was mainly attributable to preparatory work within the corporate functions for the planned launch of Emcitate and increased costs for the employee stock option program (ESOP), which will continue to vary to some extent with the development of the stock price but has no impact on cash flow. The recognized costs for the ESOP were MSEK -14.7 for the period.
Other operating income amounted to MSEK 0.5 (6.1) for the quarter and MSEK 5.2 (8.9) for the period, and other operating expenses amounted to MSEK -2.5 (-6.6) for the quarter and MSEK -7.6 (-13.4) for the period. The change in other operating income and other operating expenses is primarily explained by currency exchange rate fluctuations related to operating receivables and liabilities.
The net financial result amounted to MSEK -5.5 (-3.0) for the quarter and MSEK -13.8 (-2.0) for the period. The change compared to the same quarter and period previous year mainly consists of interest expenses related to the Company's loan financing, and revaluation of the lender's convertible right. The revaluation of the convertible right has no impact on cash flow and will continue to fluctuate with development of the stock price.
The total reported tax for the quarter amounted to MSEK -0.4 (-0.1) and for the period MSEK -0.3 (-0.1) and relates to the tax result in Egetis' subsidiary in the USA.
The result for the quarter amounted to MSEK -110.5 (-86.3) and MSEK -343.6 (-326.9) for the period. Earnings per share amounted to SEK -0.3 (-0.3) for the quarter and SEK -1.1 (-1.3) for the period, both before and after dilution.
Cash as of December 31, 2024, amounted to MSEK 351.0 (303.3).
Cash flow from operating activities amounted to MSEK -53.6 (-41.6) for the quarter and MSEK -227.9 (-278.4) for the period. Cash flow for the quarter amounted to MSEK 218.1 (223.6) and for the period MSEK 41.8 (180.4). Cash flow from operating activities is driven by costs related to the ongoing clinical trials and preparations for the planned commercialization of Emcitate.
The cash flow from investing activities amounted to MSEK -1.2 (0.4) during the quarter and MSEK -1.2 (0.0) during the period. Cash flow from financing activities amounted to MSEK 272.8 (264.8) during the quarter and MSEK 270.9 (458.9) during the period and relates primarily to the capital markets transaction conducted in the fourth quarter. In the corresponding period previous year, two capital markets transactions were conducted.
Equity amounted to MSEK 492.9 (545.6) as of December 31, 2024. Equity per average number of shares amounted to SEK 1.6 (2.1) for the period. The Company's equity ratio was 62 (72) %.
Long-term liabilities amounted to MSEK 95.2 (110.8) as of December 31, 2024. These consist of loans of MSEK 41.0 (68.8), convertible loans and convertible right of MSEK 43.1 (34.7), liabilities for leasehold rights MSEK 0.4 (2.2), deferred tax liability on leasehold rights MSEK
0.5 (-), and provisions for social charges related to the stock option programs of MSEK 10.2 (5.1). Short-term liabilities amounted to MSEK 204.2 (103.9) and consisted mostly of other short-term and accrued liabilities of MSEK 148.2 (69.8), short-term portion of loans MSEK 30.1 (5.2), and accounts payable MSEK 25.7 (28.7). The increase in accrued liabilities is due to provisions for discounts determined annually. The provisions are estimated by the Company based on standard industry practices, with final adjustment to be made after agreement with authorities upon the Emcitate market approval.
Intangible fixed assets amounted to MSEK 408.1 (409.1) as of December 31, 2024. No investments have been classified as tangible fixed assets during the period.
As of December 31, 2024, the number of ordinary shares in the company amounted to 359,238,126. The company holds 29,000,000 C-shares in treasury as hedge for the active employee stock option programs. Total number of ordinary shares and C-shares are 388,238,126.
The number of shareholders amounted to 8,190 as of December 31, 2024. The top 10 largest shareholders held 61,9 % of the share capital. Egetis Therapeutics' shares are listed on the main list of Nasdaq Stockholm.
For information about current and previous employee stock option programs please see note 8.
Number of employees amounted to 40 (29) individuals as of December 31, 2024, comprising 24 women and 16 men (17 women and 12 men).
The parent company's revenue for the quarter amounted to MSEK 25.6 (28.4) and MSEK 98.7 (93.6) for the period.
Operating expenses amounted to MSEK -65.3 (-56.0) for the quarter and MSEK -196.3 (-172.8) for the period. The parent company's result for the quarter amounted to MSEK -106.4 (-105.6) and MSEK -307.6 (-325.9) for the period.
Financial fixed assets amounted to MSEK 436.3 (435.0). Long-term loan liabilities amounted to MSEK 41.0 (68.8), convertible loans and convertible right to MSEK 43.1 (34.7), and other long-term liabilities to MSEK 10.2 (5.1).
The Board proposes that Egetis Therapeutics AB (publ) does not provide any dividend for the financial year 2024.
Revenue for the period consisted of billing for intragroup services from the parent company to the subsidiary companies: Rare Thyroid Therapeutics International AB (RTTI) and Egetis Therapeutics US Inc. totalling MSEK 63.9 (44.5), and re-billing of costs for Emcitate to RTTI AB totalling MSEK 34.7 (49.1).
The revenue increase for the period mainly pertains to re-billing of administrative services within the organization.
| MSEK | 2024 | 2023 | 2024 | 2023 |
|---|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
| Revenue | 10.8 | 32.6 | 46.1 | 57.6 |
| Costs of goods | -2.3 | -4.7 | -11.6 | -11.0 |
| Gross profit | 8.5 | 27.9 | 34.5 | 46.6 |
| Research and Development | -41.0 | -56.7 | -146.2 | -194.0 |
| Marketing and sales | -32.6 | -26.0 | -109.7 | -86.6 |
| Administrative expenses | -37.4 | -27.7 | -105.6 | -86.2 |
| Other operating income | 0.5 | 6.1 | 5.2 | 8.9 |
| Other operating expense | -2.5 | -6.6 | -7.6 | -13.4 |
| Operating expenses | -113.2 | -111.0 | -363.9 | -371.4 |
| Operating result | -104.7 | -83.1 | -329.4 | -324.8 |
| Financial items | ||||
| Finance income | 7.6 | 3.5 | 16.5 | 4.9 |
| Finance expense | -5.5 | -3.8 | -25.9 | -4.2 |
| Revaluation of convertible right | -7.6 | -2.7 | -4.5 | -2.7 |
| Sum financial items | -5.5 | -3.0 | -13.8 | -2.0 |
| Results after financial net | -110.1 | -86.1 | -343.2 | -326.8 |
| Tax | -0.4 | -0.1 | -0.3 | -0.1 |
| Results after tax | -110.5 | -86.3 | -343.6 | -326.9 |
| Share Data | ||||
| Number of outstanding shares at the end of period | 359,238,126 | 292,571,459 | 359,238,126 | 292,571,459 |
| Average number of outstanding shares during period | 348,131,709 | 287,899,467 | 306,537,424 | 256,752,282 |
| Average number of shares during period, after dilution | 350,875,472 | 290,098,106 | 310,902,926 | 260,011,478 |
| Earnings per share before dilution (SEK) | -0.3 | -0.3 | -1.1 | -1.3 |
| Earnings per share after dilution (SEK) | -0.3 | -0.3 | -1.1 | -1.3 |
| Equity per average number of outstanding shares (SEK) | 1.4 | 1.9 | 1.6 | 2.1 |
| MSEK | 2024 | 2023 | 2024 | 2023 |
|---|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
| Net loss for the period | -110.5 | -86.3 | -343.6 | -326.9 |
| Translation exchange rate differences | -0.1 | -0.1 | 0.1 | -0.1 |
| Comprehensive income for the period | -110.5 | -86.3 | -343.5 | -327.0 |
| MSEK | 31/12/2024 | 31/12/2023 |
|---|---|---|
| ASSETS | ||
| Non-current assets | ||
| Research and development costs | 404.8 | 404.8 |
| Licenses | 3.2 | 4.3 |
| Right-of-use assets | 2.6 | 4.3 |
| Deferred tax asset | 0.6 | - |
| Equipment | 0.0 | 0.1 |
| Financial non-current assets | 0.8 | 0.8 |
| Total non-current assets | 412.2 | 414.3 |
| Current assets | ||
| Inventories | 1.0 | 0.7 |
| Accounts receivables | 15.5 | 28.2 |
| Other receivables | 8.1 | 8.2 |
| Prepaid expenses and accrued income | 4.5 | 5.5 |
| Cash and bank balance | 351.0 | 303.3 |
| Total current assets | 380.1 | 345.9 |
| Total assets | 792.3 | 760.2 |
| MSEK | 31/12/2024 | 31/12/2023 |
| Equity | ||
| Share capital | 20.4 | 15.4 |
| Other capital contributions | 2,057.7 | 1,780.0 |
| Reserves | 24.8 | 16.7 |
| Accumulated loss including net loss | -1,610.1 | -1,266.5 |
| Total equity | 492.9 | 545.6 |
| Non-current liabilities | ||
| Borrowing Deferred tax liability |
84.1 | 103.4 |
| Other non-current liabilities | 0.5 0.4 |
- 2.2 |
| Provisions | 10.2 | 5.1 |
| Total non-current liabilities | 95.2 | 110.8 |
| Current liabilities | ||
| Accounts payable | 25.7 | 28.7 |
| Current tax liabilities | 0.2 | 0.1 |
| Borrowing | 30.1 | 5.2 |
| Other liabilities | 11.0 | 6.8 |
| Accrued expenses and deferred income Total current liabilities |
137.2 204.2 |
63.0 103.9 |
| Total equity and liabilities | 792.3 | 760.2 |
| MSEK | 2024 | 2023 | 2024 | 2023 |
|---|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
| OPERATING ACTIVITIES | ||||
| Result after financial net | -110.1 | -86.1 | -343.2 | -326.8 |
| Adjustments for non-cash items | 17.6 | 9.6 | 27.0 | 17.7 |
| Tax paid | -0.4 | -0.1 | -0.3 | - |
| Cash flow from operating activities before | -92.8 | -76.7 | -316.6 | -309.3 |
| changes in working capital | ||||
| Cash flow from changes in working capital | ||||
| Increase/decrease in operating receivables | 5.3 | -9.1 | 13.4 | -22.9 |
| Increase/decrease in operating liabilities | 33.9 | 44.1 | 75.2 | 53.8 |
| Cash flow from changes in working capital | 39.2 | 35.0 | 88.6 | 30.9 |
| Cash flow from operating activities | -53.6 | -41.6 | -227.9 | -278.4 |
| INVESTING ACTIVITIES | ||||
| Acquisition of subsidiaries, net cash required | -1.2 | - | -1.2 | - |
| Investment in financial assets | - | 0.4 | - | - |
| Purchase of property, plant and equipment | - | - | - | 0.0 |
| Cash flow from investing activities | -1.2 | 0.4 | -1.2 | 0.0 |
| FINANCING ACTIVITIES | ||||
| New share issue | 301.5 | 171.9 | 301.5 | 381.9 |
| Cost new share issue | -18.8 | -12.2 | -18.8 | -26.3 |
| Repurchase of own shares | -1.5 | - | -1.5 | - |
| Proceeds from borrowings | - | 108.8 | - | 108.8 |
| Repayment of loans | -7.7 | -3.0 | -7.7 | -3.0 |
| Repayment of leases | -0.6 | -0.6 | -2.5 | -2.6 |
| Cash flow from financing activities | 272.8 | 264.8 | 270.9 | 458.9 |
| Cash flow for the period | ||||
| 218.1 | 223.6 | 41.8 | 180.4 | |
| Balance at beginning of period | 129.9 | 85.0 | 303.3 | 127.7 |
| Change in cash | 218.1 | 223.6 | 41.8 | 180.4 |
| Exchange rate difference in cash | 3.0 | -5.3 | 5.8 | -4.8 |
| CASH BALANCE AT THE END OF THE PERIOD | ||||
| 351.0 | 303.3 | 351.0 | 303.3 |
| MSEK | Share capital | Other capital contributions |
Accumulated loss incl. net results for the period |
Other reserves | Total equity |
|---|---|---|---|---|---|
| Opening balance 01/01/2024 | 15,4 | 1 780,0 | -1 266,5 | 16,7 | 545,6 |
| Rights issue | 5,0 | 296,5 | - | - | 301,5 |
| Costs, rights issue | - | -18,8 | - | - | -18,8 |
| Comprehensive income for the period | - | - | -343,5 | - | -343,5 |
| Transactions with shareholders | |||||
| Issued warrants | 3,4 | 3,4 | |||
| Repurchase of own shares | -1,5 | -1,5 | |||
| Costs due to share-based payments of employee stock option | - | - | - | 6,2 | 6,2 |
| Closing balance 31/12/2024 | 20,4 | 2 057,7 | -1 610,1 | 24,8 | 492,9 |
| Opening balance 01/01/2023 | 11,3 | 1 428,4 | -939,6 | 6,1 | 506,2 |
| Share issue | 4,1 | 377,8 | - | - | 381,9 |
| Costs, share issue | - | -26,3 | - | - | -26,3 |
| Comprehensive income for the period | - | - | -327,0 | - | -327,0 |
| Transactions with shareholders | |||||
| Issued warrants | 3,4 | 3,4 | |||
| Costs due to share-based payments of employee stock option | - | - | - | 7,2 | 7,2 |
| Closing balance 31/12/2023 | 15,4 | 1 780,0 | -1 266,5 | 16,7 | 545,6 |
| Event | Change in number of common shares |
Change in number of C shares |
Change in share capital, SEK |
Total number of shares |
Total share capital, SEK |
|---|---|---|---|---|---|
| Opening balance 01/01/2024 | 292,571,459 | - | - | 292,571,459 | 15,398,504 |
| Directed share issue 10/03/2024 | 43,885,718 | - | 2,309,775 | 336,457,177 | 17,708,279 |
| Directed share issue, 10/25/2024 | 22,780,949 | - | 1,198,998 | 359,238,126 | 18,907,277 |
| Share issue, 12/16/2024 | - | 29,000,000 | 1,526,316 | 388,238,126 | 20,433,593 |
| Closing balance 12/31/2023 | 359,238,126 | 29,000,000 | 5,035,090 | 388,238,126 | 20,433,593 |
The issued C-shares were repurchased immediately after issuance and are held in treasury as of the balance sheet date. The purpose of holding the C-shares and the repurchase is to ensure future delivery of shares to participants in, as well as to cover any social costs for, the outstanding incentive programs. The C-shares will be converted into common shares before delivery to the participants in the programs.
The key ratios below are useful to those who read the financial statements and a complement to other performance targets in evaluating strategic investment implementation and the Group's ability to achieve financial goals and commitments.
| MSEK | 2024 | 2023 |
|---|---|---|
| Jan-Dec | Jan-Dec | |
| Equity | 492.9 | 545.6 |
| Equity ratio % | 62 | 72 |
| Number of outstanding shares at the end of the period | 359,238,126 | 292,571,459 |
| Average number of outstanding shares during the period | 306,537,424 | 256,752,282 |
| Average number of shares during the period after dilution | 310,902,926 | 260,011,478 |
| Share Data | ||
| Earnings per share | -1.1 | -1.3 |
| Earnings per share after dilution | -1.1 | -1.3 |
| Cash flow from operating activities per average number of outstanding shares | -0.7 | -1.1 |
| Equity per average number of outstanding shares | 1.6 | 2.1 |
| Equity per average number of shares after dilution | 1.6 | 2.1 |
| Dividend | - | - |
| Average number of employees | 35 | 27 |
| Effect from dilution is not considered when result is negative. |
| MSEK | 2024 Oct-Dec |
2023 Oct-Dec |
2024 Jan-Dec |
2023 Jan-Dec |
|---|---|---|---|---|
| Revenue | 25.6 | 28.4 | 98.7 | 93.6 |
| Costs of goods | - | - | - | - |
| Gross profit | 25.6 | 28.4 | 98.7 | 93.6 |
| Research and Development | -13.7 | -20.1 | -47.5 | -56.3 |
| Marketing and sales | -15.8 | -10.7 | -48.3 | -38.4 |
| Administrative expenses | -35.8 | -25.4 | -100.0 | -78.1 |
| Other operating income Other operating expense |
0.2 -0.2 |
4.1 -3.9 |
0.8 -1.3 |
4.5 -4.4 |
| Operating expenses | -65.3 | -56.0 | -196.3 | -172.8 |
| Operating result | -39.7 | -27.6 | -97.7 | -79.2 |
| Financial items | ||||
| Finance income | 6.9 | 3.4 | 13.6 | 4.8 |
| Finance expense | -6.0 | -3.7 | -24.0 | -3.9 |
| Revaluation of convertible right | -7.6 | -2.7 | -4.5 | -2.7 |
| Sum financial items | -6.7 | -3.0 | -14.9 | -1.8 |
| Results after financial net | -46.4 | -30.6 | -112.6 | -80.9 |
| Group contribution received/ given | -60.0 | -75.0 | -195.0 | -245.0 |
| Tax | - | - | - | - |
| Results after tax | -106.4 | -105.6 | -307.6 | -325.9 |
| MSEK | 31/12/2024 | 31/12/2023 |
|---|---|---|
| ASSETS | ||
| Non-current assets | ||
| Equipment | 0.0 | 0.1 |
| Financial non-current assets Total non-current assets |
436.3 436.3 |
435.0 435.0 |
| Current assets | ||
| Receivables from Group companies | 0.6 | 0.5 |
| Other receivables | 0.7 | 0.0 |
| Prepaid expenses and accrued income | 4.5 | 9.3 |
| Cash and bank balance Total current assets |
332.1 337.8 |
271.6 281.5 |
| Total assets | 774.1 | 716.5 |
| MSEK | 31/12/2024 | 31/12/2023 |
| Equity | ||
| Restricted Equity | ||
| Share capital | 20.4 | 15.4 |
| Non-restricted equity | ||
| Share premium reserve | 782.7 | 830.9 |
| Reserves | 24.8 | 16.7 |
| Net loss for the period Total equity |
-307.6 | -325.9 |
| 520.3 | 537.1 | |
| Non-current liabilities | ||
| Borrowing | 84.1 | 103.4 |
| Provisions | 10.2 | 5.1 |
| Total non-current liabilities | 94.3 | 108.6 |
| Current liabilities | ||
| Liabilities to group company | 90.5 | 38.1 |
| Accounts payable Borrowing |
7.3 30.1 |
5.5 5.2 |
| Other liabilities | 8.4 | 4.3 |
| Accrued expenses and deferred income | 23.2 | 17.7 |
| Total current liabilities | 159.5 | 70.9 |
| Total equity and liabilities | 774.1 | 716.5 |
Egetis applies International Financial Reporting Standards (IFRS) as adopted by the EU. This report is prepared in accordance with IAS 34 Interim Financial Reporting and the Annual Accounts Act and should be read together with the Egetis consolidated financial statements for the year ended December 31, 2023. The interim report does not include all disclosures that would otherwise be required in a complete set of financial statements. Applied accounting principles and calculation methods are the same as in the latest annual report for 2023. Some amendments to existing standards became applicable from January 1, 2024, however none of these have a material impact on the consolidated financial statements or accounting policies. The parent company and the Group's accounting currency is SEK. All the numbers in this interim report are, if nothing else is stated, presented in million SEK.
The preparation of interim reports requires certain critical accounting estimates to be made. Furthermore, company management is required to make assessments when applying accounting principles. See the Group's accounting principles in the annual report 2023 regarding more information on estimates and assessments.
The parent company Egetis Therapeutics AB (publ) prepares financial reports in accordance with the Swedish Financial Reporting Board's recommendation RFR 2 Accounting for Legal Entities and the Swedish Annual Accounts Act. The parent company applies the exception from application of IFRS 16 Leases.
All business operations involve risk. Risks may be company specific or due to events in the external environment and may affect a certain industry or market. The group is, among others, exposed to the following operational and financial risks.
Pharmaceutical development, Manufacturing, Regulatory, Commercialization, Competition and Market Acceptance and Intellectual property.
Financial risks:
Foreign currency, Need of working capital, General market risk, Credit and Interest rate risks.
A more detailed description of the Group's risk exposure is included in Egetis 2023 Annual Report, Risks and Risk Management section and Note 3. There are no major changes in the Group's risk exposure in 2024 compared with 2023.
Egetis Therapeutics is dependent on the efficient and uninterrupted operation of various IT systems to run its business. A significant breakdown or other disruption in the IT systems (for example as a result of a virus attack or network congestion attacks) can affect the ability to conduct business in general and can lead to delays and increased costs in the Company's research and development work.
There is a risk that the Company, as a result of such as viral pandemics, will not succeed in recruiting participants for its clinical studies, either because participants do not want, or due to restrictions should not, visit hospitals to avoid infection. There is also a risk that new variants of different microorganisms will lead to lockdowns in
Sweden or in other countries, which could mean that the Company or its partners cannot conduct research and development work according to the existing clinical development plan. There is also a risk that caregivers need to allocate resources to meet the effects of different pandemics, which can lead to limited resources to participate in the Company's clinical trials.
Continued and/or escalating tension in the full-scale military invasion of Ukraine by Russia, the conflicts in the middle east, potential global tariff war led by the US can ignite an inflationary situation in the society. These events could have a significant negative impact on the global macroeconomic situation and the Swedish economy. It could result in the Company or its partners not being able to conduct R&D efforts according to plan.
A more detailed description of the Group's risk exposure is included in Egetis 2023 Annual Report, Risks and Risk Management section and Note 3. There are no major changes in the Group's risk exposure in 2024 compared with 2023.
Other information in accordance with IAS 34.16A are found on the pages before the income statement and statement of comprehensive income. For information on earnings, cash flow and financial position, see page 8. For events after the period, see page 1.
As of January 1, 2024, the group has transitioned from a cost-based income statement to a function-based income statement. The transition has been carried out to align the income statement with the internal review process by the Company's management. Furthermore, the transition to the function-based income statement is motivated by alignment to a format commonly used by the industrial peer group.
The below tables illustrate the impact on the income statements resulting from the transition, from a cost based to function-based income statement.
| Cost based | Costs of sales of |
goods Project costs | Other external costs |
Employee costs |
Depreciation and impairment |
Other operating expenses |
Function based |
||
|---|---|---|---|---|---|---|---|---|---|
| Revenue | |||||||||
| Revenue Costs of goods sold |
32.6 0.0 |
-4.7 | 32,6 Total revenue -4.7 Costs of goods sold |
||||||
| 32.6 | -4.7 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 27,9 Gross profit | ||
| Operating expenses Costs of sales of goods Project costs |
-4.7 -52,9 |
4.7 | 52,9 | 0.0 0.0 |
|||||
| Other external costs Employee costs |
-28.0 -30.7 |
28.0 | 30.7 | 0.0 0.0 |
|||||
| Depreciation and impairment Other operating expenses |
-0.9 -0,5 |
0.9 | 0.5 | 0.0 0.0 |
|||||
| -42,6 -10.4 0.1 |
-8,2 -4.8 -13,2 |
-8.0 -11.0 -13,7 |
-0.9 | -58,7 Research and Development -26,0 Marketing and sales -27,7 Administrative expenses |
|||||
| 6.1 -6.6 |
6,1 Other operating income -8,6 Other operating expense |
||||||||
| Operating results | -83,1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0,0 | -83.1 Operating result | |
| Financial items | Financial items | ||||||||
| Interest income and similar items Interest expense and similar items Revaluation of convertible right |
3.5 -3.8 -2,7 |
3,5 Finance income -3,8 Finance expense -2.7 Revaluation of convertible |
|||||||
| Sum financial items | -3,0 | 0.0 | 0,0 | 0.0 | 0,0 | 0,0 | 0,0 | -3.0 Sum financial items | |
| Results after financial net | -86,1 | 0,0 | 0,0 | 0,0 | 0,0 | 0,0 | 0,0 | -86,1 Results after financial net | |
| Tax | -0.1 | -0.1 Tax | |||||||
| Net loss for the period | -86.3 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | -86.3 Results after tax |
| Costs of sales of |
Other external |
Employee | Depreciation and |
Other operating |
Function | ||||
|---|---|---|---|---|---|---|---|---|---|
| Cost based | goods Project costs | costs | costs | impairment | expenses | based | |||
| Revenue | 57.6 | ||||||||
| Revenue Costs of goods sold |
0.0 | -11.0 | 57.6 Total revenue -11.0 Costs of goods sold |
||||||
| 57.6 | -11.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 46.6 Gross profit | ||
| Operating expenses | |||||||||
| Costs of sales of goods Project costs |
-11.0 -193.5 |
11.0 | 193.5 | 0.0 0.0 |
|||||
| Other external costs | -85.8 | 85.8 | 0.0 | ||||||
| Employee costs | -84.0 | 84.0 | 0.0 | ||||||
| Depreciation and impairment | -3.6 | 3.6 | 0.0 | ||||||
| Other operating expenses | -4.6 | 4.6 | 0.0 | ||||||
| -157.0 -36.5 |
-19.3 -21.1 |
-17.7 -28.9 |
-194.0 Research and Development -86.6 Marketing and sales |
||||||
| 0.0 | -45.3 | -37.3 | -3.6 | 0.0 | -86.2 Administrative expenses | ||||
| 8.9 | 8.9 Other operating income | ||||||||
| -13.4 | -13.4 Other operating expense | ||||||||
| Operating results | -324.8 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | -324.8 Operating result | |
| Financial items | Financial items | ||||||||
| Interest income and similar items | 4.9 | 4.9 Finance income | |||||||
| Interest expense and similar items | -4.2 | -4.2 Finance expense | |||||||
| Revaluation of convertible right | -2.7 | -2.7 Revaluation of convertible right | |||||||
| Sum financial items | -2.0 | -2.0 Sum financial items | |||||||
| Results after financial net | -326.8 | -326.8 Results after financial net | |||||||
| Costs of | Depreciation | Other | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Cost based | sales of | goods Project costs | external costs |
Employee costs |
and impairment |
operating expenses |
Function based |
||
| Revenue | |||||||||
| Revenue | 32,5 | -4.1 | 28.4 Total revenue | ||||||
| Costs of goods sold | 0.0 | 0,0 Costs of goods sold | |||||||
| 32,5 | 0,0 | 0,0 | 0,0 | 0,0 | 0,0 | -4,1 | 28,4 Gross profit | ||
| Operating expenses | |||||||||
| Costs of sales of goods | |||||||||
| Project costs | -17,8 | 17,8 | 0.0 | ||||||
| Other external costs | -12.4 | 12.4 | 0.0 | ||||||
| Employee costs | -28.0 | 28,0 | 0.0 | ||||||
| Depreciation and impairment | 0,0 | 0.0 | 0.0 | ||||||
| Other operating expenses | -3,9 | 3,9 | 0.0 | ||||||
| -13,4 | -0.8 | -5,9 | -20,1 Research and Development | ||||||
| -4.2 | 0,2 | -8,7 | -10,7 Marketing and sales | ||||||
| -0.2 | -11.8 | -13.5 | 0.0 | -25,4 Administrative expenses | |||||
| 4,1 | 4,1 Other operating income | ||||||||
| -3,9 | -3,9 Other operating expense | ||||||||
| Operating results | -27,6 | 0,0 | 0,0 | 0,0 | 0,0 | 0,0 | 0,0 | -27,6 Operating result | |
| Financial items | Financial items | ||||||||
| Interest income and similar items | 3,4 | 3.4 Finance income | |||||||
| Interest expense and similar items | -3.7 | -3,7 Finance expense | |||||||
| Revaluation of convertible right | -2,7 | -2.7 Revaluation of convertible | |||||||
| Sum financial items | -3,0 | 0,0 | 0,0 | 0,0 | 0,0 | 0,0 | 0,0 | -3,0 Sum financial items | |
| Results after financial net | -30,6 | 0,0 | 0.0 | 0.0 | 0,0 | 0,0 | 0,0 | -30,6 Results after financial net | |
| Appropriations | -75.0 | -75,0 Appropriations | |||||||
| 18x | Tax | ||||||||
| Net loss for the period | -105,6 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | -105,6 Results after tax |
| Costs of sales of |
Other external |
Employee | Depreciation and |
Other operating |
Function | |||
|---|---|---|---|---|---|---|---|---|
| Cost based | goods Project costs | costs | costs | impairment | expenses | based | ||
| Revenue | ||||||||
| Revenue | 98.1 | -4.5 | 93.6 Total revenue | |||||
| Costs of goods sold | 0.0 | 0.0 | 0.0 Costs of goods sold | |||||
| 98.1 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | -4.5 | 93.6 Gross profit | |
| Operating expenses | ||||||||
| Costs of sales of goods | 0.0 | 0.0 | 0.0 | |||||
| Project costs | -55.2 | 55.2 | 0.0 | |||||
| Other external costs | -43.7 | 43.7 | 0.0 | |||||
| Employee costs | -73.9 | 73.9 | 0.0 | |||||
| Depreciation and impairment | -0.1 | 0.1 | 0.0 | |||||
| Other operating expenses | -4.4 | 4.4 | 0.0 | |||||
| -36.9 | -1.8 | -17.6 | -56.3 Research and Development | |||||
| -16.9 | -2.2 | -19.3 | -38.4 Marketing and sales | |||||
| -1.4 | -39.7 | -37.0 | -0.1 | -78.1 Administrative expenses | ||||
| 4.5 | 4.5 Other operating income | |||||||
| -4.4 | -4.4 Other operating expense | |||||||
| Operating results | -79.2 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | -79.2 Operating result |
| Financial items | Financial items | |||||||
| Interest income and similar items | 4.8 | 4.8 Finance income | ||||||
| Interest expense and similar items | -3.9 | -3.9 Finance expense | ||||||
| Revaluation of convertible right | -2.7 | -2.7 Revaluation of convertible right | ||||||
| Sum financial items | -1.8 | -1.8 Sum financial items | ||||||
| Results after financial net | -80.9 | -80.9 Results after financial net | ||||||
| Appropriations | -245.0 | -245.0 Appropriations | ||||||
| Tax | 0.0 | 0.0 Tax | ||||||
| Net loss for the period | -325.9 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | -325.9 Results after tax |
The Group applies segment reporting with mainly two independent development areas, Emcitate and Aladote. The highest executive decision-maker in the Company allocates the Company's resources between these two R&D projects. The Aladote project has been parked since June 2023. Revenue for Emcitate is attributable to the 'Managed Access Program' use of the drug candidate.
Revenue and expenses attributable to Emcitate and Aladote are reported below.
| 2024 | 2023 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Oct-Dec | Oct-Dec | ||||||||
| MSEK | Emcitate | Aladote | Common | Sum | MSEK | Emcitate | Aladote | Common | Sum |
| Revenue | 10,8 | - | - | 10,8 | Revenue | 32,6 | - | - | 32,6 |
| Costs of sales of goods | -2,3 | - | - | -2,3 | Costs of sales of goods | -4,7 | - | - | -4,7 |
| Project costs | -38,4 | 0,2 | - | -38,2 | Project costs | -50,4 | -2,5 | - | -52,9 |
| Other | - | -0,6 | -74,4 | -75,0 | Other | - | - | -58,1 | -58,1 |
| Operating results | -29,9 | -0,4 | -74,4 | -104,7 | Operating results | -22,5 | -2,5 | -58,1 | -83,1 |
| Net financial items | -5,5 | Net financial items | -3,0 | ||||||
| Pretax profit | -110,1 | Pretax profit | -86,1 |
| 2023 Oct-Dec |
||||
|---|---|---|---|---|
| MSEK | Emcitate | Aladote | Common | Sum |
| Revenue | 32,6 | 32,6 | ||
| Costs of sales of goods | -4,7 | -4,7 | ||
| Project costs | -50,4 | -2,5 | -52,9 | |
| Other | -58,1 | -58,1 | ||
| Operating results | -22,5 | -2,5 | -58,1 | -83,1 |
| Net financial items | -3,0 | |||
| Pretax profit | -86,1 |
| 2024 | 2023 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Jan-Dec | Jan-Dec | ||||||||
| MSEK | Emcitate | Aladote | Common | Sum | MSEK | Emcitate | Aladote | Common | Sum |
| Revenue | 46.1 | - | - | 46.1 | Revenue | 57.6 | - | 0.0 | 57.6 |
| Costs of sales of goods | -11.6 | - | - | -11.6 | Costs of sales of goods | -11.0 | - | - | -11.0 |
| Project costs | -139.4 | -0.6 | - | -140.0 | Project costs | -189.4 | -4.1 | 0.0 | -193.5 |
| Other | - | -0.6 | -223.2 | -223.8 | Other | - | - | -177.9 | -177.9 |
| Operating results | -104.9 | -1.3 | -223.2 | -329.4 | Operating results | -142.9 | -4.1 | -177.9 | -324.8 |
| Net financial items | -13.8 | Net financial items | -2.0 | ||||||
| Pretax profit | -343.2 | Pretax profit | -326.8 |
| 2024 | 2023 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Jan-Dec | Jan-Dec | ||||||||
| MSEK | Emcitate | Aladote | Common | Sum | MSEK | Emcitate | Aladote | Common | Sum |
| Revenue | 46.1 | - | - | 46.1 | Revenue | 57.6 | - | 0.0 | 57.6 |
| Costs of sales of goods | -11.6 | - | - | -11.6 | Costs of sales of goods | -11.0 | - | - | -11.0 |
| Project costs | -139.4 | -0.6 | - | -140.0 | Project costs | -189.4 | -4.1 | 0.0 | -193.5 |
| Other | - | -0.6 | -223.2 | -223.8 | Other | - | - | -177.9 | -177.9 |
| Operating results | -104.9 | -1.3 | -223.2 | -329.4 | Operating results | -142.9 | -4.1 | -177.9 | -324.8 |
| Net financial items | -13.8 | Net financial items | -2.0 | ||||||
| Pretax profit | -343.2 | Pretax profit | -326.8 |
| 2024 | 2023 | 2024 | 2023 | |
|---|---|---|---|---|
| MSEK | Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
| License sales | - | 14.5 | - | 14.5 |
| Sales of goods | 10.8 | 18.2 | 46.1 | 43.1 |
| Total | 10.8 | 32.6 | 46.1 | 57.6 |
Egetis has a contractual obligation to pay the former owners of Rare Thyroid Therapeutics International AB and Erasmus Medical Center, the equivalent of 3% and 10% of the net sales of the product, respectively. In addition, former owners have the right to a one-time payment equal to 50% of the net proceeds in the event of a future sale of the U.S. Rare Pediatric Disease Priority Review Voucher (PRV).
Peder Walberg and Elisabeth Svanberg have been providing consultancy services to the Company, invoicing MSEK 0.7 and 1.0 respectively (1.9 and 0.0) during the period.
| MSEK | 31/12/2024 | 31/12/2023 |
|---|---|---|
| Convertible loan (Excluding convertible right) | -26,8 | -23,5 |
| Convertible right | -16,3 | -11,1 |
| Borrowing - non-current | -41,0 | -68,8 |
| Borrowing - Current | -30,1 | -5,2 |
| Total | -114,1 | -108,6 |
A more detailed description of the Group's borrowing and terms can be found in note 22 in Egetis Annual Report 2023.
The debt financing in Euros is divided into two parts, 10 million euros ("Tranche A") and 15 million euros ("Tranche B"). Tranche A was utilized on November 30, 2023 and matures on April 1, 2027. Tranche B was available for utilization until September 30, 2024, provided that the Company meets certain conditions. Currently, the Company has an ongoing dialogue with BlackRock regarding the conditions and a prolongation of the Tranche B draw down window.
The interest rate for the tranches is based on the ECB's base rate (MRO) plus a margin. An interest rate discount will be applied upon FDA approval of Emcitate.
Egetis implements stock option plans for employees (ESOP) and key consultants. The options are granted to participants free of charge. The options have a three-year vesting period from the grant date, provided, with customary exceptions, that the participant is still employed by/providing services to Egetis. Once the options are vested, they can be exercised within a one-year period or a six-months period dependent on the terms of the respective ESOP. Each vested option entitles the holder to acquire one share in Egetis at a predetermined price, unless recalculation based on the terms and conditions has not been applied. The options have been valued at each grant date according to the Black-Scholes valuation model. For further information, see Note 11 in the Annual Report 2023.
During the second quarter the stock option plan, ESOP 2020/2024 with 2,800,000 outstanding options, forfeited and a new Stock option plan, ESOP 2024/2027 was allotted. The CEO and the rest of the management team (ten individuals) were granted 1,700,000 and 4,893,400 employee stock options, respectively.
During the fourth quarter of 2024, the average share price exceeded the exercise price of the ESOP-2022 why a dilution impact is reported in the number of shares after dilution. However, as earnings per share are negative, no dilution is reported in the key ratio earnings per share after dilution. As of December 31, 2024, the Company has four ESOPs outstanding. Full utilization of the granted employee stock options and the lender warrants would increase the number of shares in the Company by 29,003,720.
| Option plan 2024/2027 |
Option plan 2023/2026 |
Option plan 2022/2026 |
Option plan 2021/2025 |
Option plan 2020/2024 |
Warrants to lender |
Total number of outstanding options |
|
|---|---|---|---|---|---|---|---|
| Number of outstanding options 01/01/2024 | - | 8 491 276 | 7 109 272 | 4 850 000 | 2 900 000 | 1 090 977 | 24 441 525 |
| Number of granted options during the period | 8 461 932 | - | - | - | - | - | 8 461 932 |
| Number of forfeited options during the period | -163 000 | -470 803 | -309 934 | -150 000 | -2 900 000 | - | -3 993 737 |
| Number of outstanding options 12/31/2024 | 8 298 932 | 8 020 473 | 6 799 338 | 4 700 000 | 0 | 1 090 977 | 28 909 720 |
| Corresponding number of shares after recalculation 12/31/2024 |
8 298 932 | 8 020 473 | 6 799 338 | 4 794 000 | 0 | 1 090 977 | 29 003 720 |
Earnings per share. Net income divided by average number of ordinary shares before dilution.
Number of shares at end of period. The number of outstanding ordinary shares before dilution at the end of the period.
Number of shares after dilution. The number of issued shares after dilution effect of potential shares at end of period. Outstanding stock options and warrants are only considered if they are "in the money".
Average number of shares during the period. Average number of outstanding ordinary shares before dilution for the period.
Average number of shares during the period after dilution. Average number of issued shares after dilution effect of potential shares. Outstanding stock options and warrants are only considered if they are "in the money". Project costs Refer to external costs that are directly attributable to the Group's costs regarding research and development of drug candidates.
Equity ratio, % The period's closing equity divided by the period's closing balance sheet. The Company uses the alternate Equity ratio as it shows the proportion of total assets represented by shareholders' equity and has been included to allow investors to assess the Company's capital structure.
Cash flow from operations per share. Cash flow from operating activities divided by the average number of shares outstanding at the end of the period. The Company uses the alternate key figure Cash flow from operations per share because the Company believes that the key ratio gives investors a better understanding of the Company's cash flow in relation to its number of shares adjusted for changes in the number of shares outstanding during the period.
Equity per share. Equity divided by number of shares outstanding at the end of the period. Outstanding stock options and warrants are only considered if they are "in the money". The Company uses the alternate key ratio equity per share because the Company believes that the key ratio gives investors a better understanding of the historical return per share adjusted for changes in the number of shares outstanding during the period.
Number of employees (average). The average number of employees at the end of each period.
| 2024 | 2023 | ||
|---|---|---|---|
| Jan-Dec | Jan-Dec | ||
| A | Equity, MSEK | 492.9 | 545.6 |
| B | Balance sheet total, MSEK | 792.3 | 760.2 |
| A/B | Equity ratio | 62% | 72% |
| A | Net result, MSEK | -343.5 | -327.0 |
| B | Equity, MSEK | 492.9 | 545.6 |
| A/B | Return on equity, % | neg. | neg. |
| A | Cash flow from operating activities, MSEK | -227.9 | -278.4 |
| B | Average number of outstanding shares during the period, thousands | 306,537 | 256,752 |
| A/B | Cash flow from operating activities per shares, SEK | -0.7 | -1.1 |
| A | Equity, MSEK | 492.9 | 545.6 |
| B | Average number of outstanding shares during the period, thousands | 306,537 | 256,752 |
| A/B | Equity per average number of shares before dilution, SEK | 1.6 | 2.1 |
| A | Equity, MSEK | 492.9 | 545.6 |
| B | Average number of shares at the end of the period after dilution, thousands | 310,903 | 256,752 |
| A/B | Equity per average number of shares after dilution, SEK | 1.6 | 2.1 |
Interim report January 1- March 31: April 30, 2025 Annual General Meeting: May 6, 2025 Half-year report January 1- June 30: August 21, 2025 Interim report January 1- September 30: November 7, 2025
This report, and further information is available on the website, www.egetis.com This report has not been reviewed by the Company's auditor. This is a translation of the Swedish interim report.
Nicklas Westerholm, CEO Yilmaz Mahshid, CFO [email protected] [email protected]
Karl Hård, VP Investor Relations and Business Development [email protected]
This information is such information as Egetis Therapeutics AB (publ) is obliged to disclose in accordance with EU market abuse regulation and the Securities Markets Act. The information was submitted, through the above contact persons, for publication on February 26, 2025, at 7.00 am (CET).
Egetis Therapeutics AB (publ) Klara Norra Kyrkogata 26, 111 22 Stockholm, Sweden Org.nr. 556706-6724 Phone: +46(0)8-679 72 10 www.egetis.com
ABGSC: Alexander Krämer Bryan, Garnier & Co: Oscar Haffen Lamm Carnegie: Arvid Necander Handelsbanken: Mattias Häggblom & Rickard Anderkrans Nordea: Patrik Ling Pareto Securities: Chien-Hsun Lee Redeye: Fredrik Thor
This Year-End report for January-December 2024 provides a true and fair overview of the parent's and group's business activities, financial position, and results of operations, and describes significant risks and uncertainties to which the companies in the group are exposed.
Stockholm, February 26, 2025
| Mats Blom | Thomas Lönngren | ||
|---|---|---|---|
| Chairman of the board | Board member | ||
| Gunilla Osswald | Elisabeth Svanberg | ||
| Board member | Board member | ||
| Behshad Sheldon | Nicklas Westerholm | ||
| Board member | CEO |
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