Annual Report • Feb 17, 2022
Annual Report
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Year-end report January-December 2021
| 2021 | 2020 | 2021 | 2020 |
|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
| 3,511 | 5,289 | 38,543 | 40,662 |
| -32,058 | -74,314 | -104,542 | -178,024 |
| -29,570 | 129,798 | -144,969 | 34,223 |
| 143,965 | 287,850 | 143,965 | 287,850 |
| 93% | 88% | 93% | 88% |
| -0.2 | -0.7 | -0.6 | -2.6 |
| -0.2 | -0.7 | -0.6 | -2.6 |
| 12 | 9 | 11 | 9 |
Last year was a transformative busy year for Egetis, in which we achieved important milestones in our exciting Emcitate program. I'm proud of our progress to become a nimble and highly experienced rare disease company, well positioned for the future.
In early October, the U.S. Food and Drug Administration (FDA) granted Emcitate Fast Track Designation for the treatment of MCT8 deficiency. This designation is an acknowledgement from the FDA of the importance of Emcitate to address the significant unmet medical need for patients from this devastating disease. With a Fast Track Designation comes opportunities to expedite both the new drug application (NDA) submission and FDA's review which could enable an earlier regulatory approval of Emcitate.
In October, an investigator-initiated real-life cohort study at 33 sites conducted by the Erasmus Medical Center, Rotterdam, The Netherlands reported longterm treatment effects in 67 subjects, up to 6 years, with Emcitate. The study was published in the Journal of Clinical Endocrinology & Metabolism.
This long-term data confirms the positive results from the previous Triac Trial I and verifies that the beneficial effects are maintained over time, up to six years. The consistent efficacy seen across several key clinical and biochemical parameters regardless of age, further supports the use of Emcitate in the treatment of MCT8 deficiency.
Based on the new long-term data, we had further positive interactions with the regulatory agencies in the US and Europe. In December, the European Medicines Agency (EMA) concluded that the clinical data from the Triac Trial I, together with the published data from long-term treatment will suffice for a regulatory submission of a Marketing Authorisation Application (MAA) to the EMA for the treatment of MCT8 deficiency. We plan to submit the MAA in the first half of 2023. Having all clinical data required for regulatory submission in EU already at hand significantly reduces the remaining risk for Emcitate.
After the period, in January 2022, we announced our intention to submit the NDA in the US for Emcitate in mid-2023 under the Fast Track Designation granted by the FDA. This followed recent positive regulatory interactions, in which the FDA acknowledges that treatment effects on T3 levels and the decrease in chronic thyrotoxicosis in MCT8 deficiency could provide a basis for marketing approval in the US.
We have agreed with the FDA to perform a small, randomized study in 16 patients for up to 30 days to verify our T3 results, seen in previous clinical trials and publications. It is well-established that the T3 levels in untreated MCT8 patients are significantly elevated, and we have previously shown that Emcitate is able to rapidly and durably normalize these levels. The primary source of patients for this study will be through our existing named patient program.
The outcome of these regulatory interactions have created a major step towards marketing applications in EU and the US, making Emcitate available to patients who suffer from MCT8 deficiency, increasing the likelihood of success for Emcitate and the probability for Egetis to receive a US Rare Pediatric Disease Priority Review Voucher (PRV).
The ongoing Triac Trial II remains important to further establish the effects of early intervention on the neurocognitive development aspects of the disease, previously seen in young patients in the Triac Trial I. Patients continue to enter the study despite the challenging COVID-19 situation. Results from the Triac Trial II are expected in the first quarter of 2024 and is expected to be submitted post-approval to regulatory authorities shortly thereafter.
Parallel to our clinical program with Emcitate, there is a continued interest from physicians across the globe to use Emcitate for patients that suffer from MCT8 deficiency.
More than 140 patients in more than 25 countries are being treated with Emcitate on a named patient or compassionate use basis demonstrating the significant unmet medical need in this patient population and verifies the interest to treat patients that suffer from MCT8 deficiency.
We are committed to help transforming and extending the lives of patients with rare diseases such as MCT8 deficiency. One important pillar is raising disease awareness, and in September we launched an awareness campaign, including the website www.mct8deficiency.com. In addition to other disease educational activities, e.g., at scientific and medical conferences targeting health care professionals, the website will be used for educational purposes through the expanding network of key opinion leaders, physicians and patient advocacy groups focused on MCT8 deficiency.
These activities aim to shorten the time to diagnosis of MCT8 deficiency and enable earlier treatment, to help relieve the heavy burden of disease that MCT8 deficiency places on the affected individuals, their families and the caregivers they are heavily dependent on.
Preparations for the planned Phase IIb/III study with Aladote are ongoing. The COVID-19 pandemic is still making it challenging to start a clinical study in an emergency/intensive care setting. Therefore, pending how the situation evolves, we expect study start will likely take place later this year.
We remain committed to the continued development of Aladote, which has the potential to be the first approved drug to benefit patients with an increased risk of liver injury, who are not adequately treated with standard of care N-acetylcysteine (NAC) after a paracetamol overdose. Aladote has been granted ODD in the US and we have an ongoing dialogue with EMA on the appropriate indication for an ODD in the EU.
In December 2021 and January 2022, we received Notices of Intent to Grant for new patents in the US and Europe, respectively. These patents further strengthen our robust calmangafodipir patent portfolio that includes a composition-of-matter patent with protection until year 2032 in US and EU.
In 2021, we have significantly strengthened our organization with the hiring of Dr Kristina Sjöblom Nygren as new CMO, and of Dr Yilmaz Mahshid as new CFO. We plan more key recruitments in 2022 as we
continue to grow and add competence to the Company.
In 2021, Dr Thomas Lönngren (Chairman) and Mats Blom joined our board of directors.
We reported a cash position of approximately 144 million SEK on December 31, 2021.
We are still being affected by the ongoing COVID-19 pandemic. We continue to carefully monitor this development and take every precaution to ensure that patients, healthcare staff, our organization and those working on our trials are safe and well, and that our operations continue according to plan.
Our pipeline focus to provide treatment for patients suffering from rare and serious diseases remains firm as we shape the future of Egetis.
We plan to commercialize Emcitate in the US and Europe ourselves and will stepwise initiate the establishment of a small and focused organization in 2022 and 2023, to ensure the successful commercialization. Given the ultra-rare disease setting and uniqueness of Emcitate we plan for a commercial team of less than 50 FTEs at the time of launch.
We believe our core expertise could provide a platform to potentially be leveraged for additional late-stage orphan drug projects.
I look forward to relaying news to you around the projects and the progress of Egetis during the year ahead.
Finally, I extend my sincere thanks to all employees at Egetis for their committed work during 2021, the board of directors for governance and helpful counsel, our shareholders for their continued support and to all patients and physicians participating in the development of our product candidates.
Egetis Therapeutics is an innovative and integrated pharmaceutical drug development company, focusing on projects in late-stage development for treatment of serious diseases with significant unmet medical needs in the orphan drug segment. The drug candidate Emcitate is developed as the first potential treatment for patients with MCT8 deficiency, a rare disease with high unmet medical need and no available treatment. Triac Trial I (Phase IIb) and a long-term real-life study have been completed with clinically relevant and highly significant results on serum T3 concentrations and secondary clinical endpoints. Triac Trial II is an ongoing study in very young MCT8 deficiency patients (<30 months of age) investigating neurocognitive effects of early intervention with Emcitate. Results are expected in Q1 2024. Egetis intends to submit a marketing authorization application for Emcitate to the European Medicines Agency in H1 2023 based on existing clinical data. As a result of fruitful FDA interactions, Egetis will conduct a randomized,
placebo-controlled study in 16 patients to verify the results on T3 levels seen in previous clinical trials and publications. Egetis intends to submit an NDA in the US for Emcitate in mid-2023 under the Fast Track Designation granted by the FDA. Emcitate holds Orphan Drug Designation (ODD) in the US and EU and has been granted Rare Pediatric Disease Designation.
The drug candidate Aladote is a first in class drug candidate developed to reduce the risk of acute liver injury associated with paracetamol poisoning. A proof of principle study has been successfully completed and the design of the upcoming pivotal Phase IIb/III study for Aladote has been finalized after completed interactions with FDA, EMA and MHRA. Aladote has been granted ODD in the US and an application for ODD was submitted in Europe in Q1 2021. There is an ongoing dialogue with EMA on the appropriate indication for an ODD in the EU. Egetis Therapeutics (STO: EGTX) is listed on the Nasdaq Stockholm main market. For more information, see www.egetis.com
Receives FDA Fast Track Designation for Emcitate for MCT8 deficiency.
New real-world data published in the Journal of Clinical Endocrinology & Metabolism (van Geest et al. 2021) confirms long-term effcacy and safety of Emcitate in MCT8 deficiency patients up to six years.
Intends to submit a marketing authorization application (MAA) for Emcitate in Europe based on existing clinical data. Having all clinical data required for regulatory submission already at hand significantly reduces the remaining risk for Emcitate.
Egetis is committed to help transforming and extending the lives of patients with MCT8 deficiency. Egetis' disease awareness initiative launched in 2021, the MCT8 deficiency focused "Cuddly toy campaign", has been shortlisted at the prestigious Pharmaceutical Marketing Society awards in the category of best health care professional disease awareness campaign.
Fruitful regulatory interactions clarify the regulatory path forward for Emcitate.
Targeting Emcitate EU MAA submission H1 2023.
Targeting Emcitate US NDA submission in mid-2023 under the Fast Track Designation.
FDA acknowledges that effects on T3 levels and the manifestations of chronic thyrotoxicosis could provide a basis for Emcitate approval.
For the US submission, a 30-day, placebo-controlled study in 16 patients will be conducted to verify the results on T3 levels seen in previous clinical trials.
The outcome from the regulatory interactions increases the likelihood of success for Emcitate and the probability to receive a Rare Pediatric Disease Priority Review Voucher (PRV) in the US.
Receives a conditional acceptance from the FDA for the use of the brand name Emcitate in the US (brand name already accepted in the EU).
Emcitate is Egetis' lead candidate drug in clinical development. It addresses MCT8 deficiency, which is a rare genetic disease with high unmet medical need and no available treatment, affecting 1:70,000 males.
Thyroid hormone is crucial for the development and metabolic state of virtually all tissues. Thyroid hormone transport across the plasma membrane is required for the hormone's metabolism and intracellular action and is facilitated by thyroid hormone transporters, including monocarboxylate transporter 8 (MCT8). Mutations in the gene for MCT8, located on the X-chromosome, cause MCT8 deficiency, also called Allan-Herndon-Dudley syndrome (AHDS) in affected males.
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. 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, resulting in significantly shortened life expectancy.
Most patients will never develop the ability to walk or even sit independently. At present there is no approved therapy available for the treatment of MCT8 deficiency.
Emcitate was granted Orphan Drug Designation in the EU in 2017 and the US in 2019. In the US, FDA has granted Emcitate Rare Pediatric Disease Designation (RPD) in November 2020 and Fast Track Designation in October 2021. Upon approval of the NDA, sponsors holding an RPD and meeting the criteria specified can apply to receive a US Rare Pediatric Disease 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.
A Phase IIb 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, strong data from long-term treatment, up to 6 years, with Emcitate was published in the Journal of Clinical Endocrinology & Metabolism. The data comes from an investigator-initiated real-life cohort study at 33 sites conducted by the Erasmus Medical Center, Rotterdam, The Netherlands, where the efficacy and safety of Emcitate was investigated in 67 patients with MCT8 deficiency.
Based on the new long-term data, we had further positive interactions with the regulatory agencies in the US and Europe. In December, the European Medicines Agency (EMA) concluded that the clinical data from the Triac Trial I, together with the published data from long-term treatment, will suffice for a regulatory submission of a Marketing Authorisation Application (MAA) to the EMA for the treatment of MCT8 deficiency. Egetis plans to submit the MAA in the first half of 2023.
In recent positive regulatory interactions, 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. We have agreed with the FDA to perform a small, randomized study in 16 patients for up to 30 days to verify our T3 results, seen in previous clinical trials and publications. It is wellestablished that the T3 levels in untreated MCT8 patients are significantly elevated, and we have previously shown that Emcitate is able to rapidly and
durably normalize these levels. The primary source of patients will be through our existing named patient program. Egetis is targeting an US NDA submission for Emcitate in mid-2023 under the Fast Track Designation
A Phase IIb/III early intervention study (Triac Trial II) is ongoing. This study is an international, open label, multi-center study in boys younger than 30 months with MCT8 deficiency, conducted in both Europe and North America. Patient recruitment is expected to be completed in Q1 2022. Results from the Triac Trial II are expected in the first quarter of 2024 and are expected to be submitted post-approval to regulatory authorities shortly thereafter.
Given the possibility to proceed with regulatory submissions in both EU and US prior to data being available from the Triac Trial II, and following discussions with regulatory agencies, Egetis will no longer conduct an interim analysis based on 48-week data but will perform the statistical analysis on the complete dataset after the full 96 weeks of treatment, making the data more robust. Results are expected in Q1 2024 and data from the Triac Trial II is expected to be submitted post-approval to regulatory authorities shortly thereafter.
Emcitate is already supplied on a named patient or compassionate use basis, following individual regulatory approvals from national regulatory agencies. Compassionate use and named patient programs are mechanisms to 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 or are suitable.
Preparation for the pivotal Phase IIb/III study for Aladote continues, targeting study start in 2022, pending the COVID-19 situation.
Aladote was presented at the scientific meeting of the North American Congress of Clinical Toxicology (NACCT) on October 18, 2021, by Professor James Dear from the University of Edinburgh, UK, under the heading 'Clinical studies with calmangafodipir in acetaminophen overdose'.
Gets Notice of Allowance for a new US patent for a combination therapy with Aladote.
Gets Notice of Intent to Grant for a new European patent for a combination therapy with Aladote and Nacetylcysteine.
Aladote is a "first-in-class" drug candidate with the potential to reduce the risk of acute liver injury associated with paracetamol/acetaminophen poisoning. Aladote has shown a beneficial effect in relevant preclinical models, even in the timewindow when N-acetylcysteine (NAC) treatment no longer is effective. A proof of principle study in patients with paracetamol poisoning has been successfully completed. The study results established the safety and tolerability of the combination of Aladote and NAC. Further, the results indicate that Aladote may reduce liver injury in this patient population. Aladote has been granted Orphan Drug Designation (ODD) in the US.
An application for an ODD in the EU was submitted in March, and we have an ongoing dialogue with EMA on the appropriate indication for an ODD in the 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
In Q2 2021 the Company parked further PledOx development following the POLAR results. Our partner Solasia Pharma K.K. will continue the preclinical program in taxane induced peripheral neuropathy.
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 injury. The current standard of care for paracetamol poisoning, NAC, is effective if the patient receives medical care within eight hours of ingestion.
The Phase IIb/III study is 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 total planned number of patients are 225, who will be enrolled in the US, UK and in at least one EU country. The study consists of two parts with an interim analysis which includes a futility analysis and dose selection where the most effective dose will be continued. Application for market approval in the US, EU and UK is planned after successful completion of the study
Revenue amounted to KSEK 3,511 (5,289) during the quarter and 38,543 (40,662) for the period. Revenue consisted of Emcitate sales of KSEK 3,211 (1,727) during the quarter and KSEK 15,652 (1,727) during the period and forwarding of expenses related to PledOx to Solasia Pharma K.K. (Solasia) of KSEK - (3,163) during the quarter and KSEK 22,591 (38,935) during the period.
Operating expenses amounted to KSEK 36,131 (77,588) during the quarter and KSEK 144,224 (217,961) during the period. The project expenses amounted to KSEK 18,505 (65,858) during the quarter and KSEK 88,671 (183,276) during the period. The project expenses consisted mainly of expenses due to Emcitate of KSEK 15,271 (13,854) and Aladote KSEK 2,947 (3,992) for the quarter and Emcitate KSEK 37,340 (13,854) and Aladote KSEK 18,964 (15,730) for the period. Lower projects costs in the quarter and period are due to delayed initiation of the Aladote study and the parked PledOx project.
Employee costs amounted to KSEK 10,498 (6,188) during the quarter and KSEK 30,131 (22,151) for the period.
Other external costs amounted to KSEK 3,785 (3,410) for the quarter and KSEK 14,513 (10,001) for the period. The increase is mainly due to higher auditor expenses and consultancy costs. Depreciation and amortization amounted to KSEK 672 (237) for the quarter and KSEK 2,455 (395) for the period. The amortization of licences was KSEK 1,082 (183) during the period. Remaining depreciation/amortization derives from right of use assets according to IFRS 16. Other operating expenses amounted to KSEK 173 (-) for the quarter and 598 (243) for the period and consists of exchange rate differences.
Operating results amounted to KSEK -32,620 (-72,299) for the quarter and KSEK -105,681 (-177,299) for the period. Net financial items amounted to KSEK 561
(-2,015) for the quarter and KSEK 1,139 (-725) for the period. Results after financial items amounted to KSEK -32,058 (-74,314) for the quarter and KSEK -104,542 (-178,024) for the period. Result per share before and after dilution amounted to SEK -0.2 (-0.7) for the quarter and SEK -0.6 (-2.6) for the period both before and after dilution.
Cash as of December 31, 2021, amounted to KSEK 143,965 (287,850).
Cash flow from operating activities amounted to KSEK -25,979 (-39,224) for the quarter and KSEK -130,110 (-134,639) for the period. Total Cash flow amounted to KSEK -29,570 (129,798) for the quarter and KSEK -144,969 (34,223) for the period. Cash flow from operating activities is mainly driven by costs related to the projects. Cash flow from investing activities amounted to KSEK -1,306 (-59,543) during the period of which KSEK 1,250 are due to deferred purchase price of RTT and KSEK 56 are due to acquisition of equipment. Cash flow from financing activities amounted to KSEK -2,285 (228,565) for the period and are mainly due to amortization of loans, numbers for the previous period relates to the issuance of shares.
As of December 31, 2021, equity amounted to KSEK 527,039 (630,723). Shareholders' equity per average number of shares amounted to SEK 3.2 (5.8), for the period. The company's equity ratio was 93 (88) %.
As of December 31, 2021, non-current liabilities amounted to KSEK 3,060 (16,135). These consist mainly of liabilities that derive from right of use liabilities according to IFRS 16 of KSEK 2,650 (3,526) and other long-term liabilities of KSEK 410 (12,609). Current liabilities amount to KSEK 39,170 (70,141) of which other liabilities amount to KSEK 34,573 (54,530) and accounts payable amount to KSEK 4,596 (15,611).
As of December 31, 2021, non-current assets amounted to KSEK 416,366 (417,130). No significant investments were allocated to tangible assets.
The number of shares as of December 31, 2021, were 165,068,560 (165,068,560). The number of shareholders were 6,895 as of December 31, 2021. The ten largest shareholders hold 63.1 % of outstanding shares. Egetis Therapeutics shares are listed on Nasdaq Stockholm's main market.
The average share price during the period have been lower than the subscription prices of the programs and plans. Hence no dilution has been recognized to the shareholders.
Full utilization of options and warrants approved by the AGM would increase the number of shares with 10,513,600 to a total of 175,582,160.
The 2021 Annual General Meeting resolved on a 2021/2025 stock option plan of 5,000,000 stock options for employees of Egetis Therapeutics, of which 4,900,000 ESOPs were granted to the employees as of December 31, 2021.
To ensure the delivery of shares to participants in the company's incentive programs as well as to cover social security contributions when the share awards and employee options are exercised, the Parent Company has issued 6,571,000 warrants to its subsidiary Egetis Therapeutics Incentive AB.
The 2020 Annual General Meeting resolved on a 2020/2024 stock option plan of 3,000,000 stock options for employees of PledPharma (previous company name), of which 2,900,000 ESOPs were granted to the employees as of December 31, 2021.
To ensure the delivery of shares to participants in the company's incentive programs as well as to cover social security contributions when the share awards and employee options are exercised, the Parent Company has issued 3,942,600 warrants to its
subsidiary PledPharma I AB (previous company name).
Number of employees as of December 31, 2021, were 12 (10) persons, 7 women and 5 men.
The parent company's revenues for the quarter amounted to KSEK 6,243 (3,847) and for the period to KSEK 38,795 (39,267). Sales during the period consisted of KSEK 22,591 (38,935) due to forwarding of expenses related to PledOx to Solasia. Other income for the quarter amounted to KSEK 6,243 (684) and for the period to KSEK 16,204 (332). Other income for the period consisted of KSEK 12,469 (332) management fees invoiced to the subsidiary RTT and KSEK 3,735 (0) are forwarding of expenses to RTT.
The parent company's result after financial net amounted to KSEK -11,447 (-60,219) for the quarter and -59,982 (-163,125) for the period.
Financial non-current assets amount to KSEK 432,889 (431,979) and other non-current liabilities amount to KSEK 410 (5,109).
| KSEK | 2021 | 2020* | 2021 | 2020* |
|---|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
| Revenue | ||||
| Revenues | 3,211 | 4,890 | 38,243 | 40,662 |
| Other operating income | 300 | 399 | 300 | - |
| 3,511 | 5,289 | 38,543 | 40,662 | |
| Operating expenses | ||||
| Costs of sales of goods | -2,498 | -1,895 | -7,856 | -1,895 |
| Project costs | -18,505 | -65,858 | -88,671 | -183,276 |
| Other external costs | -3,785 | -3,410 | -14,513 | -10,001 |
| Employee costs | -10,498 | -6,188 | -30,131 | -22,151 |
| Depreciation and impairment | -672 | -237 | -2,455 | -395 |
| Other operating expenses | -173 | - | -598 | -243 |
| Sum operating expenses | -36,131 | -77,588 | -144,224 | -217,961 |
| Operating results | -32,620 | -72,299 | -105,681 | -177,299 |
| Financial items | ||||
| Finance income | 1,229 | 3 3 | 1,327 | 163 |
| Finance expense | -667 | -2,048 | -188 | -888 |
| Sum financial items | 561 | -2,015 | 1,139 | -725 |
| Results after financial net | -32,058 | -74,314 | -104,542 | -178,024 |
| Tax | - | - | - | - |
| Results after tax | -32,058 | -74,314 | -104,542 | -178,024 |
| Statement of comprehensive income | ||||
| Other comprehensive income | - | - | - | - |
| Comprehensive income for the period | -32,058 | -74,314 | -104,542 | -178,024 |
| Net earnings and comprehensive | ||||
| income is entirely attributable to parent company shareholders |
||||
| *) Restated, see note 6. | ||||
| Share Data | ||||
| Number of shares at the end of period | 165,068,560 | 165,068,560 | 165,068,560 | 165,068,560 |
| Average number of shares during period | 165,068,560 | 109,117,145 | 165,068,560 | 67,391,206 |
| Earnings per share before dilution (SEK) | -0.2 | -0.7 | -0.6 | -2.6 |
| Earnings per share after dilution (SEK) | -0.2 | -0.7 | -0.6 | -2.6 |
| Equity per average number of shares | 3.2 | 5.8 | 3.2 | 9.4 |
| Equity per average number of shares | 3.2 | 5.8 | 3.2 | 9.4 |
| after dilution |
Egetis Therapeutics Year-end report January-December 2021 10
| KSEK | 31/12/2021 | 31/12/2020* |
|---|---|---|
| ASSETS | ||
| Non-current assets | ||
| Research and development costs | 404,817 | 404,817 |
| Licences | 6,490 | 7,571 |
| Right-of-use assets | 4,088 | 4,666 |
| Equipment | 187 | 75 |
| Financial non-current assets | 785 | - |
| Total non-current assets | 416,366 | 417,130 |
| Current assets | ||
| Inventories | 694 | 3,138 |
| Accounts receivables | 3,456 | 3,883 |
| Other receivables | 3,340 | 2,960 |
| Prepaid expenses and accrued income | 1,448 | 2,039 |
| Cash and bank balance | 143,965 | 287,850 |
| Total current assets | 152,902 | 299,871 |
| Total assets | 569,269 | 717,000 |
| KSEK | 31/12/2021 | 31/12/2020* |
|---|---|---|
| Equity | ||
| Share capital | 8,688 | 8,688 |
| Other capital contributions | 1,262,837 | 1,262,837 |
| Reserves | 1,305 | 448 |
| Accumulated loss including net loss | -745,792 | -641,250 |
| Total equity | 527,039 | 630,723 |
| Non-current liabilities | ||
| Other non-current liabilities | 2,650 | 16,026 |
| Provisions | 410 | 109 |
| Total non-current liabilities | 3,060 | 16,135 |
| Current liabilities | ||
| Accounts payable | 4,596 | 15,611 |
| Other liabilities | 17,179 | 14,542 |
| Accrued expenses and deferred income | 17,394 | 39,988 |
| Total current liabilities | 39,170 | 70,141 |
| Total equity and liabilities | 569,269 | 717,000 |
*)Restated, see note 6.
| KSEK | 2021 | 2020 | 2021 | 2020 |
|---|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
| OPERATING ACTIVITIES | ||||
| Result after financial net | -32,058 | -74,314 | -104,542 | -178,024 |
| Adjustments for non-cash items | 257 | 711 | 2,683 | 1,334 |
| Tax paid | - | - | - | - |
| Cash flow from operating activities before changes in | -31,801 | -73,602 | -101,859 | -176,690 |
| working capital | ||||
| Cash flow from changes in working capital | ||||
| Increase/decrease in operating receivables | 1,340 | 6,073 | 3,082 | 16,428 |
| Increase/decrease in operating liabilities | 4,482 | 28,306 | -31,333 | 25,624 |
| Cash flow from changes in working capital | 5,822 | 34,378 | -28,251 | 42,051 |
| Cash flow from operating activities | -25,979 | -39,224 | -130,110 | -134,639 |
| INVESTING ACTIVITIES | ||||
| Acquisition of subsidiaries, net cash required | -1,250 | -59,520 | -5,000 | -59,520 |
| Investment in financial assets | - | - | -785 | - |
| Purchase of property, plant and equipment | -56 | -24 | -172 | -24 |
| Cash flow from investing activities | -1,306 | -59,543 | -5,957 | -59,543 |
| FINANCING ACTIVITIES | ||||
| New share issue | – | 250,750 | – | 250,750 |
| Cost new share issue | – | -22,130 | – | -22,130 |
| Repayment of loans | -1,875 | - | -7,500 | - |
| Repayment of leases | -410 | -55 | -1,402 | -215 |
| Cash flow from financing activities | -2,285 | 228,565 | -8,902 | 228,405 |
| Cash flow for the period | -29,570 | 129,798 | -144,969 | 34,223 |
| Balance at beginning of period | 173,150 | 159,424 | 287,850 | 255,101 |
| Change in cash | -29,570 | 129,798 | -144,969 | 34,223 |
| Exchange rate difference in cash | 384 | -1,371 | 1,084 | -1,473 |
| CASH BALANCE AT THE END OF THE PERIOD | 143,965 | 287,850 | 143,965 | 287,850 |
| KSEK | Share capital | Other capital contributions |
Accumulated loss incl. net results for the |
Other reserves | Total equity |
|---|---|---|---|---|---|
| period* | |||||
| Opening balance 01/01/2021 | 8,688 | 1,262,837 | -641,250 | 448 | 630,723 |
| Comprehensive income for the period Costs due to share-based payments |
- | - | -104,542 | - | -104,542 |
| of employee stock option plan | - | - | - | 857 | 857 |
| Closing balance 31/12/2021 | 8,688 | 1,262,837 | -745,792 | 1,305 | 527,039 |
| Opening balance 01/01/2020 | 2,818 | 705,278 | -463,220 | - | 244,876 |
| Comprehensive income for the period | - | - | -178,024 | - | -178,024 |
| Transactions with shareholders | |||||
| Issue in kind | 3,356 | 331,454 | - | - | 334,810 |
| New share issue | 2,514 | 248,236 | - | - | 250,750 |
| Cost new share issue | - | -22,130 | - | - | -22,130 |
| Costs due to share-based payments | |||||
| of employee stock option plan | - | - | - | 448 | 448 |
| Closing balance 31/12/2020 | 8,688 | 1,262,837 | -641,249 | 448 | 630,723 |
*) Restated, see note 6.
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.
| KSEK | 2021 | 2020 | 2021 | 2020 |
|---|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
| Equity | 527,039 | 630,723 | 527,039 | 630,723 |
| Equity ratio % | 93% | 88% | 93% | 88% |
| Return on equity % | neg. | neg. | neg. | neg. |
| Number of shares at the end of the period | 165,068,560 | 165,068,560 | 165,068,560 | 165,068,560 |
| Number of shares at the end of the period after dilution | 165,068,560 | 165,068,560 | 165,068,560 | 165,068,560 |
| Average number of shares during the period | 165,068,560 | 109,117,145 | 165,068,560 | 67,391,206 |
| Average number of shares during the period after dilution | 165,068,560 | 109,117,145 | 165,068,560 | 67,391,206 |
| Share Data | ||||
| Earnings per share | -0.2 | -0.7 | -0.6 | -2.6 |
| Earnings per share after dilution | -0.2 | -0.7 | -0.6 | -2.6 |
| Cash flow per share from operating activities | -0.2 | -0.2 | -0.8 | -0.8 |
| Equity per average number of shares | 3.2 | 5.8 | 3.2 | 9.4 |
| Equity per average number of shares after dilution | 3.2 | 5.8 | 3.2 | 9.4 |
| Dividend | - | - | - | - |
| Average number of employees | 12 | 9 | 11 | 9 |
*Effect from dilution is not considered when results are negative.
| KSEK | 2021 | 2020 | 2021 | 2020 |
|---|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | |
| Revenue | ||||
| Revenues | - | 3,163 | 22,591 | 38,935 |
| Other operating income | 6,243 | 684 | 16,204 | 332 |
| 6,243 | 3,847 | 38,795 | 39,267 | |
| Operating expenses | ||||
| Project costs | -3,993 | -52,004 | -54,949 | -169,422 |
| Other external costs | -3,791 | -3,857 | -14,417 | -9,806 |
| Employee costs | -10,498 | -6,190 | -30,174 | -22,152 |
| Depreciation and impairment | -15 | -1 | -43 | -1 |
| Other operating expenses | -93 | - | -463 | -290 |
| Sum operating expenses | -18,390 | -62,051 | -100,046 | -201,670 |
| Operating results | -12,147 | -58,204 | -61,251 | -162,403 |
| Financial items | ||||
| Finance income | 1,220 | 33 | 1,299 | 163 |
| Finance expense | -520 | -2,048 | -31 | -885 |
| Sum financial items | 700 | -2,015 | 1,268 | -722 |
| Results after financial net | -11,447 | -60,219 | -59,982 | -163,125 |
| Appropriations | -45,000 | - | -68,000 | - |
| Tax | - | - | - | - |
| Results after tax | -56,447 | -60,219 | -127,982 | -163,125 |
| KSEK | 31/12/2021 | 31/12/2020* |
|---|---|---|
| ASSETS | ||
| Non-current assets | ||
| Equipment | 152 | 23 |
| Financial non-current assets | 432,736 | 431,956 |
| Total non-current assets | 432,889 | 431,979 |
| Current assets | ||
| Accounts receivables | - | 2,470 |
| Other receivables | 751 | 2,266 |
| Prepaid expenses and accrued income | 1,257 | 1,135 |
| Cash and bank balance | 138,946 | 285,830 |
| Total current assets | 140,955 | 291,701 |
| Total assets | 573,843 | 723,680 |
| KSEK | 31/12/2021 | 31/12/2020* |
| Equity | ||
| Restricted Equity | ||
| Share capital | 8,688 | 8,688 |
| Non-restricted equity | ||
| Share premium reserve | 636,235 | 799,360 |
| Reserves | 1,305 | 448 |
| Net loss for the period | -127,982 | -163,125 |
| Total equity | 518,246 | 645,371 |
| Non-current liabilities | ||
| Other non-current liabilities | - | 5,000 |
| Provisions | 410 | 109 |
| Total non-current liabilities | 410 | 5,109 |
| Current liabilities | ||
| Liabilities to group company | 38,173 | 19,209 |
| Accounts payable | 2,018 | 10,755 |
| Other liabilities | 7,571 | 5,840 |
| Accrued expenses and deferred income | 7,425 | 37,396 |
| Total current liabilities | 55,187 | 73,199 |
| Total equity and liabilities | 573,843 | 723,680 |
*)Restated, see note 6.
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, 2020. 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 2020. Some amendments to existing standards became applicable from January 1, 2021, 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 thousands 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 2020 regarding more information on estimates and assessments.
The accounting of the acquisition of Rare Thyroid Therapeutics International AB (RTT) in 2020 was based on information that had not been taken into account at the initial acquisition date, namely, if the company had important processes and staff required for generating output in place. The acquisition was reported as a Business Combination in accordance with IFRS 3 instead of an asset acquisition. For this transaction, it was primarily the intangible asset Emcitate that was acquired. For an asset acquisition of this nature, the identified asset Emcitate must therefore be reported in accordance with IAS 38 Intangible Assets and not as part of an acquisition analysis associated with a business combination as per IFRS 3.
Because this transaction was reported as a business combination in the consolidated financial statements ending December 31, 2020, the carrying amount for intangible assets was too high. It also meant that the carrying amounts for liabilities were incorrect, specifically, deferred tax and the liability for additional consideration. In the parent company financial statements ending December 31, 2020, the value of shares in subsidiaries and the liability for additional consideration were incorrect.
To correct for this, the liability for additional consideration in both the consolidated and parent company financial statements must be reversed such that no deferred tax is reported in the consolidated financial statements. It also means that the value of the intangible asset Emcitate must be lowered by the amount corresponding to the liability and deferred tax that had been reported in the consolidated financial statements. The value of shares in subsidiaries reported by the parent company must also be lowered by the amount corresponding to the prior reported liability for additional consideration.
Please see Note 6 for a compilation of the effects of this error correction, for the consolidated and parent company income statements and balance sheets ending December 31, 2020. Correction of the error has not had any impact on cash flow for either the group or parent company.
A company acquisition can be classified as either a business combination or an asset acquisition. For each specific acquisition, an individual assessment must be made. In order to report the transaction as a business combination in accordance with IFRS there must be an integrated quantity of activities and assets which, at a minimum, comprise one input and one significant process. The input and process must then be able to generate an output (return). If an acquisition does not currently generate output, but there is an identifiable asset that can generate output in the future, there must be an organized workforce in order to report it as a business
combination. If the assessment is that the acquisition does not meet the criteria for reporting it as a business combination, it must be reported as an asset acquisition instead.
An optional concentration test can be applied to determine whether an acquisition is an asset acquisition. The key driver is that substantially all of the fair value of the gross assets acquired must be concentrated in a single identifiable asset or group of similar identifiable assets. If so, it is an asset acquisition.
For an asset acquisition, the cost of acquisition is allocated to the individual assets acquired and liabilities assumed on a relative fair value basis. For asset acquisitions, the transaction costs are added to the cost of acquisition. No initial deferred tax from temporary differences is reported for an asset acquisition. Egetis' principle for recognition of contingent liabilities in the form future royalty streams to the sellers of an asset, is to report them at the rate that they arise. Accordingly, no such future additional payments are reported as part of the cost of acquisition.
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. Leasing costs are charged to profit and do not impact the balance sheet. Lease payments are recognized on a straight-line basis over the term of the lease. The parent company accounts the acquisition costs of group entities as participation in group entities under financial non-current assets and not through the income statement.
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 Group's risk exposure is included in Egetis 2020 Annual Report, note 3. There are no major changes in the Group's risk exposure in 2021 compared with 2020.
Egetis is closely monitoring the developments and is evaluating the extent to which this may affect operations in the short and long term. Therefore, Egetis continue to carefully monitor the impact of the COVID-19 pandemic and take every precaution to ensure that staff, collaborators, and study participants are safe and stay well, while progressing our clinical studies with high data quality. Due to the ongoing COVID-19 pandemic, it is challenging to start a clinical study in an emergency/intensive care setting. Another risk and uncertainty that the company currently has identified is recruitment of patients in the ongoing Emcitate study.
Other information in accordance with IAS 34.16A are found on the pages before the income statement and statement of comprehensive income. Information on earnings, cash flow and financial position, see page 8. For events after the period, see page 1.
All financial assets and liabilities are measured at amortized costs. No financial assets or liabilities have been reclassified between the valuation categories. The fair value of financial assets and liabilities that are valued at amortized cost is deemed to essentially correspond to their fair value.
| KSEK | Non-current | Current | Total |
|---|---|---|---|
| Group December 31, 2021 FINANCIAL ASSETS MEASURED AT AMORTIZED COST |
|||
| Financial non-current assets | 785 | - | 785 |
| Accounts receivable | - | 3,456 | 3,456 |
| Cash | - | 143,965 | 143,965 |
| Total financial assets | 785 | 147,421 | 148,206 |
| FINANCIAL LIABILITIES MEASURED AT AMORTIZED COST |
|||
| Lease liablilities | 2,650 | 1,502 | 4,152 |
| Accounts payable | - | 4,596 | 4,596 |
| Deferred purchase price | - | 5,000 | 5,000 |
| Other liabilities | - | 7,500 | 7,500 |
| Total | 2,650 | 18,598 | 21,248 |
| Total financial liabilities | 2,650 | 18,598 | 21,248 |
| Group December 31, 2020 FINANCIAL ASSETS MEASURED AT AMORTIZED COST |
|||
| Accounts receivable | - | 3,883 | 3,883 |
| Cash | - | 287,850 | 287,850 |
| Total financial assets | - | 291,733 | 291,733 |
| FINANCIAL LIABILITIES MEASURED AT AMORTIZED COST |
|||
| Lease liablilities | 3,526 | 1,141 | 4,667 |
| Accounts payable | - | 15,611 | 15,611 |
| Deferred purchase price | 5,000 | 5,000 | 10,000 |
| 7,500 | 7,500 | 15,000 | |
| Total | 16,026 | 29,252 | 45,278 |
| Total financial liabilities | 16,026 | 29,252 | 45,278 |
As of April 1, 2019, the group has categorized and identified two independent segments of development for calmangafodipir, PledOx and Aladote. As a result of the acquisition of RTT the segment report has been expanded with Emcitate. These three segments are independent R&D projects for which the chief operating decision maker in the company allocates company resources. The PledOx revenues consists of forwarding of expenses for the Asian part of the POLAR studies. Emcitate revenues are due to Named Patient Use (NPU) of the drug candidate.
The table below specify revenues and costs attributed to PledOx and Aladote and Emcitate. The PledOx project has been parked and will only be presented where relevant comparison numbers are necessary.
| 2021 Oct-Dec |
2020 Oct-Dec |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| KSEK | PledOx Aladote Emcitate | Common | Sum | KSEK | PledOx Aladote Emcitate Common | Sum | |||||
| Revenues | - | - | 3,211 | - | 3,211 | Revenues | 3,163 | - | 1,727 | 399 | 5,289 |
| Costs of goods sold | - | - | -2,498 | - | -2,498 | Costs of goods sold | - | - | -1,895 | - | -1,895 |
| Project costs | -286 | -2,947 | -15,271 | - | -18,505 | Project costs | -48,012 | -3,992 | -13,854 | - | -65,858 |
| Other | - | - | - | -14,827 -14,827 | Other | - | - | - | -9,835 | -9,835 | |
| Operating results | -286 | -2,947 | -14,558 | -14,827 -32,619 | Operating results | -44,849 -3,992 | -14,022 | -9,436 -72,299 | |||
| Net financial items | 561 | Net financial items | -2,015 | ||||||||
| Pretax profit | -32,058 | Pretax profit | -74,314 |
| 2021 Jan-Dec |
2020 Jan-Dec |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| KSEK | PledOx Aladote Emcitate | Common | Sum | KSEK | PledOx Aladote Emcitate Common | Sum | |||||
| Revenues | 22,591 | - | 15,652 | - | 38,243 | Revenues | 38,935 | - | 1,727 | - | 40,662 |
| Costs of goods sold | - | - | -7,856 | - | -7,856 | Costs of goods sold | - | - | -1,895 | - | -1,895 |
| Project costs | -32,367 -18,964 | -37,340 | - | -88,671 | Project costs | -153,692 -15,730 | -13,854 | - -183,276 | |||
| Other | - | - | - | -47,396 -47,396 | Other | -53 | - | - | -32,738 -32,791 | ||
| Operating results Net financial items Pretax profit |
-9,776 -18,964 | -29,545 | -47,396 -105,681 1,139 -104,542 |
Operating results Net financial items Pretax profit |
-114,809 -15,730 | -14,022 -32,738 -177,299 | -725 -178,024 |
Revenue from Japan are attributable to the segment PledOx and revenues to other countries are attributable to the segment Emcitate. The PledOx segment has a single customer who accounts for all revenues reported. Revenues from this single customer amounts to KSEK 22,591 (33,201) for the period.
| KSEK | 2021 | 2020 | 2021 | 2020 |
|---|---|---|---|---|
| Country | Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
| Japan | - | 3,163 | 22,591 | 38,935 |
| France | 547 | - | 2,921 | 327 |
| Spain | - | - | 2,894 | 273 |
| Sweden | 284 | 87 | 1,324 | 83 |
| Great Britain | 528 | - | 2,781 | 172 |
| Other countries | 1,852 | 1,640 | 5,732 | 872 |
| Total | 3,211 | 4,890 | 38,243 | 40,662 |
| 2021 | 2020 | 2021 | 2020 | |
|---|---|---|---|---|
| KSEK | Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec |
| Re-invoicing of | ||||
| costs to Solasia | - | 3,163 | 22,591 | 38,935 |
| Sales of goods | 3,211 | 1,727 | 15,652 | 1,727 |
| Total | 3,211 | 4,890 | 38,243 | 40,662 |
The below table presents a reconciliation of changes in liabilities divided by cash-flow and non-cash flow activities due to lease liabilities and other liabilities that are classified as financing activities.
| No affect on cash flow | |||||
|---|---|---|---|---|---|
| 31/12/2020 Cash flow Acquisition of business New lease agreements | 31/12/2021 | ||||
| Lease liablilities | 4,666 | -1,402 | - | 888 | 4,152 |
| Other liabilities | 15,000 | -7,500 | - | - | 7,500 |
| Closing balance | 19,666 | -8,902 | - | - | 10,764 |
| No affect on cash flow | |||||
|---|---|---|---|---|---|
| 31/12/2019 Cash flow Acquisition of business New lease agreements | 31/12/2020 | ||||
| Lease liablilities | 117 | -215 | - | 4,764 | 4,666 |
| Other liabilities | - | - | 15,000 | - | 15,000 |
| Closing balance | 117 | -215 | 15,000 | 4,764 | 19,666 |
In November 2021, the parent company noted that the acquisition of Rare Thyroid Therapeutics International AB should have been reported as an asset acquisition, and the intangible Emcitate measured in accordance with IAS 38, instead of a business acquisition accounted for in accordance with IFRS 3. The accounting error has resulted in a significantly higher carrying amount of capitalized research and development costs because a liability for contingent consideration as well as deferred tax liability were recorded in the Group, both of which should not have been recorded since the transaction was in effect an asset deal and not an acquisition of a business.
Shares in subsidiaries have been overstated because a long-term debt for additional purchase consideration have been recorded in the parent Company's accounts.
In the consolidated accounts the correction results in a lower carrying amount of capitalized research and development corresponding to the reversal of the liability for contingent consideration as well as the deferred tax liability. In the parent entity's accounts the correction results in a lower value of shares in subsidiaries corresponding to the reversal of the long-term debt for additional purchase consideration.
Previously booked additional purchase consideration will now be considered as a contingent liability regarding royalties, see Note 7.
The following summary shows the effects of the correction of errors, on the Group's and the Parent Company's balance sheet and income statement as of 31 December 2020. The correction of errors has had no effect on the Group's and the Parent Company's cash flow.
| KSEK 31/12/2020 |
According to previously approved annual report |
Correction of misstatement |
After correction of misstatement |
|---|---|---|---|
| Balance sheet (extract) | |||
| Research and development costs | 581,784 | -176,967 | 404,816 |
| Other non-current liabilities | -74,242 | 58,216 | -16,026 |
| Deferred tax liabilities | -119,847 | 119,847 | - |
| Net | 387,694 | 1,096 | 388,790 |
| Accumulated loss including net loss | -642,346 | 1,096 | -641,250 |
| Total equity | 629,627 | 1,096 | 630,723 |
| KSEK | 31/12/2020 According to previously approved annual report |
Correction of misstatement |
31/12/2020 After correction of misstatement |
|
|---|---|---|---|---|
| Income statement (extract) Other external costs |
-11,097 | 1,096 | -10,001 | |
| Results after financial net | -179,120 | 1,096 | -178,024 | |
| Comprehensive income for the period | -179,120 | 1,096 | -178,024 |
| KSEK 31/12/2020 |
According to previously approved annual report |
Correction of misstatement |
After correction of misstatement |
|---|---|---|---|
| Balance sheet (extract) | |||
| Shares in subsidiaries | 490,172 | -58,216 | 431,956 |
| Other non-current liabilities | -63,216 | 58,216 | -5,000 |
| Net | 426,956 | 0 | 426,956 |
| Equity | 645,371 | 0 | 645,371 |
Egetis has a contractual obligation, on future net sales from Emcitate, to provide royalty payments to the previous owners of Rare Thyroid Therapeutics International AB and Erasmus Medical Centre corresponding to a low double-digit percentage of net sales of the product.
Peder Wahlberg has been providing consultancy services to the company, invoicing KSEK 1,614 during 2021.
Earnings per share. Net income divided by average number of shares before dilution.
Number of shares at end of period. The number of outstanding 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.
Average number of shares during the period. Average number of outstanding 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.
Equity ratio, % The period's closing equity divided by the period's closing balance sheet. The company uses the alternate ratio Equity 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.
Return on equity, % Net income divided by shareholders' equity. The company uses the alternate key figure Return on equity, % because the company believes that the key ratio gives investors a better understanding of the return generated on the total capital that the shareholders have invested in the Company.
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
| 2021 | 2020 | 2021 | 2020 | ||
|---|---|---|---|---|---|
| Oct-Dec | Oct-Dec | Jan-Dec | Jan-Dec | ||
| A | Equity, KSEK | 527,039 | 630,723 | 527,039 | 630,723 |
| B | Balance sheet total, KSEK | 569,269 | 717,000 | 569,269 | 717,000 |
| A/B | Equity ratio % | 93% | 88% | 93% | 88% |
| A | Net result, KSEK | -32,058 | -74,314 | -104,542 | -178,024 |
| B | Equity, KSEK | 527,039 | 630,723 | 527,039 | 630,723 |
| A/B | Return on equity, % | neg. | neg. | neg. | neg. |
| A | Cash flow from operating activities, KSEK | -25,979 | -39,224 | -130,110 | -134,639 |
| B | Average number of shares under the period, before dilution, | 165,069 | 109,117 | 165,069 | 67,391 |
| A/B | Cash flow from operating activities per shares, SEK | -0.2 | -0.4 | -0.8 | -2.0 |
| A | Equity, KSEK | 527,039 | 630,723 | 527,039 | 630,723 |
| B | Average number of shares at the end of the period before dilution, | 165,069 | 109,117 | 165,069 | 67,391 |
| A/B | Equity per average number of shares before dilution, SEK | 3.2 | 5.8 | 3.2 | 9.4 |
| A | Equity, KSEK | 527,039 | 630,723 | 527,039 | 630,723 |
| B | Average number of shares at the end of the period after dilution, | 165,069 | 109,117 | 165,069 | 67,391 |
| A/B | Equity per average number of shares after dilution, SEK | 3.2 | 5.8 | 3.2 | 9.4 |
Interim report January 1- March 31: April 26, 2022. Annual General Meeting: May 10, 2022. Half-year report January 1- June 30: August 19, 2022. Interim report January 1- September 30: November 8, 2022.
This report, and further information is available on the website, www.egetis.com This is a translation of the Swedish interim report.
Nicklas Westerholm, CEO Yilmaz Mahshid, CFO E-mail: [email protected] E-mail: [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 17, 2022, at 8.00 am (CET).
Egetis Therapeutics AB (publ.) Klara Norra kyrkogata 26, 111 22 Stockholm Org.nr. 556706-6724 Phone: +46(0)8-679 72 10 www.egetis.com
ABGSC, Adam Karlsson Carnegie, Ulrik Trattner Pareto Securities, Dan Akschuti Redeye, Kevin Sule Rx Securities, Dr. Joseph Hedden
This Year-end report for the January-December 2021 period 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 17, 2022.
| Thomas Lönngren | Elisabeth Svanberg |
|---|---|
| Chairman of the board | Board member |
Gunilla Osswald Mats Blom
Board member Board member
Board member CEO
Peder Walberg Nicklas Westerholm
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