All-time-high sales and positive study result
Financial Summary April-June
· Net sales during the quarter amounted to KSEK 40 509 (17 359) corresponding to an increase of 133% compared with the same period in 2019.
· Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to KSEK -777 (-2 330). This corresponds to an EBITDA margin of -1,9% (-13,4%).
· Earnings before interest and taxes (EBIT) amounted to KSEK -1 917 (-3 377) which corresponds to an EBIT margin of -4,7% (-19,5%).
· Net income for the period was KSEK -3 595 (-1 723) and earnings per share before and after dilution was
· Cash flow from operations before changes in working capital amounted to KSEK 730 (-2 094).
· Cash flow from investment activities amounted to KSEK -17 710 (-13 415).
· Cash flow for the period amounted to KSEK -7 988 (-12 576).
· Liquid funds at the end of the period amounted to KSEK 433 537 (137 317).
Financial Summary January-June
· Net sales for the period amounted to KSEK 74 341 (35 173) corresponding to an increase of 111% compared with the same period in 2019.
· Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to KSEK 427 (-4 972). This corresponds to an EBITDA margin of 0,6% (-14,1%).
· Earnings before interest and taxes (EBIT) amounted to KSEK -1 835 (-7 037) corresponding to an EBIT margin of -2,5% (-20,0%).
· Net income for the period was KSEK -1 894 (-4 694) and earnings per share before and after dilution was
· Cash flow from operations before changes in working capital amounted to KSEK 891 (-3 928).
· Cash flow from investment activities amounted to KSEK -31 953 (-24 096).
· Cash flow for the period amounted to KSEK -30 688 (-22 136).
Significant events during the period
· In the beginning of April, the company announced a sales increase for the first quarter of 2020 that was significantly higher than expected. Sales for the first quarter of 2020 was
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· In May, the first patient was enrolled in SESAR, a study comparing inhaled sedation and intravenous sedation for patients with Acute Respiratory Distress Syndrome, ARDS. The study is conducted in
· At the annual general meeting of
· All warrants in the company's incentive program 2017/21 have been exercised by the warrant holders, leading to an increase in the number of shares and votes in the company by 310 149. Accordingly, the share capital was increased by SEK 31 015. Through the exercise of the warrants,
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Significant events after the period
· On
· On
· On
Outlook 2020 - covid-19
In comparison with the situation before the covid-19 pandemic, the company sees a higher growth. Several intensive care clinics have prepared for the pandemic through material procurement and training, mainly for the treatment of covid-19-related ARDS. Of the increase in growth, about 40% comes from new intensive care clinics having started using inhaled sedation and 60% from existing customers increasing their use. The rate of sales growth decreased at the end of the quarter compared with the beginning. This coincides with a slowdown in the spread of covid-19 in
For the full year 2020,
CEO comments
Positive top line results
- a milestone on the road to our vision
Operations during the second quarter continued to be characterized by the covid-19 pandemic but also by intensive work ahead of our upcoming US expansion. First, however, I would like to address the most important milestone in many years that occurred shortly after the end of the quarter when we announced positive top line results in our pivotal phase 3 study SED-001. The study is the single largest progress in the area of inhaled sedation since AnaConDa was developed and we are extremely proud to have conducted the world's largest study of inhalation sedation in intensive care.
The goal when we initiated the work with the study several years ago was to be able to register inhaled sedation with IsoConDa (isoflurane), administered with AnaConDa, in
The strong top line results confirm the clinical experience of physicians worldwide and the strong study results will form the basis for the application for European market approval that we will submit as soon as possible during the fourth quarter of this year. In a first registration round, the application will cover 16 European countries and if all goes well, we expect approval in the second half of 2021. A market approval in
The secondary objectives in the SED-001 study are currently being analyzed and will be presented together with the primary objectives in a scientific journal at the beginning of next year. Of course, we have high hopes also regarding the secondary results, but the strong top line results are sufficient as a basis for our application for market approval.
The SED-001 study is designed as a non-inferiority study, which means that its primary purpose is to show that our therapy is not worse than propofol in maintaining an adequate sedation level. The secondary goals of the study include time to wake up, proportion of time with spontaneous breathing, need for painkillers, ICU- and ventilator-free days and organ function over time. If these goals succeed in showing good results, it is of course a bonus, but nothing that we count on due to the study design. In that respect, we have higher hopes for the large investigator-initiated studies that we support; SESAR, INASED and ISCA.
These studies are done partly to show that inhaled sedation with AnaConDa has lung protective properties (SESAR) with increased survival as a result and partly to show a reduced incidence of delirium (INASED) and improved cognitive recovery after sedation which is a major problem in intensive care. Positive results would significantly strengthen our clinical base and each of the studies have the potential to dramatically change the view of inhaled sedation in relation to intravenous sedation. Through this type of study, we gather evidence which, if it is positive, together with already published evidence, can form the basis for a paradigm shift in intensive care. The studies are an important support in our continued regulatory and commercial expansion and provide an indication of the great potential of our therapy.
The same applies to the ISCA study, Inhaled Sedation in Covid-19-related Acute Respiratory Distress Syndrome, which was initiated in the quarter and is performed on at least 400 patients in about 30 intensive care units in
The covid-19 pandemic has not only affected the type of studies we choose to support but has also continued to strongly influence our entire business since ICU sedation is exactly the treatment that severe covid-19 ill patients need. In addition, our treatment can increase patient flow at ICU, which is important when access to ICU beds is limited.
Sales in the quarter were
Our commercial expansion has undeniably received an extra boost from the pandemic. In these times of crisis, it is obvious that a not yet achieved market approval has not played as big a role as usual and once we get a market approval, we will get it from a higher base than would have been the case without covid-19.
The pandemic has led to us receiving of a large number of inquiries about clinical studies, retrospective data collection and other studies to further clarify the benefits of inhaled sedation. It is, of course, extremely gratifying at the same time as it takes up some administrative resources. The ISCA study is one of the studies we, during the quarter, have decided to support, and we try to prioritize wisely between all the proposals that come to us.
There is great interest in our treatment even in the markets that we ourselves do not cover. During the quarter, we signed sales agreements with distributors in the
For
Part of the preparations for the clinical studies are the toxicity studies that are currently underway and where we are breaking new ground week by week. The studies are progressing at a good pace and according to plan, but it has been a challenge to be the first company ever to carry out this type of long-term sedation. A large part of the work has been put on pure methodological issues in this full-scale tox program.
During the winter and spring of 2021, the plan is to start hiring staff in
All in all, we are adding another extremely intensive but successful quarter behind us. The pandemic has undeniably accelerated interest in our treatment, despite the fact that the pandemic itself thankfully seems to be slowing down in many countries, which means a return to normal conditions in the intensive care units around the world. I look forward to coming back to you.
Please find the full interim report at: www.sedanamedical.com under Investors/annual & interim reports.
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For additional information, please contact:
+46 70 675 33 30
christer.ahlberg@sedanamedical.com (mailto:)
Maria Engström, CFO,
+46 70 674 33 30
maria.engstrom@sedanamedical.com
The company's Certified Adviser is
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About
Today, mechanically ventilated intensive care patients are sedated intravenously which leads to several challenges for both patients and care givers. Challenges that are solved by inhaled sedation. Based on an estimate of seven to eight million patients being sedated in intensive care due to mechanical ventilation globally, on average three to four days,
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