Hard work to meet the intensive care needs during COVID-19
Financial Summary January-March
· Net sales during the quarter amounted to KSEK 33 832 (17 814) corresponding to an increase of 90% compared with the same period in 2019.
· Earnings before interest, taxes, depreciation and amortization (EBITDA) amounted to KSEK 1 204 (-2 641). This corresponds to an EBITDA margin of 3,6% (-14,8%).
· Earnings before interest and taxes (EBIT) amounted to KSEK 82 (-3 660) which corresponds to an EBIT margin of 0,2%
(-20,5%).
· Earnings per share before dilution was
· Cash flow from operations before changes in working capital amounted to KSEK 161 (-1 834).
· Cash flow from investment activities amounted to KSEK -14 243 (-10 681).
· Cash flow for the period amounted to KSEK -22 700 (-9 560).
· Liquid funds at the end of the period amounted to KSEK 442 553 (149 849).
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Significant events during the period
· In January, the last patient was included in the pivotal IsoConDa-study. Thus, all 300 patients have been included in the European study which is expected to show" top-line" results during Q2 2020.
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Significant events after the period
· As sales during the last days of March turned out to be significantly higher than expected, which led to that the company is reporting significantly higher sales for the first quarter of 2020 than announced on
Outlook 2020
· Since the end of the quarter
CEO comments
The first quarter of 2020 was largely marked by the covid-19 pandemic. With our treatment you can say that we are in the center of events and there are a couple of reasons why demand for our treatment has risen sharply as a result of the pandemic.
To begin with, our treatment - sedation of mechanically ventilated patients - is exactly the one that severe covid-19 patients need. These severely ill intensive care patients are normally ventilated for a very long time and sedated for up to two weeks. To succeed with a long and deep sedation, a mixture of several intravenous drugs is usually required, which in itself entails risks. By choosing inhaled sedation with AnaConDa, the patient can be sedated with volatile drugs (such as isoflurane) that allow for deep, safe and effective sedation, and also release syringe pump capacity which has become a shortage in intensive care during the pandemic.
Furthermore, long-term sedated patients who have been intravenously sedated are often difficult to awake. It can take a very long time, up to several days. With inhaled sedation, the patient wakes up within a few minutes, usually within an hour, regardless of sedation time. This is because isoflurane is not metabolized in the body's organs but is eliminated through the lungs, with minimal degradation in the body. Patients usually wake up easily and are relatively alert after inhalation sedation, releasing resources from the intensive care that usually take care of awakening patients with side effects such as delirium, hallucinations, nightmares, dementia-like conditions and agitation. Through faster and easier awakening, the patient flow in the intensive care unit can be increased, which has been important during the pandemic when access to intensive care beds has been limited.
Another feature of inhaled sedation that has also driven demand for AnaConDa is the potential anti-inflammatory effect previously shown in studies in ARDS patients. The theory is that inhaled sedation reduces inflammation in the lungs which improves oxygen uptake. ARDS (Acute Respiratory Distress Syndrome) or lung failure is the condition that often affects the severely ill covid-19 patients. In October last year, we announced that
Overall, demand for the quarter increased dramatically. We had a turnover of
We have also worked a lot to ensure our delivery capacity. Both our contract manufacturers in
The interest in our treatment has, to say the least, increased sharply as a result of the pandemic. Both volumes and demand are rising, and inquiries are coming in from both existing and new markets. As an example, in February, we opened our own direct sales organization in Benelux and sales got off to a fast start. In
In addition, we are currently receiving a number of inquiries about clinical studies, retrospective data collection and other studies to further clarify the benefits of inhaled sedation. Of course, it is extremely gratifying while at the same time taking on some administrative resources. We try to prioritize wisely between all the proposals that come to us.
One of the most important milestones of the quarter was that the last patient in January was included in our registration based IsoConDa study. In the light of the pandemic, we are pleased that the clinical part of the study could be completed in January. However, the administration remains to go through the data, and since access to our examiners is naturally limited by the pandemic, as previously announced, we see some risk of delaying the compilation of the study. We expect the topline result to be presented at the end of the second quarter or early in the third quarter of this year. However, we still expect to keep the timetable and submit the application in the third quarter, or early in the fourth quarter of 2020, and that we could thus obtain approval during the second half of 2021.
Overall, the quarter has been extremely intense. The effects of the covid-19 pandemic on people's lives and health can be devastating and it is very rewarding to work in a company that can help in this global challenge. The pandemic has accelerated interest in our treatment and at the time of writing we see no slowdown in this. I look forward to coming back to you.
Please find the full interim report at: www.sedanamedical.com under Investors/annual & interim reports.
To participate, please dial: +46 8 5055 83 68
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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
This information is such that
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