Sedana Medical AB (publ), Interim report Q1, 2019

Clear regulatory pathway to approval in EU and USA

First quarter, January - March 2019

•  Net sales during the first quarter amounted to KSEK 17,814 (15,487) corresponding to an increase of 15% compared with the same period in 2018.

•  Earnings before interest, taxes, depreciation and amortisation (EBITDA) amounted to KSEK -2,641 (-788) KSEK. This corresponds to an EBITDA margin of -14,8% (-5,1%).

•  Earnings before interest and taxes (EBIT) amounted to KSEK -3,660 (-1,730), which corresponds to an EBIT margin of -20,5% (-11,2%)

•  Cash flow from operations before changes in working capital amounted to KSEK -1,834 (-821).

•  Cash flow from investment activities amounted to KSEK -10,681 (-4,381).

•  Cash flow for the period amounted KSEK -9,560 (-6,279).

•  Liquid funds at the end of the period amounted to KSEK 149,849 (79,213).

Significant events during January– March

•  Sedana Medical AB (publ) has been approved for its planned pediatric study from the Pediatric Committee of EMA, European Medicines Agency, (PDCO).
  
  
•  Sedana Medical AB (publ) announced on the 8th of March 2019 the results of the interim analysis for the company's pivotal phase III study which shows smaller variations in efficacy than anticipated and the study will therefore only need to cover a total of 300 patients instead of initially estimated 550 patients.

Significant events after the reporting period

•  During the pre-IND meeting the US Food and Drug Administration (FDA) was positive about the combination registration of IsoConDa and AnaConDa in the US. Sedana Medical now has a clear view of measures that have to be taken in order to reach marketing authorization approval of both IsoConDa and AnaConDa in the US. The meeting also confirmed Sedana Medical's estimate of the time and cost of a US approval that is expected to occur in 2024.

CEO comments 

The first quarter of 2019 has been our most successful so far regarding our clinical and regulatory development. It is above all three crucial milestones that we have achieved; interim analysis of our registration study, the approval of our planned pediatric study and the implementation and outcome of the pre-IND meeting held with the FDA in the US in March 2019.

The interim analysis for our registration-based Phase III study (which aims to get IsoConDa approved for inhaled sedation in intensive care in Europe) showed smaller variations in effect than expected. It was the best possible outcome since this meant the study will only need a total of 300 patients instead of initially estimated 550 patients.

The interim analysis sets out our way forward in Europe and we believe that with 223 patients included by the end of April and with the current inclusion rate, we can include the last patient in the study around the turn of the year 2019/2020. This means that we expect to apply for a market approval in the summer of 2020 in 16 European countries in a first round of
registration. If all goes well, we can have a European market approval in the second half of 2021.

In February we were approved for our study plan on children (PIP, Paediatric Investigation Plan) from the European Medicines Agency's pediatric committee, PDCO. The approval is important because it is one of the prerequisites for a

European market approval for our therapy. Since the filed registration documentation will now include children and in that sense be complete, the market approval will give Sedana Medical ten years of market exclusivity in Europe for the use of isoflurane in sedation in intensive care.

After the end of the quarter, we were able to announce the result of the pre-IND meeting that we had with the FDA in March. Overall, the FDA was positive about the registration of IsoConDa and AnaConDa as a combination product in the US and we now have a very clear picture of what needs to be done. The meeting confirmed our appreciation of the time and cost of a registration that is expected to occur in 2024. It is really gratifying that the FDA is behind a combination registration and that we now have a clear way forward for how we will get our therapy registered in the US.

Together these three important milestones show that it is possible to achieve our goals and that the path is now clearly set out to make inhaled sedation in intensive care a new global standard using our products AnaConDa and IsoConDa.

During the quarter, we also started a research foundation, the Sedana Medical Research Foundation, which constitutes a unique opportunity for the scientific community to increase knowledge about sedation of critically ill patients. Through the foundation, one to three individual academic researchers will be granted between € 10-30,000 per year, for up to two years, which promotes the conditions for investigator-initiated studies in our area.

During the quarter, we also significantly strengthened links with key opinion leaders, mainly in Spain and France, where we hosted Advisory Boards to better understand regional differences and gain a deeper understanding of the clinical processes in each country.

In the quarter, we have made two successful investments in the market. We were the gold sponsor of the world's largest intensive care conference ISECEM in Brussels, where we organized eight very well-attended scientific symposia in the field of inhalation sedation. We also participated in Germany's largest symposium in intensive care in Bremen, where interest in Sedana Medical was very large. During our lectures, we had 250 attendees in the audience, consisting of both existing and potential customers.

The first quarter of 2019 was not only the best ever clinically, but also sales-wise, where quarterly sales were the best ever in the company's history. It is also important to see that our second largest market, France, is now growing significantly, more than 40% growth in the quarter. The total sales increase for Sedana Medical over the past twelve months was 31 percent, well in line with our goal of growing 20 percent annually until the registration of IsoConDa in Europe. The fact that growth in the individual quarter is not quite as strong is explained by the fact that the first quarter of 2018 was extraordinary with many cases of influenza in large parts of Europe and, above all, in our main market Germany.

In conclusion, the first quarter provides a solid foundation for our continued journey. After an intensive quarter, we have a new clear picture of what we need to do to achieve our goal of becoming a global standard method for sedation of mechanically ventilated patients in intensive care. I look forward to the continued journey with you all.

Christer Ahlberg, President and CEO

Please find the full Q1 report at: www.sedanamedical.com under Investors.

Sedana Medical will hold a telephone conference at 10:30 am (CET) today Wednesday May 8, 2019. 
To participate, please dial: +46 8 566 42 692
Or join us at: https://tv.streamfabriken.com/sedana-medical-q1-2019  

For additional information, please contact:

Christer Ahlberg, CEO, Sedana Medical AB
+46 70 675 33 30
christer.ahlberg@sedanamedical.com

Maria Engström, CFO, Sedana Medical AB
+46 70 674 33 30
maria.engstrom@sedanamedical.com

Thomas Eklund, Chairman of the Board, Sedana Medical AB
+46 70 824 20 25
thomas.eklund@investorab.com 

Sedana Medical is listed on Nasdaq First North in Stockholm. 
The company's Certified Adviser is Erik Penser Bank, +46 8 463 83 00, certifiedadviser@penser.se.

This information is such that Sedana Medical AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact persons above, on May 8, 2019 at 7:00 a.m. (CET). 

_____________________________________

Sedana Medical AB (publ) has developed and sells the medical device AnaConDa, for the administration of volatile anaesthetics to mechanically ventilated patients. A major clinical registration study is currently ongoing to obtain market approval in Europe for inhalation sedation in intensive care units with the pharmaceutical IsoConDa® (isoflurane).

Sedana Medical has direct sales in the Nordic countries, Germany, France, Great Britain and Spain as well as external distributors in the rest of Europe, Canada, Australia, Japan and South Korea. The company headquarters are based in Stockholm, Sweden with R&D operations in Ireland.