Interim Report 1 Januari – 31 March 2017
Non-regulatory
An eventful quarter with positive sales development
1 januari – 31 mars 2017 in brief
- Net sales during the period increased to 9 891 (8 538) KSEK which corresponded to an increase of 16% compared with the same period in 2016.
- Earnings before interest, taxes, depreciation and amortisation (EBITDA) was 408 (1 139) KSEK. This corresponded to an EBITDA margin of 4,1% (13,4%).
- Earnings before interest and taxes (EBIT) was 270 (1 078) KSEK which corresponded to an EBIT margin of 2,7% (12,6%).
- Cash flow from operations before change in working capital amounted to 279 (616) KSEK.
- Liquid funds at the end of the period amounted to 12 624 (1 762) KSEK.
Significant events during the period
- 1 February Christer Ahlberg started as new CEO for Sedana Medical group.
- In March, AnaConDa was approved in South Korea, which is the first approval on the Asian market.
- The in-house developed product Anaconda-S was launched during the quarter.
Significant events after the period
- A decision was made on the issue and distribution of shares and on conversion to a public company at the Extraordinary General Meeting on 5 April.
- The first patient was recruited to the registration study for the approval of IsoConDa.
- The headquarters of the group was registered in Danderyd.
- A new affiliate was established in Sweden to administer incentive programs in Sedana Medical AB (publ).
Sedana Medical in brief
Sedana Medical is a Swedish medical technology group which develops, manufactures and sells the medical device AnaConDa. AnaConDa is based on proprietary technology for vaporization and reflection of anesthetic gases. The device is sold to intensive care units globally and is used for sedation of patients.
Sedana Medical operates in several countries in Europe via affiliates and branch offices of the parent company Sedana Medical AB (publ). Germany is the Group's largest market, with more than 85% of total sales.
Sedana Medical has initiated a clinical registration study in Germany with the aim of gaining European clinical approval for the pharmaceutical IsoConDa (isoflurane). IsoConDa will be used with AnaConDa for inhalation sedation in the intensive care unit. The clinical study is expected to be completed in 2018.
CEO comments
Sedana Medical's vision is to develop inhalation sedation with our products AnaConDa and IsoConDa into a global standard model for the sedation of mechanically ventilated patients in intensive care. We hope to realise this ambitious vision by offering, with the AnaConDa technology and the medicinal product IsoConDa (isoflurane), a solution that addresses the problems that present-day intravenous sedatives cause or do not solve sufficiently well. In the first quarter of 2017 we came a major step closer to realising that vision.
To attain our level of ambition, the company initiated work on an initial public offering on Nasdaq First North during the quarter. As part of this work, I was appointed CEO in February this year. Our CFO, Maria Engström, also took up her position during the same period. The injection of capital from the initial public offering is primarily intended to be used to fund work on registration documentation and the clinical studies in the EU and the United States for our future medicinal product IsoConDa that are necessary to obtain marketing authorisation.
In operational terms, the first quarter of 2017 was very eventful. We held our first investigator meeting in Germany with the physicians who are to be involved in the strategically very important clinical study of our candidate drug IsoConDa (isoflurane). The study is being carried out at around 20 intensive care units in Germany and will cover a total of up to 550 patients. When the study is completed and we obtain marketing authorisation, Sedana Medical will be the first company in the world to be able to offer intensive care an approved solution for inhalation sedation.
We launched the newly developed and recently approved AnaConDa-S. AnaConDa-S is designed in a way that enables many more patients, including those with lower lung capacity, to be sedated than was possible with the older model. AnaConDa-S expands our target group by around 25 per cent, and the response from the health service has been very positive.
At the start of the year, we took our first step into the Asian market through the approval of AnaConDa in South Korea and an agreement with a local distributor in South Korea has now been established.
I have followed Sedana Medical's determined efforts to develop the next generation of drugs for sedation with great interest. As the newly appointed CEO, it is a source of great inspiration for me to be able to lead the Group into a new phase in which, after many years of steady development and sales work, we document and establish a new treatment standard in the market with potential of SEK 10 to 20 billion annually. The establishment of inhalation sedation for intensive care patients signifies a paradigm shift as IsoConDa is administered and eliminated via the airways instead of intravenously via the bloodstream, which is the usual technique. The net sales development in the Group has been very positive over the past years. During the first quarter of 2017, this trend continued and net sales increased by 16% compared with the corresponding period of the previous year. This was despite a very strong first quarter 2016. EBITDA was again positive and amounted to SEK 0.45 million for the first quarter of the year. This was despite the fact that we have had increased operational expenses in connection with the planned initial public offering and the recruitment of a new CEO and CFO. The trend in sales is in line with our ambitious growth targets, and we see continued strong demand from many customers.
Sedana Medical is well positioned to lead efforts to offer the first commercial solution for inhalation sedation in intensive care.
Christer Ahlberg, President and CEO
Läs delårsrapporten i sin helhet här:
För ytterligare information, besök www.sedanamedical.com eller kontakta:
Christer Ahlberg, VD Sedana Medical AB (publ)
Mobil: +46 (0)70 – 675 33 30
Email: christer.ahlberg@sedanamedical.com
Maria Engström, CFO Sedana Medical AB (publ)
Mobil: +46 (0)70 674 33 30