Correction of previously announced press release Sedana Medical AB (publ), Interim report Q2, 2018
Regulatory
In the press release published 30 August 07:00 CET the following has been reported: · EBITDA amounted to 1 794 (1 081) KSEK and the EBITDA margin was -6,0% (5,6%). Correct reporting is: · EBITDA amounted to -1 794 (1 081) KSEK and the EBITDA margin was -6,0% (5,6%). Below is the corrected press release in full.
Sedana Medical AB (publ), Interim report Q2, 2018
The registration process for the United States commenced and European study resumed at full speed
Financial Summary April-June
- Net sales during the third quarter amounted to 14 485 (9 549) KSEK corresponding to an increase of 52% compared with the same period in 2017.
- Earnings before interest, taxes, depreciation and amortisation (EBITDA) amounted to -1 006 (673) KSEK. This
corresponds to an EBITDA margin of -6,9% (7,1%).
- Earnings before interest and taxes (EBIT) amounted to -2 007 (408) KSEK, which corresponds to an EBIT margin of -13,9% (4,3%).
- Cash flow from operations before changes in working capital amounted to -389 (-1 461) KSEK.
- Cash flow from investment activities amounted to -8 812 (-11 559) KSEK.
- Cash flow for the period amounted to 102 325 (88 065) KSEK.
- Liquid funds at the end of the period amounted to 181 591 (100 738) KSEK.
Financial Summary January-June
- Net sales during the first six months increased to 29 972 (19 440) KSEK corresponding to an increase of 54% compared with same period in 2017.
- EBITDA amounted to -1 794 (1 081) KSEK and the EBITDA margin was -6,0% (5,6%).
- EBIT amounted to -3 737 (678) KSEK and the EBIT margin was -12,5% (3,5%).
- Cash flow from operations before change in working capital amounted -1 210 (-1 183) KSEK.
Significant events during the period
- Sedana Medical AB (publ) announced that the schedule for patient recruitment in the ongoing Phase 3 IsoConDa study is likely to be extended.
- Sedana Medical AB (publ) reported record-breaking sales growth in the first quarter of 2018.
- Sedana Medical AB (publ) completed a directed new share issue of SEK 112 million.
- Sedana Medical AB (publ) announced the recruitment Gunilla Mickelsson as Global Marketing Director.
Significant events after the period
- Sedana Medical AB (publ) announced on the 26th of July that the Company has received approval from the central ethical committee for its pivotal phase 3-study in Germany, IsoConDa, to continue to use the original study protocol after certain clarifications. This means that the study will resume in full after it was restricted in April this year.
CEO comments
During the second quarter, the following important events took place on our way to consolidating our world market leadership in inhalation sedation within intensive care:
– A targeted share issue providing SEK 112 million to be used to access the US market with a market potential of more than SEK 6 billion annually.
– The ongoing clinical trial in Germany can now be resumed with full force after approval by the Ethics Committee, which means that we take a further step closer to a registration
of the IsoConDa drug in Europe, which also substantially increases the potential of our AnaConDa product.
– Sales growth for the quarter amounted to 52% compared with same quarter in the previous year, despite the fact that the drug has not yet been approved, which underlines the medical value of inhalation sedation.
We are grateful for the ongoing trust that all our investors shown in us. This enabled us to complete a successful directed share issue to institutional investors of SEK 112 million on June 5. It was gratifying that the interest was high yet again, and shares were subscribed to by, amongst others, Handelsbanken Fonder, Norrons Asset Management, Alfred Berg Asset Management, Swedbank Robur and Cliens Asset Management plus additional renowned institutions in Germany, the UK and
Finland. With this share issue, we can now accelerate the work to reach market approval in the United States.
REGISTRATION DEVELOPMENT IN USA AND EUROPE
In order to fully sell inhalation sedation, you must have a medical device that administers the volatile pharmaceuticals to the patient and also have the pharmaceutical approved for sedation within intensive care. In Europe, our medical device AnaConDa is approved for the administration of the volatile pharmaceuticals. However, the drug IsoConDa is not yet approved for sedation within intensive care, which significantly limits the marketing of inhalation sedation. In the United States neither AnaConDa nor IsoConDa are approved.
The two most important tasks we have for the next few years are thus:
1. Register inhalation sedation with our drug candidate IsoConDa (isoflurane) in Europe, which also significantly increases the market potential of AnaConDa. The total annual market potential for both AnaConDa and IsoConDa in Europe is approximately SEK 6 billion.
2. Register inhalation sedation in the United States with both our drug candidate IsoConDa and our medical device AnaConDa. Market potential in the US amounts to more than SEK 6 billion annually.
To succeed with these tasks, we need to complete our clinical registration study currently under way in Germany. Performing clinical studies in intensive care is challenging and complex and requires great commitment by both sponsor and investigator. Therefore, it is a success that we can now return to recruit all types of mechanically ventilated patients in accordance with the study protocol and that the interruption we communicated in April this year did not significantly disrupt the study
time frame. We can now, as soon as we train the study centers on the updates in the study protocol, focus on the registration work of inhalation sedation with AnaConDa and IsoConDa in both Europe and the United States.
In order to succeed, we have recruited additional people with a solid background of global product development and registration that will lead this work in the future. The registration work for both pharmaceutical and medical device has begun in the United States due to the successful share issue in June. The work is focused on conducting the first meeting with the U.S. Food and Drug Administration (FDA) in the end of 2018 or the beginning of 2019. The meeting will clarify the
requirements we must meet to get both products approved in the United States. Following that meeting the Company will be able to more clearly set out a schedule for when the therapy will be approved in the United States.
BUILDING THE MARKET
The work to increase the use of the AnaConDa technology and to establish ourselves in several European countries continues. It is important that we are represented in several European markets with established networks and reference clinics when the approval of IsoConDa comes. This will allow us to quickly penetrate the market after the registration. Therefore, it is gratifying to see that our strategy works. Germany is the locomotive in our sales development and the development of establishing inhalation sedation at new clinics remains strong. The great interest from French clinics continues as well. It is gratifying that there are new clinics, but also that more existing clinics increase the number of beds for treatment with our therapy. EBITDA in Q2 was MSEK -1.0, which is in line with our plans as operational costs increase as we develop the organization and increase our market presence.
During the quarter we have recruited Gunilla Mickelsson as Global Marketing Director. Gunilla most recently comes from SOBI and will strengthen our organization in the exciting phase the company is currently in. Her long experience in marketing and sales in the pharmaceutical industry and market development globally will be a key element in the success of achieving our goals and our vision. During the first half of the year we have seen increased interest from US-based Key Opinion Leaders and intensive care clinics. Several of these are interested in assisting as centers for future clinical studies in the United States.
In summary, I am very pleased with our work during the quarter. We have good development in all our three focus areas.
- Registration of the drug IsoConDa in Europe.
- The development of registration work in the United States with both AnaConDa and IsoConDa.
- Market building and preparation for an effective and successful launch in Europe when the therapy is registered.
We have built up a solid competence and a network within the company. In addition, we have the ability to recruit people who add further competence in both marketing and sales as well as product development which will secure our future. Sedana Medical is well positioned to lead the work of offering the first commercial solution for inhalation sedation within intensive care, a market with a sales potential of SEK 10-20 billion annually.
Christer Ahlberg, President and CEO
For more information, please contact:
Christer Ahlberg, VD, 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, styrelseordförande, Sedana Medical AB
+46 70 824 20 25
Sedana Medical is listed on Nasdaq First North in Stockholm
and Erik Penser Bank (+46 8 463 83 00) is certified adviser to Sedana Medical.
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 30 August 2018 at 11:00 am (CET).
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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 and Spain as well as external distributors in the rest of Europe, Canada, Australia and South Korea. The company headquarters are based in Stockholm, Sweden with R&D operations in Ireland.