Sedana Medical AB (publ), Third Quarter Report 2021

Sedaconda (isoflurane) approved in 11 European markets

STOCKHOLM, Nov. 4, 2021 /PRNewswire/ --

Third quarter 2021

• Net sales totalled SEK 28 M (21), equivalent to an increase of 32% compared to the third quarter of 2020. At constant exchange rates, sales increased by 34% with all regions showing positive growth.
• Gross profit was SEK 19 M (13), equivalent to a margin of 68% (62). The improved margin is primarily an effect of lower transportation costs, favorable product mix and timing effects.
• Earnings before interest, taxes, depreciation, and amortisation (EBITDA) totalled SEK -14 M (-10), equivalent to an EBITDA margin of -50% (-47).
• Operating income (EBIT) totalled SEK-16 M (-12), equivalent to an EBIT margin of -57% (-55).
• Net profit for the quarter was SEK -15 M (-13), and earnings per share before and after dilution were SEK -0.17 (-0.15).
• Cash flow from operating activities totalled SEK -15 M (-5).
• Cash flow from investing activities totalled SEK -33 M (-22).
• Cash flow for the period totalled SEK -48 M (-27).
• Cash and cash equivalents at the end of the period was SEK 262 M, compared to SEK 308 M at the beginning of the quarter.

January-September 2021

• Net sales for the period totalled SEK 113 M (96), equivalent to an increase of 18%. At constant exchange rates, sales increased by 23%.
• Gross profit was SEK 74 M (62), equivalent to a margin of 66% (65).
• Earnings before interest, taxes, depreciation, and amortisation (EBITDA) totalled SEK -37 M (-9), equivalent to an EBITDA margin of -32% (-9).
• Operating income (EBIT) totalled SEK -43 M (-13), equivalent to an EBIT margin of -38% (-14).
• Net profit for the period was SEK -41 M (-15), and earnings per share before and after dilution were SEK -0.45 (-0.17).
• Cash flow from operating activities totalled SEK -40 M (-11).
• Cash flow from investing activities totalled SEK -77 M (-54).
• Cash flow for the period totalled SEK -117 M (-58).
• Cash and cash equivalents at the end of the period was SEK 262 M, compared to SEK 376 M at the beginning of the year.

CEO Comments

Approval in 11 EU markets and continued sales growth provide strong platform for the upcoming launch

This third quarter report is my first as Sedana Medical's CEO. In the first weeks after joining Sedana Medical on October 1, I have made it a priority to visit intensive care units in several countries and gather first-hand feedback from our customers. I had the opportunity to speak with many physicians, nurses and hospital administrators about their views on inhaled sedation and their experience with Sedaconda ACD (previously named AnaConDa). I am inspired by the fact that the clear benefits of inhaled sedation vs. previous standard of care, which we have shown in our pivotal trial, are seen and confirmed by hospital staff for their patients every day. I find this strong feedback very encouraging as we continue our journey to make inhaled sedation the standard therapy in intensive care.

I am especially pleased to see that clinics across Europe continue to use Sedaconda ACD in broad patient groups in a time when the number of Covid-19 patients has declined significantly in ICUs across many of our European markets. This confirms that – while Covid-19 has improved our starting position for the upcoming launch as many more ICUs are now trained and equipped to use our products - Sedana Medical's long-term potential is not dependent on Covid-19.

Sales in the quarter totalled SEK 28 million, an increase of 34 percent at fixed exchange rates compared to last year. It is very positive to note that all of our businesses have contributed to the positive development. Our largest market Germany has continued to show steady growth while our other direct markets have returned to positive year-over-year growth after the first two quarters had been impacted by the extraordinary development during the first wave of the Covid-19 pandemic. We have also seen a strong increase in demand in our distributor markets, specifically from Latin America.

During the third quarter, we reached a key milestone when our proprietary pharmaceutical product Sedaconda (isoflurane) obtained European DCP approval. To date, we have received national approvals for 11 of the 15 EU countries that were included in the DCP approval. The approval in today's largest market Germany was received in the end of September. The national approvals will enable us to commercialize the full therapy for inhaled sedation of mechanically ventilated patients in the ICU, consisting of our Sedaconda ACD device, our Sedaconda isoflurane drug and different accessories. We continue to expect product on the shelf in the first launch markets towards the end of the year.

Also during the quarter, the results of our pivotal study Sedaconda (SED001) were published in the renowned scientific journal, Lancet Respiratory Medicine. This publication in the leading journal in the field is an important element for our pre-launch activities. We hosted scientific symposia at both the annual congress of the European Society of Intensive Care Medicine, ESICM Lives, and the world's largest conference for intensive care and emergency medicine, ISICEM.

The United States represent the largest commercial opportunity for Sedaconda. Preparations for the US registration have continued during the quarter with the recruitment of the first Sedana Medical employees in the United States. We are working towards obtaining an Investigational New Drug (IND) approval before year end to enable the start of our pivotal studies at the turn of Q1/Q2, 2022. On the commercial side, we are thoroughly asssessing which go-to-market strategy will offer the most attractive route for Sedana Medical. A decision whether we will build up our own commercial infrastructure in the US will be communicated in 2022 at the latest.

I am excited to join my passionate and highly qualified colleagues at Sedana Medical at this important point in our company's history. With differentiated products, convincing scientific evidence and existing usage of Sedaconda ACD in 34 countries around the globe, we have a strong platform for continued success, and I look forward to getting back to you on our future progress.

Johannes Doll, CEO and President

 Significant events during the period

• In January and February an application for market approval for the drug candidate Sedaconda (isoflurane), previously known as IsoConDa, for inhaled sedation in intensive care was submitted in Switzerland and the United Kingdom.
• In February the first patient was included in the company's paediatric study IsoCOMFORT (SED002), which is being conducted to study whether inhaled sedation with Sedaconda (isoflurane) delivered via Sedaconda ACD is a safe and more effective method of sedation than intravenously administered midazolam, for children below 18 years of age.
• In June the pivotal phase 3 Sedaconda study (SED001) was selected as one of the top three posters at the 52nd DGIIN & ÖGIAIN Intensive Care Conference.
• In early July, Sedana Medical's Quality Management System (QMS) received approval under the EU Medical Device Regulation (MDR) 2017/745. This approval means that Sedana Medical's Class I medical device accessories can continue to be sold with CE marking in the EU.
• In July, a successful End of Phase 2 advisory meeting was completed with the US Food and Drug Administration (FDA). The FDA accepted Sedana Medical's proposed phase 3 programme, including the study design and the primary endpoint for the studies. The positive outcome allows the company to enter phase 3 in line with the communicated timeline.
• In July, a positive outcome was obtained for the application for European marketing authorisation for the pharmaceutical product Sedaconda (isoflurane) for inhaled sedation in intensive care, what is known as DCP approval. Sedaconda is indicated for the sedation of mechanically ventilated adult intensive care patients and is to be administered only via the Sedaconda ACD medical device.
• In August, the results of the company's pivotal study Sedaconda (SED001) was published in the highly respected scientific journal The Lancet Respiratory Medicine.
• At the end of September, marketing authorisation was obtained for inhaled sedation in Germany. The application was approved by the German regulatory authority BfArM and is based on the DCP approval obtained by Sedana Medical in July.

Significant events after the period

• After being appointed by the Board in May, Johannes Doll took office as Sedana Medical's new CEO on October 1, 2021.

Please find the full interim report at: sedanamedical.com 

This document has been prepared in a Swedish and English version. In the event of any deviations, the Swedish version shall prevail.

Sedana Medical will hold a telephone conference at 13:30 pm (CET)

Thursday November 4, 2021.

To participate, please dial: +46 8 505 583 65

For additional log in information:

https://tv.streamfabriken.com/sedana-medical-q3-2021 

https://financialhearings.com/event/13795 

For additional information, please contact:

Johannes Doll, CEO, +46 (0)76 303 66 66

Susanne Andersson, CFO, +46 (0)73 066 89 04

ir@sedanamedical.com

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 November 4, 2021, at 07:00 am (CET).

Sedana Medical is listed on Nasdaq First North Growth Market in Stockholm.

The company's Certified Adviser is Erik Penser Bank, +46 8 463 83 00, certifiedadviser@penser.se.

About Sedana Medical

Sedana Medical AB (publ) is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient's life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care.

Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordic, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors.

Sedana Medical was founded in 2005, is listed on Nasdaq First North Growth Market (SEDANA) and headquartered in Stockholm, Sweden.

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