Nyxoah Reports First Quarter 2022 Financial and Operating Results

REGULATED INFORMATION

Nyxoah Reports First Quarter 2022 Financial and Operating Results

Mont-Saint-Guibert, Belgium – May 10, 2022, 08:50pm CET / 2:50pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today reported financial and operating results for the first quarter of 2022.  

First Quarter 2022 Financial and Operating Highlights

• Generated revenue of €660,000 from the commercialization of Genio® in Europe, primarily in Germany, which represents year-over-year growth of more than three-and-and-half times and is more than double what was achieved in the fourth quarter of 2021
• Exited the first quarter with 15 active implant sites in Germany, representing 25% growth over Q4 2021; Nyxoah expects to add an extra 10 sites by the end of the third quarter of 2022, bringing the total to 25 active implanting accounts and driving quarterly sales acceleration and market leadership in Germany by the end of 2022
• Completed the first commercial Complete Concentric Collapse (CCC) patients in Germany
• Accelerated monthly patient enrollment in the DREAM U.S. IDE study and continue to expect implants to be completed in the second quarter of 2022
• The U.S. FDA approved Nyxoah’s request to reduce the sample size in DREAM to 115 patients from the original 134, driven by new and favorable data from the BETTER SLEEP study; aside from the updated sample size, all other study parameters, including performance goals, statistical power, and significance level, remain identical to the original approved study 
• Nominated Raymond Cohen, Chief Executive Officer and board member of Axonics, Inc. and Virginia Kirby, Executive-in-Residence at the Discovery Launchpad at the University of Minnesota’s Office of Technology Commercialization, for appointment to the Board of Directors, pending approval by the Annual Shareholders’ Meeting on June 8, 2022; Don Deyo and Jan Janssen are stepping down, keeping the total number of board members at eight

“I am extremely pleased with our first quarter results and strong execution that resulted in an acceleration in sales and DREAM implants as we progress towards achieving all of our strategic priorities for 2022 and beyond,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “On the commercial side, the €660,000 of revenue we booked in the first quarter was roughly equal to the revenue performance from the previous three quarters combined. We now have 15 active implant sites in Germany, and we will continue to add 10 more sites by the end of the third quarter. This growth validates our patient-centric, ‘Going Deep’ strategy of developing Centers of Excellence as we increase therapy penetration at each of these sites. We were also thrilled to implant our first commercial CCC patients in Germany, and we expect continued acceleration in CCC implants following the positive response to our BETTER SLEEP data presentation at the World Sleep Congress in Rome, where we hosted 55 key opinion leaders during the pre-Congress symposium.”

Mr. Taelman continued, “We are also happy with the acceleration in the pace of implants in our DREAM U.S. pivotal study, given recent weekly implant rates, which have increased meaningfully over the last month. We believe we have enough patients enrolled to complete the study by the end of the second quarter of 2022, particularly in light of the FDA’s approval to reduce the sample size to 115 patients. We also continue our dialogue with FDA regarding our IDE submission for our ACCCESS trial for CCC patients in the U.S., and we expect to implant our first patient before the end of this year.”

“Finally, I am thrilled to announce the nominations of Ray Cohen and Ginny Kirby for appointment to the Board of Directors. They will bring a wealth of knowledge that will benefit Nyxoah as we complete DREAM, prepare for our U.S. launch, and advance our pipeline. I look forward to working closely with both of them,” concluded Mr. Taelman.

First Quarter 2022 Results

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AS AT AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 – INTERIM CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (IN THOUSANDS)

The accompanying notes are an integral part of these condensed consolidated interim financial statements

UNAUDITED CONSOLIDATED BALANCESHEET (in thousands)

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AS AT AND FOR THE THREE MONTHS ENDED MARCH 31, 2022 – INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS)