Nyxoah Reports Third Quarter 2023 Financial and Operating Results
Partners with ResMed Germany to increase OSA awareness and therapy penetration
Mont-Saint-Guibert, Belgium - November 8, 2023 10:05pm CET / 4:05pm 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 third quarter of 2023.
Recent Financial and Operating Highlights

  * Filed the third module in the modular PMA submission.
  * Accelerated U.S. pre-commercialization efforts, focused on market access
    around CPT coding.
  * Initiated a commercial partnership with strategic investor ResMed in
    Germany. This collaboration introduces a novel continuum of care into the
    German OSA market.

* Reported third-quarter sales of EUR1.0 million and ended the quarter with 46

    active German accounts.
  * Ended the quarter with a cash position of EUR72.5 million, providing an
    anticipated cash runway into late 2024.

"Nyxoah is entering one of the most exciting times in the company's history. We will report data from our DREAM U.S. pivotal trial early next year, shortly thereafter complete our modular PMA submission, and expect FDA approval late 2024," commented Olivier Taelman, Chief Executive Officer. "Hypoglossal nerve stimulation (HGNS) remains highly underpenetrated and guiding patients through their OSA journey is key to unlocking the market's potential. Our agreement with
ResMed Germany, which takes ResMed from a valued investor to commercial partner,
creates a continuum of care that directs patients towards the appropriate treatment, resulting in greater therapy penetration."

    CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
                                 (in thousands)
                           For the three months ended     For the nine months
                                  September 30            ended September 30
                         ------------------------------------------------------
                                 2023        2022       2023 2022
                             ------------ -----------  ------------------------
 Revenue                           EUR 976       EUR 182     EUR 2,524        EUR 1,777
 Cost of goods sold               ( 336)       ( 63)      ( 930)         ( 685)
                             ------------ -----------  ---------- -------------
 Gross profit                      EUR 640       EUR 119     EUR 1,594        EUR 1,092

Research and
Development Expense (6,568) (4,221) (19,330) (11,286)
Selling, General and
Administrative
Expense (5,058) (4,763) (16,794) (13,492)
Other

 income/(expense)                      ?          87         265            237
 Operating loss for                                            EUR
 the period                   EUR (10,986)   EUR (8,778)    (34,265)     EUR (23,449)
 Financial income                  2,178       5,127       3,592         11,372
 Financial expense               (1,033)     (2,524)     (2 765)        (5,473)
                             ------------ -----------  ---------- -------------
 Loss for the period                                           EUR
 before taxes                  EUR (9,841)   EUR (6,175)    (33,438)     EUR (17,550)
 Income taxes                      2,229        (65)       1,119         ( 379)
                             ------------ -----------  ---------- -------------
 Loss for the period                                           EUR
                               EUR (7,612)   EUR (6,240)    (32,319)     EUR (17,929)
 Loss attributable to                                          EUR
 equity holders                EUR (7,612)   EUR (6,240)    (32,319)     EUR (17,929)

Other comprehensive
loss
Items that may be
subsequently
reclassified to
profit or loss (net
of tax)
Currency translation

 differences                       ( 10)         100       ( 88)          ( 14)
                             ------------ -----------  ---------- -------------

Total comprehensive

 loss for the year,                                            EUR
 net of tax                    EUR (7,622)   EUR (6,140)    (32,407)     EUR (17,943)
                             ------------ -----------  ---------- -------------
 Loss attributable to                                          EUR
 equity holders                EUR (7,622)   EUR (6,140)    (32,407)     EUR (17,943)
                             ------------ -----------  ---------- -------------
 Basic Loss Per Share                                          EUR
 (in EUR)                      EUR (0.266)   EUR (0.242)     (1.166)      EUR (0.695)
 Diluted Loss Per                                              EUR
 Share (in EUR)                EUR (0.266)   EUR (0.242)     (1.166)      EUR (0.695)

CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)

                                                    As at
                                      ----------------------------------
                                       September 30
                                           2023        December 31 2022
                                      --------------- ------------------

ASSETS
Non-current assets

 Property, plant and equipment             4,328                  2,460
 Intangible assets                        45,720                 39,972
 Right of use assets                       3,602                  3,159
 Deferred tax asset                           47                     47
 Other long-term receivables                 668                    173
                                      ----------- ----------------------
                                        EUR 54,365               EUR 45,811

Current assets

 Inventory                                 1,709                    882
 Trade receivables                         1,918                  1,463
 Other receivables                         2,437                  1,775
 Other current assets                      1,683                  1,284
 Financial assets                         59,239                 76,968
 Cash and cash equivalents                13,250                 17,888
                                      ----------- ----------------------
                                        EUR 80,236              EUR 100,260
                                      ----------- ----------------------
 Total assets                          EUR 134,601              EUR 146,071
                                      ----------- ----------------------

EQUITY AND LIABILITIES
Capital and reserves

 Capital                                   4,926                  4,440
 Share premium                           246,130                228,275
 Share based payment reserve               7,468                  5,645
 Other comprehensive income                   88                    176
 Retained loss                         (150,070)              (118,212)
                                      ----------- ----------------------

Total equity attributable to

 shareholders                          EUR 108,542              EUR 120,324
                                      ----------- ----------------------

LIABILITIES
Non-current liabilities

 Financial debt                            8,407                  8,189
 Lease liability                           2,990                  2,586
 Pension liability                            75                      ?
 Provisions                                  125                     59
 Deferred tax liability                        6                      ?
                                      ----------------------------------
                                        EUR 11,603               EUR 10,834

Current liabilities

 Financial debt                              769                    388
 Lease liability                             788                    719
 Trade payables                            4,480                  4,985
 Current tax liability                     2,367                  3,654
 Other payables                            6,052                  5,167
                                      ----------- ----------------------
                                        EUR 14,456               EUR 14,913
                                      ----------- ----------------------
 Total liabilities                      EUR 26,059               EUR 25,747
                                      ----------- ----------------------
 Total equity and liabilities          EUR 134,601              EUR 146,071
                                      ----------- ----------------------

Revenue
Revenue was EUR1.0 million for the third quarter ending September 30, 2023, compared to EUR182,000 for third quarter ending September 30, 2022.
Cost of Goods Sold
Cost of goods sold was EUR336,000 for the three months ending September 30, 2023,
representing a gross profit of EUR640,000, or gross margin of 66.0%. This compares
to total cost of goods sold of EUR63,000 in the third quarter ending September
30, 2022, for a gross profit of EUR119,000, or gross margin of 65.4%.
Research and Development Expenses

Research  and development expenses were EUR6.6 million for the three months ending
September  30, 2023, versus EUR4.2 million for the prior year period, driven by an

acceleration in clinical activities, notably the start of the ACCCESS study.
Selling, General and Administrative Expenses
Selling, general and administrative expenses rose to EUR5.1 million for the third
quarter of 2023, up from EUR4.8 million in the third quarter of 2022. This was due
primarily to increased commercial efforts in Germany and other European markets,
as well as investments in Nyxoah's corporate infrastructure. The Company expects
to continue adding headcount across the organization ahead of the U.S. commercial launch.
Operating Loss
Total operating loss for the third quarter 2023 was EUR11.0 million versus EUR8.8
million in the third quarter of 2022. This was driven by the acceleration in the
Company's R&D spending, as well as ongoing commercial and clinical activities.
Cash Position

As  of  September  30, 2023, cash  and  financial  assets totaled EUR72.5 million,
compared   to   EUR94.9   million   on  December  31, 2022. Total  cash  burn  was

approximately EUR4.0 million per month during the third quarter of 2023.
Third Quarter 2023 Report
Nyxoah's financial report for the third quarter 2023, including details of the consolidated results, are available on the investor page of Nyxoah's website (https://investors.nyxoah.com/financials).
Conference call and webcast presentation
Nyxoah will conduct a conference call open to the public today at 10:30pm CET / 4:30pm ET. A webcast of the call will be accessible via the Investor Relations page of the Nyxoah website or through this link: Nyxoah's Q3 2023 earnings call webcast (https://edge.media-server.com/mmc/p/5tvtajxd/). For those not planning to ask a question of management, the Company recommends listening via the webcast.
If you plan to ask a question, please use the following link: Nyxoah's Q3 2023
earnings call (https://register.vevent.com/register/BIf7f85a84dfcc481b932b1fc8e8fbae95). After
registering, an email will be sent, including dial-in details and a unique conference call access code required to join the live call. To ensure you are connected prior to the beginning of the call, the Company suggests registering a
minimum of 10 minutes before the start of the call.
The archived webcast will be available for replay shortly after the close of the
call.
About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah's lead solution is the Genio® system, a patient-centered, leadless
and battery-free hypoglossal neurostimulation therapy for OSA, the world's most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.
Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse
(CCC) patients, currently contraindicated in competitors' therapy. Additionally,
the Company is currently conducting the DREAM IDE pivotal study for FDA and U.S.
commercialization approval.
For more information, please visit http://www.nyxoah.com/.
Caution - CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.
Forward-looking statements
Certain statements, beliefs and opinions in this press release are forward- looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah's goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by
the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the "Risk Factors" section of the Company's Annual Report on Form 20-F for the year ended December 31, 2022, filed with the Securities and Exchange Commission ("SEC") on March 22, 2023, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a
representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods.
No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward- looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements,
which speak only as of the date of this press release.
Contacts:
Nyxoah
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com (mailto:David.demartino@nyxoah.com)
+1 310 310 1313
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