Nyxoah îãååçú òì úåöàåúéä äëñôéåú åäúôòåìéåú ìøáòåï äùìéùé ùì 2024
àéùåø FDA áãøê òã ìøáòåï äøàùåï ùì 2025, äöååú äîñçøé áàøä"á ðáðä áäú÷ãîåú
äçáøä îîåîðú áîìåàä áîæåîðéí òã àîöò 2026
îåðè-ñðè-âéáøè, áìâéä, 6 áðåáîáø 2024, (GLOBE NEWSWIRE) :
Nyxoah SA (ðàñã"÷/éåøåð÷ñè áøéñì: NYXH) , çáøú èëðåìåâéåú øôåàéåú äîôúçú çìåôåú èéôåì ôåøöåú ãøê ìãåí ðùéîä áùéðä (OSA) áàîöòåú ðåéøåîåãåìöéä, ãéååçä äéåí òì úåöàåúéä äëñôéåú åäúôòåìéåú ìøáòåï äùìéùé ùì 2024.
ãâùéí ôéððñééí åúôòåìééí àçøåðéí
*äöéâä úåöàåú îùëðòåú ùì ðúåðé DREAM áàâåãä äáéðìàåîéú ìùéðä ëéøåøâéú áñôèîáø.
*âééñä 24.6 îéìéåï àéøå áàîöòåú úåëðéú ATM î÷øï ééòåãéú àçú ìùéøåúé áøéàåú áàøä"á, îöèáøú îöèøôú äîàôùøú äúàîåú áùìáéí ì÷øàú äîòáø ìîñçåø áàøä"á åäàøëú éúøú äîæåîðéí òã àîöò 2026.
*çéæå÷ äàøâåï áàøä"á òí äòñ÷úå ùì â'åï ìðãøé ëîðäì ëñôéí åäöèøôåúí ùì îñôø îðäìéí îñçøééí îåáéìéí áàøä"á.
*ãéååçä òì îëéøåú ùì 1.3 îéìéåï àéøå áøáòåï äùìéùé, äîééöâéí öîéçä ùì 30% ìòåîú äøáòåï äùìéùé ùì 2023.
*éúøú îæåîðéí ëåììú ùì 71.0 îéìéåï àéøå áñåó äøáòåï, 95.6 îéìéåï àéøå ôøåôåøîä ëåìì 24.6 îéìéåï àéøå ùâåéñå.
REGULATED INFORMATION
Nyxoah Reports Third Quarter Financial and Operating Results
FDA approval on track for first quarter 2025, U.S. commercial team build out in progresss
Company fully funded with cash until mid 2026
Mont-Saint-Guibert, Belgium – November 6, 2024, (GLOBE NEWSWIRE)–
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today reported financial and operating results for the third quarter of 2024.
Recent Financial and Operating Highlights
- Presented compelling DREAMdata results at International Surgical Sleep Society in September.
- Raised €24.6 million through an ATMprogram from a single U.S. healthcare-dedicated fund providingincremental flexibility as we shift into U.S. commercialization andextending cash runway until mid 2026.
- Strengthened U.S. organizationwith the hiring of John Landry as Chief FinancialOfficer and the addition of severalkey commercial leaders in the U.S.
- Reported third quarter salesof €1.3 million, representing 30% growth versus thirdquarter 2023.
- Total cashposition of €71.0 million at the end of thequarter, €95.6 million proforma including the€24.6 million raised.
"Our actions in the third quarter have further positioned us well for a successful U.S. commercial launch. On the back of the robust DREAM data presented in September, we have raised additional capital and are actively focused on building up our U.S. commercial team," commented Olivier Taelman, Nyxoah’s Chief Executive Officer. "I am more confident than ever that we have set Genio up for a strong commercial start in the U.S. immediately after FDA approval."
Third Quarter 2024 Results
CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in thousands)
|
|
Forthe three months ended September 30,
|
|
Forthe nine months ended September 30,
|
|
|
2024
|
|
2023
|
|
2024
|
|
2023
|
|
Revenue
|
1,266
|
|
976
|
|
3,258
|
|
2,524
|
|
Costof goods sold
|
(482)
|
|
(336)
|
|
(1,217)
|
|
(930)
|
|
Grossprofit
|
€784
|
|
€640
|
|
€2,041
|
|
€1,594
|
|
Researchand Development Expense
|
(7,902)
|
|
(6,568)
|
|
(22,573)
|
|
(19,330)
|
|
Selling,General and Administrative Expense
|
(8,042)
|
|
(5058)
|
|
(20,396)
|
|
(16,794)
|
|
Otherincome/(expense)
|
180
|
|
−
|
|
430
|
|
265
|
|
Operatingloss for the period
|
€(14,980)
|
|
€(10,986)
|
|
€(40,498)
|
|
€(34,265)
|
|
Financialincome
|
1,138
|
|
2,178
|
|
4,615
|
|
3,592
|
|
Financialexpense
|
(3,043)
|
|
(1,033)
|
|
(5,480)
|
|
(2,765)
|
|
Lossfor the period before taxes
|
€(16,885)
|
|
€(9,841)
|
|
€(41,363)
|
|
€(33,438)
|
|
Incometaxes
|
(173)
|
|
2,229
|
|
(724)
|
|
1,119
|
|
Lossfor the period
|
€(17,058)
|
|
€(7,612)
|
|
€(42,087)
|
|
€(32,319)
|
|
|
|
|
|
|
|
|
|
|
Lossattributable to equity holders
|
€(17,058)
|
|
€(7,612)
|
|
€(42,087)
|
|
€(32,319)
|
|
|
|
|
|
|
|
|
|
|
Othercomprehensive income/(loss)
|
|
|
|
|
|
|
|
|
Itemsthat may not be subsequently reclassified to profit or loss (net of tax)
|
|
|
|
|
|
|
|
|
Currencytranslation differences
|
(209)
|
|
(10)
|
|
(221)
|
|
(88)
|
|
Totalcomprehensive loss for the year, net of tax
|
€(17,267)
|
|
€(7,622)
|
|
€(42,308)
|
|
€(32,407)
|
|
Lossattributable to equity holders
|
€(17,267)
|
|
€(7,622)
|
|
€(42,308)
|
|
(32,407)
|
|
|
|
|
|
|
|
|
|
|
Basicloss per share (in EUR)
|
€(0.496)
|
|
€(0.266)
|
|
€(1.346)
|
|
€(1.166)
|
|
Dilutedloss per share (in EUR)
|
€(0.496)
|
|
€(0.266)
|
|
€(1.346)
|
|
€(1.166)
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)
|
|
|
|
Asat
|
|
|
|
|
September 30,
2024
|
|
December31, 2023
|
|
ASSETS
|
|
|
|
|
|
|
Non-currentassets
|
|
|
|
|
|
|
Property,plant and equipment
|
|
|
4,461
|
|
4,188
|
|
Intangibleassets
|
|
|
49,558
|
|
46,608
|
|
Rightof use assets
|
|
|
3,635
|
|
3,788
|
|
Deferredtax asset
|
|
|
53
|
|
56
|
|
Otherlong-term receivables
|
|
|
1,475
|
|
1,166
|
|
|
|
|
€ 59,182
|
|
€55,806
|
|
Currentassets
|
|
|
|
|
|
|
Inventory
|
|
|
5,272
|
|
3,315
|
|
Tradereceivables
|
|
|
2,504
|
|
2,758
|
|
Otherreceivables
|
|
|
2,992
|
|
3,212
|
|
Othercurrent assets
|
|
|
1,837
|
|
1,318
|
|
Financialassets
|
|
|
42,299
|
|
36,138
|
|
Cashand cash equivalents
|
|
|
28,678
|
|
21,610
|
|
|
|
|
€ 83,582
|
|
€68,351
|
|
Totalassets
|
|
|
€ 142,764
|
|
€124,157
|
|
|
|
|
|
|
|
|
EQUITYAND LIABILITIES
|
|
|
|
|
|
|
Capitaland reserves
|
|
|
|
|
|
|
Capital
|
|
|
5,908
|
|
4,926
|
|
Sharepremium
|
|
|
290,906
|
|
246,127
|
|
Sharebased payment reserve
|
|
|
8,943
|
|
7,661
|
|
Othercomprehensive income
|
|
|
(84)
|
|
137
|
|
Retainedloss
|
|
|
(200,966)
|
|
(160,829)
|
|
Totalequity attributable to shareholders
|
|
|
104,707
|
|
€98,022
|
|
|
|
|
|
|
|
|
LIABILITIES
|
|
|
|
|
|
|
Non-currentliabilities
|
|
|
|
|
|
|
Financialdebt
|
|
|
19,143
|
|
8,373
|
|
Leaseliability
|
|
|
2,636
|
|
3,116
|
|
Pensionliability
|
|
|
47
|
|
9
|
|
Provisions
|
|
|
398
|
|
185
|
|
Deferredtax liability
|
|
|
12
|
|
9
|
|
|
|
|
€22,236
|
|
€11,692
|
|
Currentliabilities
|
|
|
|
|
|
|
Financialdebt
|
|
|
399
|
|
364
|
|
Leaseliability
|
|
|
1,151
|
|
851
|
|
Tradepayables
|
|
|
7,109
|
|
8,108
|
|
Currenttax liability
|
|
|
2,495
|
|
1,988
|
|
Otherpayables
|
|
|
4,667
|
|
3,132
|
|
|
|
|
€ 15,821
|
|
€14,443
|
|
Totalliabilities
|
|
|
€ 38,057
|
|
€26,135
|
|
Totalequity and liabilities
|
|
|
€ 142,764
|
|
€124,157
|
Revenue
Revenue was €1.3 million for the third quarter ending September 30, 2024, compared to €1.0 million for the third quarter ending September 30, 2023.
Cost of Goods Sold
Cost of goods sold was €482,000 for the three months ending September 30, 2024, representing a gross profit of €0.8 million, or gross margin of 62.0%. This compares to total cost of goods sold of €336,000 in the third quarter of 2023, for a gross profit of €0.6 million, or gross margin of 66.0%.
Research and Development
For the third quarter ending September 30, 2024, research and development expenses were €7.9 million, versus €6.6 million for the third quarter ending September 30, 2023.
Operating Loss
Total operating loss for the third quarter ending September 30, 2024, was €15.0 million versus €11.0 million in the third quarter ending September 30, 2023. This increase was primarily driven by expanded commercial activities, higher R&D investments, and ongoing clinical activities.
Cash Position
As of September 30, 2024, cash and financial assets totaled €71.0 million, compared to €57.7 million on December 31, 2023. Total cash burn was approximately €5.6 million per month during the third quarter 2024.
Third Quarter 2024
Nyxoah’s financial report for the third quarter 2024, 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
Company management will host a conference call to discuss financial results on Wednesday, November 6, 2024, beginning 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 2024 earnings call webcast. 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 2024 earnings call. 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 reinventing sleep for the billion people that suffer from obstructive sleep apnea (OSA). We are a medical technology company that develops breakthrough treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable. Through our commitment to innovation and clinical evidence, we have shown best-in-class outcomes for reducing OSA burden.
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 announced positive outcomes from the DREAM IDE pivotal study for FDA and U.S. commercialization approval.
Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.
Contacts:
Nyxoah
Loïc Moreau
[email protected]
For Media
In United States
FINN Partners – Glenn Silver
[email protected]
In Belgium/France
Backstage Communication – Gunther De Backer
[email protected]
In International/Germany
MC Services – Anne Hennecke
[email protected]
Attachment
- ENGLISH_Q3 2024 Earnings PR
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