Nyxoah Reports Third Quarter Financial and Operating Results
Nyxoah reported third quarter 2024 financial results with revenue of €1.3 million, representing 30% growth versus Q3 2023. The company's total cash position reached €71.0 million at quarter-end, with an additional €24.6 million raised through an ATM program. Operating loss increased to €15.0 million from €11.0 million in Q3 2023. Research and development expenses were €7.9 million, up from €6.6 million year-over-year. The company remains on track for FDA approval in Q1 2025 and is building its U.S. commercial team, with cash runway extended until mid-2026.
Nyxoah ha riportato i risultati finanziari del terzo trimestre 2024 con un fatturato di 1,3 milioni di euro, una crescita del 30% rispetto al terzo trimestre 2023. La posizione totale di liquidità dell'azienda ha raggiunto i 71,0 milioni di euro alla fine del trimestre, con ulteriori 24,6 milioni di euro raccolti tramite un programma di ATM. La perdita operativa è aumentata a 15,0 milioni di euro, rispetto agli 11,0 milioni di euro nel terzo trimestre 2023. Le spese per ricerca e sviluppo sono state di 7,9 milioni di euro, in aumento rispetto ai 6,6 milioni di euro dell'anno precedente. L'azienda rimane sulla buona strada per l'approvazione della FDA nel primo trimestre del 2025 ed è in fase di costruzione del suo team commerciale negli Stati Uniti, con una disponibilità di cassa estesa fino a metà 2026.
Nyxoah informó los resultados financieros del tercer trimestre de 2024 con ingresos de 1,3 millones de euros, lo que representa un crecimiento del 30% en comparación con el tercer trimestre de 2023. La posición total de efectivo de la empresa alcanzó los 71,0 millones de euros al final del trimestre, con 24,6 millones de euros adicionales recaudados a través de un programa de ATM. La pérdida operativa aumentó a 15,0 millones de euros desde 11,0 millones de euros en el tercer trimestre de 2023. Los gastos en investigación y desarrollo fueron de 7,9 millones de euros, un incremento respecto a los 6,6 millones de euros del año pasado. La empresa sigue en camino para la aprobación de la FDA en el primer trimestre de 2025 y está formando su equipo comercial en EE. UU., con fondos disponibles hasta mediados de 2026.
Nyxoah는 2024년 3분기 재무 결과를 발표하며 수익이 130만 유로에 달했으며, 이는 2023년 3분기 대비 30% 성장한 수치입니다. 회사의 총 현금 보유고는 분기 말 기준 7100만 유로에 달하며, 추가로 2460만 유로가 ATM 프로그램을 통해 모금되었습니다. 운영 손실은 1100만 유로에서 1500만 유로로 증가했습니다. 연구 및 개발 비용은 790만 유로로, 지난해 660만 유로에서 증가했습니다. 회사는 2025년 1분기 FDA 승인을 목표로 하고 있으며, 미국 상업 팀을 구성하는 중이며, 2026년 중반까지 자금을 확보하고 있습니다.
Nyxoah a annoncé les résultats financiers du troisième trimestre 2024, avec des revenus de 1,3 million d'euros, représentant une croissance de 30 % par rapport au troisième trimestre 2023. La position totale de trésorerie de l'entreprise a atteint 71,0 millions d'euros à la fin du trimestre, avec 24,6 millions d'euros supplémentaires levés par le biais d'un programme d'ATM. La perte opérationnelle a augmenté à 15,0 millions d'euros, contre 11,0 millions d'euros au troisième trimestre 2023. Les dépenses en recherche et développement se sont élevées à 7,9 millions d'euros, en hausse par rapport à 6,6 millions d'euros l'année précédente. L'entreprise reste sur la bonne voie pour obtenir l'approbation de la FDA au premier trimestre 2025 et constitue son équipe commerciale aux États-Unis, avec des liquidités disponibles jusqu'à mi-2026.
Nyxoah berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 mit Einnahmen von 1,3 Millionen Euro, was einem Wachstum von 30% im Vergleich zum dritten Quartal 2023 entspricht. Die gesamte Barposition des Unternehmens belief sich zum Quartalsende auf 71,0 Millionen Euro, wobei zusätzlich 24,6 Millionen Euro durch ein ATM-Programm gesammelt wurden. Der operative Verlust stieg von 11,0 Millionen Euro im dritten Quartal 2023 auf 15,0 Millionen Euro. Die Ausgaben für Forschung und Entwicklung lagen bei 7,9 Millionen Euro, ein Anstieg von 6,6 Millionen Euro im Vergleich zum Vorjahr. Das Unternehmen bleibt auf Kurs für die FDA-Zulassung im ersten Quartal 2025 und baut sein US-Vertriebsteam aus, während die Liquidität bis Mitte 2026 gesichert ist.
- Revenue growth of 30% year-over-year to €1.3 million
- Strong cash position of €71.0 million plus €24.6 million from ATM program
- Cash runway extended until mid-2026
- Operating loss increased to €15.0 million from €11.0 million year-over-year
- Gross margin declined to 62.0% from 66.0% in Q3 2023
- Monthly cash burn of €5.6 million in Q3 2024
Insights
The Q3 2024 results show mixed signals. Revenue grew
The company's cash position is robust at
The monthly cash burn of
The company's preparation for U.S. market entry is well-timed. The presentation of DREAM data results and strategic hiring of commercial leadership indicate a methodical approach to market penetration in the competitive sleep apnea space.
The U.S. sleep apnea device market represents a significant opportunity, with neuromodulation treatments gaining traction as alternatives to CPAP. Early commercial team building ahead of FDA approval is important for rapid market entry, though success will ultimately depend on reimbursement coverage and physician adoption.
The addition of experienced commercial leaders and a new CFO with U.S. market expertise strengthens the execution capability for the planned 2025 launch.
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 progress
Company fully funded with cash until mid 2026
Mont-Saint-Guibert, Belgium – November 6, 2024, 10:05pm CET / 4:05pm ET – 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 DREAM data results at International Surgical Sleep Society in September.
- Raised €24.6 million through an ATM program from a single U.S. healthcare-dedicated fund providing incremental flexibility as we shift into U.S. commercialization and extending cash runway until mid 2026.
- Strengthened U.S. organization with the hiring of John Landry as Chief Financial Officer and the addition of several key commercial leaders in the U.S.
- Reported third quarter sales of €1.3 million, representing
30% growth versus third quarter 2023. - Total cash position of
€71 .0 million at the end of the quarter, €95.6 million proforma including the€2 4.6 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)
|
| For the three months ended September 30, |
| For the nine months ended September 30, | |||||
|
| 2024 |
| 2023 |
| 2024 |
| 2023 | |
| Revenue | 1,266 |
| 976 |
| 3,258 |
| 2,524 | |
| Cost of goods sold | (482) |
| (336) |
| (1,217) |
| (930) | |
| Gross profit | |
| |
| |
| | |
| Research and Development Expense | (7,902) |
| (6,568) |
| (22,573) |
| (19,330) | |
| Selling, General and Administrative Expense | (8,042) |
| (5 058) |
| (20,396) |
| (16,794) | |
| Other income/(expense) | 180 |
| − |
| 430 |
| 265 | |
| Operating loss for the period | |
| |
| €(40,498) |
| | |
| Financial income | 1,138 |
| 2,178 |
| 4,615 |
| 3,592 | |
| Financial expense | (3,043) |
| (1,033) |
| (5,480) |
| (2,765) | |
| Loss for the period before taxes | |
| |
| €(41,363) |
| | |
| Income taxes | (173) |
| 2,229 |
| (724) |
| 1,119 | |
| Loss for the period | €(17,058) |
| |
| €(42,087) |
| | |
|
|
|
|
|
|
|
|
| |
| Loss attributable to equity holders | €(17,058) |
| |
| €(42,087) |
| | |
|
|
|
|
|
|
|
|
| |
| Other comprehensive income/(loss) |
|
|
|
|
|
|
| |
| Items that may not be subsequently reclassified to profit or loss (net of tax) |
|
|
|
|
|
|
| |
| Currency translation differences | (209) |
| (10) |
| (221) |
| (88) | |
| Total comprehensive loss for the year, net of tax | €(17,267) |
| |
| €(42,308) |
| | |
| Loss attributable to equity holders | €(17,267) |
| |
| €(42,308) |
| (32,407) | |
|
|
|
|
|
|
|
|
| |
| Basic loss per share (in EUR) | |
| |
| |
| | |
| Diluted loss per share (in EUR) | |
| |
| |
| | |
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)
|
|
|
| As at | ||
|
|
|
| September 30, |
| December 31, 2023 |
| ASSETS |
|
|
|
|
|
| Non-current assets |
|
|
|
|
|
| Property, plant and equipment |
|
| 4,461 |
| 4,188 |
| Intangible assets |
|
| 49,558 |
| 46,608 |
| Right of use assets |
|
| 3,635 |
| 3,788 |
| Deferred tax asset |
|
| 53 |
| 56 |
| Other long-term receivables |
|
| 1,475 |
| 1,166 |
|
|
|
| € 59,182 |
| |
| Current assets |
|
|
|
|
|
| Inventory |
|
| 5,272 |
| 3,315 |
| Trade receivables |
|
| 2,504 |
| 2,758 |
| Other receivables |
|
| 2,992 |
| 3,212 |
| Other current assets |
|
| 1,837 |
| 1,318 |
| Financial assets |
|
| 42,299 |
| 36,138 |
| Cash and cash equivalents |
|
| 28,678 |
| 21,610 |
|
|
|
| € 83,582 |
| |
| Total assets |
|
| € 142,764 |
| |
|
|
|
|
|
|
|
| EQUITY AND LIABILITIES |
|
|
|
|
|
| Capital and reserves |
|
|
|
|
|
| Capital |
|
| 5,908 |
| 4,926 |
| Share premium |
|
| 290,906 |
| 246,127 |
| Share based payment reserve |
|
| 8,943 |
| 7,661 |
| Other comprehensive income |
|
| (84) |
| 137 |
| Retained loss |
|
| (200,966) |
| (160,829) |
| Total equity attributable to shareholders |
|
| 104,707 |
| |
|
|
|
|
|
|
|
| LIABILITIES |
|
|
|
|
|
| Non-current liabilities |
|
|
|
|
|
| Financial debt |
|
| 19,143 |
| 8,373 |
| Lease liability |
|
| 2,636 |
| 3,116 |
| Pension liability |
|
| 47 |
| 9 |
| Provisions |
|
| 398 |
| 185 |
| Deferred tax liability |
|
| 12 |
| 9 |
|
|
|
| €22,236 |
| |
| Current liabilities |
|
|
|
|
|
| Financial debt |
|
| 399 |
| 364 |
| Lease liability |
|
| 1,151 |
| 851 |
| Trade payables |
|
| 7,109 |
| 8,108 |
| Current tax liability |
|
| 2,495 |
| 1,988 |
| Other payables |
|
| 4,667 |
| 3,132 |
|
|
|
| € 15,821 |
| |
| Total liabilities |
|
| € 38,057 |
| |
| Total equity and liabilities |
|
| € 142,764 |
| |
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.
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 reporting data from Nyxoah’s DREAM U.S. pivotal trial; receipt of FDA approval; entrance to the U.S. market; and the anticipated closing and use of the proceeds from the offering. 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, 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.
This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the offering, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.
Contacts:
Nyxoah
Loïc Moreau
IR@nyxoah.com
For Media
In United States
FINN Partners – Glenn Silver
glenn.silver@finnpartners.com
In Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be
In International/Germany
MC Services – Anne Hennecke
nyxoah@mc-services.eu
Attachment
FAQ
What was Nyxoah's (NYXH) revenue in Q3 2024?
When is Nyxoah (NYXH) expecting FDA approval?
How much cash does Nyxoah (NYXH) have as of Q3 2024?
What was Nyxoah's (NYXH) operating loss in Q3 2024?
