Nyxoah Reports Second Quarter and First Half 2024 Financial and Operating Results
Nyxoah SA (NYXH) reported its Q2 and H1 2024 financial results. Key highlights include:
- Completed FDA regulatory submission, with U.S. approval expected by end of 2024
- Raised over €85 million in growth capital
- Q2 2024 sales of €0.8 million
- H1 2024 sales growth of 29% year-over-year
- Total cash position of €77.8 million at quarter-end
The company is focusing on U.S. commercial readiness, with key leadership appointments made. Nyxoah's cash runway extends into mid-2026, fully funding the U.S. launch. Q2 operating loss was €13.3 million, driven by increased R&D spending and ongoing commercial and clinical activities.
Nyxoah SA (NYXH) ha riportato i risultati finanziari per il secondo trimestre e il primo semestre del 2024. I principali punti salienti includono:
- Completata la presentazione per la regolamentazione FDA, con l'approvazione negli Stati Uniti attesa per la fine del 2024
- Raccolti oltre 85 milioni di euro in capitale per la crescita
- Vendite del secondo trimestre 2024 pari a 0,8 milioni di euro
- Crescita delle vendite del primo semestre 2024 del 29% rispetto all'anno precedente
- Posizione di cassa totale di 77,8 milioni di euro alla fine del trimestre
L'azienda si sta concentrando sulla preparazione commerciale negli Stati Uniti, con importanti nomine nella leadership già effettuate. La disponibilità di cassa di Nyxoah si estende fino al metà del 2026, finanziando completamente il lancio negli Stati Uniti. La perdita operativa del secondo trimestre è stata di 13,3 milioni di euro, influenzata dall'aumento delle spese per R&D e dalle continuative attività commerciali e cliniche.
Nyxoah SA (NYXH) informó sobre sus resultados financieros para el segundo trimestre y el primer semestre de 2024. Los aspectos más destacados incluyen:
- Presentación regulatoria de la FDA completada, con aprobación en EE. UU. esperada para finales de 2024
- Recaudados más de 85 millones de euros en capital de crecimiento
- Ventas del segundo trimestre de 2024 por 0,8 millones de euros
- Crecimiento de ventas del primer semestre de 2024 del 29% interanual
- Posición total de efectivo de 77,8 millones de euros al final del trimestre
La empresa se centra en la preparación comercial en EE. UU., con importantes nombramientos en el liderazgo ya realizados. La disponibilidad de efectivo de Nyxoah se extiende hasta mediados de 2026, financiando por completo el lanzamiento en EE. UU. La pérdida operativa del segundo trimestre fue de 13,3 millones de euros, impulsada por el aumento del gasto en I+D y las actividades comerciales y clínicas en curso.
Nyxoah SA (NYXH)는 2024년 2분기 및 상반기 재무 결과를 보고했습니다. 주요 하이라이트는 다음과 같습니다:
- FDA 규제 제출 완료, 2024년 말까지 미국 승인이 예상됨
- 성장 자본으로 8500만 유로 이상 모금
- 2024년 2분기 판매액은 80만 유로
- 2024년 상반기 판매액이 전년 대비 29% 증가
- 분기 말 총 현금 보유액은 7780만 유로
회사는 미국 상업적 준비에 집중하고 있으며, 주요 리더십 임명이 이루어졌습니다. Nyxoah의 현금 운영 자금은 2026년 중반까지 연장되어 있으며, 미국 출시를 완전히 자금 지원합니다. 2분기 운영 손실은 1330만 유로였으며, 이는 R&D 지출 증가와 ongoing 상업 및 임상 활동에 의해 주도되었습니다.
Nyxoah SA (NYXH) a rapporté ses résultats financiers pour le deuxième trimestre et le premier semestre 2024. Les faits saillants incluent :
- Dossier réglementaire FDA complété, avec une approbation aux États-Unis attendue d'ici la fin de 2024
- Plus de 85 millions d'euros levés en capital de croissance
- Ventes du deuxième trimestre 2024 de 0,8 million d'euros
- Croissance des ventes du premier semestre 2024 de 29% par rapport à l'année précédente
- Position de liquidités totale de 77,8 millions d'euros à la fin du trimestre
L'entreprise se concentre sur la préparation commerciale aux États-Unis, avec des nominations clés à la direction déjà effectuées. La trésorerie de Nyxoah s'étend jusqu'à la mi-2026, finançant entièrement le lancement aux États-Unis. La perte opérationnelle du deuxième trimestre s'élevait à 13,3 millions d'euros, entraînée par l'augmentation des dépenses en R&D et les activités commerciales et cliniques en cours.
Nyxoah SA (NYXH) hat seine Finanzergebnisse für das 2. Quartal und das erste Halbjahr 2024 veröffentlicht. Die wichtigsten Höhepunkte sind:
- Abschluss der FDA-Regulierungsanmeldung, mit einer Genehmigung in den USA, die bis Ende 2024 erwartet wird
- Über 85 Millionen Euro an Wachstumskapital eingeworben
- Umsatz im 2. Quartal 2024 von 0,8 Millionen Euro
- Umsatzwachstum im ersten Halbjahr 2024 von 29% im Vergleich zum Vorjahr
- Gesamte Liquiditätsposition von 77,8 Millionen Euro zum Quartalsende
Das Unternehmen konzentriert sich auf die kommerzielle Vorbereitung in den USA, mit wichtigen Führungskräfte, die bereits ernannt wurden. Die Liquiditätsreserve von Nyxoah reicht bis Mitte 2026 und finanziert vollständig den Marktstart in den USA. Der operative Verlust im 2. Quartal betrug 13,3 Millionen Euro, was auf steigende F&E-Ausgaben und laufende kommerzielle sowie klinische Aktivitäten zurückzuführen ist.
- Completed FDA regulatory submission, with U.S. approval expected by end of 2024
- Raised over €85 million in growth capital
- H1 2024 sales growth of 29% year-over-year
- Cash runway extended into mid-2026, fully funding U.S. launch
- Gross margin improved to 63.6% in Q2 2024 from 62.2% in Q2 2023
- Q2 2024 sales decreased to €0.8 million from €1.1 million in Q2 2023
- Operating loss increased to €13.3 million in Q2 2024 from €11.9 million in Q2 2023
- Net loss for Q2 2024 was €13.1 million, up from €12.8 million in Q2 2023
- Cash burn rate of approximately €4.0 million per month in Q2 2024
Insights
Nyxoah's Q2 2024 results show mixed signals. While revenue grew
The company's cash position is strong at
Nyxoah's submission of the final module in their modular PMA to the FDA is a significant milestone. This initiates the interactive review process, keeping the company on track for potential U.S. approval by end of 2024. The FDA's interactive review allows for efficient resolution of any questions or concerns, potentially expediting the approval process.
However, investors should note that FDA approval is never guaranteed. The upcoming presentation of full DREAM U.S. pivotal study data at the ISSS meeting in September will be crucial. Positive data could strengthen Nyxoah's position with the FDA and differentiate Genio in the market. The company's focus on U.S. commercial readiness, including key leadership appointments, demonstrates confidence in eventual approval.
Nyxoah's strategic focus on the U.S. market is evident in their recent moves. The appointment of Scott Holstine as Chief Commercial Officer and other key sales, marketing and market access leaders signals a strong commitment to U.S. commercialization. This is important as the U.S. represents the largest market for OSA treatments.
The company's emphasis on Genio's "unique, patient centric hypoglossal nerve stimulation solution" suggests a differentiation strategy in a competitive market. The upcoming ISSS meeting presentation will be pivotal in establishing this differentiation. Investors should watch for post-presentation market reactions and any updates on reimbursement strategies, as these will be critical for successful U.S. market penetration.
REGULATED INFORMATION
Nyxoah Reports Second Quarter and First Half 2024 Financial and Operating Results
FDA regulatory submission complete, U.S. approval on track for end of 2024
U.S. commercial launch fully funded with over
Mont-Saint-Guibert, Belgium – August 6, 2024, 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 second quarter and first half of 2024.
Recent Financial and Operating Highlights
- Submitted final module in the modular PMA submission, initiating FDA interactive review.
- Strengthening U.S. commercial organization, highlighted by the appointments of Scott Holstine as Chief Commercial Officer and key sales, marketing and market access leaders.
- Raised over
€85 million in growth capital through a€48.5 million equity offering and a€37.5 million loan facility agreement with the European Investment Bank (EIB). - Reported second quarter 2024 sales of
€0.8 million and first half 2024 sales growth of29% over the same period last year. - Total cash position of
€77.8 million at the end of the quarter, excluding the€37.5 million EIB loan facility.
“With the FDA interactive review well advancing, our focus is fully shifted to U.S. commercial readiness. Key commercial leadership is in place, and we are kicking off the recruitment of top sales and marketing talents. We will present the full DREAM U.S. pivotal study data at the ISSS meeting in September, which will further differentiate Genio’s unique, patient centric hypoglossal nerve stimulation solution,” commented Olivier Taelman, Nyxoah Chief Executive officer. “Our recent
Second Quarter and First Half 2024 Results
CONSOLIDATED STATEMENTS OF LOSS AND OTHER COMPREHENSIVE LOSS (unaudited)
(in thousands)
| For the three months ended June 30, | For the six months ended June 30, | |||||||
| 2024 | 2023 | 2024 | 2023 | |||||
| Revenue | 771 | 1,107 | 1,992 | 1,548 | ||||
| Cost of goods sold | (281) | (419) | (735) | (594) | ||||
| Gross profit | | | | | ||||
| Research and Development Expense | (7,472) | (6,605) | (14,671) | (12,762) | ||||
| Selling, General and Administrative Expense | (6,383) | (6,185) | (12,355) | (11,736) | ||||
| Other income/(expense) | 58 | 219 | 249 | 265 | ||||
| Operating loss for the period | | | | | ||||
| Financial income | 2,069 | 789 | 3,477 | 1,414 | ||||
| Financial expense | (1,445) | ( 775) | (2,436) | (1,732) | ||||
| Loss for the period before taxes | | | | | ||||
| Income taxes | (441) | (928) | (551) | (1,110) | ||||
| Loss for the period | | | | | ||||
| Loss attributable to equity holders | | | | | ||||
| Other comprehensive income/(loss) | ||||||||
| Items that may not be subsequently reclassified to profit or loss (net of tax) | ||||||||
| Currency translation differences | (82) | (50) | (22) | (78) | ||||
| Total comprehensive loss for the year, net of tax | | | | | ||||
| Loss attributable to equity holders | | | | | ||||
| Basic loss per share (in EUR) | | | | | ||||
| Diluted loss per share (in EUR) | | | | | ||||
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)
| As at | |||||
| June 30, 2024 | December 31, 2023 | ||||
| ASSETS | |||||
| Non-current assets | |||||
| Property, plant and equipment | 4,386 | 4,188 | |||
| Intangible assets | 49,310 | 46,608 | |||
| Right of use assets | 3,391 | 3,788 | |||
| Deferred tax asset | 51 | 56 | |||
| Other long-term receivables | 1,419 | 1,166 | |||
| | | ||||
| Current assets | |||||
| Inventory | 5,098 | 3,315 | |||
| Trade receivables | 2,609 | 2,758 | |||
| Other receivables | 2,885 | 3,212 | |||
| Other current assets | 1,298 | 1,318 | |||
| Financial assets | 50,061 | 36,138 | |||
| Cash and cash equivalents | 27,724 | 21,610 | |||
| | | ||||
| Total assets | | | |||
| EQUITY AND LIABILITIES | |||||
| Capital and reserves | |||||
| Capital | 5,905 | 4,926 | |||
| Share premium | 290,822 | 246,127 | |||
| Share based payment reserve | 8,841 | 7,661 | |||
| Other comprehensive income | 115 | 137 | |||
| Retained loss | (185,540) | (160,829) | |||
| Total equity attributable to shareholders | | | |||
| LIABILITIES | |||||
| Non-current liabilities | |||||
| Financial debt | 8,600 | 8,373 | |||
| Lease liability | 2,721 | 3,116 | |||
| Pension liability | 35 | 9 | |||
| Provisions | 339 | 185 | |||
| Deferred tax liability | 10 | 9 | |||
| | | ||||
| Current liabilities | |||||
| Financial debt | 595 | 364 | |||
| Lease liability | 827 | 851 | |||
| Trade payables | 9,078 | 8,108 | |||
| Current tax liability | 2,335 | 1,988 | |||
| Other payables | 3,549 | 3,132 | |||
| | | ||||
| Total liabilities | | | |||
| Total equity and liabilities | | | |||
Revenue
Revenue was
Cost of Goods Sold
Cost of goods sold was
Research and Development
For the second quarter ending June 30, 2024, research and development expenses were
Operating Loss
Total operating loss for the second quarter ending June 30, 2024 was
Cash Position
As of June 30, 2024, cash and financial assets totaled
Second Quarter and First Half 2024
Nyxoah’s financial report for the second quarter and first half 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 Tuesday, August 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 Q2 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 Q2 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 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 announced positive outcomes from the DREAM IDE pivotal study for FDA and U.S. commercialization approval.
For more information, please see the Company’s annual report for the financial year 2023 and 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 entry into of the loan facility agreement and the synthetic warrant agreement with the EIB; the use of proceeds from the loan facility agreement; the Genio® system 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; reporting data from Nyxoah’s DREAM U.S. pivotal trial; filing for FDA approval; and entrance to the U.S. market. 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.
Contacts:
Nyxoah
David DeMartino, Chief Strategy Officer
IR@nyxoah.com
For Media
Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be
International/Germany
MC Services – Anne Hennecke
anne.hennecke@mc-services.eu
Attachment
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