Nyxoah מדווחת על התוצאות הכספיות והתפעוליות לרבעון השני ולמחצית הראשונה של 2024
ההגשה הרגולטורית של ה-FDA הושלמה, אישור בארה"ב יתקבל עד לסוף שנת 2024
השקה מסחרית בארה"ב במימון מלא עם גיוס הון חדש של למעלה מ-85 מיליון אירו
מונט-סנט-גיברט, בלגיה, 6 באוגוסט 2024, (GLOBE NEWSWIRE) :
Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH) ("Nyxoah" או "החברה"), חברת טכנולוגיות רפואיות שמתמקדת בפיתוח ומסחור של פתרונות ושירותים חדשניים לדום נשימה בשינה (OSA), דיווחה היום על תוצאותיה הכספיות והתפעוליות לרבעון השני ולמחצית הראשונה של 2024.
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 €85 million in new capital raised
Mont-Saint-Guibert, Belgium – August 6, 2024,:(GLOBE NEWSWIRE)
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 themodular PMA submission, initiating FDA interactive review.
- Strengthening U.S. commercialorganization, highlighted by the appointments of Scott Holstine as ChiefCommercial Officer and key sales, marketing and market access leaders.
- Raised over €85 million in growthcapital through a €48.5 million equity offering and a €37.5 million loanfacility agreement with the European Investment Bank (EIB).
- Reported second quarter 2024 salesof €0.8 million and first half 2024 sales growth of 29% over the sameperiod last year.
- Total cash position of €77.8 millionat 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 €85 million in capital raise provides us with a cash runway into mid-2026, fully funding the U.S. launch."
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 goodssold
|
(281)
|
|
(419)
|
|
(735)
|
|
(594)
|
|
Gross profit
|
€490
|
|
€688
|
|
€1,257
|
|
€954
|
|
Research andDevelopment Expense
|
(7,472)
|
|
(6,605)
|
|
(14,671)
|
|
(12,762)
|
|
Selling, General andAdministrative Expense
|
(6,383)
|
|
(6,185)
|
|
(12,355)
|
|
(11,736)
|
|
Otherincome/(expense)
|
58
|
|
219
|
|
249
|
|
265
|
|
Operating loss for theperiod
|
€(13,307)
|
|
€(11,883)
|
|
€(25,520)
|
|
€(23,279)
|
|
Financialincome
|
2,069
|
|
789
|
|
3,477
|
|
1,414
|
|
Financialexpense
|
(1,445)
|
|
( 775)
|
|
(2,436)
|
|
(1,732)
|
|
Loss for the periodbefore taxes
|
€(12,683)
|
|
€(11,869)
|
|
€(24,479)
|
|
€(23,597)
|
|
Income taxes
|
(441)
|
|
(928)
|
|
(551)
|
|
(1,110)
|
|
Loss for the period
|
€(13,124)
|
|
€(12,797)
|
|
€(25,030)
|
|
€(24,707)
|
|
|
|
|
|
|
|
|
|
|
Loss attributable toequity holders
|
€ (13,124)
|
|
€(12,797)
|
|
€(25,030)
|
|
€(24,707)
|
|
|
|
|
|
|
|
|
|
|
Other comprehensiveincome/(loss)
|
|
|
|
|
|
|
|
|
Items that may not besubsequently reclassified to profit or loss (net of tax)
|
|
|
|
|
|
|
|
|
Currency translationdifferences
|
(82)
|
|
(50)
|
|
(22)
|
|
(78)
|
|
Total comprehensiveloss for the year, net of tax
|
€(13,206)
|
|
€(12,847)
|
|
€(25,052)
|
|
€(24,785)
|
|
Loss attributable toequity holders
|
€(13,206)
|
|
€(12,847)
|
|
€(25,052)
|
|
€(24,785)
|
|
|
|
|
|
|
|
|
|
|
Basic loss per share(in EUR)
|
€(0.428)
|
|
€(0.447)
|
|
€(0.843)
|
|
€(0.907)
|
|
Diluted loss pershare (in EUR)
|
€(0.428)
|
|
€(0.447)
|
|
€(0.843)
|
|
€(0.907)
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENT OF FINANCIAL POSITION (unaudited)
(in thousands)
|
|
|
|
As at
|
|
|
|
|
June 30,
2024
|
|
December 31, 2023
|
|
ASSETS
|
|
|
|
|
|
|
Non-current assets
|
|
|
|
|
|
|
Property, plant andequipment
|
|
|
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-termreceivables
|
|
|
1,419
|
|
1,166
|
|
|
|
|
€ 58,557
|
|
€ 55,806
|
|
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 cashequivalents
|
|
|
27,724
|
|
21,610
|
|
|
|
|
€ 89,675
|
|
€ 68,351
|
|
Total assets
|
|
|
€ 148,232
|
|
€ 124,157
|
|
|
|
|
|
|
|
|
EQUITY AND LIABILITIES
|
|
|
|
|
|
|
Capital and reserves
|
|
|
|
|
|
|
Capital
|
|
|
5,905
|
|
4,926
|
|
Share premium
|
|
|
290,822
|
|
246,127
|
|
Share based paymentreserve
|
|
|
8,841
|
|
7,661
|
|
Other comprehensiveincome
|
|
|
115
|
|
137
|
|
Retained loss
|
|
|
(185,540)
|
|
(160,829)
|
|
Total equityattributable to shareholders
|
|
|
€ 120,143
|
|
€ 98,022
|
|
|
|
|
|
|
|
|
LIABILITIES
|
|
|
|
|
|
|
Non-currentliabilities
|
|
|
|
|
|
|
Financial debt
|
|
|
8,600
|
|
8,373
|
|
Lease liability
|
|
|
2,721
|
|
3,116
|
|
Pension liability
|
|
|
35
|
|
9
|
|
Provisions
|
|
|
339
|
|
185
|
|
Deferred taxliability
|
|
|
10
|
|
9
|
|
|
|
|
€11,705
|
|
€ 11,692
|
|
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
|
|
|
|
|
€ 16,384
|
|
€ 14,443
|
|
Total liabilities
|
|
|
€ 28,089
|
|
€ 26,135
|
|
Total equity andliabilities
|
|
|
€ 148,232
|
|
€ 124,157
|
Revenue
Revenue was €0.8 million for the second quarter ending June 30, 2024, compared to €1.1 million for the second quarter ending June 30, 2023.
Cost of Goods Sold
Cost of goods sold was €281,000 for the three months ending June 30, 2024, representing a gross profit of €490,000, or gross margin of 63.6%. This compares to total cost of goods sold of €419,000 in the second quarter of 2023, for a gross profit of €0.7 million, or gross margin of 62.2%.
Research and Development
For the second quarter ending June 30, 2024, research and development expenses were €7.5 million, versus €6.6 million for the second quarter ending June 30, 2023.
Operating Loss
Total operating loss for the second quarter ending June 30, 2024 was €13.3 million versus €11.9 million in the second quarter ending June 30, 2023. 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 June 30, 2024, cash and financial assets totaled €77.8 million, compared to €57.7 million on December 31, 2023. Total cash burn was approximately €4.0 million per month during the second quarter 2024.
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.
Contacts:
Nyxoah
David DeMartino, Chief Strategy Officer
[email protected]
For Media
Belgium/France
Backstage Communication – Gunther De Backer
[email protected]
International/Germany
MC Services – Anne Hennecke
[email protected]
Attachment
- ENGLISHQ2 2024 Earnings PR
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