Nyxoah(NYXH)
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Invitation to attend the annual and the extraordinary shareholders' meetings of the Company to be held on June 12, 2024
Newsfilter· 2024-05-10 05:00
REGULATED INFORMATIONMay 10, 2024, 7:00am CET / 1:00am ET NYXOAH SA(Euronext Brussels: NYXH) Rue Edouard Belin 12, 1435 Mont-Saint-Guibert, Belgium(hereinafter the "Company") Invitation to attend the annual and the extraordinary shareholders' meetings of the Company to be held on June 12, 2024 The board of directors of the Company is pleased to invite its securities holders to attend the annual shareholders' meeting of the Company, to be held on Wednesday, June 12, 2024 at 2:00 p.m. CET at the Company's sea ...
Nyxoah(NYXH) - 2023 Q4 - Annual Report
2024-03-20 20:06
Table of Contents As filed with the Securities and Exchange Commission on March 20, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transiti ...
Nyxoah(NYXH) - 2023 Q1 - Quarterly Report
2023-04-20 21:03
Exhibit 99.1 REGULATED INFOMATION Publication relating to transparency notifications Mont-Saint-Guibert (Belgium), April 20, 2023, 10.30pm CET / 4.30pm ET – In accordance with article 14 of the Act of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announces that it received two transparency notifications as detailed below. Together Partnership On April 18, 2023, Nyxoah received a transparency notification from Together Partnership following the crossing of th ...
Nyxoah(NYXH) - 2022 Q4 - Earnings Call Transcript
2023-03-23 01:26
Nyxoah S.A. (NASDAQ:NYXH) Q4 2022 Earnings Conference Call March 22, 2023 4:30 PM ET Company Participants Olivier Taelman - Chief Executive Officer Loïc Moreau - Chief Financial Officer Conference Call Participants Adam Maeder - PSC Jon Block - Stifel Suraj Kalia - Oppenheimer Operator Thank you for standing by. And welcome to the Nyxoah Fourth Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answe ...
Nyxoah(NYXH) - 2022 Q4 - Annual Report
2023-03-22 20:40
Table of Contents As filed with the Securities and Exchange Commission on March 22, 2023 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transiti ...
Nyxoah(NYXH) - 2022 Q4 - Annual Report
2023-03-22 20:14
[Executive Summary](index=1&type=section&id=Executive%20Summary) [Company Overview](index=1&type=section&id=Company%20Overview) Nyxoah SA is a medical technology company focused on developing and commercializing innovative solutions for Obstructive Sleep Apnea (OSA), reporting its financial and operating results for the fourth quarter and full year 2022 - Nyxoah SA is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA)[3](index=3&type=chunk) [Recent Financial and Operating Highlights](index=1&type=section&id=Recent%20Financial%20and%20Operating%20Highlights) Nyxoah achieved significant milestones in Q4 and FY 2022, including completing all 115 implants in the DREAM U.S. pivotal study, filing the first PMA module, and demonstrating positive preliminary 12-month data for early DREAM patients. Commercially, the company saw substantial sales growth and market share gains in Germany, strengthening its supply chain and initiating the ACCCESS U.S. IDE study - Completed all **115 implants** in the DREAM U.S. pivotal trial, with 12-month data expected early next year[6](index=6&type=chunk) - Filed the first module in the modular PMA submission[6](index=6&type=chunk) - Submitted 12-month data on the first **34 DREAM patients** to SLEEP 2023, demonstrating a **65% AHI responder rate** and a **76% ODI responder rate**[6](index=6&type=chunk) Commercial Performance Highlights | Metric | Q4 2022 | Change/Status | | :-------------------------- | :---------- | :------------ | | Quarterly Sales | €1.3 million | Sequential German market share gain | | Active German Accounts (End of Year) | 38 | Up from 12 entering 2022 | - Strengthened supply chain with Belgium manufacturing facility receiving clearance from the EU notified body[6](index=6&type=chunk) - Implanted the first patients in the ACCCESS U.S. IDE pivotal study to treat complete concentric collapse (CCC), with implant completion expected in **2024**[6](index=6&type=chunk) Cash Position | Metric | End of 2022 | | :---------------- | :---------- | | Total Cash Position | €94.8 million | [2023 Key Objectives](index=1&type=section&id=2023%20Key%20Objectives) For 2023, Nyxoah aims to focus on patient follow-up in the DREAM study to achieve primary endpoints, prepare for U.S. regulatory approval, manufacturing, and market access, and further accelerate revenue and market share growth in Germany - Focus on patient follow-up in the DREAM study resulting in reaching the primary endpoints[6](index=6&type=chunk) - U.S. regulatory, manufacturing and market access readiness[6](index=6&type=chunk) - Drive further revenue and market share growth in Germany[6](index=6&type=chunk) [Fourth Quarter and Full Year 2022 Financial Results](index=2&type=section&id=Fourth%20Quarter%20and%20Full%20Year%202022%20Results) [Consolidated Statements of Loss and Other Comprehensive Loss](index=2&type=section&id=Consolidated%20Statements%20of%20Loss%20and%20Other%20Comprehensive%20Loss) Nyxoah reported significant revenue growth in Q4 and FY 2022, but also experienced increased operating and net losses due to substantial investments in research and development, as well as selling, general, and administrative expenses Consolidated Statements of Loss and Other Comprehensive Loss (in thousands €) | Metric | Q4 2022 | Q4 2021 | FY 2022 | FY 2021 | | :------------------------------------ | :------ | :------ | :------ | :------ | | Revenue | 1,307 | 295 | 3,084 | 852 | | Cost of goods sold | (465) | (105) | (1,150) | (303) | | Gross profit | 842 | 190 | 1,934 | 549 | | Research and Development Expense | (4,575) | (3,335) | (15,861) | (12,344) | | Selling, General and Administrative Expense | (5,363) | (3,937) | (18,855) | (14,712) | | Operating loss for the period | (9,050) | (6,543) | (32,499) | (26,242) | | Loss for the period | (13,296) | (6,248) | (31,225) | (27,619) | | Basic loss per share (in EUR) | (514) | (238) | (1,209) | (1,161) | [Consolidated Statement of Financial Position](index=3&type=section&id=Consolidated%20Statement%20of%20Financial%20Position) As of December 31, 2022, Nyxoah's total assets decreased to €146.1 million from €170.8 million in 2021, primarily driven by a significant reduction in cash and cash equivalents, despite an increase in intangible assets. Total equity attributable to shareholders also declined Consolidated Statement of Financial Position (in thousands €) | Metric | Dec 31, 2022 | Dec 31, 2021 | | :-------------------------------- | :----------- | :----------- | | **ASSETS** | | | | Non-current assets | 45,811 | 30,770 | | Current assets | 100,260 | 140,060 | | Total assets | 146,071 | 170,830 | | **EQUITY AND LIABILITIES** | | | | Total equity attributable to shareholders | 120,324 | 148,622 | | Total liabilities | 25,747 | 22,208 | | Total equity and liabilities | 146,071 | 170,830 | - Cash and cash equivalents decreased from **€135,509 thousand** in 2021 to **€17,888 thousand** in 2022[11](index=11&type=chunk) - Intangible assets increased from **€25,322 thousand** in 2021 to **€39,972 thousand** in 2022[11](index=11&type=chunk) [Revenue Analysis](index=4&type=section&id=Revenue) Nyxoah's revenue significantly increased in Q4 2022 to €1.3 million (from €295,000 in Q4 2021) and for the full year 2022 to €3.1 million (from €0.9 million in 2021), primarily driven by the commercialization of the Genio® system, particularly in Germany Revenue Performance (in thousands €) | Period | 2022 Revenue | 2021 Revenue | YoY Change | | :------- | :----------- | :----------- | :--------- | | Q4 | 1,307 | 295 | +343% | | Full Year | 3,084 | 852 | +262% | - The increase in revenue was attributable to the Company's commercialization of the Genio® system, primarily in Germany[13](index=13&type=chunk) [Cost of Goods Sold and Gross Profit Analysis](index=4&type=section&id=Cost%20of%20Goods%20Sold) Cost of goods sold increased in Q4 and FY 2022, reflecting higher revenue. Gross profit also rose, with gross margin remaining stable at 64.4% for Q4 2022 and slightly decreasing to 62.7% for the full year 2022 Cost of Goods Sold and Gross Profit (in thousands €) | Metric | Q4 2022 | Q4 2021 | FY 2022 | FY 2021 | | :----------------- | :------ | :------ | :------ | :------ | | Cost of goods sold | 465 | 105 | 1,150 | 303 | | Gross profit | 842 | 190 | 1,934 | 549 | | Gross margin | 64.4% | 64.4% | 62.7% | 64.4% | [Operating Expenses Analysis](index=4&type=section&id=Operating%20Expenses%20Analysis) Operating expenses, including R&D and SG&A, saw substantial increases in 2022, driven by investments in next-generation product development, ongoing clinical studies (DREAM), expanded commercial efforts in Europe, and corporate infrastructure build-out for the anticipated U.S. launch [Research and Development Expenses](index=4&type=section&id=Research%20and%20Development%20Expenses) Research and Development Expenses (in thousands €) | Period | 2022 Expense | 2021 Expense | YoY Change | | :------- | :----------- | :----------- | :--------- | | Q4 | 4,575 | 3,335 | +37.2% | | Full Year | 15,861 | 12,344 | +28.5% | - The increase reflects investments in the development of next-generation versions of the Genio® system and ongoing clinical studies, most notably DREAM in the U.S.[16](index=16&type=chunk) [Selling, General and Administrative Expenses](index=5&type=section&id=Selling%2C%20General%20and%20Administrative%20Expenses) Selling, General and Administrative Expenses (in thousands €) | Period | 2022 Expense | 2021 Expense | YoY Change | | :------- | :----------- | :----------- | :--------- | | Q4 | 5,363 | 3,937 | +36.2% | | Full Year | 18,855 | 14,712 | +28.2% | - The increase was primarily due to increased commercial efforts in Germany and other European markets, as well as investments in Nyxoah's corporate infrastructure ahead of the U.S. commercial launch[19](index=19&type=chunk)[20](index=20&type=chunk) [Operating Loss](index=5&type=section&id=Operating%20Loss) Nyxoah's operating loss widened to €9.1 million for Q4 2022 and €32.5 million for the full year 2022, up from €6.5 million and €26.2 million respectively in 2021, driven by accelerated R&D spending and ongoing commercial and clinical activities Operating Loss (in thousands €) | Period | 2022 Operating Loss | 2021 Operating Loss | YoY Change | | :------- | :------------------ | :------------------ | :--------- | | Q4 | (9,050) | (6,543) | +38.3% | | Full Year | (32,499) | (26,242) | +23.8% | - The increased operating loss was driven by the acceleration in the Company's R&D spending, as well as ongoing commercial and clinical activities[21](index=21&type=chunk) [Cash Position](index=5&type=section&id=Cash%20Position) As of December 31, 2022, Nyxoah's total cash and financial assets decreased to €95 million from €135.5 million at the end of 2021, reflecting an average monthly cash burn of approximately €3.4 million during 2022 Cash and Financial Assets (in millions €) | Metric | Dec 31, 2022 | Dec 31, 2021 | Change | | :------------------------ | :----------- | :----------- | :----- | | Cash and Financial Assets | 95.0 | 135.5 | -40.5 | | Monthly Cash Burn (2022) | 3.4 | N/A | N/A | [Additional Information](index=5&type=section&id=Additional%20Information) [Full Year Report & Conference Call Details](index=5&type=section&id=Full%20Year%20Report%20%26%20Conference%20Call%20Details) The full audited consolidated results for 2022 are available on Nyxoah's investor website, and a conference call and webcast were held on March 22, 2023, to discuss these results - Nyxoah's financial report for the full year of **2022**, including details of the audited consolidated results, are available on the investor page of Nyxoah's website[23](index=23&type=chunk) - A conference call and webcast presentation were scheduled for **March 22, 2023**, at **10:30pm CET / 4:30pm ET**[24](index=24&type=chunk) [About Nyxoah](index=6&type=section&id=About%20Nyxoah) Nyxoah is a medical technology company focused on Obstructive Sleep Apnea (OSA), with its Genio® system as a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy. The Genio® system holds European CE Mark approval, including an expanded indication for Complete Concentric Collapse (CCC) patients, and is currently undergoing the DREAM IDE pivotal study for U.S. FDA approval - Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA)[26](index=26&type=chunk) - Nyxoah's lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA[26](index=26&type=chunk) - The Genio® system received its European CE Mark in **2019** and CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients[27](index=27&type=chunk) - The Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval[27](index=27&type=chunk) [Forward-looking Statements](index=6&type=section&id=Forward-looking%20statements) This section contains forward-looking statements reflecting the company's current expectations regarding its Genio® system, clinical studies, regulatory pathways, and financial performance, which are inherently subject to various risks, uncertainties, and assumptions that could cause actual results to differ materially - Forward-looking statements reflect the Company's current expectations regarding the Genio® system, planned and ongoing clinical studies, potential advantages, regulatory pathway, and financial outlook[29](index=29&type=chunk) - These statements involve risks, uncertainties, assumptions, and other factors that could cause actual results or events to differ materially from those expressed or implied[29](index=29&type=chunk) - Risks and uncertainties include those set forth in the 'Risk Factors' section of the Company's Annual Report on Form 20-F for the year ended **December 31, 2021**[29](index=29&type=chunk) [Contacts](index=6&type=section&id=Contacts) Contact information for Nyxoah's Chief Strategy Officer, David DeMartino, is provided for inquiries - Contact for Nyxoah is **David DeMartino**, Chief Strategy Officer[30](index=30&type=chunk)
Nyxoah(NYXH) - 2022 Q3 - Earnings Call Transcript
2022-11-14 05:38
Nyxoah S.A. (NASDAQ:NYXH) Q3 2022 Results Earnings Conference Call November 8, 2022 4:30 PM ET Company Participants Jeremy Feffer - Vice President, Investor Relations Olivier Taelman - Chief Executive Officer Loïc Moreau - Chief Financial Officer Conference Call Participants Simran Kaur - Piper Sandler Jonathan Block - Stifel Nicolaus Ross Osborn - Cantor Fitzgerald Operator Good day. And thank you for standing by. Welcome to the Nyxoah Third Quarter 2022 Conference Call. [Operator Instructions] Please be a ...
Nyxoah(NYXH) - 2022 Q2 - Earnings Call Transcript
2022-08-13 21:29
Nyxoah S.A. (NASDAQ:NYXH) Q2 2022 Results Conference Call August 8, 2022 4:30 PM ET Â Company Participants Jeremy Feffer - VP, IR Olivier Taelman - CEO Loic Moreau - CFO Conference Call Participants Ross Osborn - Cantor Fitzgerald Simran Kaur - Piper Sandler Suraj Kalia - OpCo Operator Good day, and thank you for standing by. Welcome to the Nyxoah Second Quarter '22 Conference Call. [Operator Instructions] Please be advised, todayÂ's conference is being recorded. I would like to hand the conference call to ...
Nyxoah(NYXH) - 2021 Q4 - Annual Report
2022-03-24 20:41
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________________ to _____________________________ ...
Nyxoah(NYXH) - 2021 Q4 - Annual Report
2022-03-24 20:34
Exhibit 99.1 REGULATED INFORMATION Mont-Saint-Guibert, Belgium – March 24, 2022, 9:30pm CET / 4:30pm 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 full year ending December 31, 2021. Full Year 2021 Operational and Financial Highlights "2021 was a very strong year for Nyxoah. I am pro ...