Nyxoah(NYXH) - 2022 Q4 - Annual Report

Executive Summary Company Overview 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] Recent Financial and Operating Highlights 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] - Filed the first module in the modular PMA submission[6] - 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] 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] - 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] Cash Position | Metric | End of 2022 | | :---------------- | :---------- | | Total Cash Position | €94.8 million | 2023 Key Objectives 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] - U.S. regulatory, manufacturing and market access readiness[6] - Drive further revenue and market share growth in Germany[6] Fourth Quarter and Full Year 2022 Financial Results Consolidated Statements of Loss and Other Comprehensive Loss 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 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] - Intangible assets increased from €25,322 thousand in 2021 to €39,972 thousand in 2022[11] Revenue Analysis 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] Cost of Goods Sold and Gross Profit Analysis 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 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 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] Selling, General and Administrative Expenses 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][20] Operating Loss 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] Cash Position 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 Full Year Report & Conference Call Details 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] - A conference call and webcast presentation were scheduled for March 22, 2023, at 10:30pm CET / 4:30pm ET[24] About Nyxoah 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] - Nyxoah's lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA[26] - 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] - The Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval[27] Forward-looking Statements 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] - 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] - 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] 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]