Nyxoah(US:NYXH)2025-11-13 22:02Financial Performance - Revenue for the nine months ending September 30, 2025, was €4.4 million, a 33.3% increase from €3.3 million for the same period in 2024[15] - The net loss for the nine months ending September 30, 2025, was €66.6 million, compared to a net loss of €42.1 million for the same period in 2024[19] - Revenue for the nine months ended September 30, 2025, increased to €4,376 thousand, up 34% from €3,258 thousand for the same period in 2024[31] - Gross profit for the nine months ended September 30, 2025, was €2,701 thousand, compared to €2,041 thousand for the same period in 2024, reflecting a growth of 32%[31] - The operating loss for the nine months ended September 30, 2025, was €64,857 thousand, compared to €40,498 thousand for the same period in 2024, indicating a loss increase of 60%[31] - Loss for the period for the nine months ended September 30, 2025, was €66,572 thousand, compared to €42,087 thousand for the same period in 2024, an increase of 58%[31] - Basic Loss Per Share for the nine months ended September 30, 2025, was €(1.778), compared to €(1.346) for the same period in 2024, reflecting a worsening of 32%[31] Expenses - Selling, general and administrative expenses rose by €15.4 million or 75.4%, from €20.4 million in 2024 to €35.8 million in 2025, driven by U.S. commercialization efforts[16] - Research and development expenses increased by €7.3 million or 27.8%, from €26.4 million in 2024 to €33.7 million in 2025[17] - Operating expenses for the nine months ended September 30, 2025, totaled €67.558 million, up from €42.539 million in the same period of 2024, marking an increase of approximately 58.8%[144] - The Company recognized an impairment loss of €0.8 million for a discontinued R&D project during the period ended September 30, 2025[71] - The Company recognized a gain of €92,000 from a modification of lease agreements during the nine months ended September 30, 2025[72] Cash and Assets - Cash and cash equivalents totaled €22.5 million as of September 30, 2025, down from €85.6 million on December 31, 2024[20] - Total assets decreased from €158,406 thousand as of December 31, 2024, to €93,599 thousand as of September 30, 2025, representing a decline of approximately 41%[28] - Cash and cash equivalents dropped significantly from €34,186 thousand as of December 31, 2024, to €10,869 thousand as of September 30, 2025, a decline of about 68%[28] - Current assets as of September 30, 2025, total €35.3 million, including €10.9 million in cash and cash equivalents and €11.6 million in marketable securities[51] - The total inventory increased to €6.1 million as of September 30, 2025, compared to €4.7 million as of December 31, 2024, driven by preparations for commercialization in the US and EU[75] Financing and Capital - The company is actively exploring financing options to meet future working capital needs, including public or private equity and debt financing[53] - The Company signed a €37.5 million loan facility agreement with the European Investment Bank, intended for research and development and scaling manufacturing capacity[122] - The first tranche of the loan facility, amounting to €10 million, was disbursed on July 26, 2024[123] - The company raised €45.9 million from the issuance of 5,374,755 new shares on May 28, 2024, at a share price of €8.54 per share in a public offering[94] - The total number of outstanding warrants increased from 2,040,231 as of September 30, 2024, to 3,218,569 as of September 30, 2025[104] Legal and Regulatory - The FDA approved the Genio system on August 8, 2025, for patients with an Apnea-Hypopnea Index (AHI) of 15 to 65, with commercialization efforts commencing shortly thereafter[14] - The company has engaged in litigation against Inspire Medical, Inc. for alleged patent infringement, with ongoing legal costs recognized in Research and Development Expense[128][129] Market and Sales - During Q3 2025, the company recognized €231,000 in revenue from U.S. sales following FDA approval[14] - The company expects to ramp up sales in Germany and other European markets, with ongoing efforts in the Middle East following successful distributor agreements[21] - The company generated its first revenue in Dubai in Q1 2025 and continued to expand into Kuwait and Abu Dhabi in Q2 2025[22] - The company generated revenue of €4.4 million in the first nine months of 2025, primarily from activities in the EU, with U.S. revenue starting in Q3 2025 amounting to €231,000[52] Employee and Management Compensation - The company reported total employee benefits of €31.9 million for the nine months ended September 30, 2025, up from €18.6 million for the same period in 2024[153] - For the nine months ended September 30, 2025, total remuneration for executive management was €3,082,000, a decrease of 7% from €3,315,000 in the same period of 2024[171] - Short-term remuneration for executive management increased to €1,994,000 for the nine months ended September 30, 2025, up 34% from €1,482,000 in 2024[171] Shareholder Information - As of September 30, 2025, the company's share capital amounts to €6.5 million represented by 37,544,782 shares, with a share premium of €332.7 million before transaction costs[91] - The share premium increased from €260.6 million on January 1, 2024, to €332.7 million on December 31, 2024[92] - The Company granted a total of 103,642 Restricted Stock Units (RSUs) to 7 directors, which vested at the shareholders' meeting in June 2025[114] Other Financial Information - Total financial liabilities increased to €11.7 million as of September 30, 2025, compared to €10.5 million as of December 31, 2024[64] - Total financial debt amounted to €19.035 million, an increase from €18.973 million as of December 31, 2024[116] - Financial income increased from €4.6 million for the nine months ended September 30, 2024, to €6.6 million for the nine months ended September 30, 2025, mainly due to fair value adjustments on synthetic warrants and increased exchange differences[155] - Total financial expenses increased from €5.5 million for the nine months ended September 30, 2024, to €8.2 million for the nine months ended September 30, 2025, primarily due to an increase in exchange differences[159]