X4 Pharmaceuticals(XFOR) - 2024 Q4 - Annual Results

Financial Performance - X4 Pharmaceuticals reported net revenues of $2.6 million for XOLREMDI® since its launch in May 2024, with expectations for increased sales in 2025 [3]. - X4 reported a net loss of$ 37.5 million for the full year 2024, compared to a net loss of $101.2 million in 2023 [20]. - Product revenue for Q4 2024 was$ 1.434 million, compared to $0 in Q4 2023, indicating a significant increase [28]. - The net loss for Q4 2024 was$ 39.821 million, compared to a net loss of $19.130 million in Q4 2023, representing a 108.5% increase in losses [28]. Expenses - Research and Development (R&D) expenses for the full year 2024 were$ 81.6 million, up from $72.0 million in 2023 [15]. - Selling, General, and Administrative (SG&A) expenses for the full year 2024 were$ 61.5 million, compared to $35.5 million in 2023 [15]. - Research and development expenses for Q4 2024 were$ 21.702 million, up from $15.272 million in Q4 2023, reflecting a 42.5% increase [28]. - Selling, general and administrative expenses rose to$ 15.145 million in Q4 2024 from $9.927 million in Q4 2023, a 52.5% increase [28]. - A strategic restructuring announced in February 2025 is expected to reduce spending by$ 30-35 million annually [12]. Cash and Assets - X4 had a cash position of $102.8 million as of December 31, 2024, and expects sufficient funds to support operations into the first half of 2026 [15]. - Total current assets decreased to$ 112.175 million as of December 31, 2024, down from $122.076 million as of December 31, 2023 [30]. - Cash and cash equivalents decreased to$ 55.699 million from $99.216 million year-over-year, a decline of 43.8% [30]. - The company reported a total stockholders' equity of$ 22.149 million as of December 31, 2024, down from $51.099 million a year earlier, a decrease of 56.7% [30]. - Total liabilities increased to$ 124.298 million as of December 31, 2024, compared to $96.159 million as of December 31, 2023, marking a 29.3% increase [30]. Clinical Trials and Regulatory Challenges - The company anticipates full enrollment in the Phase 3 4WARD trial for chronic neutropenia by Q3 or Q4 2025, with top-line data expected in the second half of 2026 [1]. - The 4WARD trial is now activated at approximately 90% of targeted sites worldwide [14]. - The ongoing Phase 3 clinical trial for mavorixafor may face delays or unsatisfactory outcomes, impacting future commercialization efforts [25]. - X4 Pharmaceuticals anticipates potential challenges in obtaining and maintaining regulatory approvals for mavorixafor, which could affect its market strategy [25]. Licensing and Partnerships - X4 entered into a licensing agreement with Norgine Pharma UK, receiving €28.5 million upfront and potential milestone payments of up to €226 million [6]. - The company recognized a gain of$ 105 million from the sale of a priority review voucher (PRV) in 2024 [20].