X4 Pharmaceuticals Reports $2.6 Million Revenue from XOLREMDI, Faces $37.5 Million Net Loss

X4 Pharmaceuticals, Inc. reported a significant financial performance for the fiscal year ending December 31, 2024, with net product revenue of $2.6 million from its recently launched drug, XOLREMDI, which received FDA approval for the treatment of WHIM syndrome. This marks the company's first revenue from product sales, as there were no revenues reported in the previous fiscal year. Despite this initial revenue, X4 Pharmaceuticals continues to face substantial operating losses, reporting a net loss of $37.5 million for 2024, a notable improvement from the $101.2 million loss in 2023. The company attributes this reduction in losses to a combination of increased revenue and a significant gain of $105 million from the sale of a Priority Review Voucher (PRV).

In terms of operational developments, X4 Pharmaceuticals has undergone a strategic restructuring, resulting in a 30% reduction in its workforce, which is expected to decrease annual spending by approximately $30 to $35 million. This restructuring is aimed at focusing resources on advancing mavorixafor for chronic neutropenia while optimizing the U.S. promotion of XOLREMDI. The company has also entered into a licensing agreement with Norgine Pharma UK Limited, granting Norgine exclusive rights to distribute and market mavorixafor in Europe, Australia, and New Zealand, with an upfront payment of €28.5 million and potential milestone payments totaling up to €226 million.

X4 Pharmaceuticals is currently conducting a pivotal Phase 3 clinical trial, known as the 4WARD study, to evaluate mavorixafor's efficacy and safety in patients with chronic neutropenia. The trial aims to enroll 150 participants and is expected to complete enrollment by the third or fourth quarter of 2025. The company has also initiated a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for mavorixafor, which has been accepted for processing.

As of December 31, 2024, X4 Pharmaceuticals had cash and cash equivalents totaling $55.7 million, alongside short-term marketable securities of $46.4 million. However, the company has raised concerns regarding its liquidity, indicating that its current cash reserves may not be sufficient to fund operations for the next 12 months. The company is actively seeking additional capital to meet its operational needs and comply with financial covenants under its Hercules Loan Agreement, which requires maintaining a minimum cash level of $15 million.

Looking ahead, X4 Pharmaceuticals remains focused on the commercialization of XOLREMDI and the advancement of mavorixafor for chronic neutropenia. The company acknowledges the challenges it faces, including the need for substantial additional funding and the inherent risks associated with drug development and regulatory approval processes. Despite these challenges, X4 Pharmaceuticals is optimistic about its potential to provide new therapeutic options for patients with rare immune disorders.