NASDAQ:XFOR
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Financial Update
On August 8, 2024, X4 Pharmaceuticals, Inc. (NASDAQ:XFOR) announced financial results for the second quarter of 2024. The company recorded the first revenues for XOLREMDI™ following its commercial launch in April 2024. Revenue in the second quarter of 2024 totaled $0.6 million. X4 sells XOLREMDI exclusively to a specialty pharmacy that dispenses the product to patients that have had it prescribed to them. Gross product revenue is recorded based on the amount of drug product delivered to the specialty pharmacy at the wholesale acquisition cost. The invoiced revenue for the second quarter of 2024 was $0.7 million, with a reduction of $0.1 million for distributor discounts, estimated rebates that may be owed to U.S. government payors, future co-pay assistance payments that may be owed to patients who enroll in the patient assistance program, and for potential product returns. The cost of revenue for the three months ending June 30, 2024 was $0.3 million, which consisted of an insignificant amount of drug product direct costs, $0.125 million for the amortization of an intangible asset related to accrued and paid milestone payments associated with the Genzyme licensing agreement, approximately $0.1 million of accrued sales-based royalty payments due under the Genzyme licensing agreement, and approximately $0.1 million of costs related to drug product stocking.
R&D expenses for the second quarter of 2024 were $20.9 million compared to $15.6 million for the second quarter of 2023. The increase was primarily due to increased clinical operation costs associated with the Phase 2 chronic neutropenia (CN) trial and the launch of the Phase 3 CN trial along with increased regulatory, medical affairs and quality costs. SG&A expenses for the second quarter of 2024 were $13.3 million compared to $10.2 million for the second quarter of 2023. The increase was primarily due to an increase in sales and marketing expenses to support the pre-launch and post-launch activities of XOLREMDI.
During the second quarter of 2024 the company sold a Priority Review Voucher (PRV) for $105 million in cash and recorded it as a gain on sale of non-financial asset.
The company exited the second quarter of 2024 with approximately $169.5 million in cash, cash equivalents, restricted cash, and short-term marketable securities. We estimate the company has sufficient capital to fund operations into late 2025, and this estimate does not include any potential future XOLREMDI revenues. As of August 5, 2024, X4 had approximately 168.5 million shares outstanding and, when factoring in stock options, warrants, and restricted stock units, a fully diluted share count of 295.4 million.
Full Data Set for Phase 2 CN Trial to be Presented in November 2024
X4 announced that the company will be presenting the full dataset from the Phase 2 trial of mavorixafor in chronic neutropenia (CN) in November 2024, ahead of the American Society of Hematology (ASH) meeting. Included in this presentation will be results from patients that received mavorixafor and were eligible for dose adjustments in their granulocyte-colony stimulating factor (G-CSF) treatment. The company previously announced preliminary data from that trial in June 2024, which showed that 100% of patients who had completed the 6-months study achieved target absolute neutrophil count (ANC) increases of >500 cells per µL at months 3 and 6. For a full overview of the interim results, please see our previous report.
Phase 3 4WARD Study Initiated
X4 has initiated participant screening for the Phase 3 4WARD trial of mavorixafor in CN patients with congenital, autoimmune, or idiopathic chronic neutropenia. The trial is expected to enroll 150 participants with an ANC <1500 cells/mL and a history of two or more infections requiring intervention in the last 12 months. The primary endpoint is a two-component endpoint based on a positive ANC response and annualized infection rate, with secondary endpoints evaluating severity and duration of infection, antibiotic use, fatigue, quality of life, and safety. Enrollment should be completed by mid-2025.
Conclusion
We look forward to the full data set from the Phase 2 CN trial in November 2024, particularly data on infection rates and potential decreases in G-CSF dosing while maintaining clinically relevant ANC levels. During the quarterly conference call, management indicated that all of the patients that were in the open-label extension of the 4WHIM trial have been prescribed XOLREMDI, which is a positive sign and indicates the importance the company has placed on ensuring patient access in a timely manner. With everything in line with our expectations our valuation remains at $5.00 per share.
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