By David Bautz, PhD
READ THE FULL XFOR RESEARCH REPORT
Monetary Replace
On August 8, 2024, X4 Prescription drugs, Inc. (NASDAQ:XFOR) introduced monetary outcomes for the second quarter of 2024. The corporate recorded the primary revenues for XOLREMDI following its industrial launch in April 2024. Income within the second quarter of 2024 totaled $0.6 million. X4 sells XOLREMDI solely to a specialty pharmacy that dispenses the product to sufferers which have had it prescribed to them. Gross product income is recorded primarily based on the quantity of drug product delivered to the specialty pharmacy on the wholesale acquisition price. The invoiced income for the second quarter of 2024 was $0.7 million, with a discount of $0.1 million for distributor reductions, estimated rebates which may be owed to U.S. authorities payors, future co-pay help funds which may be owed to sufferers who enroll within the affected person help program, and for potential product returns. The price of income for the three months ending June 30, 2024 was $0.3 million, which consisted of an insignificant quantity of drug product direct prices, $0.125 million for the amortization of an intangible asset associated to accrued and paid milestone funds related to the Genzyme licensing settlement, roughly $0.1 million of accrued sales-based royalty funds due beneath the Genzyme licensing settlement, and roughly $0.1 million of prices associated to drug product stocking.
R&D bills for the second quarter of 2024 have been $20.9 million in comparison with $15.6 million for the second quarter of 2023. The rise was primarily attributable to elevated medical operation prices related to the Part 2 continual neutropenia (CN) trial and the launch of the Part 3 CN trial together with elevated regulatory, medical affairs and high quality prices. SG&A bills for the second quarter of 2024 have been $13.3 million in comparison with $10.2 million for the second quarter of 2023. The rise was primarily attributable to a rise in gross sales and advertising bills to help the pre-launch and post-launch actions of XOLREMDI.
Through the second quarter of 2024 the corporate offered a Precedence Evaluate Voucher (PRV) for $105 million in money and recorded it as a achieve on sale of non-financial asset.
The corporate exited the second quarter of 2024 with roughly $169.5 million in money, money equivalents, restricted money, and short-term marketable securities. We estimate the corporate has adequate capital to fund operations into late 2025, and this estimate doesn’t embody any potential future XOLREMDI revenues. As of August 5, 2024, X4 had roughly 168.5 million shares excellent and, when factoring in inventory choices, warrants, and restricted inventory models, a completely diluted share rely of 295.4 million.
Full Knowledge Set for Part 2 CN Trial to be Introduced in November 2024
X4 introduced that the corporate shall be presenting the total dataset from the Part 2 trial of mavorixafor in continual neutropenia (CN) in November 2024, forward of the American Society of Hematology (ASH) assembly. Included on this presentation shall be outcomes from sufferers that obtained mavorixafor and have been eligible for dose changes of their granulocyte-colony stimulating issue (G-CSF) therapy. The corporate beforehand introduced preliminary knowledge from that trial in June 2024, which confirmed that 100% of sufferers who had accomplished the 6-months examine achieved goal absolute neutrophil rely (ANC) will increase of >500 cells per µL at months 3 and 6. For a full overview of the interim outcomes, please see our earlier report.
Part 3 4WARD Research Initiated
X4 has initiated participant screening for the Part 3 4WARD trial of mavorixafor in CN sufferers with congenital, autoimmune, or idiopathic continual neutropenia. The trial is anticipated to enroll 150 individuals with an ANC <1500 cells/mL and a historical past of two or extra infections requiring intervention within the final 12 months. The first endpoint is a two-component endpoint primarily based on a constructive ANC response and annualized an infection fee, with secondary endpoints evaluating severity and length of an infection, antibiotic use, fatigue, high quality of life, and security. Enrollment needs to be accomplished by mid-2025.
Conclusion
We look ahead to the total knowledge set from the Part 2 CN trial in November 2024, significantly knowledge on an infection charges and potential decreases in G-CSF dosing whereas sustaining clinically related ANC ranges. Through the quarterly convention name, administration indicated that the entire sufferers that have been within the open-label extension of the 4WHIM trial have been prescribed XOLREMDI, which is a constructive signal and signifies the significance the corporate has positioned on guaranteeing affected person entry in a well timed method. With all the things consistent with our expectations our valuation stays at $5.00 per share.
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