KORU Medical Systems, Inc. reported strong third-quarter 2024 financial results and raised its full-year 2024 guidance for revenue, gross margin, and year-end cash. The company achieved $8.2 million in revenue, marking the third consecutive quarter of double-digit growth. This growth was accompanied by improved gross margin and operating leverage. The company attributes its success to a strong recurring chronic subcutaneous immunoglobulin (SCIg) patient base and expanding collaborations in its novel therapies business, fueled by the increasing trend of subcutaneous drug administration.
Third-quarter 2024 net revenues totaled $8.2 million, a 16.8% increase year-over-year. Domestic core revenues grew by 11.7% to $6.4 million, driven by higher consumable and pump volumes from new patients and market share gains. International core revenues saw a 5.1% increase to $1.1 million, primarily due to higher consumable volumes attributed to increased Ig supply, expanded approved indications, and geographic growth. This international growth was partially offset by lower orders from a distribution partner who expedited orders in the second quarter of 2024 due to a BSI regulatory review, which has since been successfully appealed. Novel Therapies revenues reached $0.6 million, a substantial 275.6% increase, fueled by clinical trial orders and progress on non-recurring engineering (NRE) milestones within multiple collaboration agreements.
Gross profit for the quarter reached $5.2 million, a 19% increase, with gross margin expanding by 140 basis points to 63.4%. This improvement stems from a favorable sales mix of clinical trial orders, a more profitable NRE services mix, and higher average selling prices. Operating expenses totaled $6.9 million, a 12.3% increase primarily due to new hires, bonus accruals, and severance related to the elimination of the CTO role. Despite increased operating expenses, the net loss for the quarter was $1.6 million, or ($0.03) per diluted share, compared to a net loss of $1.4 million, or ($0.03) per diluted share, in the prior year period. This was primarily due to an increase in operating expenses of $0.8 million, and a prior year tax benefit of $0.2 million offset by an increase in gross profit of $0.8 million. Adjusted EBITDA improved to ($0.4) million, or ($0.01) per diluted share, compared to ($0.9) million, or ($0.02) per diluted share, in the prior year period. Cash and cash equivalents stood at $8.8 million as of September 30, 2024, reflecting $1.7 million in cash usage during the quarter.
The company provided a reconciliation of adjusted EBITDA and adjusted diluted EPS. KORU Medical Systems focuses on developing, manufacturing, and commercializing innovative, patient-centric large volume subcutaneous infusion solutions. Its flagship product, the FREEDOM Syringe Infusion System, includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™, and HIgH-Flo Subcutaneous Safety Needle Sets™. Used for self-administration at home and by healthcare professionals in ambulatory infusion centers, the FREEDOM System first received FDA clearance in 1994. KORU Medical’s Novel Therapies business supports biopharmaceutical companies with products for feasibility/clinical trials during drug development, and offers customized FREEDOM System solutions for clinical and commercial applications across various drug categories. The company will host a conference call and webcast on November 13, 2024, to discuss these results and provide a corporate update.
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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.