• Revenue: $8.4 million for Q2 2024, a 22% increase over Q2 2023.

• Domestic Core Revenue: $6.2 million, a 14% growth driven by higher consumable volumes.

• International Core Revenue: $1.6 million, a 46% year-over-year growth.

• Novel Therapies Revenue: $600,000, a 50% improvement compared to the prior year.

• Gross Margin: 65%, an 890 basis point increase from the prior year.

• Cash Balance: $10.5 million as of June 30, 2024.

• 2024 Revenue Guidance: Raised to $32 million to $32.5 million.

• 2024 Gross Margin Guidance: Expected between 61% and 62%.

• Operating Expense: Approximately $23.5 to $24 million expected for 2024.

• Warning! GuruFocus has detected 4 Warning Signs with KRMD.

Release Date: August 07, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• KORU Medical Systems Inc (NASDAQ:KRMD) reported record revenues of $8.4 million for Q2 2024, marking a 22% growth over the same period in 2023.

• The company achieved a 46% year-over-year growth in its international core business, driven by improved IG supply and increased penetration in CIDP and SID approved indications.

• KORU Medical Systems Inc (NASDAQ:KRMD) received regulatory clearance for its FREEDOM EDGE infusion system in Japan, expanding its international reach.

• The company improved its gross margin to 65%, an 890 basis point increase compared to the prior year, due to manufacturing efficiencies.

• KORU Medical Systems Inc (NASDAQ:KRMD) raised its 2024 full-year revenue and gross margin guidance, reflecting confidence in continued growth and operational improvements.

Negative Points

• The company anticipates more pressure on margins due to expanding into lower SP lesions and ongoing inflationary pressures in the supply chain.

• KORU Medical Systems Inc (NASDAQ:KRMD) expects higher cash usage in the second half of the year, driven by capital investments and R&D project spending.

• The company noted a $300,000 accelerated shipment in Q2 that is not expected to recur, potentially impacting future revenue growth.

• There is uncertainty regarding the impact of the expanded label for SCIG therapy, as it depends on healthcare practitioner adoption.

• KORU Medical Systems Inc (NASDAQ:KRMD) faces challenges in timing novel therapies revenues, which can be delayed due to collaboration complexities.

Q & A Highlights

Q: What is the current status of prefilled syringe penetration, and how is the 50 ml prefilled syringe launch progressing? A: Linda Tharby, President and CEO, explained that the market uptake for prefilled syringes is strengthening, with CSL's entire prefilled syringe platform now compatible with KORU's devices. The transition from vials to prefilled syringes is expected to bring more patients into the category due to its ease of use.

Q: Do you plan to pursue TV2 clearance in other geographies beyond Japan? A: Linda Tharby confirmed that KORU is cleared for Cube true usage in the US and internationally. The Japan clearance is significant as it covers 95% of the Japanese market. KORU plans to seek further approvals in Latin America and Asia-Pacific regions.

Q: How will the expanded label for Simplify, allowing direct SCIG therapy, impact your business? A: Linda Tharby noted that the expanded label for Simplify allows healthcare providers to start patients directly on SCIG therapy, which was previously off-label. This change is expected to simplify the process and potentially increase SCIG adoption.

Q: What is the strategy for entering the Japanese market following the recent approval? A: Linda Tharby stated that KORU is setting up distributor and pharmaceutical company programs in Japan. The focus will initially be on consumables, as the market is largely electronic pump-based. Significant revenue contributions are expected in 2025.

Q: Can you provide more details on the collaboration with SCHOTT Pharma? A: Linda Tharby highlighted that SCHOTT is the world's largest prefilled device manufacturer. The collaboration will focus on using KORU's Freedom system with SCHOTT's prefilled syringes, aiming to enhance convenience and infusion time. Commercial potential will be clearer in 2025.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus.