Release Date: March 12, 2025

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

Positive Points

• KORU Medical Systems Inc (NASDAQ:KRMD) achieved record-setting revenues in the fourth quarter, with a 23% increase, and full-year revenues grew by 18%.
• The company expanded its gross margins, achieving a record-setting gross profit for the full year 2024.
• KORU Medical Systems Inc (NASDAQ:KRMD) successfully entered multiple new international geographies, contributing to a 32% growth in international revenues.
• The company added four new collaborations to its novel therapies pipeline in 2024, with two more announced in early 2025.
• KORU Medical Systems Inc (NASDAQ:KRMD) maintained a strong cash position, ending the year with a cash balance of $9.6 million, exceeding expectations.

Negative Points

• The novel therapies segment is subject to revenue lumpiness, which could impact overall financial performance.
• The company faces potential challenges from tariffs, although the impact is expected to be minimal.
• There is a dependency on the immunoglobulin market, which currently accounts for 90% of total revenues.
• The FDA's announcement regarding the voluntary withdrawal of certain immunoglobulin lots could pose a short-term risk.
• The company's guidance for 2025 indicates a deceleration in revenue growth compared to 2024.

Q & A Highlights

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

Q: Can you break down the 2025 growth assumptions for domestic and international markets, and the expected contribution from pharma services and clinical trials? A: Tom Adams, CFO: For domestic growth, we expect between 10% and 15% revenue growth. Internationally, we anticipate over 20% growth as we expand in that region. For novel therapies, we expect around $2 to $3 million in revenue from NRE and clinical product sales.

Q: What factors are driving above-market growth domestically and internationally in 2025? A: Tom Adams, CFO: Internationally, we are seeing growth from entering new geographies and expanding in existing ones, such as Japan. Domestically, we continue to add new customers and see market growth due to increased diagnosis of infections.

Q: Can you provide an update on the oncology opportunity and what remains to be done for filing? A: Linda Tharby, CEO: We are confident about FDA approval. Our focus is on market assessment, proving our value proposition, understanding reimbursement, and establishing a new distribution partner in the US. Progress is being made in all areas.

Q: How did the core domestic business outperform market growth in the fourth quarter, and can this growth be replicated? A: Linda Tharby, CEO: The team used AI to identify growth opportunities, signed new agreements, and implemented a price increase. While 20% growth may not be consistent, we are confident in 10% to 15% growth, with potential upside from new account wins and market growth.

Q: How does the international expansion impact working capital and cash flow positivity for the year? A: Tom Adams, CFO: The international expansion is factored into our guidance. We are aware of longer payment terms and have planned inventory levels accordingly. We expect to be operational cash flow positive and have sufficient capital for strategic opportunities.

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