KORU Medical Systems Q2 2025 presentation: Record revenue drives raised guidance

Introduction & Market Context

KORU Medical (TASE:BLWV) Systems (NASDAQ:KRMD) reported record quarterly revenue in its Q2 2025 earnings presentation on August 6, 2025, as the company continues to benefit from the growing shift of healthcare delivery from hospitals to homes.

The medical device company, which specializes in large-volume subcutaneous drug delivery systems, is capitalizing on a total addressable market of $450 million for subcutaneous immunoglobulin (SCIg) therapy that currently has less than 20% penetration. KORU’s Freedom Infusion System is used by approximately 45,000 chronic SCIg patients globally.

As shown in the following slide highlighting the market opportunity, KORU is pursuing a three-pillar growth strategy focused on protecting its core domestic business, expanding internationally, and enabling more drugs to reach more patients:

Quarterly Performance Highlights

KORU Medical Systems delivered record Q2 2025 revenue of $10.2 million, representing 21% growth compared to the same period last year. This strong performance builds on the momentum from Q1 2025, when the company reported revenue of $9.6 million.

The company’s growth was broad-based across all business segments. Domestic core revenue increased 15% year-over-year to $7.1 million, while international core revenue surged 34% to $2.2 million. The company’s pharma services and clinical trials segment demonstrated the strongest growth at 42% year-over-year.

The following chart breaks down KORU’s Q2 2025 revenue performance by segment:

For the first half of 2025, KORU reported total revenue of $19.8 million, representing 19% growth compared to the first half of 2024. The company’s adjusted EBITDA for the first half reached $0.01 million, marking a 101% improvement and achieving positive territory.

The comprehensive financial performance for the first half of 2025 is illustrated in this summary:

Strategic Initiatives

KORU Medical Systems is actively expanding beyond its core SCIg market through several strategic initiatives. The company has identified 10 opportunities to bring new drugs onto its Freedom Infusion System, with plans to add 5 new drugs by the end of 2026.

The company’s drug pipeline strategy is detailed in the following slide, which outlines collaborations with pharmaceutical partners and independent 510(k) submissions:

Internationally, KORU is gaining market share in key regions, with international core revenue growth outpacing the already strong SCIg market. The company is particularly focused on expansion in Japan, Canada, and Western Europe.

KORU is also investing in product development to capture near-term growth opportunities. Key initiatives include a flow controller with improved cost of goods sold and capacity (Phase 1 launched in Q2 2025), a next-generation pump that accommodates prefilled syringes and vials (510(k) submission expected in Q4 2025-Q1 2026), and new consumable sets with improved comfort (510(k) submission expected in 2H 2026).

The company’s roadmap for 2025 highlights key milestones across its three strategic pillars:

Financial Analysis

Despite strong revenue growth, KORU’s gross margin experienced a slight decline in Q2 2025. The company reported a gross margin of 63.5%, representing a 150 basis point decrease year-over-year. Management attributed this decline to a 90 basis point impact from tariffs and a 90 basis point impact from a prior year favorable inventory revaluation adjustment, partially offset by volume efficiencies and higher pharma services margins.

The following slide illustrates KORU’s gross margin performance and outlook:

KORU continues to make progress toward profitability, with Q2 2025 net loss narrowing to ($0.2M). The company’s cash usage in Q2 was $0.6 million, bringing the cash balance to $8.1 million as of June 30, 2025. Management expects cash usage in the second half of 2025 to be neutral-to-positive.

The company’s cash usage has significantly decreased over the past three years, as shown in this chart:

Forward-Looking Statements

Based on strong first-half performance, KORU Medical Systems raised its full-year 2025 revenue guidance to $39.5-$40.5 million, representing 18-20% growth. This is an increase from the previous guidance of $38.5-$39.5 million provided after Q1 results.

The company reiterated its gross margin guidance of 61-63% for the full year and maintained its expectation of positive cash flow from operations for 2025. Management anticipates potential headwinds in the second half from international mix and tariffs, which are factored into the guidance.

Looking beyond 2025, KORU outlined a pathway to sustained 20%+ growth through a combination of SCIg market growth, share gains, new products, international expansion, new drug opportunities, and business development initiatives:

The company’s strategic priorities are summarized in this comprehensive overview, highlighting both near-term execution and long-term growth drivers:

KORU Medical Systems’ stock closed at $3.28 on August 6, 2025, down 0.61% for the day. The stock has traded between $1.86 and $5.05 over the past 52 weeks, suggesting potential upside if the company continues to execute on its growth strategy and path to profitability.

Full presentation:

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