KORU Medical (KRMD) Q3 2025: International Revenue Soars 230% as Pre-Fill Syringe Shift Accelerates
KORU Medical’s international business surged on the back of rapid pre-filled syringe adoption, offsetting domestic inventory headwinds and confirming the company’s pivot to a global growth model. Strategic pharma collaborations and pipeline expansion in both immunoglobulin and oncology set up a multi-year runway for market share gains. Management’s raised outlook signals confidence in sustaining 20%+ growth as new geographies and therapies scale.
Summary
- Pre-Fill Syringe Conversions Drive International Expansion: Rapid European adoption fueled a dramatic international revenue mix shift.
- Pharma Pipeline and Oncology Entry Broaden Growth Optionality: New collaborations and clinical progress diversify revenue drivers beyond core immunoglobulin.
- Margin Discipline Maintained Amid Mix Shift: Operations held gross margins above 60% despite tariff and geographic pressures.
Performance Analysis
KORU Medical’s third quarter results were defined by a stark shift in geographic revenue mix, with international sales up 230% year over year, propelled by European pre-filled syringe (“PFS”, a ready-to-use drug device format) conversions. This surge more than offset a 5% decline in domestic revenue, which management attributed to US distributor inventory reductions and a one-off cross-geography order that temporarily distorted reported numbers. After normalizing for these factors, underlying US growth remained healthy, and overall core business revenue grew 30%.
Gross margin held at 60.2% despite a 320 basis point drop, as higher manufacturing costs, lower yields, and tariff impacts from supplier sourcing affected profitability. The company’s ability to maintain margins above 60%—even as lower-ASP international sales grew—demonstrates operational discipline and cost management. Cash flow from operations turned positive, and net losses were halved year-to-date, reflecting both revenue scale and tight expense control. The company ended the quarter with $8.5 million in cash, supporting continued pipeline investment and international expansion.
- International Pre-Fill Conversions: Majority of international growth was driven by European PFS adoption, with further country rollouts expected over the next 24 months.
- US Core Immunoglobulin Resiliency: End-user demand and specialty pharmacy sales tracked above market, even as distributor inventory reductions created temporary headwinds.
- Margin Management: Cost discipline and operational efficiency offset mix and tariff headwinds, preserving full-year margin guidance.
With recurring revenue from the US SCIG (subcutaneous immunoglobulin, a home- and clinic-based therapy) franchise and accelerating international adoption, KORU is executing on its plan to shift the business mix toward higher-growth, global opportunities.
Executive Commentary
"We achieved our second consecutive quarter with more than $10 million in revenue, representing 27% year-over-year growth. The key growth driver was our core subcutaneous immunoglobulin, or SCIG, business, which grew 30%, driven by international expansion, continued global share gains, and strong underlying patient growth."
Linda Tharby, President and CEO
"Our reported domestic revenue declined 5%, while international revenue grew by 230%. There were three specific factors that drove this geographic shift... The bottom line here is that our core business is solid and market demand is robust. We continue to grow our market position, and we are really pleased to have posted 30% overall core growth, which underscores the strength of our business on a global scale."
Tom Adams, Chief Financial Officer
Strategic Positioning
1. International Expansion Through Pre-Filled Syringe Adoption
KORU’s international growth strategy is anchored by the rapid conversion of European markets from vials to pre-filled syringes, leveraging the company’s Freedom Infusion System to simplify patient administration and training. Management expects to double international market share from mid-teens to as much as 40% within several years, representing a $10 to $20 million revenue opportunity. The cadence of country rollouts is dictated by pharma partner strategies and local reimbursement, with most major conversions targeted for completion by the end of 2026.
2. Pharma Collaboration Pipeline Diversifies Growth
Seven active immunoglobulin (“IG”) collaborations with all four major IG manufacturers continue to drive share gains and expand KORU’s addressable market. Importantly, two collaborations were delayed to 2027, but management does not expect a material impact to near-term revenue. Outside IG, nine active collaborations in rare disease, orthopedics, and oncology create new revenue streams, with up to four non-IG drugs potentially launching by end of 2026. The non-IG pipeline could add up to $10 million in revenue by 2028, providing important diversification.
3. Oncology Infusion Entry Unlocks New Market
Completion of a US-based oncology pilot study validated workflow and patient benefits for KORU’s Freedom Edge system, with 70% of nurses reporting improved ability to multitask. The company is preparing a 510(k) FDA submission, targeting commercial launch in the second half of 2026. Oncology infusion consumables represent a $60 million market today, projected to more than double by 2030, positioning KORU to capture incremental growth outside its core IG franchise.
4. Margin Management Amid Global Mix Shift
Despite rapid international growth at lower ASPs and tariff headwinds, KORU maintained gross margin guidance at 61% to 63%, crediting operational excellence programs and ongoing cost optimization. Management reiterated a long-term target of 65%+ gross margin as volume and efficiency gains offset mix pressure.
5. Disciplined Capital Allocation and Profitability Focus
Operating expenses grew just 3% year-to-date as revenue rose 22%, underscoring disciplined capital deployment. Net losses were halved, and positive adjusted EBITDA was achieved, reflecting a focus on sustainable profitability as the business scales.
Key Considerations
This quarter marked a decisive shift in KORU’s business mix and growth profile, with international expansion and pipeline execution emerging as the primary levers for future value creation. Investors should weigh the following:
Key Considerations:
- International Growth Sustainability: Pre-filled syringe conversions have a multi-year runway, but require continued execution in country-specific commercialization and partnership management.
- Pipeline Execution: Timely clinical and regulatory progress in oncology, orthopedics, and rare disease are critical to realizing the $10 million non-IG revenue target by 2028.
- Gross Margin Resilience: Sustaining 60%+ margins amid global mix shift and tariff pressure will test operational flexibility and pricing discipline.
- Pharma Partner Dependence: Launch delays or changes in partner strategy could impact pipeline timing and revenue realization.
Risks
KORU’s international and pipeline-driven growth exposes the company to regulatory, reimbursement, and execution risks, particularly as country-by-country pre-fill conversions and new therapy launches introduce variability. Tariff volatility and manufacturing cost inflation could further pressure margins if not offset by operational gains. Pharma partner delays, as seen this quarter, remain a structural risk to pipeline timing and revenue realization.
Forward Outlook
For Q4 2025, KORU guided to:
- Revenue split of approximately 70% US, 23-24% international, remainder in PST/pharma services
- Gross margin in the 61% to 63% range
For full-year 2025, management raised guidance:
- Revenue of $40.5 to $41 million (20% to 22% growth)
- Positive cash flow from operations, ending cash of at least $8.2 million
Management highlighted several factors that support continued acceleration:
- Ongoing international PFS conversions and new country launches
- Anticipated 510(k) filings and oncology market entry in 2026
- Pharma pipeline additions and expanded patient reach
Takeaways
KORU’s Q3 was a validation of its international and pipeline-centric growth thesis, with strong execution offsetting short-term domestic headwinds and positioning the company for sustained 20%+ growth.
- International Momentum: Rapid European PFS adoption is transforming KORU’s revenue mix and market share trajectory.
- Pipeline Optionality: Broadening the drug and therapy portfolio through pharma partnerships and oncology entry provides new growth vectors and diversification.
- Margin Watch: Margin discipline will remain a key investor focus as international and lower-ASP business scales.
Conclusion
KORU Medical enters the final quarter of 2025 with accelerating international momentum, a robust and diversifying pipeline, and disciplined execution underpinning its raised growth outlook. Sustaining margin resilience and delivering on pipeline milestones will be critical as the business pivots to a more global, multi-therapy model.
Industry Read-Through
KORU’s success with pre-filled syringe conversions and international market penetration is a strong signal for medtech and drug delivery peers, highlighting the importance of device simplicity, pharma partnership alignment, and country-specific commercialization strategies. The company’s progress in oncology infusion underscores the growing opportunity for workflow-enhancing, nurse-friendly devices as infusion clinics seek efficiency and patient comfort. Gross margin discipline amid global expansion will be a key benchmark for other specialty device makers navigating similar mix and tariff pressures.