KORU Medical Systems, Inc. (KRMD) Market Cap
KORU Medical Systems, Inc. has a market capitalization of $190.6M.
Financials based on reported quarter end 2025-12-31
Price: $4.11
▲ 0.09 (2.24%)
Market Cap: 190.58M
NASDAQ · time unavailable
CEO: Linda Tharby
Sector: Healthcare
Industry: Medical - Instruments & Supplies
IPO Date: 1994-04-05
Website: https://www.korumedical.com
KORU Medical Systems, Inc. (KRMD) - Company Information
Market Cap: 190.58M · Sector: Healthcare
KORU Medical Systems, Inc. designs, manufactures, and markets portable medical devices primarily for the ambulatory infusion market in the United States and internationally. It offers mechanical infusion product comprising the FREEDOM infusion systems that include the FREEDOM60 syringe driver, the FreedomEdge syringe driver, HIgH-Flo subcutaneous safety needle sets, and precision flow rate tubing. The company also provides education and training materials to clinicians, patients, and patient advocates. It sells its products through direct sales and medical device distributors, as well as online. KORU Medical Systems, Inc. was incorporated in 1980 and is headquartered in Chester, New York.
Analyst Sentiment
Based on 5 ratings
Analyst 1Y Forecast: $7.00
Average target (based on 3 sources)
Consensus Price Target
Low
$6
Median
$7
High
$8
Average
$7
Potential Upside: 70.3%
Price & Moving Averages
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Fundamentals Overview
KRMD exited Q4 2025 with continued strong top-line momentum (Q4 revenue $10.9M, +23% YoY; FY $41.1M, +22% YoY) and reiterated 2026 growth guidance of $47.5M–$50.0M (+15% to +22%) alongside gross margin of 61%–63%. Management’s narrative is upbeat on Europe (EUR MDR-certified FREEDOM60 shipping; $50M TAM; expect 1–2 new prefill markets per quarter) and on new-label expansion via RYSTIGGO (UCB-backed infusion clinic entry). However, the candor in the Q&A underscores specific fragilities: gross margin was down 30 bps YoY in Q4 due to tariffs/material costs, PST remains timing/milestone dependent (Q4 -30% YoY), and guidance explicitly bakes in geopolitical risk (Middle East). Despite this, they signaled a “slow and steady” US cadence while international steps up in 2H 2026—meaning the year’s upside is execution-heavy, centered on prefill market go-lives and 510(k) recognition timing.
Growth Catalysts
- Domestic Core pump/consumables momentum: Q4 Domestic Core +18% YoY driven by SCIg market growth (8%–10% in the quarter) plus new KORU patient starts and market share gains
- International Core +71% YoY in Q4 driven by new patient starts and increased penetration, with prefilled syringe conversions a key tailwind
- EU MDR certification for FREEDOM60 with prefilled syringe compatibility (positions ongoing valve-to-prefilled syringe conversion across Europe)
- 510(k) clearance for RYSTIGGO (January 2026), adding a non-IG commercial channel in infusion clinics
- Two new pharma collaborations announced: Phase III nephrology molecule and Phase I multi-indication drug (adding ~3 million annual infusions combined)
Business Development
- UCB collaboration for RYSTIGGO (first collaboration; enables infusion clinic channel; UCB reportedly +65% YoY global RYSTIGGO sales growth)
- Roche collaboration: Roche Phesgo 510(k) application submitted on time (December 2025), targeting oncology market entry in H2 2026
- New signed collaboration(s) in the quarter: Phase III nephrology drug and Phase I multi-indication drug (combined ~3 million annual infusions)
Financial Highlights
- Q4 revenue: $10.9M (+23% YoY), third straight quarter of >20% revenue growth
- Full-year revenue: $41.1M (+22% YoY vs $33.6M in 2024)
- Q4 gross margin: 30 bps reduction vs prior year Q4 (driven by higher material costs and tariffs, mostly offset by stronger US customer mix / higher ASPs)
- Full-year gross margin: 62.3% (in line with start-of-2025 expectations); remained >50% each quarter
- Full-year operating leverage: operating expenses +3% with revenue +22%
- Adjusted EBITDA: +$0.6M for FY (124% improvement vs prior year); 3 consecutive quarters of positive adjusted EBITDA
- Cash: $8.9M ending cash; full-year cash usage of ~$0.7M; positive cash flow from operations in both Q3 and Q4 (and for full year)
- 2026 guidance initiated: revenue $47.5M–$50.0M (+15% to +22%); gross margin 61%–63%; target positive adjusted EBITDA and positive cash flow for full-year
Capital Funding
- No buyback/debt data provided in transcript
- Ending cash (12/31/2025): $8.9M; full-year cash usage: ~$0.7M
- Planned capital expenditures to support future new product launches (including next-gen pumps)
Strategy & Ops
- EU shipping start: FREEDOM60 MDR-cleared with prefilled syringe compatibility began shipping into EU markets (prefill conversions expected in multiple EU markets)
- Product progression cadence mentioned: FREEDOM60 modifications/IFU update approved in Q4 2025; approval on IFU received in Q4 2025; started distributing into market in early 2026
- Next steps: FREEDOM360 described as launching 'at the back end of the year' (fits all prefills)
- Next-gen pump roadmap: FREEDOM60 510(k) and MDR submissions expected 'this year' (2026); Phase II Flow Controller 510(k) projected late 2026 or early 2027
- Pipeline commercialization runway: near-term 2026 commercial-stage assets include vancomycin, deferoxamine, and Phesgo (2 of 4 new collaborations signed; 2 additional 510(k) submissions expected for deferoxamine and vancomycin this year)
Market Outlook
- Europe (OUS) TAM: ~$50M total addressable market
- Europe share math given by management: moved share position from ~10% (2024) to ~20% (2025); goal framing if positioned closer to ~60% US share
- Europe geography cadence (prefill markets): expects a new market 'added 1 to 2 every quarter' during 2026 (from current/low-penetration markets to higher prefill penetration)
- 2026 revenue cadence: Q1 momentum continued after record Q4; international step-up expected in back half as countries go online for prefills; US described as 'slow and steady' plus additional growth from '5 tenant approvals' during the year
Risks & Headwinds
- Tariffs/material cost pressure: Q4 gross margin down 30 bps vs prior-year Q4 driven by higher material costs and tariff-related charges (mostly offset by higher US mix / ASPs)
- PST revenue volatility: PST decreased 30% YoY in Q4; Tom emphasized it is milestone/timing-driven and does not reflect reduced collaboration activity
- Geopolitical risk embedded in guidance: management incorporated geopolitical risk from recent Middle East events into 2026 assumptions
- Revenue recognition / cadence risk: management expects first half of 2025 had a meaningful EU prefill inventory build that will not repeat at the same level in 2026; expects back-half ramp tied to pending/recent 510(k) clearances and prefilled syringe introductions into new geographies
- Operational startup costs: planned start-up costs for next-generation pump production line could pressure near-term margins, partially offset by operational excellence programs
Sentiment: MIXED
Note: This summary was synthesized by AI from the KRMD Q4 2025 earnings transcript. Financial data is complex; please verify all metrics against official SEC filings before making investment decisions.