Skip to content
    KRMD
    Earnings call· Jun 2026(Q2 FY26)

    KORU Medical Systems Q2 FY26 earnings call KRMD

    Aug 5, 2026 Source

    Executive summary

    KORU Q2 FY26 — Record Revenue, Positive Net Income, and Strategic Technology Acquisition

    KORU Medical Systems delivered a strong second quarter, marked by record revenue and a return to positive net income, driven by robust domestic and international core business growth. The company made a strategic acquisition of connected monitoring technology to enhance its drug delivery platform. While full-year revenue guidance was narrowed due to slower international market ramp-up, management remains confident in long-term opportunities and strategic pillars.

    Highlights

    5

    • Record quarterly revenue of $12 million, representing 18% growth year over year.

    • Gross margin improved by 160 basis points year over year to 65.1% for the quarter.

    • Achieved positive net income for the first time since 2019.

    • Domestic core revenue grew 12% year over year to $8 million, outpacing the underlying SCIG market.

    • International core revenue grew 59% year over year to $3.5 million.

    Concerns

    3

    • Full-year revenue guidance narrowed to $47.5 million - $48.5 million due to slower-than-anticipated international market ramp-up.

    • PST revenue decreased 35% year over year to $600,000, driven by lower orders for clinical trials due to customer order timing.

    • Strategic decision to withdraw FESGO 510K application in the US due to specific label considerations, pivoting oncology focus to alternative molecules.

    Guidance & targets

    7
    CategoryTargetConfidence
    Full-year revenue
    $47.5 million to $48.5 million
    high materiality
    High
    Full-year gross margin
    62% to 64%
    high materiality
    High
    Year-end cash balance
    greater than $7.5 million
    medium materiality
    High
    Full-year adjusted EBITDA
    positive
    high materiality
    High
    Long-term revenue target
    $100 million
    high materiality
    High
    Long-term gross margin target
    above 65%
    high materiality
    High
    Long-term EBITDA margin target
    20% or greater
    high materiality
    High

    Segment performance

    3
    SegmentRevenueYoYQoQMargin
    Domestic Core
    Growth driven primarily by momentum from new patient starts and continued market share gains, outpacing the underlying SCIG market.
    		$8 million12%——
    International Core
    Growth fueled by high volumes of pumps and consumables, driven by sales to distributors supporting pre-filled syringe conversion in Europe and new patient starts in established markets.
    		$3.5 million59%——
    PST
    Driven primarily by lower orders for clinical trials due to customer order timing; inherent variability expected quarter-to-quarter.
    		$600,000-35%——

    Operational metrics

    11
    Gross margin
    65.1%up 160 bps YoY
    Q2 FY26

    Reported for the second quarter.

    Gross margin
    63.5%
    Q2 FY25

    Gross margin in the prior year period.

    Gross margin
    63.3%up 20 bps
    H1 FY26

    Reported for the first half of the year.

    Operating expenses growth
    9%
    H1 FY26

    Operating expenses increased only 9% against revenue growth, demonstrating improved operating leverage.

    Net losses improvement
    60%
    H1 FY26

    Net losses improved by 60% year over year.

    Adjusted EBITDA
    $900,000
    H1 FY26

    Positive adjusted EBITDA for the first half of the year.

    Cash usage improvement
    62%vs a year ago
    H1 FY26

    Demonstrated improvement in cash usage compared to the prior year.

    Cash balance
    $8.3 million
    Q2 FY26

    Cash balance at the end of the second quarter.

    Cash usage
    $500,000
    Q2 FY26

    Minimal cash usage in the second quarter, despite expecting it to be the heaviest usage quarter.

    Unused debt facility
    $10 million
    Q2 FY26

    Access to unused debt facility for additional financial flexibility; not drawn down for technology acquisition.

    IG patient base
    60,000
    Q2 FY26

    Number of chronic and recurring Ig patients served by the Freedom Infusion System.

    Industry KPIs

    8
    MetricValueDetails
    New product launch rampFreedom 360 (next generation pump)
    Procedure volume growth—
    FCF conversion leverage guidancePositive adjusted EBITDA for FY26; $10M unused debt facility; long-term EBITDA margin target 20% or greater
    Installed base system placements60,000patients
    Segment franchise organic growthDomestic Core: 12%; International Core: 59%%
    Consumables recurring revenue mix—
    Indicated addressable patient populationOncology TAM: $60M (current), growing to $140M (next 4-5 years); Deferoxamine: 200,000 annual US infusionsUSD / infusions
    Pivotal trial clinical evidence milestonesSID pivotal clinical trials reaching endpoints

    Deals & partnerships

    1
    UndisclosedAcquisition of a connected monitoring technology asset

    Acquisition of a connected monitoring technology asset to enhance patient experience, deepen value proposition, generate real-time data insights, and assist in clinical trials. It is a multi-year build.

    Risks & headwinds

    4
    Slower international market ramp-upNear-term (Q3 and Q4 FY26)

    Impacts Q3 and Q4 FY26 revenue, leading to narrowed full-year revenue guidance of $47.5M-$48.5M.

    Mitigation: Deliberate setup of proper market foundations in select geographies, positioning for more effective long-term launch; opportunity expected to materialize more meaningfully in 2027.

    FESGO US 510K withdrawalNear-term (H2 FY26)

    Impacts US oncology market entry timeline, previously planned for H2 FY26.

    Mitigation: Pivoting US oncology strategy to alternative high-volume oncology biologics; international FESGO initiatives continue to advance.

    PST revenue variabilityQuarter-to-quarter

    PST revenue down 35% YoY to $600,000 in Q2 FY26.

    Mitigation: Acknowledged as inherent variability based on customer timelines for clinical trials.

    Biogen/Appellus post-acquisition integrationNear-term

    Potential challenges to the timing and magnitude of near-term clinical trial activity.

    Mitigation: Focus remains on long-term partnership and supporting their clinical development pipeline as subcutaneous infusion programs advance.

    What to watch in Q3 FY26

    5

    International Core Growth Rate

    Next quarter (Q3 FY26)
    Current59% YoY (Q2 FY26)
    TargetAcceleration in non-tender markets

    Why it matters

    The pace of international expansion in non-tender markets is critical for overall revenue growth and achieving long-term targets, as current guidance reflects a slower ramp.

    Looking ahead to the back half of this year, we remain highly focused on executing our our international expansion, though we expect our near-term international core growth to moderate as we navigate some specific regional launch dynamics.

    Q&A highlights

    6

    What needs to happen to unlock non-tender international markets, and can 2026 growth be pulled forward, or will it mostly hit in 2027?

    Management stated that unlocking non-tender markets requires getting all elements in place across different regions, including managing channels through distributors and home care companies. They view it as a timing delay, with patient starts warming up, and the major opportunity still expected over the next 12-18 months, primarily impacting 2027.

    “It's really about getting all of these different dynamics in place in all the different countries there.”

    asked by Frank Takkinen · answered by Adam Kalbermatten

    2 min read6 chapters

    Detailed Narrative

    01

    Strategic Pillars & Digital Transformation

    KORU Medical Systems is actively transforming from a mechanical device manufacturer into a dominant digitally enabled drug delivery platform. The core strategy involves scaling industry-leading mechanical platforms while selectively integrating smart capabilities, as demonstrated by the recent acquisition of a connected monitoring technology asset. This approach aims to enhance patient support, provide data-driven insights to partners, and build foundational capabilities for connected health solutions, preserving the simple mechanical experience patients rely on.

    02

    International Expansion Dynamics

    While international business grew significantly by 59% year over year, near-term growth is expected to moderate📎 due to complexities in specific regional launches within non-tender markets. The company is focused on establishing the right distribution and reimbursement pathways, which is taking longer than initially forecasted. This deliberate setup is crucial for long-term market leadership and positions KORU for more effective launches, with the opportunity expected to materialize more meaningfully in 2027.

    03

    Oncology Strategy & FESGO Withdrawal

    KORU has made a strategic decision to withdraw its 510K application for FESGO in the US due to specific considerations with the FESGO label identified during discussions with the FDA. This pivot shifts the US oncology focus towards other high-volume oncology biologics, which are deemed more favorable. The oncology market remains a core strategic priority with a total addressable market (TAM) expected to grow from $60 million to $140 million over the next 4-5 years, and international FESGO initiatives continue to advance.

    04

    Secondary Immunodeficiency (SID) Opportunity

    The secondary immunodeficiency (SID) market represents a new, incremental, high-growth patient population for KORU. This growth is driven by patients developing immunodeficiencies following treatments like chemotherapy or cell therapies. Major pharmaceutical players are prioritizing SID, with several pivotal clinical trials expected to reach endpoints within the next 12-18 months. KORU's existing platform and on-label SCIG drugs position it well to capture this volume and broaden its total addressable market.

    05

    Connected Monitoring Technology Acquisition

    KORU acquired a connected monitoring technology asset in Q2 FY26 to enhance the patient experience and deepen its value proposition. This technology is expected to provide meaningful new capabilities in generating real-time data insights, assisting in clinical trials with pharmaceutical partners, and supporting precise adherence tracking. While a multi-year build, it is seen as an important building block for positioning KORU's platform and expanding its competitive moat.

    06

    Pipeline Progress & Freedom 360

    The 510K application for the Freedom Infusion System with deferoxamine remains active, with the team engaged in collaborative discussions with the FDA. This application aims to unlock an estimated 200,000 annual US infusions. Additionally, KORU remains on track for a 510K submission by the end of next year for its next-generation pump, Freedom 360, having successfully completed the final, highest-risk stages of its development process in Q2.

    AI-generated summary of the company’s earnings call. Not investment advice.