Can you provide more details on the use case, development stage, and deployment timeline for the newly acquired connected monitoring technology?

Management expressed excitement about the opportunistic acquisition, aiming to bring additional value to patients by enabling communication and data collection from infusions. They emphasized it is a 'multi-year build' and currently in early stages of development. “I want to stress that it's a multi-year build here, so it's going to take some time, but it's something that we look at the ability to communicate with patients, collect additional data from the infusion.”

What was the FDA feedback regarding FESGO, and what are the characteristics of attractive oncology molecules for KORU's US strategy?

Management explained that discussions with the FDA revealed a 'consideration with the FESGO label' itself, making other high-volume oncology biologics more attractive for the US market. They reiterated strong conviction in the overall oncology market opportunity, which is expected to grow to $140 million, and confirmed FESGO initiatives continue internationally. “Through those discussions, identified a consideration with the FESGO label, so with the actual drug label, that made pursuing other high volume oncology biologics as a higher attractive opportunity for us.”

Are there changes to the US oncology market entry timelines, and what is the updated outlook for the domestic core business, specifically regarding SCIG market growth and KORU's outperformance?

Management confirmed that the US oncology entry timeline will be 'a little bit delayed' from the previously planned second half entry. For the domestic core business, they stated it remains very strong, continues to outperform the SCIG market, and the recent guidance change is isolated to the international segment. “I think it's fair to say that's going to shift a bit now. We're still working. through exactly what that timing's going to look like and announce that, but I can say we are actively in that process. So, you know, we're going to be a little bit delayed.”

KRMD

KORU (KRMD) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 5, 2026

Source: earnings call transcript

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

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

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

Category	Target	Timeline	Confidence
Full-year revenue	$47.5 million to $48.5 million high materiality	FY26	High
Full-year gross margin	62% to 64% high materiality	FY26	High
Year-end cash balance	greater than $7.5 million medium materiality	FY26	High
Full-year adjusted EBITDA	positive high materiality	FY26	High
Long-term revenue target	$100 million high materiality	Long-term	High
Long-term gross margin target	above 65% high materiality	Long-term	High
Long-term EBITDA margin target	20% or greater high materiality	Long-term	High

Segment performance

Segment	Revenue	YoY	QoQ	Margin
Domestic Core Growth driven primarily by momentum from new patient starts and continued market share gains, outpacing the underlying SCIG market.	$8 million	12%	—	—
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 million	59%	—	—
PST Driven primarily by lower orders for clinical trials due to customer order timing; inherent variability expected quarter-to-quarter.	$600,000	-35%	—	—

Deals & partnerships

Undisclosed Acquisition 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

Slower international market ramp-up Near-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 withdrawal Near-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 variability Quarter-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 integration Near-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

International Core Growth Rate

Next quarter (Q3 FY26)

Current 59% YoY (Q2 FY26)

Target Acceleration 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.

Find out whether KRMD delivers this. Inve re-checks your case every morning.

Q&A highlights

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 read 6 chapters

Detailed narrative

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.

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.

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.

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.

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.

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.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.