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Delivered 18% revenue growth in Q2, reaching positive net income for the first time since 2019, validating the company's path toward profitable scale.

Domestic core business grew 12% by outpacing the subcutaneous immunoglobulin (SCIG) market through high patient retention and capturing new patient starts.

International revenue surged 59% driven by established market momentum and distributor-led conversions to prefilled syringe (PFS) formats in Europe.

Withdrew the US FDA 510(k) application for Phesgo following label-specific considerations, pivoting the domestic oncology strategy toward other high-volume biologics.

Acquired a connected monitoring technology asset to integrate data-driven insights into the mechanical platform, aimed at enhancing patient adherence and pharma clinical trial integrity.

Positioned the Freedom system to capture incremental growth from the emerging secondary immunodeficiency (SID) market as major clinical trials conclude over the next 12-18 months.

Narrowed full-year revenue guidance to $47.5M-$48.5M, reflecting a more moderate ramp in international non-tender markets as foundational distribution and reimbursement pathways take longer to establish.

Raised gross margin guidance to 62%-64% following a key multi-year supplier contract extension that secured improved pricing and derisked the bottom end of previous estimates.

Maintained the timeline for the Freedom360 next-generation pump, with a US 510(k) submission targeted for the end of 2027 after completing high-risk development stages.

Expects near-term international growth to moderate in the second half of 2026, with more meaningful revenue contributions from new geographies shifting into 2027.

Anticipates positive adjusted EBITDA for the full year 2026 while continuing strategic investments in R&D and sales and marketing.

Pharma Services revenue declined 35% due to customer order timing, highlighting the inherent quarterly variability of clinical trial-related business.

The Biogen acquisition of Apellis may create near-term timing challenges for clinical trial activity during standard post-acquisition integration.

The shift to focus on international markets for Phesgo resulted in a drawdown of the estimated annual infusion opportunity to 600,000, as the company pulled out of the U.S. market for that drug., though international oncology efforts remain active.

Cash guidance adjusted to a year-end balance greater than $7.5M to account for the technology acquisition and associated R&D headcount costs.

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Management explained that unlike tender markets which convert 'overnight', competitive markets require a methodical 1-by-1 patient conversion process through distributors.

The delay in international growth is characterized as a timing issue rather than a loss of opportunity, with patient starts currently 'warming up' for a 12-18 month ramp.

The decision was driven by specific drug label considerations identified during FDA discussions that made other oncology molecules more attractive for US entry.

Management remains 'bullish' on oncology, noting the international Phesgo opportunity remains intact due to higher infusion volumes in European markets.

The acquisition is described as a 'multi-year build' intended to add digital value to the core mechanical system without sacrificing its simplicity.

Primary benefits include providing real-world evidence for specialty pharmacies and improving data capture for pharmaceutical partners during clinical trials.

KORU is targeting SID as a high-growth patient population resulting from immunosuppressive treatments like chemotherapy.

The company is well-positioned because many ongoing SID clinical trials use drugs already on KORU's label, allowing for rapid adoption once trials reach endpoints in late 2027.