This article first appeared on GuruFocus .
Release Date: August 05, 2026
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
Positive Points
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Record quarterly revenue of $12 million, up 18% year-over-year, with 20% growth in the first half of 2026.
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Achieved positive net income for the first time since 2019, a major milestone.
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Gross margin improved to 65.1%, up 160 basis points year-over-year, and raised full-year guidance to 62%-64%.
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International revenue grew 59% year-over-year, driven by strong demand in established markets and pre-filled syringe conversions.
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Acquired a connected monitoring technology asset to enhance patient experience and provide real-time data insights, strengthening the platform's value proposition.
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Domestic core business grew 12% year-over-year, outpacing the underlying SCIG market with continued market share gains.
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Completed final development stages for Freedom 360, the next-generation pump, on track for 510 submission by end of next year.
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Generated positive cash flow from operations in Q2, with minimal cash usage of $500,000 and year-end cash expected above $7.5 million.
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Extended a key supplier contract with improved pricing, supporting continued margin expansion.
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Positioned to benefit from the growing secondary immunodeficiency (SID) market, with several pivotal trials expected to conclude in the next 12-18 months.
Negative Points
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Narrowed full-year revenue guidance to $47.5-$48.5 million due to slower-than-expected ramp in international pre-filled syringe markets.
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International growth is expected to moderate in the near term as certain regional launches take longer to materialize.
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PST revenue declined 35% year-over-year due to lower clinical trial orders, highlighting inherent variability in this segment.
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Withdrew the U.S. FDA application for FESGO, delaying U.S. oncology market entry and shifting focus to alternative molecules.
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The connected monitoring technology acquisition is a multi-year build, with no immediate revenue contribution.
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Biogen's acquisition of Apellis may cause near-term delays in clinical trial activity, impacting PST timelines.
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Cash balance remains modest at $8.3 million, though sufficient for foreseeable operations.
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International expansion requires establishing proper distribution and reimbursement pathways, which is taking longer than initially anticipated.
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The company's long-term growth targets depend on successful execution of multiple strategic initiatives, which carry execution risks.
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The FESGO withdrawal reduces the U.S. oncology opportunity, with the total addressable market now estimated at $600K versus previous higher figures.
Q & A Highlights
Q: Can you provide more color on the OUS dynamics and what needs to happen to unlock growth in the non-tender markets that was previously expected in 2026? Could any of these initiatives be pulled forward into 2026, or will they mostly hit in 2027? A: Adam Kalbermatten (President and CEO): We remain excited about the international opportunity as a major growth driver. The back-half focus is on getting all the different elements in place across various regional dynamics. We are making good progress, and patient starts are warming up. Over the next 12 to 18 months, we still see a big opportunity, but it's a delay in timing. We are moving as quickly as possible to establish the right distribution and reimbursement pathways, which is crucial for long-term health.
Q: Can you provide more detail on the FDA feedback regarding the FESGO withdrawal and define the characteristics of an attractive oncology molecule for KORU in the U.S.? A: Adam Kalbermatten (President and CEO): We are still very excited about the oncology market opportunity, which we see as a $60 million TAM today, growing to upwards of $140 million over the next four to five years. Through ongoing discussions with the FDA, we identified specific considerations with the FESGO label that made pursuing other high-volume oncology biologics a more attractive opportunity for our U.S. entry. We are pivoting to focus on molecules with more attractive volume and return on investment. Internationally, we still see FESGO as a compelling long-term growth driver.
Q: What is the go-to-market strategy for secondary immunodeficiency (SID), and does it differ from the core SCIG market in the U.S.? A: Adam Kalbermatten (President and CEO): Many major pharmaceutical companies are already engaged in SID clinical trials, with endpoints expected towards the end of 2027. Many of these trials use existing SCIG drugs that KORU already has on label. We are tracking these trials and preparing the channels needed to get our products to patients. The advantage is that since the drugs are already on label, we are well-positioned to capture this new incremental high-growth patient population as approvals come online.
Q: Regarding the FESGO withdrawal, the deck now sizes the opportunity around $600K versus the previously called out $1.1 or $1.2 million. Is that delta simply the U.S. coming out, and how do the international economics compare? A: Adam Kalbermatten (President and CEO) and Tom Adams (CFO): Yes, the drawdown reflects pulling the U.S. market out of the FESGO opportunity. We are still focused on the U.S. for other molecules, but internationally, we need to do additional work on real-world evidence for the MDR process in Europe. The economics remain favorable internationally, though reimbursement differs from the U.S. Tom Adams added that the volume of infusions internationally is much more prevalent than in the U.S., making it a higher-volume opportunity.
Q: Now that you've been in the CEO seat, what does it take to make this a sustainable 20% grower, especially if the U.S. is growing in the low double-digit to mid-teens range? A: Adam Kalbermatten (President and CEO): Our long-term strategy is built on three growth pillars: growing domestically and defending share, growing internationally, and working with pharma to bring more drugs on label. We have a strong track record of taking more than our fair share in the IG market. To increase growth rates, we need to bring new drugs on label and expand internationally. Expanding our TAM through new indications like oncology is key to serving more patients and driving long-term growth.
Q: Can you provide more detail on the connected monitoring technology acquisition, its use case, and the development stage? A: Adam Kalbermatten (President and CEO): We are very excited about this opportunistic acquisition. We love the simplicity of our mechanical system, and this technology will allow us to bring additional value to patients by enabling communication and data collection during infusions. It's a multi-year build, and we are in the early stages. The technology will provide real-time insights for patients, specialty pharmacies, and pharma partners, and will be a key differentiator in our PST business for clinical trial data capture.
Q: Can you provide insight into what percent of international markets are tender versus gradual one-by-one conversion markets, and will pursuing the gradual markets smooth out OUS revenue expectations? A: Adam Kalbermatten (President and CEO): The European market is primarily dominated by electronic pumps today. We are following where prefilled syringes are entering the market. Previously, we converted a pharmaceutical tender market quickly. The other countries are more competitive, non-tender-driven markets, requiring us to manage channels through distributors and home care companies. We have many of those relationships in place and are working through new patient starts. The market doesn't convert all at once; it converts through new patient starts, similar to the U.S. domestic market.
Q: Can you provide an update on the outlook for the domestic core business and whether you still expect 8% to 10% core SCIG market growth with several hundred basis points of outperformance? A: Tom Adams (CFO): Our U.S. business remains very strong, and we continue to outperform the SCIG market. Our guidance continues to assume a strong U.S. market and a solid PST clinical trial business. The guidance adjustment is fairly isolated to our international business.
Q: Regarding the FESGO pivot, are there any changes to the timeline for U.S. oncology market entry? A: Adam Kalbermatten (President and CEO): We had been planning our U.S. oncology entry for later this year, expecting approval with FESGO in the second half. That timing will now shift as we work through the pivot to alternative molecules. We are actively in the process and will announce the new timing, but we will be a bit delayed.
For the complete transcript of the earnings call, please refer to the full earnings call transcript .
