Q2 2025 KORU Medical Systems Inc Earnings Call

Speaker #1: Hello, and welcome the KORU Medical Systems second quarter 2025 financial results, conference call, and webcast. At this time, all participants are in listen-only mode.

Speaker #1: The question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to Louisa Smith of the Gilmartin Group.

Speaker #1: Please go ahead.

Speaker #3: Thank you, Judith, and good afternoon, everyone. Joining me on the call today are Linda Tharby, president and CEO of KORU Medical Systems, and Tom Adams, chief financial officer.

Speaker #3: Earlier today, KORU released financial results for the second quarter and did June 30th, 2025. A copy of the press release is available on the company's website.

Speaker #3: I encourage listeners to have our press release in front of you, which includes our financial results as well as commentary on the quarter. Additionally, we will use slides to support further commentary in today's call, which are also available on the Investor Relations section of our website.

Speaker #3: During this call, we will make certain forward-looking statements regarding our business plans and other matters. These comments are based on our predictions and expectations as of today.

Speaker #3: Actual events or results could differ materially due to risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC.

Speaker #3: We assume no obligation to update any forward-looking statements. During the call, management will also discuss certain non-GAAP financial measures. You will find additional disclosures, including reconciliations of these non-GAAP measures with comparable GAAP measures in our press release via accompanying investor presentation and SEC filing.

Speaker #3: For the benefit of those listening to the replay, this call was held and recorded on Wednesday, August 6th, 2025, at approximately 4:30 PM Eastern Time.

Speaker #3: Since then, the company may have made additional comments related to the topics discussed. I'd now like turn the call over to Linda Tharby, president and CEO.

Speaker #3: Linda, please go head.

Speaker #4: Thank you, Louisa. Good afternoon, everyone, and thank you for joining today's earnings call. I'll begin with some commentary on our strategic vision and the opportunity ahead in the large volume subcutaneous drug delivery market.

Speaker #4: Followed by highlights from the second quarter. Tom will then review our financial results before we open the call for your questions. Let me start with the big picture.

Speaker #4: KORU is a leader in the large-volume subcutaneous drug delivery market, with the Freedom System being cleared for use with the first drug in 2017.

Speaker #4: We are well positioned to capitalize on the accelerating shift from hospital IV-based treatments to more convenient subcutaneous therapies delivered at home and in infusion clinics.

Speaker #4: Today, our Freedom System serves approximately 45,000 patients primarily on IG therapy for chronic conditions. Providing a strong stable base of recurring revenue. We are also focused on expanding beyond SEIG, where we currently have 10 active opportunities and many more we are pursuing to bring new drugs onto our Freedom infusion platform.

Speaker #4: Over the past decade, healthcare has begun to shift from the hospital to infusion clinics to the home. KORU is uniquely positioned to capitalize.

Speaker #4: We are cleared for use with all SEIG drugs on the market. Between subcutaneous and IV formulations, we estimate that the opportunity for drug delivery devices for IG therapy is approximately $450 million.

Speaker #4: With only 20% penetrated by subcutaneous formulations. Beyond IG, there are currently more than 50 drugs in development that are formulated at volumes of greater than 10 mL.

Speaker #4: Requiring a specialized drug delivery solution a significant opportunity that aligns with KORU's core competencies in large volume drug delivery. Our strategy is based on three growth pillars.

Speaker #4: Depending on growing our core domestic business, where we are the market leader, and have the opportunity to increase penetration, expanding internationally, where sub-Q penetration is higher, and we have share growth opportunity, and enabling the delivery of additional drug therapies to reach more patients.

Speaker #4: Now turning to our results for the second quarter. We reached a historic milestone in Q2 with over $10 million in revenue. Revenue grew over 20% with continued momentum across all three strategic growth pillars.

Speaker #4: Our domestic core business continues to outperform a growing SEIG market, and we are seeing significant acceleration in an international expansion with over 30% growth.

Speaker #4: Our pharma services and clinical trial segment also saw strong growth driven by clinical supply agreements. We continue to expand our patient base through market share gains with recurring revenues from chronic SEIG patients.

Speaker #4: Further, the FDA recently approved an expanded indication for empaveli. A non-SEIG drug already on our label for C3G and primary IC MPGN. Creating further opportunity.

Speaker #4: We also submitted a 510(k) ahead of schedule for a rare disease biologic, another milestone in our strategy to bring more non-IG drugs onto the Freedom platform.

Speaker #4: Following our success in the EU, we have also initiated a US-based oncology pilot program with over 50 patients enrolled at six infusion centers across four different subcutaneous oncology drugs.

Speaker #4: Insights from this pilot will help with data generation, to inform our strategic decisions around the pursuit of the oncology opportunity. Which we look forward to updating you on in the coming quarters.

Speaker #4: We also advanced our goals towards profitability this quarter. With Q2 cash usage of $600,000, this was driven by the trifecta of strong revenue growth, sustained gross margin performance, and disciplined cash capital allocation that is delivering meaningful operating leverage.

Speaker #4: And finally, I'm cited to announce that Adam Kalbermatten has joined KORU as chief commercial officer. Bringing 20 years of success in leading drug delivery partnerships across pharma and biotech in both large and small-cap companies.

Speaker #4: Adam will be instrumental in further acceleration of our global commercial and PST strategies. Two weeks in, he has hit the ground running. Let's take a closer look at performance across our three strategic pillars, starting with our core business results.

Speaker #4: Our domestic core business continued to outperform strong SEIG market growth, fueled by market share gains in key counts. The addition of the new label expansion for Empaveli will provide an opportunity to further grow our patient base.

Speaker #4: Internationally, we continue to deliver significant growth fueled by expansion into new geographies and our first pre-filled syringe market conversion in Europe. An early step in what we believe is a much larger long-term strategy.

Speaker #4: We expect even further contribution from our pre-fill efforts in the back half. You'll notice we've updated our pipeline slide to distinguish between core IG opportunities and new drugs added to our label.

Speaker #4: I’ll elaborate on the latter in the next slide. We believe this view more clearly illustrates how device innovation, label expansion, and strategic collaborations are driving share gains and targeted geographic expansion for our core IG business.

Speaker #4: Within our IG partnerships, we made two key advances this quarter. First, we completed all pump and consumable registrations in Japan paving the way for sales alongside two leading IG therapies.

Speaker #4: We expect to realize sales in the back half of this year. The final step, clearance of our flow controller with the third IG drug is expected in 2026.

Speaker #4: In addition, one of our IG drug collaborations progressed to a combined phase two three trial. More broadly, we continue to make strong progress across our IG device and drug partnerships with a major milestone on the horizon.

Speaker #4: Multiple anticipated clearance for our next-generation pump in 2026. Which will unlock new market share and geographic expansion opportunities. Moving to our third growth pillar, we continue to see good progress in our opportunity to enable the delivery of more drugs and ultimately bring more patients to our platform.

Speaker #4: Our pipeline includes five new drugs that we expect to be commercialized on our Freedom infusion platform. By the end of 2026, and 10 total pipeline drugs.

Speaker #4: A mix of independent 510(k) submissions and formal pharmaceutical collaborations. Notably, we named two drugs we are pursuing independently. Deferoximine for ion collation and vancomycin and antibiotic with both now expected to receive clearance by 2026.

Speaker #4: In total, these two drugs represent approximately $1 million in total infusions, of which we expect to realize about $500,000 in incremental revenue next year. Through our relationships with specialty pharmacies, we're in the process of identifying and potentially pursuing additional drugs that fit into this category to drive additional annual infusions into our core business.

Speaker #4: As noted in my opening marks, the FDA recently approved an expanded indication for empaveli. Representing approximately $100,000 annual infusions. We estimate KORU's opportunity to be around $20,000.

Speaker #4: Of those infusions. We've also submitted ahead schedule a 510(k) for a rare disease biologic representing $40,000 annual infusions. We hope to receive clearance on this by the end of this year.

Speaker #4: Our revised total addressable market for new drugs now stands at approximately $1.8 billion. Based on estimated patient populations and dosing schedules, NASPs. From our prior $2.2 billion.

Speaker #4: As our new drug pipeline continues to evolve, we will assess each therapy's infusion volume to determine KORU's serviceable opportunity. We are encouraged by our robust and growing pipeline, with some near-term commercial opportunities.

Speaker #4: Moving to product development. Our initiatives are progressing well and will be drivers of near-term growth. I'm pleased to report that we launched our phase one flow controller in Q2 ahead of schedule.

Speaker #4: Phase two flow control submission is expected by the first half of 2026, and will provide enhanced performance and expanded label indications that will expand our access to new patients in new markets.

Speaker #4: Our xt-gen pump development is on track with a 510(k) submission expected by Q4 of 2025, to Q1 of 2026. This pump will accommodate all available pre-filled syringes, will be vial and syringe compatible, and offer patients improved mobility and usability.

Speaker #4: We now expect to file a 510(k) for our new consumable sets in the second half of 2026. Allowing us the time and opportunity to incorporate further market feedback.

Speaker #4: We do not expect this to have any negative impact on revenue figures in 2025 or 2026. Where our or prioritizing the pump development, a decision that has the potential to accelerate our international growth.

Speaker #4: Overall, I'm very pleased with the momentum we built in the first half of the year, and remain confident in our ability to carry this trajectory through the remainder of 2025.

Speaker #4: We've established a strong foundation to execute across all of our growth pillars, and our teams continue to deliver a steady, focused progress every day.

Speaker #4: With that, I'll turn the call over to Tom to walk through our cial results and share our updated 2025 guidance.

Speaker #5: Thank you, Linda. Starting with revenue, we were pleased to deliver record revenues of $10.2 million in the second quarter, representing 21% growth over the prior year period.

Speaker #5: Our domestic core revenues were $7.1 million, a 15% increase over the prior year. This performance continues to demonstrate our ility to outpace the overall SEIG market growth, driven by new patient starts and market share gains.

Speaker #5: Leading to continued strength in consumable volumes. In our international core business, we delivered revenues of $2.2 million, representing growth of 34% over the prior year.

Speaker #5: This growth was driven by expansion into new geographies and the continued success of our pre-filled syringe strategy in Europe. Our pharma services and linical trials revenues were $900,000, representing 42% growth over the prior year.

Speaker #5: Driven by strength in clinical trial orders from a non-IG partner, demonstrating the diversification of our PST business beyond SEIG. Moving over to our gross margin performance, starting with the our second quarter margins were 63.5%, representing a 150 basis point decline year over year.

Speaker #5: This decline was primarily driven by two specific factors. Tariff impacts this year of 90 basis points and a prior year favorable inventory revaluation adjustments of 90 basis points.

Speaker #5: These headwinds were partially offset by volume efficiencies and improved PST margins. For the second half of the year, we expect gross margins in the 61 to 63% range impacted by increased revenue in lower average selling price markets, and ongoing tariff impacts.

Speaker #5: We are reiterating our guidance range of 61 to 63% for the full year 2025. Turning to cash, we finished the quarter with an $8.1 million cash balance, representing cash usage of $600,000 during the second quarter.

Speaker #5: Driven by lower net losses resulting from higher revenues, sustained gross margins, and disciplined operating expense spending. From the net loss, we removed non-cash-related items of $600,000, driven primarily by stock compensation expenses and depreciation.

Speaker #5: Our working capital was higher in the quarter, driven by inventory replenishment and timing of accounts receivable collections. We also had an investment in the quarter for manufacturing equipment, related to our new products.

Speaker #5: Looking at our cash usage strategy and trajectory over the past three years, we've made significant progress in reducing our cash consumption. We improved from $5.9 million in cash usage in 2023 to $1.9 million in 2024.

Speaker #5: With the majority of our significant infrastructure investments behind us, we continue to trend favorably. Cash usage for the first half was $1.5 million, and for the second half of 2025, we expect our usage to be neutral to positive.

Speaker #5: Putting us on track to achieve our goal of positive cash flow from operations for the full year 2025, and ending the year with at least $8.1 million in cash.

Speaker #5: Our first half financial highlights demonstrate strength across our P&L. Revenue grew 19% to $19.8 million compared to $16.6 million in the first half of 2024, with a corresponding operating expense increase of 3%.

Speaker #5: This demonstrates our ability to run a disciplined capital allocation process, and edge closer towards profitability. Gross margin remains strong at 63.1%, down 50 basis points year over year.

Speaker #5: Our adjusted EBITDA improved 101% to be slightly positive, compared to a negative $1.3 million in the first half of '24. And adjusted earnings per share of $0.00 per share, versus a loss of $0.00 per share in the same period last year.

Speaker #5: Looking ahead, we are raising our revenue guidance to $39 and a half to $40 and a half million. Representing 18 to 20% growth. An increase from our prior range of 30 and a half to 39 and a half million.

Speaker #5: Driven by significant opportunities for further growth from pre-filled conversions, internationally, partially offset by an expected inventory reduction. From a large distributor in the US in Q3.

Speaker #5: We are reiterating our gross margins in the range of 61 to 63%. We anticipate gross margin pressures from the first half to second half, driven by a onger mix of growth and international markets, with lower average selling prices.

Speaker #5: In addition to supply chain inflationary entire pressures. We expect pricing and manufacturing efficiencies to mitigate some of these unfavorable impacts. For cash flow generation, we are reiterating our expectations.

Speaker #5: Of positive cash flow from operations for the full year 2025, we anticipate operating expenses exclusive of stock compensation in the range of $26 to $27 million.

Speaker #5: With higher operating expenses spent occurring in the second half of 2025. Driven largely by R&D project work. Additionally, we still expect less than $2 million of investing activities in capital expenditures for new production lines.

Speaker #5: I'll now turn the call back over to Linda, for some closing commentary on future milestones and our vision for continued growth.

Speaker #4: Thank you, Tom. We're very pleased with our second quarter performance, and the momentum across all of our strategic growth pillars. Our strong results, expanding pipeline, and profitability trajectory demonstrate the strength of our business model, and the significant opportunities ahead.

Speaker #4: Key milestones ahead include advancing our phase two flow controller and next-gen pump submissions, continuing our international expansion with focus on the pre-fill opportunity, and pipeline progression with expected filing of three new drugs by Q1 of 2026.

Speaker #4: As for the longer-term vision for company, our goal is to sustain plus 20% growth through investments in core international and new product and new drug pipeline initiatives.

Speaker #4: 2025 has been a pivotal year in setting that foundation. To close a few key takeaways that we believe make KORU a compelling growth story.

Speaker #4: We delivered another strong quarter, with revenue growing over 20%, fueled recurring core revenue and continued patient growth in our core IG business, further strengthened by international expansion.

Speaker #4: We are starting to see the tailwinds of macro trends favoring subcutaneous delivery. Our pipeline of 10 new drugs with more on the horizon meaningfully expands our long-term opportunity.

Speaker #4: Our RAISE guidance reflects the confidence we have in our strategy and execution. And finally, a sincere thank you to the entire KORU team, for showing up with purpose and passion every day to help patients around the world.

Speaker #4: Operator, please open the line for questions.

Speaker #1: Thank ou. We will now be conducting the question and answer session. If ou'd like to ask a question, please key in star, and then one on your telephone keypad.

Speaker #1: You may key in star and then two, to leave the question queue. For participants making use of speaker equipment, it may be necessary to keep your handset, before selecting the star key.

Speaker #1: Our first question comes from Frank Tegenen, of Lake Street Capital Markets. Please go ahead.

Speaker #6: Great. Thanks for taking the questions. Congrats on this all quarter and, and guide up. I was hoping to start with the guide, looks looks like you flowed through the, the beat, looks like you've got good momentum in the core business, OUS is clearly trending favorably as well.

Speaker #6: I'm just curious if you could kind of parse out expectations, domestic versus OUS, and then maybe cadencing Q3 versus, Q4 expectations.

Speaker #4: Yeah. Hi, Frank. Thank you. we're very pleased with the quarter and obviously in the, momentum we expect with the million-dollar raise in the overall guidance range.

Speaker #4: what I would say on, the guidance range is obviously the international is driving, tremendous growth for us, we expect that to continue at an even an accelerated pace in the back half, offset by what Tom talked , on the, US side.

Speaker #4: I'll turn it over to Tom for further comments on Q3 versus Q4.

Speaker #7: Yeah. Hi, Frank. Yeah. So, Frank, the way, the way we're looking at our business is, you know, with the million-dollar raise as, as Linda mentioned correctly, most of that, most of that raise we will see in ur international markets, we're eing some really nice, revenue growth with the pre-filled opportunity that we, both recognized in our prepared remarks.

Speaker #7: And so you can expect really steady and strong growth outpacing what you've seen in the first two quarters. And then, as Linda mentioned, domestically, we did receive some word from a large U.S. distributor that they are going to implement an inventory reduction program here in Q3.

Speaker #7: So we see a little bit of, of, of drop-off in Q3 from that, but then we should e it bounce back up, in, in Q4.

Speaker #7: And then on the, on the PST side, we continue to see, you know, stable growth on our PST, which is our clinical trials and services business.

Speaker #7: So you can expect more of what you saw the first half of the year. in the back half.

Speaker #6: Got it. That's helpful. And then maybe just to follow up on kind of something you ys both referenced, pre-filled syringes in Europe, I know that's just getting started and that's a, a large growth opportunity.

Speaker #6: So any, h, incremental color you can provide on what's driving that success and then, kind of how we should ink about the, durability of that, that growth and, and how, how large of an opportunity that can be for you guys.

Speaker #4: Yeah. So, on pre-fills, quite excited to see that really, taking shape this quarter. but just to describe the broad opportunity, pharma is converting their drug, specifically our IG partners, from presentation in a vial to a pre-filled syringe.

Speaker #4: Our Freedom Systems, works perfectly with the pre-filled syringe, and that the patient puts that syringe in the pump, closes the device, and you're ready to perform your infusion.

Speaker #4: So it cuts out a number of the steps more than a 40% reduction, and plus 75% patient preference for pre-fills. So what's driving the international opportunity is the, you know, our share position has historically been in the 10 to 15% range in Europe.

Speaker #4: and what we see is as the pre-fill market converts to pre-fills, that we are the preferred device. And so that conversion you're seeing now is, is just one country that we've verted, and that's reflected partially in our Q2 results.

Speaker #4: We expect to see more in the back half. And we're working now with, all of our pharma partners, but one in particular on their pre-filled syringe conversion program.

Speaker #4: we believe there are several more markets, that we can convert, into '26, and then with our new pump opportunity, in, you know, we expect to be launching with them by the mid of '26, and several new markets around the world.

Speaker #6: Got it. That's helpful color. I'll stop there. Thank you. Congrats again.

Speaker #4: Thank ou.

Speaker #1: Next question comes from Chase Nickelbacher, of Craig Helm, please go ahead.

Speaker #8: Good afternoon. congrats on the nice quarter here, and, thanks for taking the estions. maybe just to follow up on something Frank asked there. In that one market, I might have ed this, Linda, sorry.

Speaker #8: In that one market that has converted, internationally, what is, what, what is or what do you expect your market share to be there? kind of compared to that market share rate that we, that you just kind of shared in Europe.

Speaker #4: Yeah. So we know that, our share position coming into the year was probably somewhere between 10 and 15 percent. We think now it's, it's in the low 20 percentage, that market is a top five market.

Speaker #4: in Europe, and we believe there are, you ow, four or five other markets that, that we can go to, for further conversions. So, we're, we're just getting started.

Speaker #4: We 't think the conversion is fully complete. You'll see more on that, which is giving the, as the confidence to, to raise our guidance, by the million-dollar range, due to what we, anticipate will be further conversions in the back half.

Speaker #8: Got it. And so that is that, is that low 20s numbers, are you, are you saying in Europe? Are you, ou're, you're saying in that market specifically, right?

Speaker #8: And so gen five.

Speaker #4: We're ing on.

Speaker #8: Market share?

Speaker #4: Yeah. I'm saying, overall in Europe, we 't have yet all of the details on, exactly how much we have in that particular market. whether that is brought in as to, we just 't have that range for that particular market yet, you know, the team will be In Europe and working more closely with the pharma partner to figure that out, over the course of the next couple of months.

Speaker #4: What we do know is.

Speaker #8: Yeah.

Speaker #4: A lot of, a lot of obviously untapped opportunity. We know that that market in particular was one where our share position was probably lower than most.

Speaker #4: it's where we faced our biggest competitor in electronic pumps. so it, so we feel good about that first market. And more to come.

Speaker #8: Got it. Thanks. just on, domestic SEIG market in the quarter, can ou share what, the growth rate was and kind , you know, any commentary you're aring about kind of how, your pharma partners are thinking about the remainder of the year for the SEIG market in the US?

Speaker #4: Yeah. I would say we've seen the growth rates continue in that high single-digit, low double-digit range through the first half of the year. We look at who has reported thus far in IG; they're all reporting strong double-digit growth in their SEIG franchises.

Speaker #4: So we're ouraged by that. and that has really just, we continue to see, further new patient starts on SEIG, which is really driving a lot of growth.

Speaker #4: We continue to see new patients being diagnosed, and then finally, we know that there is a trial occurring now for secondary immunodeficiency, which has previously been a very strong driver in Europe for SEIG.

Speaker #4: And, when that trial is concluded, we believe we'll be another growth driver for the SEIG market in the US.

Speaker #8: Got it. And, maybe last couple from me, maybe just on the, consumable delay. Can you just speak to specifically, you ow, what kind of, what kind of product design elements you're looking to add to that, that, that kind of caused that delay?

Speaker #8: and then kind of along the same lines, on the next-gen pump, what's, what's left to do before the submission there, you know, how kind of competent are you in that timeline late '25, early '26?

Speaker #8: Thanks.

Speaker #4: So, on the consumable delay, I, I think, this was a major shift in our consumables line. It was both, looking at two things. Number one was a dramatic improvement in comfort, which related to the needle technology.

Speaker #4: And the second was a big improvement in convenience. So reducing the number of steps required by the patient to perform the infusion, quite dramatically.

Speaker #4: just in, in showing this and regular research with our customers, with patients, and, and with our pharma partners, we just want to make a few tweaks to it that they, that we think will appeal, better to, the overall requirements in the market.

Speaker #4: So chose to take a, bit of a delay in that program. And again, I don't see that impacting our '25 or '26 revenues. so, excited for what we learned, and, we'll make those changes and progress forward.

Speaker #4: on the next-gen pump, you know, we're, we're, we feel very confident. we, we've had it out with, with, patients, with, with, specialty pharmacies, with, pharma companies, everybody's super excited about that launch.

Speaker #4: we don't see any major delays, at this point, we're through all of the major technical hurdles. and, you know, we, we believe touch wood that, by the end of Q1 at the latest, we'll, we'll be submitting for 510(k) approval.

Speaker #8: Thanks, Linda. Congrats again.

Speaker #4: Thank ou.

Speaker #1: The next question comes from Caitlin Cronin, of Tynacord. Please go ahead.

Speaker #9: Hi. Thanks so much for taking the questions, and congrats on a great quarter. You know, just, going off of the next-gen pump, just a reminder of, you know, why that is important, particularly for OUS, and then with the prioritizing that now, what is the timing of, of that clearance and, launch OUS?

Speaker #4: So, the next-gen pump, the importance of it is that with the launch of pre-fills, patients take multiple pre-fills with their weekly, dosing regimen. And in order to use those multiple pre-fills, they're all in different sizes.

Speaker #4: And in order for patients to do that today, what they're doing is sometimes using a pre-fill, and then they have to take a pre-fill and go into pull it into a different size syringe, or they could use two different pumps.

Speaker #4: So just in explaining it, sounds complex. So our new pump will work with any pre-fill available on the marketplace. To, you ow, they go from 5 mLs to 50 mLs, and it will also work with any vial or pre-fill.

Speaker #4: It also has, expanded mobility, dosing window, ease of use. So, very excited about that, and, and the value prop is, is, very strong. Regarding, timing, we expect to submit for US 510(k), as I've id, and then EU, we would follow one quarter beyond that.

Speaker #4: So we're anticipating, filing in the EU by mid of 2026.

Speaker #9: That's great. And then, you know, with the, tariff impact fitting, just any updates on the expectations of that and, and, the cadence and how you're igating?

Speaker #7: Yeah. Hi, Caitlin. I can, I'll take that one. Sure. So, so the, what, with respect to the tariffs, our, our largest, supplier that has the large, that has the est, impact on tariffs is, our third-party contract manufacturer.

Speaker #7: We have, we've looked at their bills and materials, and we've worked with them to really understand the impacts from a, you know, a materials perspective, where the, where the materials came from, and what the actual tariff impact was from the value add from that, from that contractor.

Speaker #7: And it's, you know, when we look at our business over the full year, it's about a $90 bips impact, which is, you ow, roughly 2% on every order.

Speaker #7: That's how detailed we were, looking that. So we feel pretty, pretty strong that we have that under control. in terms of just mitigation, you know, we're, we're constantly doing operate, operational excellence programs in our own facilities.

Speaker #7: Looking at ways to, to create efficiencies through our volumes. And also, certain programs for rebates from vendors, c. As we grow our, our company, and we continue to see increases in volumes, we're able take advantage of some of those volumes.

Speaker #7: And some of those efficiencies through that process. So, so we feel pretty good that we have everything under control from a tariff-related standpoint.

Speaker #9: That's great. And maybe just one more, you know, confidence on, that distributor impact in the US is really going to be just a, a Q3 event.

Speaker #7: Yeah.

Speaker #4: Yeah. maybe I'll start and then turn it to Tom. we look most importantly, at our volumes relative to what we call our end-user demand.

Speaker #4: So we have, data on what those distributors sell to our end-user specialty pharmacies. That demand is very, very strong. So then we can deduce how much inventory they're carrying, and we know that based upon our demand and the overall market growth, that we feel quite good about the end-user demand being sustained.

Speaker #4: So, you ow, a one time, they're overall company goal to reduce a week of inventory. You know, we'll take a small hit in the, in the third quarter, but won't impact us, that much relative to some of the other growth drivers.

Speaker #4: I.E. international that we talked through.

Speaker #7: Yeah. Just to add on to what Linda's saying, Caitlin, our distributors, they keep their own safety stocks. And they keep their own inventory levels, and, and sometimes they reduce them.

Speaker #7: They have initiatives to reduce them. They still service our customers, but if they're carrying, let's say they're rying four weeks, they might choose to carry three weeks during a particular period.

Speaker #7: So we just react to that. Because at the end of the day, we sell to distributors, and that's the sales that we record. So, that's the, the reason for the Q3 debt that I mentioned earlier.

Speaker #9: Got it. Makes sense. Thanks for taking the estions.

Speaker #4: Thanks, Caitlin.

Speaker #9: Operator? Operator, we can move to the next in queue.

Speaker #4: Hello?

Speaker #9: Operator, are ou ? Sorry to our audience. The operator says she's reconnecting, just a moment.

Speaker #10: Okay, folks. We will definitely

Speaker #4: be asking for a refund on this call. I ink we're just holding patient while we're waiting for operator.

Speaker #1: Apologies. We'll take next question. It's from Jason Bednar of Piper Sandler. Please proceed with your estion.

Speaker #11: All right. Congrats on a nice quarter, everyone. looks like you're expecting positive cash generation in back half of the year here, Linda, and Tom.

Speaker #11: That's good to see. I, I ess, how are you thinking strategically about cash from here now that 're kind of in that cash generation mode?

Speaker #11: Are you going to build a cushion first? Are you thinking reinvesting in the business to sustain that strong top line, or, or maybe even accelerate it?

Speaker #11: And if it's the latter, do you see this more as an R&D push or an SG&A type investment? Any color there would be great.

Speaker #4: Thanks, Jason, on the congrats on the quarter. so regarding, capital first, we're, we're viously thrilled that we, we hit the, cash flow positive, in this quarter, and, and the outlook for the remainder of the year, which, as we mentioned, is kind of the combination of both the top line revenue growth and the gross margin.

Speaker #4: But we started, I would say, about a year and a half ago to really tighten in our capital allocation and look at the balance of our portfolio in both short and long-term opportunities.

Speaker #4: what we see behind us are the big capital big investments in infrastructure and people and teams, which is why you saw the cash burn come down.

Speaker #4: And now moving forward, we have a, very good operating model where our partnerships with pharmaceutical companies and our agreements with, key counts, allow us to have a fairly low SSG&A.

Speaker #4: So as we move forward, we will absolutely look at every opportunity for growth. we, we obviously feel that most of those investments will be in SSG&A.

Speaker #4: And we're fortunate in that most of them are, one-year payback, which allows us to maintain that $8 million cash balance is how we're inking about it.

Speaker #4: but if we see big opportunities, you know, outsized growth for international opportunities, you know, ose ones pay back quickly. you know, oncology pilot, let's see where that one goes.

Speaker #4: but, but that could be another opportunity those would be opportunities where, you know, we, we would look to say, what can we either with what's in, in debt or, or otherwise, to pursue those.

Speaker #4: But we feel good about our cash position and ability to maintain that growth above 20% with what we have today.

Speaker #11: All right. That's, that's helpful. And, a nice segue into my, my follow-up question, Linda. You know, so we are getting closer and almost real-time tapping into this new pipeline with new drugs, expanded indications.

Speaker #11: What's the right way to think about the commercial uptake of that pipeline? Is it, you know, is it more of like a linear adoption curve?

Speaker #11: Does it take more of a hockey stick type approach? You know, I think 're all going to try and figure out how to, how to model these as they get, you know, become more real and move further down the path.

Speaker #11: But how would you have us think , those collectively?

Speaker #4: Yeah. I would say that, we tried, hard to give now a number of, potential, total infusions. Of course, that doesn't represent our opportunity. We'll try and give an indication.

Speaker #4: I believe I mentioned on the last call that the two products we are pursuing on our own, vancomycin and dexteroxamine, will be about half a million dollars next year.

Speaker #4: similar numbers for the two, the empaveli and the, rare disease indication next year. So, probably next year, between those two, just shy of a million dollars and upside.

Speaker #4: and then you'll see kind of a similar linear progression over the course of the years. I would say the big pops that we see, would obviously be oncology if that one occurs, given the overall size of that market.

Speaker #4: we're excited that we're in clinics, but, obviously, the value prop, is proving strong here. but more work to do in terms of reimbursement and economics around that one.

Speaker #11: Okay. Very helpful. Thanks so much.

Speaker #4: Thank ou, Jason.

Speaker #9: Operator, we can e the next question.

Speaker #11: The next question is from Anderson Shock of B Riley Securities. Please proceed with your question.

Speaker #12: Hi. Thank you for taking the questions and congrats on the really strong quarter and positive adjusted EBITDA. So with the Japan launch expected to generate revenue in the back half of the year, I guess, how should we think about the back half for international growth?

Speaker #12: Is 30% still the target for 2025? It looks like if you remain flat sequentially on international revenue, you'd be closer 50% growth year over year.

Speaker #12: Is there any seasonality we should thinking about in the back half?

Speaker #4: Yeah. Maybe I'll just touch on Japan and then I'll turn it to Tom for some of the more detailed questions on international. so overall in Japan, we still believe that it is a top 10 IG market.

Speaker #4: We're excited. SEIG is just getting started there. we just recorded our first sales. it is included in the guidance that we see, but we see a bigger impact, in Japan, for 2026 than 2025.

Speaker #4: Tom, maybe I'll it to you for the specifics around growth on international.

Speaker #7: Yeah. Anderson. So if you, if you think about the back half, you know, as we mentioned, we've, we've had a very strong front half of about 35 or so percent growth.

Speaker #7: You can expect that to increase significantly over that, over that number. As we mentioned, that when, when we think about the million-dollar increase, I'd say that's primarily all into the, into the international business.

Speaker #7: So as ou think about your model, and, where, where that goes, I would say you'd want to layer that into Q3, Q4. Almost evenly across the international business.

Speaker #11: Okay. Got it. And then on the last call, you mentioned you anticipate another order from the first quarter's tender win in the back half of the year.

Speaker #11: Do you have any updates on the timing or size of this?

Speaker #4: I would say it is included in the guidance that we provided. We do have visibility to it. I, I'm not going to give the exact numbers, but I say the, what we saw start to be fulfilled, in, in quarter two, we saw, we'll see equally strong orders in, in the back half of the year.

Speaker #11: Okay. Got it. And then on the pharma services and clinical trial side, I guess, what drove this increase? Is this just one-time NREs, or should we expect to see this quarter's revenue kind of as the new norm?

Speaker #4: Yeah. I would say, I would not expect this quarter revenues to be the norm. it was driven by, what we mentioned in the remarks, which is, clinical trial orders for a non-IG drug, which is encouraging for us.

Speaker #4: Those clinical trials generally mean the drug is in a clinical trial, and, and we'll, that one in particular is in a phase three. So we'll get a clearance soon.

Speaker #4: I think what we said about pharma services, Tom had mentioned in a prior question, is we, you can anticipate front half and back half revenues for PST to be about the same.

Speaker #4: Possibly a little bit of upside if we get more opportunities then, than we're currently anticipating.

Speaker #11: Okay. Got . Thank you for taking our estions and, good luck on the refund.

Speaker #4: Thank you so much.

Speaker #11: We have reached the end of the question and answer session, and I'll hand the call over to the CEO, Linda Tharby, for closing remarks.