Q1 2025 KORU Medical Systems Inc Earnings Call

A brief question and answer session will follow the formal presentation.

If anyone should require operator assistance during the conference <unk> zero on your telephone keypad. As a reminder, this conference is being recorded does now my pleasure to introduce your host MS. Lewis Smith Investor Relations. Thank you Ms. Smith.

May begin.

Speaker Change: Thank you. Thank you and good afternoon, everyone. Joining me on the call today are Linda Barbie, President and CEO of <unk> Medical systems, and Tom Adams, Chief Financial Officer.

Speaker Change: Earlier today cover released financial results for the first quarter ended March 31st 2025, a copy of the press release is available on the company's website.

Linda Tharby: So now that pharma partner is now pursuing active penetration outside the U.S. They have launched their platform into several markets. And so we're starting to see early uptick. And the big potential that we see here is that electronic pumps, which as you know, are the standard of care in Europe, do not work with pre-filled. You can't put a pre-filled directly into an electronic pump. You've got to transfer it into a specific syringe for use with that system. So we see potential for further upside. We don't have it. numbers or visibility on that yet, but that is certainly part of what you see in our confidence in our total OUS expansion plan over the next several years.

Speaker Change: I encourage listeners to have our press release in front of you, which includes our financial results as well as commentary on the quarter.

Speaker Change: 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 Change: During this call we will make certain forward looking statements regarding our business plans and other matters.

Speaker Change: These comments are based on our predictions and expectations as of today.

Speaker Change: 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 Change: We assume no obligation to update any forward looking statements during.

Linda Tharby: And obviously our new pump, maybe just, I'll add one other comment, which is our new pump that we're launching in the early part of next year, filing at the end of this year, will be a big driver to that international expansion effort as well. Great, and just to follow up on that one, you will have to get the new pump approved everywhere OUS where you're already distributing correct. Yes, but recall that our current pump does work with prefills. It's just does not work with all of the prefilled range. Our new pump will work with all of the prefilled.

Speaker Change: During the call management will also discuss certain non-GAAP financial measures you will find additional disclosures, including reconciliations of these not non-GAAP measures with comparable GAAP measures in our press release, the company Investor presentation, and SEC filings for the.

Speaker Change: Of those listening to the replay this call was held and recorded on Wednesday May seven 2025 at approximately 430 P M Eastern time.

Speaker Change: Since then the company May have made additional comments related to the topics discussed I'd now like to turn the call over to Linda <unk>, President and CEO Linda. Please go ahead.

Linda Tharby: Got it. Okay.

Thomas Adams: And then just a quick one on tariffs. I believe, I think most of your production of consumables is OUS. I mean, how did you factor that into the tariff kind of guidance? Yeah, thanks, Caitlin, for the question. So, yeah, as you know, most of our raw materials and components are of U.S. origin. We do send them down to Nicaragua. There is some value added onto those products, and then, you know, we purchase those products back from Nicaragua. So you have to net out the products of U.S. origin, and that was part of our factor. We did a lot of analysis looking at our complete supply chain of any parts that were non-U.S.

Speaker Change: Louisa and good afternoon, everyone and thank you for joining us on today's earnings call.

Speaker Change: I'll begin today with an overview of our strategic progress and first quarter highlights after that Tom will walk you through our financial performance and updated 2025 guidance. We'll then open the call for your questions. We had a great start to the year delivering strong results and continued growth revenue for the quarter reached nine.

Tom: Point 6 million a record for the company, representing an 18% increase over the prior year.

Tom: This performance reflects the ongoing strength of our core business, which grew 21% in the quarter driven by a solid base of recurring revenue continued success in new patient starts increased market share and deeper penetration into both new and existing geographies.

Thomas Adams: We calculated, after reviewing all that analysis, we calculated just under 100 bases. I'm what we know today with Tara. Awesome. Thanks so much. Thank you.

Tom: I'm also pleased to announce that we plan to submit two additional commercialized drugs for five 10-K clearance for use with the freedom infusion system by the end of 2025. This brings our total pipeline to five planned submissions in 2025, two for new devices and three for new drug indications.

Chase Knickerbocker: Next question comes from the line of Chase Knickerbocker with Greg Halub. Please go ahead. Hi, good afternoon. Thanks for taking the questions and congrats on the progress here.

Tom: As we continue to focus on operational efficiencies, we reported gross margin of 62, 8% an improvement of 50 basis points compared to the same period last year.

Linda Tharby: Just first from me, as we think about international markets, Can you kind of give us an update on where you're at with kind of the overall e-pump opportunity and, you know, any additional conversations and progress that you and your distributors have made in Q1, and is there any read-through to kind of obviously the strong quarter and respect the distributor dynamics there, but any kind of read-through into, you know, them expecting some increased demand from that channel? So, I think when you refer to the e-pump opportunity, Chase, you're referring to opportunity for increased volumes of our consumables with e-pumps, which is certainly driving part of our first quarter in that we saw some demand from opening up new markets and share gains, which was a big part of it.

Tom: Given our strong first quarter performance and increased visibility into the remainder of the year. We are raising our 2025 guidance to a range of 38 five.

Tom: $39 5 million, representing a 15% to 17% year over year growth.

Tom: We're also reaffirming our full year gross margin target of 61% to 63%, which is inclusive of our most recent analysis of the current global tariff situation and its impact on our supply chain and cost of goods sold.

Tom: We're also reaffirming our expectation to generate positive cash flow from operations in 2025, Tom will provide further details on our financial performance and updated guidance later in the call. We're off to a strong start in 2025 with solid execution across our strategic priorities.

Linda Tharby: But also a big part had to do with our complete system, which was the pre-filled win that we're quite excited about because it's got a lot of legs there. So, the total e-pump opportunity we see as being You know, to date, our consumable share is very low associated with e-pumps. And we have technical data that shows that our consumables work very well with all e-pumps. And so we're riding that success and our partnership with our IG companies and our new consumables launch in early 2026, we think will help us gain even further share with use with e-pumps.

Tom: The strength of our core business are expanding new drugs on label pipeline and our operational discipline continued to drive both growth and value creation, we are well positioned to deliver on our commitments and advance our leadership in the market.

Tom: Before I get into performance across each of our growth pillars I want to touch on core strategic vision and our plans to evolve as a company today.

Tom: Today, we are the global leader in large volume <unk> drug delivery supporting the at home infusion needs or approximately 45000, chronic and recurrent patients each year.

Tom: We successfully built and continue to expand the space business as the overall SCID market maintains robust underlying growth our leadership in <unk> has built a reliable growing foundation and we are equally focused on accelerating <unk> growth through new opportunities with.

Linda Tharby: Thanks, Linda. And as we're looking at the oncology opportunity, good to hear about the pilot sites. What are you kind of waiting to hear there before it's kind of all systems go? And can you speak to, you know, any other early work that you've done around, you know, call it the unique economics that are within the oncology clinic and kind of how that differs from, you know, how we're used to thinking about your products? So, first and foremost, we're going to think about safety and efficacy with use of our product in those clinics and centers, and thus far, with the work we've done so far, we feel very positive about that.

Tom: We're actively expanding our platform to support subcutaneous through Liberty of additional large volume drugs.

Tom: As more pharmaceutical companies ship formulations from IV to subcutaneous, we're well positioned to be their partner of choice with our successful track record of bringing subcutaneous drugs to commercialization.

Tom: Currently have nine active collaborations with new drug therapies, and see a significant opportunity to expand further.

Tom: These current and future collaborations will expand our addressable market and overall revenue potential.

Tom: This dual focus of our strategy on strengthening the core and growing through new drugs on label supports our long term vision.

Linda Tharby: When I speak about the positive economics, there are really two factors here. Number one is the strong feedback that we are receiving is that the workflow efficiency, i.e., I may be able to see more patients than one at a time, because I'm not needing to manually push, I'm administering with a pump, I may be able to expand my efficiency and flow of patients through the center. The second thing that we see is there is a reimbursement code. If you do a manual push, it's X dollars. If you do it with a pump, it's Y dollars.

Tom: With that I will now move on to our three pillar strategy and our progress this quarter.

Tom: Starting with our domestic core business grew 16% year on year, marking our sixth quarter of sequential growth and share gains.

Tom: The <unk> market overall grew approximately 10% in Q1, and we continue to expand our recurring revenue base through both new diagnosis and conversion of accounts internationally, we achieved 36% growth driven by both patient growth and new distributor relationships in the middle East and North.

Linda Tharby: Y dollars are much higher than with a manual push. So, we feel there could be an economic benefit for every infusion that the center also gets higher dollars. So, overall, you're seeing increased patients through the center and higher dollar revenue per patient you see through the center. So what are we really looking to see? Safety and efficacy, right? Make sure that we do a lot of good in those centers on our value prop. And then second is just confirming out that economic value prop. that I just.

Tom: Africa.

Tom: We also expanded our presence with an established EU markets through a key pre filled syringe tender win with a major pharmaceutical partner in the region.

Tom: One is a milestone for the company as we were selected for the business and whereas historically and E pump dominated market. We anticipate further opportunities as we continue to collaborate with the pharma partner on their O U S Prebuilt conversion program.

Tom: Moving to new drugs on label through our PFT platform. We have 15 collaborations in our pipeline that have the potential to be added to the freedom system in the near to long term as I mentioned on the last slide we are pleased to announce that we were planning to submit for five 10-K clearance on two already commercialized drugs.

Linda Tharby: And will it take some time to kind of prep a partner or will, you know, will that be a pretty quick process once you do kind of make the call it all systems go kind of decision? Yeah, so part of the pilot sites is obviously seeding oncology centers now, and these are big-name oncology centers that we have included in our pilot sites. So we have a distribution partner already lined up and ready to go. They've been supporting us and working with us, and they do a lot of work in oncology infusion centers, so we feel very good about that.

Tom: One for Iron Chelation and one on she biotic by the end of the year.

Tom: Working with our specialty pharmacy customers our team identified that both of these drugs, while not in our label, we're being used with the freedom system by health care professionals for at home administration.

Tom: We will be pursuing on label clearance, which we believe has the potential to have a 2026 full year impact on revenue.

Tom: These additions bring our total drugs that will be submitted for clearance. This year to three as the two new drugs joined the rare disease biologics that we announced earlier in the year.

Linda Tharby: And, of course, we've had the pharmaceutical partner lined up and ready to support our efforts as well.

Chase Knickerbocker: And maybe the only other piece is obviously we want to publish on the data that we see out of these sites, we think that will be important for widespread adoption in the U.S. Got it, thank you.

Tom: With the addition of these two drugs, we now have nine commercial opportunities spanning the end of 2025 to the end of 2026 and our pipeline we.

Tom: We continue to execute on both our robust core business strategy and the many new drug catalysts on the horizon.

Chase Knickerbocker: Thank you. Next question comes from the line of Jason Bednar with Piper Sandler. Please go ahead. Good afternoon. Nice start to the year, everyone. I want to just have a couple follow-ups from prior topics. On the international side, that was definitely the star of the quarter where a lot of the outperformance came. Really just going to rattle off a few here, I guess, just so we can maybe dial in the cadence for that segment here, the balance of the year. First, are you sizing that tender benefit? I don't think I heard it in the first quarter or the, I think you said the second quarter.

Tom: As we discussed on our last call 75% of our revenues are recurring from a chronic patient.

Tom: Patient base.

Tom: Hey that basis, 45000, plus patients with over 2 million annual infusions growing about 15% per year as we continued to gain share. We're confident in this demand as an underlying source of growth given the market has consistently expanded over the last two years and again this quarter.

Tom: We remain very positive about this core base of revenue and its potential given the chronic nature of immuno deficiency diagnosis and resilient market growth even in the face of macroeconomic uncertainty for our patient base.

Jason Bednar: Contribution as well. And then, Tom, I think you mentioned in response to Frank's question that revenue growth for internationals should trend Around or at or above, maybe, you know, that 30% level throughout the year. Maybe help me out there because you got some funky comps. You know, just from the prior year and you're trying to understand is that that segment has is performing well, just so we get it get it right. As we move throughout the year. And then final thing on international just maybe how much we should be thinking about for incremental contributions in Japan.

Tom: On the next slide you'll see that our international business continues to outperform expectations and grow rapidly as we expand into key markets outside the U S.

Tom: The total international SCID Tam is estimated at $60 million with coral currently holding approximately a 10% share.

Tom: Our goal is to grow our share to 30% to 40% over the next several years by deepening our presence and capitalizing on emerging opportunities.

Tom: <unk> 23, and 24, we achieved 32% growth and we expect to maintain that momentum through 2025. This confidence is driven by several strategic initiatives, including expanding into top 10 markets, where our presence is currently limited, but the upside potential is high.

Linda Tharby: So let me maybe start with sizing the tender benefit and the incremental on Japan, and then I'll turn it to Tom to talk about how you might think about the quarterization and go out over that international piece again. So overall, what we saw in the first quarter was the buy-in for the initial win on that prefilled syringe tender. We anticipate we are going to get another order in the back half of the year related to that tender win, and we hope, Jason, to be getting more wins in other areas related to prefills. We think we're just getting started there.

Tom: Growing our addressable market through strategic device partnerships for example, with our new pump technology.

Tom: Expanding our consumable usage with the electronic pumps and capitalizing on the growing trend pre filled syringes as we have successfully done here in the U S.

Tom: Well this is a multi year growth strategy, we are already leveraging our pharma partnerships to accelerate market entry and share capture abroad. We believe this will support sustained growth across our international business.

Thomas Adams: We think that is a multi-year opportunity. Second, on Japan, we have gotten full clearance now on our complete system, and we have got a distribution agreement in place with a new distributor in Japan, and we anticipate that our sales will really start to uptick in quarter two of this year. And thus far, we're not planning on any increment, knowing it's taken us a little bit longer to get the actual commercial volumes. If we got further sales in Japan this year, that would be upside to our current international And then, finally, on the quarterization on the international, I think the number was 30% on the full year that you can anticipate, and that quarter two would be impacted a little bit in terms of that growth percentage given the dynamic of we think some pull forward due to the dynamics Tom discussed from Q2 into Q1.

Tom: Now turning to our pipeline slide.

Tom: For new drugs, it's more robust than ever with 17 total opportunities, including 15 active collaborations with pharmaceutical partners.

Tom: The two additional opportunities come from the prior mentioned iron chelation, an antibiotic drug programs, which we are pursuing independently without a pharma partner for inclusion on our label.

Tom: Of the 17 total opportunities nine have commercial potential by 2026, which is shaping up to be a pivotal year for our pipeline strategy.

Tom: Let me highlight the key the five key pipeline development you see on the slide.

Tom: First we recently received clearance for our freedom 60 system with all drugs in Japan as one of the top 10 global markets. This represents a meaningful opportunity to expand our international footprint.

Tom: We've already established distribution and are actively working with our pharma partners on our market entry and growth plan.

Tom: Second we saw the successful completion of the phase III trial within our nephrology collaborations.

Linda Tharby: So, Tom, I'll let you get more specific on that. Yeah, just to get a little bit more specific, with your, with respect to your question on the council. Also, Jason, you know, last year, if you recall, too, we had this BSI regulatory issue, which does impact the comps where we saw some stocking in the first quarter, we saw some stocking in the second quarter, and that plays into some of the quarterly growth numbers. But what I would say is that, you know, we start off the year strong with the 2.4 that you saw there. Certainly, that 400,000 of that, I would say, would be pull-aheads for stocking of those that tender market as well as some new markets that we've added.

Tom: This program involves an expanded indication for a drug already approved for use with the freedom system. Upon FDA approval it will be eligible for immediate use with our pumps.

Tom: The addressable patient populations and number of them annual infusions are smaller compared to other programs in our pipeline. We're enthusiastic about this additional shot on goal and our new drug strategy.

Tom: Third we have made very good progress with our planned entry into the oncology infusion clinic market. We've established a U S Advisory board with leaders from major oncology infusion centers.

Wanda: you see on the slide. First, we recently received clearance for our Freedom 60 system with all IG drugs in Japan.

First we recently received clearance for our freedom 60 system with all IGT drugs in Japan as one of the top 10 global markets. This represents a meaningful opportunity to expand our international footprint.

Tom: We are actively engaged distributor partners and this quarter. We are set to begin with five pilot sites, where we were further validates the value proposition of increased efficiency using the freedom infusion system.

Wanda: As one of the top 10 global markets, this represents a meaningful opportunity to expand our international footprint. We've already established distribution and are actively working with our partner partners on a market entry and growth plan.

Thomas Adams: But we, after Q2, we expect this to gradually grow and really see some nice growth towards the end of the year in international as those new markets really start to annualize. And we see the cruise of adding those new markets into the year. So a little bit of a topsy-turvy there, but we expect to be at that 30%. And maybe the only other comment I'd add to what Tom said is, to be very clear, given last year's distributor stocking and this year's, there was no impact on our international growth in the quarter due to that stocking.

We've already established distribution R&R I totally working with our pharma partners on our market entry and growth plan.

Tom: The potential for positive economic outcome.

Tom: All while improving nursing and patient satisfaction, we look forward to continuing to update you on our pilot type progress.

Wanda: Second, we saw the successful completion of a phase three trial within our nephrology collaboration. This program involves an expanded indication for a drug already approved for use with the Freedom System.

Second we saw the successful completion of the phase III trial within our nephrology collaboration.

Tom: Finally, we've added two new programs.

This program involves an expanded indication for a drug already approved for use with the freedom system. Upon FDA approval. It will be eligible for immediate use with our pumps well the addressable patient populations and number of them annual infusions are smaller compared to other programs in our pipeline. We're enthusiastic about this additional shot on goal.

Tom: Iron chelation antibiotic therapies, which we're advancing independently.

Wanda: Upon FDA approval, it will be eligible for immediate use with our pumps. Well-addressable patient populations and number of annual infusions are smaller compared to other programs in our pipeline. We're enthusiastic about this additional shot-on goal in our new drug strategy.

Tom: As mentioned earlier these additions were driven by strong demand from our specialty pharmacy partners, who view them as ideal candidates for delivery via the freedom platform.

Tom: Both drugs are administered by nurses in the home setting because these commissions are already familiar with our platform through <unk> therapies adoption barriers are expected to be low.

And our new drug strategy.

Linda Tharby: We had the same stocking event last year, if you read through the quarter one results. So it's really a quarter two impact that Tom was highlighting.

Wanda: Third, we have made very good progress with our planned entry into the Oncology Infusion Clinic Mark.

Third we have made very good progress with our planned entry into the oncology infusion clinic market. We've established a U S Advisory board with leaders from major oncology infusion centers we.

Tom: We're still evaluating the full commercial potential patient populations and underlying demand earlier early analysis suggest these drugs wanton label could add an incremental half a million dollars to 2026 revenue potential.

Wanda: We've established a U.S. advisory board with leaders from major oncology and fusion centers. We have actively engaged distributor partners, and this quarter we are set to begin with five pilot sites where we will further validate the value proposition of increased efficiency using the Freedom Infusion System.

Jason Bednar: Okay, that's all for me. And I'll come back one one more year, Tom, just maybe I'm, you know, just being difficult here. I am trying to understand, you say gradually grow. And I'm trying to, you know, put that against really strong growth. Are you saying gradually grow sequentially on an absolute basis? Or I guess I'm just trying to understand like what what that what you mean there and then I've got one follow up on tariffs. That's exactly what I mean. It's a sequential growth. So we'll see, we'll see a drop in Q2 and then we'll see sequential growth from there.

We are actively engaged distributor partners and this quarter. We are set to begin with five pilot sites well. We were further validate the value proposition of increased efficiency using the freedom infusion system.

Tom: Overall, we've had a strong start to the year demonstrating continued momentum in our core business progress across all strategic fronts and exciting new milestones in our pipeline with that I'll now turn the call over to Tom to walk you through the financials.

Wanda: potential for positive economic outcomes, all while improving nursing and patient satisfaction. We look forward to continuing to update you on our pilot site progress.

Potential for positive economic outcome.

All while improving nursing and patient satisfaction, we look forward to continuing to update you on our pilot type progress.

Tom: Thanks Linda.

Wanda: Finally, we've added two new programs. Iron Chelation Antibiotic Therapies, which we're advancing independently. As mentioned earlier, these additions were driven by strong demand from our specialty pharmacy partners who view them as ideal candidates for delivery via the Freedom platform. Both drugs are administered by nurses in the home setting. Because these clinicians are already familiar with our platform through IG therapies, adoption barriers are expected to be low.

Tom: Starting with our first quarter results, we had a strong start to the year delivering $9 6 million in revenues, representing 18% growth over the prior year period.

Finally, we've added two new programs.

Iron chelation antibiotic therapies, which we're advancing independently.

As mentioned earlier these additions were driven by strong demand from our specialty pharmacy partners, who view them as ideal candidates for deliberate via the freedom platform.

Tom: Our domestic core revenues were $6 9, million% to 16% increase over the prior year as well.

Thomas Adams: And again, Very similar pattern to last year, where we see a very strong first quarter and a very strong back end of the year. Okay. All right. Fair enough.

Tom: Our growth continues to outpace the overall.

Jean Marc: Jean Marc.

Both drugs are administered by nurses in the home setting because these commissions are already familiar with our platform through I G therapies adoption barriers are expected to be low.

Jean Marc: The performance was driven by new patient starts continue market share gains and strong pump and consumable volumes in.

Thomas Adams: And then on the tariff side, it's more of a clarification point. Tom, I think you said 100 basis point impact from tariffs. Is that a 100 basis point impact to 2025, or is that an annualized number? I guess I'm trying to understand, would gross margin guidance have been raised by 100 basis points this year if not for tariffs? Or is that, again, 100 basis points annualized, so we're looking more like 50 basis points of lift this year, if not for tariffs? Yeah, so that that's already in our guidance. So when I said it's actually under 100 basis points.

Jean Marc: In the international core business delivered strong revenues of $2 4 million representing growth of 36% over the prior year.

Wanda: While we're still evaluating the full commercial potential, patient populations, and underlying demand, early analysis suggests these drugs, once on label, could add an incremental half a million dollars to 2026 revenue potential.

We're still evaluating the full commercial potential patient populations and underlying demand earlier early analysis suggests these draws onetime label could add an incremental half a million dollars to 2026 revenue potential overall.

Jean Marc: Growth was driven by expansion into new geographies for key tender wins for us.

Jean Marc: <unk> revenues within our rhythm infusion system.

Wanda: Overall, we've had a strong start to the year, demonstrating continued momentum in our core business, progress across all strategic fronts, and exciting new milestones in our program.

Overall, we've had a strong start to the year demonstrating continued momentum in our core business progress across all strategic fronts and exciting new milestones in our pipeline with that I'll now turn the call over to Tom to walk you through the financials.

Jean Marc: Included in the quarter was approximately 400000 of distributor stocking to support our expansion, which compared to last year's first quarter distributor stocking order of about 300000, which you may recall was related to the BSA regulatory issue that were successfully clear.

Tom: With that, I'll now turn the call over to Tom to walk you through the financials. Thanks, Wanda. Starting with our first quarter results, we had a strong start to the year, delivering 9.6 million in revenues, representing 18% growth over the prior year. Our domestic core revenues were $6.9 million, a 16% increase over the prior year as our growth continued to outpace the overall.

Tom: Thanks Linda.

Tom: Starting with our first quarter results, we had a strong start to the year delivering $9 6 million revenues, representing 18% growth over the prior year period.

Jean Marc: From a year on year basis, instead of about a 1% incremental impact on our 2025.

Thomas Adams: So within my guidance of the 6163, we can accommodate that. And again, we're offsetting things with manufacturing efficiencies. We're seeing nice mix in our products. So we have a lot of things going on in margin with. Stronger sales outside of the US. We have tariffs, we have price increases, but we're managing through all those things. So I would say, to answer your question, Jason, all those things are inclusive in my 61 to 63% guidance. If it had not been for the tariffs, sure, we could do better on that. Okay, and that that number would then be closer to is it 200 basis points on an annualized basis?

Jean Marc: As we expand internationally, we are opening new markets with distributors, which makes the international quarterly revenues a bit uneven as distributors by initial stocking inventory.

Tom: Our domestic core revenues were $6 9, million% to 16% increase over the prior year as our growth continues to outpace the overall.

Tom: website at CIGMARC. The performance was driven by new patient starts, continued market share gains, and strong pump and consumable.

Tom: Right.

Jean Marc: We believe that this quarter stocking order, we will have an impact on our second quarter International numbers, and we will still be on a strong trajectory for approximately 30% growth on the full year.

Tom: Sure.

Tom: The performance was driven by new patient starts continued market share gains and strong.

Tom: Total volumes in.

Tom: In the International Corps of Business, we delivered strong revenues of $2.4 million, representing growth of 36% over the prior year. Growth was driven by expansion and some new geographies. Key Tenderwind for use of pre-filled syringes within our Freedom Infusion System. And including in the quarter was approximately 400,000 of distributor stocking to support our expansion, which compared to last year's first quarter distributor stocking order of about 300,000, which you may recall was related to the BSI regulatory issue that was successfully cleared. from a year-on-year basis, this had about a 1% incremental impact on our 2025.

Tom: In the international core business delivered strong revenues of $2 4 million representing growth of 36% over the prior year growth was driven by expansion into new geographies.

Jean Marc: Yeah.

Jean Marc: Pharma services and clinical trials revenues were 300000, representing a 39% decline over the prior year. This part of the business is nonrecurring and revenues are driven by customer timelines for services and clinical trial studies. The decline in the period was due to lower clinical trial orders as orders were pushed from Q1.

Tom: Key tender wins for us.

Tom: Pre filled syringes within our freedom.

Tom: Hmm.

Tom: And included in the quarter was approximately 400000 of distributor stocking to support our expansion.

Tom: Which compared to last year's first quarter distributor stocking order of about 300000, which you may recall was related to the BSI regulatory issue.

Jason Bednar: Yeah, I would say just under 150. Okay. Yes. Okay. Great help, Earl. Thank you.

Jean Marc: Into Q2.

Jean Marc: Moving onto gross margin performance first quarter margins were 62, 8%, a 50 basis point improvement over the prior year margin expansion was driven by favorable product mix during the quarter, we were continuing to implement operational excellence programs and our manufacturing to help offset the impact of lower.

Tom: That's very clear.

Tom: From a year on year basis, instead of about a 1% incremental impact on our 2025.

Anderson Schock: Next question comes from the line of Anderson Schock with B Raleigh Securities. Please go ahead. Hi, congrats on the strong quarter and thank you for taking the question.

Tom: As we expand internationally, we are opening new markets with distributors, which makes the international quarterly revenues a bit uneven as distributors buy initial stocking inventory. We believe that this quarter's stocking order will have an impact on our second quarter international numbers, and we will still be on a strong trajectory for approximately 30% growth on the full year.

Tom: As we expand internationally, we are opening new markets with distributors, which makes the international quarterly revenues a bit uneven as distributors by initial stocking inventory.

Anderson Schock: So first, with the two commercialized drugs, the iron chelation and antibiotic that you plan to submit for 510K clearance, could you just provide a little more color on the market opportunity for each? Yeah, Anderson. Thank you for the note on the quarter, and good to hear your voice. So, on those two drugs, as I said, we're still working through the total patient populations. We know that, for example, the iron chelation drug, the overall patient base, we feel, is about 30,000 patients. We know the regimen is looking at a six-week, sorry, a one-week course of treatment that could be between five to seven infusions during the course of that week.

Jean Marc: Average selling prices outside of the U S.

Jean Marc: We are reiterating our margin guidance of 61, 63% for the full year 2025, which is inclusive of any currency and known supply chain.

Tom: We believe that this quarter stocking order will have an impact on our second quarter International numbers, and we will still be on a strong trajectory for approximately 30% growth on the four years.

Jean Marc: Tax on incoming raw materials or sourcing button, but we may incur during the year.

Tom: Yeah.

Tom: Pharma services and clinical trials revenues were $300,000, representing a 39% decline over the prior year. This part of the business is non-recurring, and revenues are driven by customer timelines for services and clinical trials. The decline in the period was due to lower clinical trial orders, as orders were pushed from Q1 into Q2.

Tom: Pharma services and clinical trials revenues were 300000, representing a 39% decline over the prior year. This part of the business is nonrecurring and revenues are driven by customer timelines for services in clinical trials.

Jean Marc: As a reminder, from a supply chain standpoint, we have low exposure to tariffs the majority of our raw materials or of U S origin.

Jean Marc: We have evaluated the raw materials and value as that are not of U S origin and include those potential impacts within our guidance range.

Tom: Decline in the period was due to lower clinical trial orders those orders were pushed from Q1 into Q2.

Jean Marc: We are actively monitoring the changing policy environment, we will continue to make the best efforts to take the necessary steps to mitigate potential impacts.

Tom: Yeah.

Tom: Moving on to gross margin performance. First quarter margins were 62.8 percent, a 50 basis point improvement over the prior year. Margin expansion was driven by favorable product mix during the quarter. We are continuing to implement operational excellence programs in our manufacturing that help offset the impact of lower average selling prices outside of the U.S.

Tom: Moving onto gross margin performance first quarter margins were 62, 8%.

Jean Marc: Turning to cash we finished the quarter with an $8 7 million cash balance representing cash usage of $800000 during the first quarter.

Tom: The basis point improvement over the prior year margin expansion was driven by favorable product mix during the quarter.

Linda Tharby: We know that the antibiotic drug is over 300,000 patients, but we know that still the majority of those are in the hospital, so we're not sure how much we might see move into the home. And that course of treatment is anywhere between seven and 14 days, and between... So between 7 and 14 days overall with with. one to three infusions per day. So overall, there are big numbers, particularly on the antibiotic, but we're still looking at what the total numbers could look like.

Tom: Viewing to implement operational excellence programs and our manufacturing to help offset the impact of lower average selling prices outside of the U S.

Jean Marc: Our cash usage included a lower year over year net loss of $1 2 million, marking the 36 improvements over the prior year.

Tom: We are reiterating our margin guidance of 61 to 63% for the full year 2025, which is inclusive of any current and known supply chain tariff impacts on incoming raw material or sourcing that we may incur during the year. As a reminder, from a supply chain standpoint, we have low exposures to tariffs as the majority of our raw materials are of U.S. origin. We have evaluated the raw materials and value adds that are not of U.S. origin and include those potential impacts within our guidelines.

Tom: We are reiterating our margin guidance of 61% to 63% for the full year 2025, which is inclusive of any current and known supply chain.

Jean Marc: Some cash also included 400000 of investments and equipment for our next generation consumable production line and 200000 in finance and insurance premiums.

Tom: Impacts on incoming raw material or sourcing that we may incur during the year.

Jean Marc: We have nearly flat working capital change was driven by higher inventory and accounts receivable offset by higher accounts payable and accrued expenses.

Tom: As a reminder, from a supply chain standpoint, we have low exposure to tariffs as the majority of our raw materials are of U S origin.

Jean Marc: Backing out the noncash items of 900000 or stock compensation, depreciation and amortization brings us to the $8 7 billion.

Linda Tharby: And as I mentioned in my prepared remarks, that we believe that the opportunity is probably around a half a million dollars in 2026 is our current estimate. Okay, got it. That's helpful.

Tom: We have evaluated the raw materials and value adds that are not of U S origin and include those potential impacts within our guidance range.

Jean Marc: Looking ahead, we are increasing our revenue guidance to 38, and a half to $39 5 million, representing 15 with 17% growth.

Tom: We are actively monitoring the changing policy environment, and we will continue to make the best efforts to take the necessary steps to mitigate any new potential.

Tom: We are actively monitoring the changing policy environment, we will continue to make the best efforts to take the necessary steps to mitigate any potential impacts.

Linda Tharby: And then so developing these without a partner, how should we think about the size of the investment on your Yeah. Well, I'm not going to go to the specifics of exactly. We have developed a team that has gotten quite good at figuring out how to get new drugs on labels. So, with some internal efforts, it's buying that drug. And thankfully, these drugs are not expensive drugs, so we're able to purchase those. And then it's just doing the necessary testing required here internally and some external testing for those drug candidates. What I would say overall, at a high level, is the payback is in far less than one year on those two candidates.

Jean Marc: An increase from our prior range of <unk> 38, 39 months.

Jean Marc: Key drivers behind these estimates include sustained global <unk> market growth in the 10% range continued domestic and international share of games.

Tom: Turning to cash, we finished the quarter with an $8.7 million cash balance, representing cash usage of $800,000 during the first quarter. Our cash usage included a lower year-over-year net loss of $1.2 million, marking a 36% improvement over the prior year. The use of cash also included $400,000 of investments in equipment for our next generation consumable production line and $200,000 in financing of insurance per year.

Tom: Turning to cash we finished the quarter with an $8 7 million cash balance representing cash usage of $800000 during the first quarter.

Jean Marc: Our flow control product line extensions.

Tom: Our cash usage included a lower year over year net loss of $1 3 million, marking a 36 improvement over the prior year.

Jean Marc: Japanese market entry in the first half of the year and the addition of three new collaborations through novel therapies pipeline.

Tom: The use of cash also include a 400000 of investments and equipment for our next generation consumable production line and 200000 in finance and insurance premiums.

Jean Marc: As I mentioned, we are reiterating our gross margins in the range of 61, 3%. Our gross margins will be affected this year by onetime product line costs associated with our manufacturing ramp up in the second half in.

Tom: We had nearly flat working capital changes driven by higher inventory and accounts receivable offset by higher accounts payable and accrued. Finally, backing out the non-cash items of $900,000 for stock compensation, depreciation, and amortization brings us to the $8.7 million.

Tom: We had nearly flat working capital changes driven by higher inventory and accounts receivable offset by higher accounts payable and accrued expenses.

Jean Marc: In preparation for our new consumables launch.

Jean Marc: Some impact due to higher mix of sales in international markets and supply chain inflationary and currency.

Tom: Finally backing out the noncash items of 900000 for stock compensation, depreciation and amortization brings us to the $8 7 million.

Linda Tharby: So, it was kind of a no-brainer for us to get that done. pretty quickly.

Jean Marc: Related pressures.

Jean Marc: Moving to cash we are reiterating that we expect positive cash flow from operations for the full year of 2025, we anticipate operating expenses exclusive of stock compensation in the range of $26 7 million.

Linda Tharby: So we're excited about that and anticipate that we'll file hopefully by Q3. Got it.

Tom: Looking ahead, we are increasing our revenue guidance to $38.5 to $39.5 million, representing 15% to 17% growth, an increase from the prior range of $38 to $39 million. Key drivers behind these estimates include sustained global SCIG market growth in the 8-10% range, continued domestic and international share gains our flow control product line expansion. Japanese market entry in the first half of the year, and the addition of three new collaborations to our novel therapies pipeline.

Tom: Looking ahead, we are increasing our revenue guidance 38, and a half to $39 5 million, representing 15% to 17% growth an increase from our prior range of <unk> 38 39.

Linda Tharby: And then on the EPUMP collaboration, so how many EPUMP companies are you currently working with and how many countries and are there any plans for expansion in new geographies with similar collaborations? Yeah, so we would work with any of the e-pump companies that are on the market today. That would be primarily three companies that we work with in that space. And none of those companies have subcutaneous infusion sets, so that works well for us and works well for them. And we anticipate that Those three probably have greater than 80% of the global market. And so we're pursuing the ones that have the remaining 20%, but satisfied that with the numbers that are in our plan with our current technical relationships that will be good with the numbers that we're projecting.

Jean Marc: We stay on course on continuing to improve our operating leverage.

Tom: Key drivers behind these estimates include sustained global <unk> market growth in the eight to 10.

Jean Marc: Our operating expenses will be weighted more heavily in the first half of the year.

Tom: 10% range.

Tom: Domestic and international share games.

Jean Marc: Driven by higher R&D costs associated with project work completion.

Tom: Flow control product line extension.

Jean Marc: Additionally, we expect there to be under $2 million of investments.

Tom: Japanese market entry in the first half of the year and the addition of three new collaborations to more novel therapies pipeline.

Jean Marc: Capital equipment, driven primarily by the production lines, we are setting up for next generation products.

Tom: As I mentioned, we are reiterating our gross margins in the range of 61 to 63 percent. Our gross margins will be affected this year by one-time product line costs associated with our manufacturing ramp-up in the second half. in preparation for our new consumables launch. So the impact due to higher mix of sales in international markets and supply chain inflationary and current tariff-related pressures.

Tom: As I mentioned, we are reiterating our gross margins in the range of 61, 3%. Our gross margins will be affected this year by one time product line costs associated with our manufacturing ramp up in the second half.

Jean Marc: I will now pass the call back to Linda to review, our 2025 milestones our pathway to sustained growth and some closing remarks.

Linda: Thanks, Tom I'd like to take a moment to highlight the key milestones we are targeting for 2025, we're right on track and adding new drugs to our label.

Tom: In preparation for our new consumables launch.

Tom: Some impact due to a higher mix of sales in international markets and supply chain inflationary and tariff related pressures.

Added the two new commercialized drugs that we expect to submit.

Tom: Moving to cash, we are reiterating that we expect 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, while we stay on course on continuing to improve our operating leverage. Our operating expenses will be weighted more heavily in the first half of the year, driven by higher R&D costs associated with project work completion. Additionally, we expect there to be under $2 million of investments in capital equipment driven primarily by the production lines we are setting up for our next generation.

Tom: Moving to cash we are reiterating that we expect positive cash flow from operations for the full year of 2025, we anticipate operating expenses exclusive of stock compensation in the range of $26 7 million.

Linda: For clearance this year.

Linda: As you can see by our performance in international we are on pace with our plants, there and we continue to make progress with our new product platforms. There is strong momentum behind us and with several exciting milestones ahead, we're energized by our first quarter performance and look forward to sharing further mile stone updates on our second quarter call.

Linda Tharby: Okay, got it.

Linda Tharby: Well, well, congrats again on the great starts of the year and thank you for taking our question. Thank you.

Tom: We stay on course on continuing to improve our operating leverage.

Operator: Ladies and gentlemen, we have reached the end of the question and answer session.

Tom: Our operating expenses will be weighted more heavily in the first half of the year.

Linda: I'd like to take a moment to reinforce our long term vision and the path. We're on to achieve sustainable 20 plus percent revenue growth.

Linda Tharby: I would now like to turn the floor over to Linda Tharby for closing comments. So thank you all again for joining us this afternoon. We're excited about our start to the year. I want to thank the entire CORU team for all of their exceptional efforts to start this year. And we look forward as a team to providing you with further updates on additional opportunities as we make progress towards our 2025 milestone. Have a great rest of your day. Thank you.

Tom: Driven by higher R&D costs associated with project work completion. Additionally, we expect there to be under $2 million.

Linda: The chart on this slide outlines the key drivers that were previously discussed.

Tom: And capital equipment, driven primarily by the production lines were setting up for next generation products.

Linda: Discussed that are powering our strategy across all three.

Linda: I'll now pass the call back to Linda to review our 2025 milestones, our pathway to sustained growth, and some closing remarks. Thanks, Tom.

Tom: I'll now pass the call back to Linda to review, our 2025 milestones our pathway to sustained growth and some closing remarks.

Linda: <unk> growth.

Linda: Growth pillars.

Linda: First we continued to benefit from a strong <unk> market and are consistently gaining share. This is fueling the recurring revenue engine of our core business second our upcoming next generation infusion system, including pumping assumable and flow control. Our launches are expected to unlock further market share and accelerate our entry.

Linda: I'd like to take a moment to highlight the key milestones we are targeting for 2025. We're right on track and adding new drugs to our label. Well, we've added the two new commercialized drugs that we expect to submit. for clearance this year. As you can see by performance in international, we are on pace with our plans there, and we continue to make progress with our new product platform.

Linda: Thanks, Tom I'd like to take a moment to highlight the key milestones. We are targeting for 2025, we are right on track and adding new drugs to our label well we've added the two new commercialized drugs that we expect to submit.

Operator: This concludes our today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Linda: As you previously untapped markets.

Linda: For clearance this year.

Linda: Third international expansion are currently only about 10% penetrated globally, and we see a clear opportunity to reach 30% to 40% by expanding into key markets.

Linda: As you can see if our performance in international we are on pace with our plans there and we continue to make progress with our new product platforms. There is strong momentum behind us and with several exciting milestones ahead, we're energized by our first quarter performance and look forward to sharing further mile stone update on our second quarter call.

Linda: There's strong momentum behind us, and with several exciting milestones ahead, we're energized by our first quarter performance and look forward to sharing further milestone updates on our second quarter call.

Linda: Markets, like Japan, Canada, and Western Europe.

Fourth our pipeline continues to advance with promising new on label drug and opportunities all with the potential to contribute commercial revenue as early as 2020.

Linda: I'd like to take a moment to reinforce our long-term vision and the path we're on to achieve sustainable 20-plus percent revenue growth. The chart on this slide outlines the key drivers that we've previously discussed that are powering our strategy across all three. Quora's growth pillar. First, we continue to benefit from a strong SCIG market and are consistently gaining share. This is fueling the recurring revenue engine of our core business. Second, our upcoming next-generation infusion system, including pumping consumables and flow controller launches, are expected to unlock further market share and accelerate our entry into previously untapped markets.

Linda: I'd like to take a moment to reinforce our long term vision and the path Ron to achieve sustainable 20, plus percent revenue growth. The chart on this slide outlines the key drivers that were previously discussed.

Linda: And finally, we're actively exploring new business development opportunities in adjacent markets that align with our strategy and will help push us well beyond the 20% growth thresholds.

Linda: Discussed that are powering our strategy across all three.

Linda: Or is growth.

Linda: Growth pillars.

Linda: Excited by the progress we've made the momentum we built and the opportunity ahead to scale Poirot meaningfully.

Linda: First we continue to benefit from a strong SCID market and are consistently gaining share. This is fueling the recurring revenue engine of our core business second our upcoming next generation of infusion system, including pumping up to them of bulk and flow control or launches are expected to unlock further market share and accelerate our entry.

Linda: To wrap up as we move into the Q&A portion will leave on screen. The key opportunities. We highlighted today elements that we believe make for a compelling growth story for US. These include strong macro tolerance accelerating the shift towards subcutaneous infusion solid growth in our core business with approximately 75% of recurring revenue.

Linda: You've previously untapped markets.

Linda: Third, international expansion. We're currently only about 10 percent penetrated globally, and we see a clear opportunity to reach 30 to 40 percent by expanding to key FCIG markets like Japan, Canada, and Western Europe. Fourth, our pipeline continues to advance with promising new on-label drug and opportunities, all with the potential to contribute commercial revenue as early as 2020. And finally, we're actively exploring new business development opportunities in adjacent markets that align with our strategy and will help push us well beyond the 20% growth threat.

Linda: Third international expansion are currently only about 10% penetrated globally, and we see a clear opportunity to reach 30% to 40% by expanding into key S. T E. I G markets like Japan, Canada and Western Europe.

Linda: New and meaningful expansion potential through new drugs on label and entry into infusion clinics.

Linda: But the momentum from a strong first quarter raise revenue outlook disciplined operations and positive cash flow from operations, an important milestone for <unk>, we're confident in the path ahead.

Linda: Fourth our pipeline continues to advance with promising new on label drug and opportunities all with the potential to contribute commercial revenue as early as 2026, and finally, we're actively exploring new business development opportunities in adjacent markets that align with our strategy and will help push as well.

Linda: Operator, we're now ready to take questions.

Linda: Thank you.

Speaker Change: We will now be conducting a question and answer session.

Linda: You would like to ask a question. Please press star one on your telephone keypad.

Linda: On the 20% growth thresholds.

Linda: We're excited by the progress we've made, the momentum we've built, and the opportunity ahead to scale KORU Meaningful.

Speaker Change: Permission tone will indicate your line is in the question queue.

Linda: We're excited by the progress we've made the momentum we built and the opportunity ahead to scale Poirot meaningfully.

Speaker Change: You May press Star two if you would like to remove the questions from the queue.

Linda: To wrap up, as we move into the Q&A portion, we'll leave on screen the key opportunities we highlighted today. Elements that we believe make for a compelling growth story at Coru. These include strong macro tailwinds, accelerating the shift towards subcutaneous infusion, solid growth in our core business with approximately 75% of recurring revenue, and meaningful expansion potential through new drugs on label and entry into infusion clinics.

Linda: To wrap up as we move into the Q&A portion will leave on screen. The key opportunities. We highlighted today elements that we believe make for a compelling growth story of course. These include strong macro tolerance accelerating the shift toward subcutaneous infusion solid growth in our core business with approximately 75% of recurring Rev.

Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Speaker Change: Binder, please restrict yourself to one question and one follow up after that please rejoin the queue for more questions. One moment. Please poll for questions.

Speaker Change: The first question comes from the line of Frank <unk> with Lake Street Capital markets. Please go ahead.

Linda: Venue and meaningful expansion potential through new drugs on label and entry into the infusion clinics.

Frank: Alright, Thank you for taking the questions and congrats on a really strong start to the year I was hoping to start with a little bit bigger picture one.

Linda: With a momentum from a strong first quarter, a raised revenue outlook, disciplined operations, and positive cash flow from operations, an important milestone for Quoru, we're confident in the path ahead.

Linda: The momentum from a strong first quarter raised revenue outlook disciplined operations and positive cash flow from operations, an important milestone for coral we're confident in the path ahead.

Linda: Linda I think you have.

Linda: Kind of started to maybe think about adding new drugs that you don't have current partnerships with from a pharma standpoint.

Operator: Operator, we're now ready to take questions. Thank you.

Linda: Operator, we're now ready to take questions.

Thank you.

Operator: We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your questions from the queue.

Might be the first two that you are talking about actively.

Speaker Change: We will now be conducting a question and answer session.

Linda: Great to see that maybe a bigger picture how do you think about kind of the strategy longer term is there are a number of different drugs that you can kind of pursue the same structure. How does this affect the kind of timing to market capital requirements to do it this way and maybe just kind of thought process around the strategy going forward.

Speaker Change: If you would like to ask a question. Please press star one on your telephone keypad.

Speaker Change: Information tone will indicate your line is in the question queue.

Speaker Change: Stan tool, if you would like to move to questions from the Q.

Operator: For participants using speaker equipment, it may be necessary to pick up a handset before pressing the start As a reminder, please restrict yourself to one question and one follow-up. After that, please rejoin the queue for more questions.

Speaker Change: For participants using speaker equipment it may be.

Speaker Change: Be necessary to pick up the handset before pressing the star keys as a reminder, please restrict yourself to one question and one follow up after that please rejoin the queue for more questions. One moment. Please poll for questions.

Linda: Sure.

Speaker Change: So thanks for the comment Frank we're also excited by our start to the year and this all.

Speaker Change: Opportunity to pursue drugs that are not in partnership with pharmaceutical companies essentially comes from.

Operator: One moment, please, while we poll for questions.

Frank Takkinen: The first question comes from the line of Frank Takkinen with Lake Street Capital Markets. Please go ahead. Great. Thank you for taking the questions and congrats on a really strong start to the year.

Frank: The first question comes from the line of Frank <unk> with Lake Street Capital markets. Please go ahead.

Speaker Change: The strong relationships. We currently have with our specialty pharmacies, where there are a number of drugs in this case antibiotics and iron chelation that nurses are administering in the home began to use our product and we started to see some pretty nice uptake in those skus and.

Frank: Great. Thank you for taking the questions and congrats on a really strong start to the year I was hoping to start with a little bit bigger picture one.

Frank Takkinen: I was hoping to start with a little bit bigger picture one.

Frank Takkinen: Linda, I think you have kind of started to maybe think about adding new drugs that you don't have current partnerships with from a pharma standpoint. I think this might be the first two that you're talking about actively. Great to see that.

Frank: And I think you got it.

Frank: Kind of started to maybe think about adding new drugs that you don't have current partnerships with from a pharma standpoint.

Speaker Change: Yeah. We also heard from a number of our customers that we really would like to see those encores label for us to feel comfortable using them more broadly. So we know theres a lot of upside so as we look at that whole universe of opportunities will.

Frank: Might be the first two that you're talking about actively.

Linda: Maybe a bigger picture. How do you think about kind of this strategy longer term? Is there a number of different drugs that you can kind of pursue this same structure? How does this affect kind of timing to market, capital requirements to do it this way, and maybe just kind of thought process around this strategy going forward. Sure. So thanks for the comment, Frank. We're also excited by our start to the year and this opportunity to pursue drugs that are not in partnership with pharmaceutical companies essentially comes from the strong relationships we currently have with our specialty pharmacies, where there are a number of drugs, in this case, antibiotics and iron chelation that nurses are administering in the home, began to use our product, and we started to see some pretty nice uptake in those SKUs.

Frank: Great to see that maybe a bigger picture how do you think about kind of the strategy longer term is there are a number of different drugs that you can kind of pursue the same structure. How does this affect timing to market capital requirements to do it this way and maybe just kind of thought process around this strategy going forward.

Speaker Change: We'll be doing a deeper dive into other drugs that may have been launch for you know in these cases, they've been launched for a plus plus three to five years and so we'll be looking at other drugs. So as they come out of the hospital into the home.

Frank: Sure.

Frank: So thanks for the comment Frank we're also excited by our start to the year and this.

Speaker Change: To add to that portfolio of course oncology drugs is another example, although with some of those we we are obviously working with pharma partners given.

Frank: Opportunity to pursue drugs that are not in partnership with pharmaceutical companies essentially comes from.

Frank: The strong relationships. We currently have with our specialty pharmacies, where there are a number of drugs in this case antibiotics and iron chelation that nurses are administering in the home began to use our product and we started to see some pretty nice uptake in those skus.

Speaker Change: The nature of those drugs.

Speaker Change: So as we look at every one of these we think about the revenue potential and and in this case. These are.

Speaker Change: Less than one year paybacks in terms of the investment required to get them onto our label. It's a we're currently cleared for health care professionals.

Linda: And yet, we also heard from a number of our customers that we really would like to see those on QORUS label for us to feel comfortable using them more broadly. So we know there's a lot of upside. So as we look at that whole universe of opportunities, we'll be doing a deeper dive into other drugs that may have been launched for, you know, in these cases, they've been launched for plus, plus three to five years. And so we'll be looking at other drugs, though, as they come out of the hospital into the home, to add to that portfolio.

Frank: And Ah Yeah. We also heard from a number of our customers that we really would like to see those encores label.

Speaker Change: And patients use in the home.

So this is a pretty simple one for us to look at expanding new new areas there.

Frank: For us to feel comfortable using them more broadly. So we know there's a lot of upside so as we look at that whole universe of opportunities and we'll be doing a deeper dive into other drugs that may have been launched or you know in these cases, they've been launched for a plus plus three to five years and sell.

Speaker Change: I think that as a as I I think your last part of your question was the capital needs related to this and given their in year paybacks, we don't see the opportune any need for that we as a matter of fact, I think that there are opportunities to grow both revenue and bottom line.

Frank: We'll be looking at other drugs, so as they come out of the hospital into the home odd.

Speaker Change: So we think perfect candidate and we're actively searching for more.

Frank: To add to that portfolio of course oncology drugs is another example, although with some of those we we are obviously working with pharma partners given the.

Linda: Of course, oncology drugs is another example, although with some of those, we are obviously working with pharma partners, given the nature of those drugs. So, as we look at every one of these, we think about the revenue potential, and in this case, these are less than one-year paybacks in terms of the investment required to get them onto our label. We're currently cleared for healthcare professionals and patients' use in the home. So this is a pretty simple one for us to look at expanding new areas there. I think that as I think your last part of your question was the capital needs related to this and given their in-year paybacks, we don't see any need for that.

Speaker Change: Got it that's helpful. And then maybe just for my follow up I was hoping you could help with cade and saying of revenue throughout the year, obviously strong start but there is the distributor stocking order.

Frank: The nature of those drugs.

Frank: So as we look at it every one of these we think about the revenue potential and and in this case. These are.

Speaker Change: O U S that within that Q1 number so maybe just help us kind of think about how revenues should.

Frank: Less than one year paybacks in terms of the investment required to get them onto our label. It's a we're currently cleared for health care professionals.

Speaker Change: Flowing through up here.

Speaker Change: Yeah, So maybe just stop.

Speaker Change: I'll start with the obvious which is we're very happy to be raising guidance in the macroeconomic environment.

Frank: And patients use in the home. So this is a pretty simple one for us to look at expanding new new areas there.

That's obviously driven by three factors number one and the biggest one is our international performance.

Speaker Change: There's the further confidence in our U S growth number and then we had some some clinical orders firm up in our PSP business I'm going to turn it over to Tom for specifics on the quarterly and what we can expect.

Frank:

Frank: I think that as it as I I think your last part of your question was the capital needs related to this and given there in your payback, we don't see the opportune any need for that we as a matter of fact that there are opportunities to grow both revenue and bottom line.

Frank Takkinen: We as a matter of fact think that there are opportunities to grow both revenue and bottom line so we think perfect candidates and we're actively searching for more. Got it. That's helpful.

Tom: Yeah, Frank So as we as we mentioned during the <unk>.

Tom: The remarks.

Frank: So we think perfect candidates and and we're actively searching for more.

Tom: Our international business, we're still seeing a growth of around 30%.

Speaker Change: Got it that's helpful. And then maybe just for my follow up I was hoping you could help with Cade and thing of revenue throughout the year, obviously strong start but there is the distributor stocking order.

Frank Takkinen: And then maybe just for my follow-up, I was hoping you could help with cadencing of revenue throughout the year. Obviously, strong start, but there's the distributor stocking order, OUS, that was in that Q1 number. So maybe just help us kind of think about how revenues should flow in throughout the year.

Tom: So I mentioned the stocking you're correct, we'll bring that out so we will see some impact starting in the second quarter.

Tom: As those new distributors stocked up in advance.

Speaker Change: O U S that within that Q1 number so maybe just help us kind of think about how revenues should.

Tom: For that for both Hep C us for both debt tender with them also.

Tom: Some new markets. So you could expect to see about.

Speaker Change: Slowing throughout the year.

Linda: Yeah, so maybe just I'll start with the obvious, which is we're very happy to be raising guidance in the macroeconomic environment. That's obviously driven by three factors. Number one, and the biggest one is our international performance. Second is the further confidence in our U.S. growth number. And then we had some clinical orders firm up in our PST business.

Speaker Change: Yeah, So maybe just stop.

Tom: From a Q2, you can expect to see it.

Speaker Change: I'll start with the obvious which is we're very happy to be raising guidance in the macroeconomic environment.

Tom: Gradually increasing the facility until the end of the year.

Tom: It'd be around that 30% range.

Tom: That's obviously driven by three factors number one and the biggest one is our international performance second is the further confidence in our U S growth number and then we had some some clinical orders firm up in our PSP business I'm going to turn it over to Tom for specifics on the quarterly and what we can.

Tom: On the U S side of things.

Tom: Expect us to outpace the market and we mentioned that that market is right around 10% growth rate. So we can expect to see us.

Tom: Outpace that market by a couple of points and then on the novel therapy sides.

Tom: I'm going to turn it over to Tom for specifics on the quarterly and what we can expect.

Tom: We're pretty confident with our with our pipeline right now we feel pretty good.

Speaker Change: Can expect.

Tom: Within a range of around $253 million.

Tom: Yeah, Frank. So as we, as we mentioned, during the, the remarkable our international business, we're still seeing a growth of around 30%.

Tom: Yeah, Brian So as we as we mentioned during the speech.

Tom: Right.

Speaker Change: The remarks.

Tom: Perfect. That's helpful. Thanks for taking the questions Congrats Scott.

Speaker Change: Our international business, we're still seeing a growth of about 30%.

Tom: Okay.

Tom: So I mentioned the stocking and you're correct to bring that out. So we will see, you know, some impact of that stocking in the in the second quarter, as those new distributors stocked up in advance for that for both that CS for both that tender win and also opening up the market. So you can expect to see about, you know, from that Q2, you can expect to see it. gradually increasing up until the until the end of the year to be around that 30% range.

Speaker Change: Thank you next question comes from the line of Catharine <unk> with Canaccord Genuity. Please go ahead.

Speaker Change: So I've mentioned the stocking and you are correct to bring that out so we will see some impact of that starting in the second quarter.

Speaker Change: Hi, guys congrats on a great quarter.

Speaker Change: As those new distributors stocked up in advance.

Speaker Change: Maybe just to start off I wanted to talk a little bit about the pre filled syringe opportunity O U S and in the U S. Do you have any kind of updated.

Speaker Change: For that for both that see us for both debt tender win and also opening up some new markets. So you could expect to see about <unk>.

Speaker Change: I'm not Q2, you can expect to see it.

Speaker Change: Numbers on the Prefilled syringe penetration in the U S. And then just on the tender or any more color on that and where else you could see these tenders oh, you're less going forward.

Speaker Change: Gradually increasing the until the until the end of the year.

Speaker Change: You're right in that 30% range.

Tom: On the on the US side of things, you know, you can expect us to outpace that market. And we mentioned that that market is, you know, right around 10% growth rate. So we can expect to see us outpace that market by a couple points.

Speaker Change: On the U S side of things you can expect us to outpace that market and we mentioned that that market is right around 10% growth rate. So we can expect to see us.

Speaker Change: Thanks again for the congratulations we're excited by our start to the year.

Speaker Change: So I think your first question was just on the penetration level and pre filled syringes in the U S. That's now just over 65%. So obviously has done has gone well.

Speaker Change: Outpace that market by a couple of points and then on the novel therapy sides.

Tom: And then on the novel therapy side, you know, we're pretty confident with our with our pipeline right now, we feel pretty good within our range of around two and a half to 3 million, not Perfect.

Speaker Change: We're pretty confident with our with our pipeline right now we feel pretty good.

Speaker Change: Within a range of around two $5 billion to $3 billion non stop.

Speaker Change: And quite excited so now.

Speaker Change: Yeah.

Frank Takkinen: That's helpful.

Speaker Change: Perfect. That's helpful. Thanks for taking the questions congrats guys.

Frank Takkinen: Thanks for taking the questions. Thank you.

Speaker Change: That pharma partners now pursuing active penetration outside the U S are they have launched their platform into several markets and so we're starting to see early uptick and the big potential that we see here is that.

Speaker Change: Okay.

Speaker Change: Thank you.

Caitlin Cronin: Next question comes to the line of Caitlin Cronin with Canaccord Generity. Please go ahead. Hi, guys. Congrats on a great quarter. Maybe just to start off, I want to talk a little bit about the Pre-Filled Syringe Opportunity, OUS, and in the US. Do you have any kind of updated numbers on the Pre-Filled Syringe Penetration in the US? And then just on the tender, any more color on that and where else you could see these tenders, OUS, going forward? Thanks again for the congratulations.

Speaker Change: Next question comes from the line of Caitlin Crone with Canaccord Genuity. Please go ahead.

Caitlin Crone: Hi, guys congrats on a great quarter.

Speaker Change: Electronic pumps, which as you know are the standard of care in Europe do not work with <unk>.

Caitlin Crone: Maybe just to start off I wanted to talk a little bit about the pre filled syringe opportunity O U S and in the U S. Do you have any kind of updated.

Speaker Change: Greenfields you can't put a pre sell directly into an electronic pump you've got to transfer it into a specific range for use with that system.

Caitlin Crone: Numbers on the Prefilled syringe penetration in the U S. And then just on the tender or any more color on that and where else you could see these tenders.

Speaker Change: So we see potential for further upside we don't have it.

Caitlin Crone: Going forward.

Caitlin Crone: Thanks again for the congratulations we're excited by our start to the year. So.

Speaker Change: Numbers, our visibility on that yet, but that is certainly part of what you see in and our competence and our total Oh U S expansion plan over the next several years.

Linda: We're excited by our start to the year. So I think your first question was just on the penetration level in pre-filled syringes in the U.S. That's now just over 65%, so obviously has done well and quite excited. So now that pharma partner is now pursuing active penetration outside the U.S. They have launched their platform into several markets, and so we're starting to see early uptick. And the big potential that we see here is that electronic pumps, which, as you know, are the standard of care in Europe, do not work with pre-filled. You can't put a pre-fill directly into an electronic pump.

Caitlin Crone: So I think your first question was just on the penetration level and pre filled syringes in the U S. That's now are just over 65%. So obviously has done has done well.

Speaker Change: And obviously our pump maybe just I'll add one other comment which is our new pumps that we're launching.

Caitlin Crone: And quite excited so now.

In the early part of next year.

Caitlin Crone: That pharma partners now pursuing active penetration outside the U S are they have launched their platform into several markets and so we're starting to see early uptick and the big potential that we see here is that.

Speaker Change: Milling at the end of this year will be a big driver to that international expansion effort as well.

Speaker Change: Yeah.

Speaker Change: Great and just a follow up follow up on that one you will have to get the new pump approved everywhere O U S where you are already distributing correct.

Caitlin Crone: Electronic pumps, which as you know are the standard of care in Europe do not work with.

Speaker Change: Yes, but recall that our current pump does work with Prefills. It's just.

Caitlin Crone: Greenfields you can't put a pre sell directly into an electronic pump you've got it transfer it into a specific range for use with that system.

Speaker Change: Does not work with all of the pre filled range, our new pump will work with all of the pre build range.

Linda: You've got to transfer it into a specific syringe for use with that. So we see potential for further upside. We don't have it. numbers or visibility on that yet, but that is certainly part of what you see in our confidence in our total OUS expansion plan over the next several years.

Speaker Change: Got it okay.

Caitlin Crone: So we see potential for further upside we don't habit.

Speaker Change: And then just a quick one on tariffs I believe spending most of your.

Caitlin Crone: Numbers, our visibility on that yet, but that is certainly part of what you see in.

Speaker Change: Production of consumables is or are you asking how did you factor that into the tariffs kind of guidance.

Caitlin Crone: Our competence and our total O U S expansion plan over the next several years.

Speaker Change: Yes. Thanks for the question. So yeah as you know most of our most of our raw materials and components or U S origin.

Linda: And obviously our new pump, maybe just, I'll add one other comment, which is our new pump that we're launching in the early part of next year, filing at the end of this year, will be a big driver to that international expansion effort as well. Great. And just to follow up on that one, you will have to get the new pump approved everywhere OUS where you're already distributing correct. Yes, but recall that our current pump does work with prefills. It's just does not work with all of the prefilled range. Our new pump will work with all of the prefilled.

Caitlin Crone: And obviously, our pumps may maybe just I'll add one other comment which is our new pumps that we're launching and.

Speaker Change: We do send them down to Nicaragua, there is some value added onto those products in them.

Caitlin Crone: In the early part of next year.

Speaker Change: We purchased those products back from from Nicaragua. So you haven't met out for products in the U S.

Caitlin Crone: Milling at the end of this year.

Caitlin Crone: It will be a big driver to that international expansion effort as well.

Speaker Change: And that was part of our factor, we got a lot of analysis.

Caitlin Crone: Yeah.

Caitlin Crone: Great and just a follow up on that one you will have to get the new pump approved everywhere Oh, you asked where you are already distributing correct.

Speaker Change: A complete supply chain of any parts that were non U S. We calculated after reviewing all of that analysis, we calculated just under a 100 basis points.

Caitlin Crone: Yes, but recall that our current pump does work with Prefills. It's just does not work with all of the pre filled range, our new pump will work with all of the pre build range.

Speaker Change: And what we know today with tariffs.

Speaker Change: Awesome. Thanks, so much.

Speaker Change: Welcome.

Linda: Got it, okay.

Speaker Change: Thank you next question comes from the line of Chase Knickerbocker with Craig Hallum. Please go ahead.

Caitlin Crone: Got it okay.

Caitlin Cronin: And then just a quick one on tariffs.

Caitlin Crone: And then just a quick one on tariffs I believe spending most of your.

Tom: I believe, I think most of your production of consumables is OUS, and how did you factor that into the tariff kind of guidance? Yeah, thanks, Caitlin, for the question. So, yeah, as you know, most of our raw materials and components are of U.S. origin. We do send them down to Nicaragua. There is some value added onto those products, and then, you know, we purchase those products back from Nicaragua. So you have to net out the products of U.S. origin, and that was part of our factor. We did a lot of analysis, looking at our complete supply chain of any parts that were non-U.S.

Caitlin Crone: Production of consumables is or are you asking how did you factor that into the tariffs kind of guidance.

Chase Knickerbocker: Hi, good afternoon. Thanks.

Speaker Change: Thanks for taking the questions and congrats on the progress here just first for me as we think about international markets.

Caitlin Crone: Yeah. Thanks for the question. So yeah as you know most of our most of our raw materials and components or U S origin.

Speaker Change: Can you kind of give us an update on where you're at with kind of the overall epub opportunity and any additional conversations and progress that you and your distributors have made in Q1 and is there any read through to kind of obviously the strong quarter in respect of the distributor dynamics, there, but any kind of read through into.

Caitlin Crone: We do send them down to Nicaragua, there is some value added onto those products and then we.

Caitlin Crone: We purchased those products back from from Nicaragua. So you have to net out the products of U S. R. R.

Caitlin Crone: And that was part of our factor, we got a lot of analysis.

Caitlin Crone: Looking at our complete supply chain of any parts that were non U S. We calculated after reviewing all of that analysis, we calculated just under a 100 basis points.

You know that I'm expecting some increased demand from that channel.

Caitlin Cronin: We calculated, after reviewing all that analysis, we calculated just under 100 bases. on what we know today with Tara. Awesome. Thanks so much.

Speaker Change: So.

Speaker Change: I think when you refer to the pump opportunity Chase you are referring to our opportunity for increased volumes of our consumables with heat pumps, which is certainly driving a part of our first quarter and that we.

Caitlin Crone: On what we know today with tariffs.

Caitlin Crone: Yeah.

Caitlin Crone: Awesome. Thanks, so much.

Caitlin Crone: Welcome.

Speaker Change: Thank you next question comes from the line of Chase Knickerbocker with Craig Hallum. Please go ahead.

Chase Knickerbocker: Next question comes from the line of Chase Knickerbocker with Greg Halub. Please go ahead. Hi, good afternoon. Thanks for taking the questions and congrats on the progress here.

Speaker Change: We saw some demand from opening up new markets and share gains, which was a big part of it.

Speaker Change: But also a big part had to do with our complete system, which was the pre filled win.

Chase Knickerbocker: Hi, good afternoon.

Speaker Change: Thanks for taking the questions and congrats on the progress here just first for me as we think about international markets.

Speaker Change: That that work.

Chase Knickerbocker: Just first from me, as we think about international markets, Can you kind of give us an update on where you're at with kind of the overall e-pump opportunity and, you know, any additional conversations and progress that you and your distributors have made in Q1, and is there any read-through to kind of obviously the strong quarter and respect the distributor dynamics there, but any kind of read-through into, you know, them expecting some increased demand from that channel? So, I think when you refer to the e-pump opportunity, Chase, you're referring to opportunity for increased volumes of our consumables with e-pumps, which is certainly driving part of our first quarter in that we saw some demand from opening up new markets and share gains, which was a big part of it.

Speaker Change: We're quite excited about it because it's got a lot of legs there.

Speaker Change: So that you know the total E pump opportunity, we see as being.

Speaker Change: Can you kind of give us an update on where you're at with kind of the overall heat pump opportunity and you know any additional conversations and progress that you and your distributors have made in Q1 and is there any read through to kind of obviously the strong quarter in respect of the distributor dynamics there.

Speaker Change: To date, our consumable share is very low associated with the pumps and we have technical data that shows that our consumables work very well with Oh E pumps and.

Speaker Change: So we're riding that success in our partnership with our companies and our new consumables launch in early 2026, we think will help us gain even further share with use with heat pumps.

Speaker Change: But any kind of read through into that I'm expecting some increased demand from that channel.

Speaker Change: So I think when you referred to the pump opportunity Chase you are referring to our opportunity for increased volumes of our consumables what to eat pumps, which is certainly driving a part of our first quarter and that.

Speaker Change: Thanks Linda.

Speaker Change: We're looking at the oncology opportunity.

Speaker Change: Good to hear about the pilot sites.

Speaker Change: We saw some demand from opening up new markets and share gains, which was a big part of it.

Speaker Change: What are you kind of waiting to hear there before it's kind of all all systems go.

Linda: But also a big part had to do with our complete system, which was the pre-filled win that we're quite excited about because it's got a lot of legs there. So, the total e-pump opportunity we see as being You know, to date, our consumable share is very low associated with e-pumps. And we have technical data that shows that our consumables work very well with all e-pumps. And so we're riding that success and our partnership with our IG companies and our new consumables launch in early 2026, we think will help us gain even further share with use with e-pumps.

Speaker Change: But also a big part had to do with our complete system, which was the pre filled win that.

Speaker Change: And can you speak to any other early work that you've done.

Speaker Change: That that you know.

Speaker Change: Around call it the unique economics.

Speaker Change: We're quite excited about because it's got a lot of legs there.

Speaker Change: Within the oncology clinic and kind of how that differs from from you know how we're used to thinking about your products.

Speaker Change: So that you know the total E pump opportunity, we see as being.

Speaker Change: So first and foremost we're going to think about safety and efficacy with use of our product in those clinics in centers and thus.

Speaker Change: To date, our consumable share is very low associated with the pumps and we have technical data that shows that our consumables work very well with Oh E pumps and.

Speaker Change: Thus far.

Speaker Change: The work we've done so far we feel very positive about that.

Speaker Change: So we're riding that success and our partnership with our companies and our new consumables launch in early 2026, we think will help us gain even further share with use which is heat pumps.

Speaker Change: When I speak about the positive economics, there are really two factors here number one is the strong feedback that we are receiving is that the workflow efficiency I E. I may be able to see more patients than one at a time, because I'm not needing to manually push I'm administering with a pump I may be.

Chase Knickerbocker: Thanks, Linda.

Speaker Change: Thanks, a lot and that's what we're looking at the oncology opportunity.

Linda: And as we're looking at the oncology opportunity, good to hear about the pilot sites, what are you kind of waiting to hear there before it's kind of all systems go? And can you speak to, you know, any other early work that you've done around, you know, call it the unique economics that are within the oncology clinic and kind of how that differs from, you know, how we're used to thinking about your product? So first and foremost, we're going to think about safety and efficacy with use of our product in those clinics and centers and thus far, with the work we've done so far, we feel very positive about that.

Speaker Change: We're able to expand my efficiency and flow of patients through the center.

Speaker Change: Good to hear about the pilot sites, what are you kind of waiting to hear there before it's it's kind of all all systems go and can you speak to any other early work that you've done.

Speaker Change: The second thing that we see is there is a reimbursement code if you do a manual push.

Speaker Change: It's X dollars if you do it with a pump it's Y dollars Y dollars are much higher.

Speaker Change: Around you know call. It the unique economics that are within the oncology clinic and kind of how that differs from from you know how we're used to thinking about your products.

Speaker Change: Then with a manual push so we feel there could be an economic benefits for every infusion that the center also gets a higher dollars. So overall youre seeing increased patient through the center and higher dollar revenue per patient you see through the center.

Speaker Change: So first and foremost we're going to think about safety and efficacy with use of our product in those clinics in centers and are thus far with the work we've done so far we feel very positive about that.

Speaker Change: So what are we really looking at the safety and efficacy.

Linda: When I speak about the positive economics, there are really two factors here. Number one is the strong feedback that we are receiving is that the workflow efficiency, i.e. I may be able to see more patients than one at a time. Because I'm not needing to manually push, I'm administering with a pump. I may be able to expand my efficiency and flow of patients through the center. The second thing that we see is there is a reimbursement code. If you do a manual push, it's X dollars. If you do it with a pump, it's Y dollars.

Speaker Change: When I speak about the positive economics, there are really two factors here number one is the strong feedback that we are receiving is that the workflow efficiency I E. I may be able to see more patients than one at a time, because I'm not needing to manually push I'm administering with a pump.

Speaker Change: Right it make sure that that that we do a lot of good in those centers on our value prop and then second is just confirming out that economic value prop that.

Speaker Change: That I just discussed.

Speaker Change: And while it takes some time to to kind of prep a partner will you know will that'd be a pretty quick process.

Speaker Change: I may be able to expand my efficiency and flow of patients through the center and the second thing that we see is there is a reimbursement code. If you do a manual push it's X dollars. If you do it with a pump it's Y dollars Y dollars are much higher.

Speaker Change: Once you do kind of make the call at all system to go kind of decision there.

Speaker Change: Yeah. So.

Speaker Change: Part of the pilot sites is obviously seating seating oncology centers now and these are big name oncology centers that we have included in our pilot sites. So we have a distribution partner already lined up and ready to go they've been supporting us in working with us and they do a lot of work in oncology infusion centers. So we feel very good.

Linda: Y dollars are much higher than with a manual push. So we feel there could be an economic benefit for every infusion that the center also gets higher dollars. So overall, you're seeing increased patients through the center and higher dollar revenue per patient you see through the center.

Speaker Change: Then with a manual push so we feel there could be an economic benefit for every infusion that the center also gets a higher dollars. So overall youre seeing increased patients through the center and higher dollar revenue per patient you see through the center.

Speaker Change: That and of course, we've had the pharmaceutical partner all lined up and ready to support our efforts as well and maybe the only other pieces. Obviously, we want to publish on the data that we see out of these sites, we think that will be important for widespread adoption in the U S market.

Linda: So what are we really looking to see? Safety and efficacy, right? Make sure that we do a lot of good in those centers on our value prop. And then second is just confirming out that economic value prop. that I just.

Speaker Change: So what are we really looking at the safety and efficacy.

Speaker Change: Right. It makes sure that that that we do a lot of good in those centers on our value prop and then second is just confirming out that economic value prop that.

Speaker Change: Got it thank you.

Speaker Change: Thank you next question comes from the line of Jason Bednar with Piper Sandler. Please go ahead.

Speaker Change: That I just discussed.

Linda: And will it take some time to kind of prep a partner? Or will that be a pretty quick process once you do kind of make the call-it-all-systems-go kind of decision? Yeah, so part of the pilot sites is obviously seeding, seeding oncology centers now. And these are big name oncology centers that we have included in our pilot sites. So we have a distribution partner already lined up and ready to go. They've been supporting us and working with us. And they do a lot of work in oncology infusion centers. So we feel very good about that. And of course, we've had the pharmaceutical partner lined up and ready to support our efforts as well.

Speaker Change: And will it take some time to to kind of prep a partner will you know will that'd be a pretty quick process once.

Jason Bednar: Hey, good afternoon.

Jason Bednar: For the year, everyone I wanted to instead of a couple of follow ups from prior topics.

Speaker Change: Once you do kind of make the call at all systems go kind of decision there.

Speaker Change: Yeah. So.

Jason Bednar: On the international side that was definitely the star of the quarter, where a lot of the outperformance came.

Speaker Change: Part of the pilot sites is obviously seating seating oncology centers now and these are big name oncology centers that we have included them in our pilot sites. So we have a distribution partner already lined up and ready to go they've been supporting us in working with us and they do a lot of work in oncology infusion centers. So we feel very good.

Jason Bednar: I'm really just going to rattle off a few here I guess, just so we can maybe dial and the cadence.

Jason Bednar: For that that segment here are the balance of the year.

First are you sizing that tender benefit I don't think I heard it in the first quarter or that I think you said the second quarter there are some.

Speaker Change: That and of course, we've had the pharmaceutical partner all lined up and ready to support our efforts as well and maybe the only other pieces. Obviously, we want to publish on the data that we see out of these sites, we think that will be important for widespread adoption in the U S market.

Speaker Change: Contribution as well and then Tom I think you mentioned in response to Frank's question that revenue growth for international should trend around or at or above maybe a 30% level throughout the year, maybe help me out there because you've got some funky comps you know just from the prior year and trying to understand is that segment has its there it is.

Linda: And maybe the only other piece is obviously we want to publish on the data that we see out of these sites, we think that will be important for widespread adoption in the US.

Chase Knickerbocker: Got it, thank you.

Speaker Change: Got it thank you.

Speaker Change: Forming well just so we get it get it right as we move throughout the year and then final thing on international just maybe how much we should be thinking about for incremental contributions in Japan.

Chase Knickerbocker: Thank you.

Speaker Change: Thank you next question comes from the line of Jason Bednar with Piper Sandler. Please go ahead.

Chase Bednar: Next question comes from the line of Chase and Bednar with Piper Sandler. Please go ahead. Hey, good afternoon. Nice start to the year, everyone.

Jason Bednar: Hey, good afternoon, a nice start to the year, everyone I wanted to instead of a couple of follow ups from prior topics.

Chase Bednar: I want to just have a couple follow-ups from prior topics. On the international side, that was definitely the star of the quarter where a lot of the outperformance came.

Speaker Change: So let me.

Maybe start with sizing the tender benefit and the incremental on Japan, and then I'll turn it to Tom to talk about how.

Speaker Change: On the international side that was definitely the star of the quarter, where a lot of the outperformance came.

Chase Bednar: Really just going to rattle off a few here, I guess, just so we can maybe dial in the cadence for that segment here, the balance of the year. First, are you sizing that tender benefit? I don't think I heard it in the first quarter or the, I think you said the second quarter. Contribution as well.

Speaker Change: How you might think about the quarter renovation and golar over that international piece again, so overall, what we saw in the first quarter. It was the buying for the initial win on that pre filled syringe tender. We anticipate we are going to get another order.

Speaker Change: Really just going to rattle off a few here I guess, just so we can maybe dial and the cadence.

Speaker Change: For that that segment for the balance of the year.

Speaker Change: First or are you sizing that tender benefit I don't think I heard it in the first quarter or that I think you said the second quarter there are some <unk>.

Chase Bednar: And then, Tom, I think you mentioned in response to Frank's question that revenue growth for internationals should trend Around or at or above, maybe, you know, that 30% level throughout the year. Maybe help me out there because you got some funky comps. You know, just from the prior year and you're trying to understand is that that segment has is performing well, just so we get it get it right. As we move throughout the year.

Speaker Change: Contribution as well and then Tom I think you mentioned response to Frank's question that revenue growth for international should trend around or at or above maybe a 30% level throughout the year, maybe help me out there because you got some funky comps.

Speaker Change: In the back half of the year related to that tender win and we hope Jason to be getting more wins in other areas related to pre builds we think we're just getting started there we think that is a multiyear opportunity.

Speaker Change: Second on Japan.

Speaker Change: You know just from the prior year and trying to understand is that that segment has the center is performing well just so we get it get it right as we move throughout the year and then final thing on international just maybe how much we should be thinking about for incremental contributions in Japan.

We.

Speaker Change: Have gotten full clearance now on our complete system and we have.

Chase Bednar: And then final thing on international just maybe how much we should be thinking about for incremental contributions in Japan.

Speaker Change: Distribution agreement in place with a new distributor and in Japan, and we anticipate that our sales will really start to uptick in quarter two of this year and thus far we're not planning on any increment, knowing it's taken us a little bit longer to get the actual commercial volumes.

Linda: So let me maybe start with sizing the tender benefit and the incremental on Japan, and then I'll turn it to Tom to talk about how you might think about the quarterization and go over that international piece again. So overall, what we saw in the first quarter was the buy-in for the initial win on that prefilled syringe tender. We anticipate we are going to get another order in the back half of the year related to that tender win, and we hope, Jason, to be getting more wins in other areas related to prefills. We think we're just getting started there.

Speaker Change: So let me maybe start with sizing the tender benefit and the incremental on Japan, and then I'll turn it to Tom to talk about how.

Speaker Change: If we got further.

Tom: How you might think about CT organization and Golar over that international piece again, so overall, what we saw in the first quarter was the buying for the initial win on that pre filled syringe tender. We anticipate we are going to get another order.

Speaker Change: Sales in Japan, this year that would be upside to our current international plan.

Speaker Change: And then finally on the quarter organization on the International I think the number was 30% on the full year that you can anticipate.

Speaker Change: And that.

Tom: In the back half of the year related to that tender win and we hope Jason to be getting more wins in other areas related to pre builds we think we're just getting started there we think that is a multiyear opportunity.

Speaker Change: <unk> two would be impacted a little bit in terms of that growth percentage given that dynamic we think some pull forward due to the dynamics Tom discuss from from Q2 into Q1, So Tom I'll, let you get more specific on that one yes.

Linda: We think that is a multi-year offer. Second, on Japan, we have gotten full clearance now on our complete system, and we have got a distribution agreement in place with a new distributor in Japan, and we anticipate that our sales will really start to uptick in quarter two of this year. And thus far, we're not planning on any increment, knowing it's taken us a little bit longer to get the actual commercial volumes. If we got further sales in Japan this year, that would be upside to our current international. And then finally, on the quarterization on the international, I think the number was 30% on the full year that you can anticipate.

Tom: Second on Japan, we.

Tom: Have gotten bulk clearance now on our complete system and we have a go.

Speaker Change: Just to get a little more specific.

Speaker Change: With your with respect to your question on comps.

Tom: Distribution agreement in place with a new distributor and in Japan, and we anticipate that our sales will really start to uptick in quarter two of this year and thus far we're not planning on any increment, knowing it's taken us a little bit longer to get the actual commercial volumes.

Speaker Change: Also as Jason last year, if you recall, we had the CSI regulatory issue.

Speaker Change: Which does impact the comps where we saw some stocking in the first quarter, we saw some stocking in the second quarter.

Speaker Change: And that plays into some of the.

Speaker Change: Quarterly growth numbers.

Tom: If we got further.

Speaker Change: What I would say is that we start off with.

Tom: Sales in Japan, this year that would be upside to our current international plan.

Speaker Change: We are strong with a 2.4 that you saw there.

Speaker Change: Certainly that.

Tom: And then finally on the CT organization on the International I think the number was 30% on the full year that you can anticipate and that a quarter or two would be impacted a little bit in terms of that growth percentage given that dynamic we think some pull forward.

Speaker Change: 100000 of that I would say it would be pull ahead for stocking of those those.

Speaker Change: The tender market as well as some new markets.

Tom: And that quarter two would be impacted a little bit in terms of that growth percentage, given the dynamic of we think some pull forward due to the dynamics Tom discussed from Q2 into Q1.

Speaker Change: We've added but after Q2, we expect this.

Speaker Change: To gradually grow.

Speaker Change: And you always see some nice growth towards the end of the year in international as those new markets really start to annualize and we see the.

Speaker Change: Due to the dynamics Tom discussed from from Q2 into Q1, So Tom I'll, let you get more specific on that one yeah.

Tom: So Tom, I'll let you get more specific on that. Yeah, just to get a little bit more specific, with respect to your question on the comps. Also, Jason, you know, last year, if you recall, too, we had this BSI regulatory issue, which does impact the comps where we saw some stocking in the first quarter, we saw some stocking in the second quarter, and that plays into some of the quarterly growth numbers. But what I would say is that, you know, we start off the year strong with the 2.4 that you saw there. Certainly, that 400,000 of that, I would say, would be pull-aheads for stocking of those that tender market, as well as some new markets that we've added.

Speaker Change: Improved severity in those new markets into the year. So.

A little.

Tom: Just to get a little more specific.

Speaker Change: Little bit of a topsy turvy, there, but we expect.

Tom: Uh huh.

Tom: With respect to your question on comps.

Speaker Change: We expect to be at the 30 by 30% plus growth.

Speaker Change: Also Jason last year, if you recall, we had the CSI regulatory issue.

Speaker Change: And maybe the only other comment I'd add to what Tom said is to be very clear given last year's distributor stocking and this years there was no impact on our international growth in the quarter.

Speaker Change: Which does impact the comps where we saw some stocking in the first quarter, we saw some stocking in the second quarter.

Speaker Change: And that plays into some of the.

Speaker Change: Due to that stocking we had same stocking event last year, if you read through the quarter. One results. So it's really a quarter to impact that that Tom was highlighting.

Speaker Change: Quarterly growth numbers.

Speaker Change: What I would say is that we start off with.

Speaker Change: We're strong with the $2 four that you saw there.

Speaker Change: Certainly that.

Speaker Change: 100000 of that I would say it would be pull ahead or stocking of those those.

Speaker Change: Okay. That's helpful and then I will.

Speaker Change: Come back one one more here Tom.

Speaker Change: The tender market as well as some new markets that we've added but after Q2, we expect this.

Speaker Change: And maybe.

Speaker Change: Yeah.

Speaker Change: That's been difficult here I am trying to understand you say gradually grow and.

Linda: But we, after Q2, we expect this to gradually grow and really see some nice growth towards the end of the year in international as those new markets really start to annualize. And we see the fruition of adding those new markets into the year. So a little bit of a topsy-turvy there, but we expect to be at that 30%. And maybe the only other comment I'd add to what Tom said is, to be very clear, given last year's distributor stocking and this year's, there was no impact on our international growth in the quarter due to that stocking.

Speaker Change: To gradually grow.

Speaker Change: And I'm trying to.

Speaker Change: You always see some nice growth towards the end of the year in international as those new markets really start to annualize.

Speaker Change: Put that against really strong growth are you seeing gradually grow sequentially on an absolute basis.

Speaker Change: And we see the.

Speaker Change: I guess I'm, just trying to understand like what what that what you mean, there and then I've got one follow up on tariffs.

Speaker Change: Improved severity in those new markets into the year. So.

Speaker Change: A little.

Speaker Change: Little bit about Topsy turvy, there, but we expect.

Speaker Change: It's exactly what I mean.

Speaker Change: Sequential growth, so we will see well.

Speaker Change: We expect to be at that 30%, 30% plus growth.

Speaker Change: We will see a drop in Q2, and then we will see sequential growth from there.

Speaker Change: And maybe the only other comment I'd add to what Tom said is to be very clear given last year's distributor stocking and this year. There was no impact on our international growth in the quarter.

Speaker Change: Again.

Speaker Change: Very similar pattern to last year, where we see a very strong strong first quarter and a very strong back end of the year.

Speaker Change: Due to that stocking we had same stocking about it last year, if you read through the quarter. One results. So it's really a quarter to impact that that Tom was highlighting.

Speaker Change: Okay, Alright fair enough.

Linda: We had the same stocking event last year, if you read through the quarter one results. So it's really a quarter two impact that Tom was highlighting.

Speaker Change: And then on the tariff side.

Speaker Change: It's more of a clarification point in time, I think you said 100 basis point impact from tariffs.

Chase Bednar: Okay, that's all for me.

Speaker Change: Okay. That's helpful and then.

Speaker Change: Is that a 100 basis point impact to 2025 or is that an annualized number I guess I'm trying to understand what gross margin guidance has been raised by 100 basis points. This year, if not for tariffs.

Chase Bednar: And I'll come back one one more year, Tom, just in maybe I'm, you know, just being difficult here. I am trying to understand, you say gradually grow. And I'm trying to, you know, put that against really strong growth. Are you saying gradually grow sequentially on an absolute basis? Or I guess I'm just trying to understand like what what that what you mean there and then I've got one follow up on tariffs. That's exactly what I mean. It's a sequential growth. So we'll see, we'll see a drop in Q2 and then we'll see sequential growth from there.

Speaker Change: I'll come back one one more here Tom.

Speaker Change: Maybe I'm.

Speaker Change: Yeah.

Speaker Change: It's been difficult right I am trying to understand you say gradually grow and.

Speaker Change: I'm trying to you know.

Speaker Change: Or is that taken as a 100 basis points annualized. So we're looking more like 50 basis points of lift this year if not for terrorists.

Speaker Change: Put that against really strong growth are you seeing gradually grow sequentially on an absolute basis.

Speaker Change: Yes.

Speaker Change: That's already in our guidance so when I said.

Speaker Change: Or I guess I'm, just trying to understand like what what that what you mean, there and then I've got one follow up on tariffs.

Speaker Change: It's actually under a 100 basis points.

Speaker Change: So.

Speaker Change: Within our within my guidance of the 61 63, we can that we can account we can accommodate that and again, we're offsetting things with manufacturing efficiencies.

Speaker Change: Exactly what I mean.

Speaker Change: <unk> growth. So we'll see we'll see a drop in Q2, and then we'll see sequential growth from there.

Chase Bednar: And again, Very similar pattern to last year, where we see a very strong first quarter and a very strong back end of the year. Okay. All right. Fair enough.

Speaker Change: And again.

Speaker Change: Very similar pattern to last year, where we see a very strong strong first quarter and a very strong back end of the year.

Speaker Change: We're seeing a nice mix in our products.

Speaker Change: So we have a lot of things going on in margin with stronger.

Speaker Change: Stronger sales outside of the.

Speaker Change: The U S. We have tariffs we have price increases, but we're we're managing through all of those things So I would say.

Speaker Change: Okay, Alright fair enough.

Chase Bednar: And then on the tariff side, it's more of a clarification point. Tom, I think you said 100 basis point impact from tariffs. Is that a 100 basis point impact to 2025, or is that an annualized number?

Speaker Change: Then on on the tariff side.

Speaker Change: It's more of a clarification point in time, I think you said 100 basis point impact from tariffs.

Jason Bednar: To answer your question, Jason all of those things are inclusive.

Jason Bednar: And my 61% to 63% guide.

Speaker Change: Is that a 100 basis point impact to 2025 or is that an annualized number I guess I'm trying to understand what gross margin guidance has been raised by 100 basis points. This year, if not for tariffs.

Speaker Change: Guidance, if it not been for the tariffs sure we could do better on that.

Tom: I guess I'm trying to understand, would gross margin guidance have been raised by 100 basis points this year if not for tariffs? Or is that, again, 100 basis points annualized, so we're looking more like 50 basis points of lift this year, if not for tariffs? Yeah, so that that's already in our guidance. So when I said it's actually under 100 basis points. So within my guidance of the 6163, we can accommodate that. And again, we're offsetting things with manufacturing efficiencies. We're seeing nice mix in our products. So we have a lot of things going on in margin with.

Jason Bednar: Gross margin.

Okay and that.

Jason Bednar: That number would then be.

Jason Bednar: Closer to a 200 basis points on an annualized basis.

Speaker Change: Or is that again is it a 100 basis points annualized. So we're looking more like 50 basis points of lift this year if not for tariffs.

Yeah, I would say, Joe what I'm wondering.

Okay.

Jason Bednar: Okay, Yes.

Speaker Change: Yeah. So that's already in our guidance so when I said.

Jason Bednar: Helpful.

Jason Bednar: Thank you.

Yes.

Speaker Change: It's actually under 100 basis points.

Speaker Change: Thank you next question comes from the line of Anderson shock with Pirelli Securities. Please go ahead.

Speaker Change: So.

Speaker Change: Within our within my guidance of the 61 63, we can that we can account we can accommodate that and again, we're offsetting things with manufacturing efficiencies.

Speaker Change: Hi, Congrats on the strong quarter and thank you for taking the questions. So first with the two commercialized drugs. The iron chelation antibiotics that you plan to submit for Fox and take clearance could you just provide a little more color on the market opportunity for each.

Speaker Change: We're seeing a nice mix in our products.

Speaker Change: So we have a lot of things going on in margin with.

Tom: Stronger sales outside of the U.S. We have tariffs, we have price increases, but we're managing through all those things.

Speaker Change: Stronger sales outside of the.

Speaker Change: The U S. We have terrorists in your price increases, but we're we're managing through all of those things So I would say.

Speaker Change: Yeah Anderson.

Chase Bednar: So I would say, to answer your question, Jason, all those things are inclusive in my 61 to 63% guidance. If it had not been for the tariffs, sure, we could do better on that. Okay, and that that number would then be closer to is it 200 basis points on an annualized basis? Yeah, I would say just under 150. Okay. Yes. Okay.

Speaker Change: Thank you for the note on the quarter and good to hear your voice. So on those two drugs as I said, we're still working through the total patient population.

Jason Bednar: To answer your question, Jason all of those things are inclusive.

Speaker Change: And my 61% to 63% guide.

Jason Bednar: Guidance, if it not been for the terrorists sure we could do better on that.

Speaker Change: We know that.

Gross margin.

Speaker Change: Yeah.

Speaker Change: For example, the iron chelation drug the overall patient base. We feel is about 30000 patients we know the regimen is.

Speaker Change: Okay and that.

Speaker Change: That number would then be.

Speaker Change: Is it 200 basis points on an annualized basis.

Speaker Change: Yeah, I would say just 150.

Speaker Change: Looking at a six week, Oh, sorry, a one week course of treatment that could be between five to seven infusions during the course of that week.

Speaker Change: Okay, Yes.

Chase Bednar: Very helpful. Thank you.

Speaker Change: Very helpful.

Speaker Change: Thank you.

Speaker Change: Yep.

Speaker Change: Thank you next question comes from the line of Anderson shock the Bill at least Securities. Please go ahead.

Anderson Schock: Next question comes from the line of Anderson Schock with B Rally Securities. Please go ahead. Hi, congrats on the strong quarter and thank you for taking the question.

Speaker Change: We know that the antibiotic drug is over 300000 patients, but we know that still the majority of those are in the hospital. So we're not sure how much we might see move into the home and that course of treatment is anywhere between seven and 14 days.

Speaker Change: Hi, Congrats on the strong quarter and thank you for taking the questions.

Anderson Schock: So first, with the two commercialized drugs, the iron chelation and antibiotic that you plan to submit for 510K clearance, could you just provide a little more color on the market opportunity for each? Yeah, Anderson. Thank you for the note on the quarter, and good to hear your voice. So on those two drugs, as I said, we're still working through the total patient populations. We know that, for example, the iron chelation drug, the overall patient base, we feel is about 30,000 patients. We know the regimen is looking at a six-week sorry, a one-week course of treatment that could be between five to seven infusions during the course of that week.

Speaker Change: So first with the two commercialized drugs the iron Chelation antibiotics do you plan to submit for five 10-K clearance could you just provide a little more color on the market opportunity for each.

Speaker Change: And between them.

Speaker Change: So between seven and 14 days overall with with.

Anderson: Yeah Anderson.

Anderson: Thank you for the note on the quarter and good to hear your voice.

Speaker Change: One to three infusions per day.

Speaker Change: So.

Anderson: So on those two drugs as I said, we're still working through the total patient population.

Speaker Change: Overall, there there are big numbers, particularly on the antibiotic, but we're still.

Speaker Change: Looking at what the total numbers could look like and as I mentioned in my prepared remarks.

Anderson: We know that.

Anderson: For example, the iron chelation drug the overall patient base. We feel is about 30000 patients. We know the regimen is looking.

Speaker Change: That we believe that the opportunity is probably around a half a million dollars in 2026 is our current.

Speaker Change: Estimate.

Anderson: Looking at a six week, sorry, a one week course of treatment that could be between five to seven infusions. During the course of that week are.

Speaker Change: Okay got it that's helpful. And then so developing these without a partner how should we think about the size of the investment on your end.

Speaker Change: Yeah.

Linda: We know that the antibiotic drug is over 300,000 patients, but we know that still the majority of those are in the hospital. So we're not sure how much we might see move into the home. And that course of treatment is anywhere between seven and 14 days and between So between 7 and 14 days overall with, uh, with. one to three infusions per day. So overall, there are big numbers, particularly on the antibiotic, but we're still looking at what the total numbers could look like.

Speaker Change: Well I'm not going to go to the specifics of exactly we have developed a team that has gotten quite good at figuring out how to get new drugs on label. So it some internal efforts.

Anderson: We know that the antibiotic drug is over 300000 patients, but we know that still the majority of those are in the hospital. So we're not sure how much we might see move into the home.

Speaker Change: It's buying that drug and thankfully these drugs are not expensive drugs.

Anderson: And that of course of treatment is anywhere between seven and 14 days and between.

Speaker Change: So we're able to purchase those.

Speaker Change: And then it's just doing the necessary testing are required here internally and some external testing for it for those drug candidates.

Anderson: So between seven and 14 days overall with with.

Anderson: One to three infusions per day.

Speaker Change: What I would say overall at a high level is the payback is in far less than one year on those two campuses. So it was kind of a no brainer for us to get that done.

Anderson: So.

Anderson: Overall, there there are big numbers, particularly on the antibiotic, but we're still I'm looking at what the total numbers could look like and as I mentioned in my prepared remarks that.

Anderson Schock: And as I mentioned in my prepared remarks, that we believe that the opportunity is probably around a half a million dollars in 2026 is our current estimate. Okay, got it. That's helpful.

Speaker Change: Sure.

Speaker Change: Pretty quickly so we're excited about that and anticipate that we'll file.

Anderson: We believe that the opportunity is probably around a half a million dollars in 2026 is our current.

Hopefully by Q3.

Anderson: Estimate.

Speaker Change: Okay got it and then on the pump collaborations so how many E pump companies are you currently working with and how many countries and are there any plans for expansion into new geographies with similar similar collaborations.

Speaker Change: Okay got it that's helpful. And then so developing these without a partner how should we think about the size of the investment on your end.

Linda: And then so developing these without a partner, how should we think about the size of the investment on your end? Yeah. Well, I'm not going to go to the specifics of exactly. We have developed a team that has gotten quite good at figuring out how to get new drugs on label, so with some internal efforts, it's buying that drug. And thankfully, these drugs are not expensive drugs, so we're able to purchase those. And then it's just doing the necessary testing required here internally and some external testing for those drug candidates. What I would say overall at a high level is the payback is in far less than one year on those two candidates, so it was kind of a no-brainer for us to get that done.

Speaker Change: Yeah, well I'm not going to go to the specific cause of exactly we have developed a team that has gotten quite good at figuring out how to get new drugs on label. So it's some internal efforts.

Speaker Change: Yeah. So we we would work with any of the pump companies that are on the market today that would be primarily three companies that we work with in that space and.

Speaker Change: It's buying that drug and thankfully these drugs are not expensive drugs.

Speaker Change: None of those companies have subcutaneous infusion set so that works well for us and works well for them.

Speaker Change: So we're able to purchase those.

Speaker Change: And then it's just doing the necessary testing are required here internally and some external testing for it for those drug candidates.

Speaker Change: And we anticipate that.

Speaker Change: Those three probably have greater than 80% of the global market.

Speaker Change: What I would say overall at a high level is the payback is in far less than one year on those two campuses. So it was kind of a no brainer for us to get that done.

Speaker Change: And so we're pursuing the ones that have the remaining 20%, but but satisfied that with the numbers that are in our plan with our current technical relationships that that will be will be good with the numbers that we're projecting.

Linda: pretty quickly.

Speaker Change: Sure.

Linda: So we're excited about that and anticipate that we'll file hopefully by Q3.

Speaker Change: Pretty quickly so we're excited about that and anticipate that we will file.

Speaker Change: Hopefully by Q3.

Linda: Got it. And then on the EPUMP collaboration, so how many EPUMP companies are you currently working with and in how many countries? And are there any plans for expansion into new geographies with similar collaborations? Yeah, so we would work with any of the e-pump companies that are on the market. Today, that would be primarily three companies that we work with in that space. And none of those companies have subcutaneous infusion sets, so that works well for us and works well for them.

Speaker Change: Okay got it and then on the pump collaborations. So how many you pump companies are you currently working with and how many countries and are there any plans for expansion into new geographies with similar similar collaborations.

Speaker Change: Okay got it.

Speaker Change: Well congrats again on the great start to the year and thank you for taking our questions.

Speaker Change: Thank you.

Speaker Change: Thank you ladies and gentlemen, we have reached the end of question and answer session.

Speaker Change: Yeah. So we we would work with any of the pump companies that are on the market today that would be primarily three companies that we work with in that space and.

Linda: I'd like to turn the floor over to Linda pardon me for closing comments.

Linda: So thank you all again for joining us. This afternoon, we're excited about our start to the year I want to thank the entire <unk> team for all of their exceptional efforts to start this year and we look forward as a team to a variety with further updates on <unk>.

Speaker Change: None of those companies have subcutaneous infusion set so that works well for us and works well for them and we anticipate that.

Linda: And we anticipate that... Those three probably have greater than 80% of the global market. And so we're pursuing the ones that have the remaining 20%, but satisfied that with the numbers that are in our plan with our current technical relationships that we'll be good with the numbers that we're projecting. Okay, got it.

Speaker Change: Those three probably have greater than 80% of the global market.

Linda: Additional opportunities as we make progress towards our 2025 milestones.

Speaker Change: And so we're pursuing the ones that have the remaining 20%, but but satisfied that what the numbers that are in our plan with our current technical relationships that that will be will be good with the numbers that we're projecting.

Linda: Have a great rest of your day.

Linda: Okay.

Linda: Thank you.

Linda: This concludes today's teleconference. You may disconnect your lines at this time.

Linda: Thank you for your participation.

Speaker Change: Okay got it well.

Anderson Schock: Well, congrats again on the great starts of the year, and thank you for taking our questions. Thank you.

Speaker Change: Well congrats again on the great start to the year and thank you for taking our questions.

Speaker Change: Thank you.

Thank you ladies and gentlemen, we have reached the end of question and answer session I would now like to turn the floor over to Linda pardon me for closing comments.

Operator: Ladies and gentlemen, we have reached the end of the question and answer session.

Linda: I would now like to turn the floor over to Linda Tharby for closing comments. So thank you all again for joining us this afternoon. We're excited about our start to the year. I want to thank the entire CORU team for all of their exceptional efforts to start this year. And we look forward as a team to providing you with further updates on additional opportunities as we make progress towards our 2025 milestone.

Speaker Change: So thank you all again for joining us. This afternoon, we're excited about our start to the year I want to thank the entire <unk> team for all of their exceptional efforts to start this year and we look forward as a team to variety you with further updates on addition.

Speaker Change: Opportunities as we make progress towards our 2025 milestones.

Operator: Have a great rest of your day. Thank you.

Speaker Change: Have a great rest of your day.

Speaker Change: Thank you.

Operator: This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation. Thank you, Renxu.

Speaker Change: Concludes today's teleconference. You may disconnect your lines at this time, thank you for your participation.

Speaker Change: Thank you and you have a good rest of your day.

Operator: Have a good rest of your day. © The Bulletproof Executive 2013

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