Earnings Call Transcript - KRMD Q2 2025

Operator, Operator

Hello, and welcome to the KORU Medical Systems Second Quarter 2025 Financial Results Conference Call and Webcast. As a reminder, this conference is being recorded. I would now like to turn the conference over to Louisa Smith of the Gilmartin Group. Please go ahead.

Louisa Smith, Investor Relations

Thank you, Judith, and good afternoon, everyone. Joining me on the call today are Linda Tharby, President and CEO of KORU Medical Systems; and Tom Adams, Chief Financial Officer. Earlier today, KORU released financial results for the second quarter ended June 30, 2025. A copy of the press release is available on the company's website. I encourage listeners to have our press release in front of you, which includes our financial results as well as commentary on the quarter. Additionally, we will use slides to support further commentary in today's call, which are also available on the Investor Relations section of our website. During this call, we will make certain forward-looking statements regarding our business plans and other matters. These comments are based on our predictions and expectations as of today. 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. We assume no obligation to update any forward-looking statements. During the call, management will also discuss certain non-GAAP financial measures. You will find additional disclosures, including reconciliations of these non-GAAP measures with comparable GAAP measures in our press release, the accompanying investor presentation and SEC filings. For the benefit of those listening to the replay, this call was held and recorded on Wednesday, August 6, 2025, at approximately 4:30 p.m. Eastern Time. 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 Tharby, President and CEO. Linda, please go ahead.

Linda M. Tharby, President and CEO

Thank you, Louisa. Good afternoon, everyone, and thank you for joining today's earnings call. I'll begin with some commentary on our strategic vision and the opportunity ahead in the large volume subcutaneous drug delivery market, followed by highlights from the second quarter. Tom will then review our financial results before we open the call for your questions. Let me start with the big picture. KORU is a leader in the large-volume subcutaneous drug delivery market with the Freedom system being cleared for use with the first drug in 2017. We are well positioned to capitalize on the accelerating shift from hospital IV-based treatments to more convenient subcutaneous therapies delivered at home and in infusion clinics. Today, our Freedom system serves approximately 45,000 patients primarily on Ig therapy for chronic conditions, providing a strong, stable base of recurring revenue. We are also focused on expanding beyond SCIg, where we currently have 10 active opportunities and many more we are pursuing to bring new drugs onto our Freedom Infusion platform. Over the past decade, health care has begun to shift from the hospital to infusion clinics to the home, and KORU is uniquely positioned to capitalize. We are cleared for use with all SCIg drugs on the market. Between subcutaneous and IV formulations, we estimate that the opportunity for drug delivery devices for Ig therapy is approximately $450 million, with only 20% penetrated by subcutaneous formulations. Beyond Ig, there are currently more than 50 drugs in development that are formulated at volumes of greater than 10 ml, requiring a specialized drug delivery solution, a significant opportunity that aligns with KORU's core competencies in large volume drug delivery. Our strategy is based on 3 growth pillars: defending and growing our core domestic business where we are the market leader and have the opportunity to increase penetration, expanding internationally where subcutaneous penetration is higher and we have share growth opportunity and enabling the delivery of additional drug therapies to reach more patients. Now turning to our results for the second quarter. We reached a historic milestone in Q2 with over $10 million in revenue. Revenue grew over 20% with continued momentum across all 3 strategic growth pillars. Our domestic core business continues to outperform a growing SCIg market, and we are seeing significant acceleration in international expansion with over 30% growth. Our Pharma Services and Clinical Trials segment also saw strong growth driven by clinical supply agreements. We continue to expand our patient base through market share gains with recurring revenues from chronic SCIg patients. Further, the FDA recently approved an expanded indication for Empaveli, a non-SCIg drug already on our label for C3G and primary IC-MPGN, creating further opportunity. We also submitted a 510(k) ahead of schedule for a rare disease biologic, another milestone in our strategy to bring more non-Ig drugs onto the Freedom platform. Following our success in the EU, we have also initiated a U.S.-based oncology pilot program with over 50 patients enrolled at 6 infusion centers across 4 different subcutaneous oncology drugs. Insights from this pilot will help with data generation to inform our strategic decisions around pursuit of the oncology opportunity, which we look forward to updating you on in the coming quarters. We also advanced our goals towards profitability this quarter with Q2 cash usage of $600,000. This was driven by the trifecta of strong revenue growth, sustained gross margin performance and disciplined capital allocation that is delivering meaningful operating leverage. And finally, I'm excited to announce that Adam Kalbermatten has joined KORU as Chief Commercial Officer, bringing 20 years of success in leading drug delivery partnerships across pharma and biotech in both large and small cap companies. Adam will be instrumental in further acceleration of our global commercial and PSD strategies. Two weeks in, he has hit the ground running. Let's take a closer look at performance across our 3 strategic pillars, starting with our core business results. Our domestic core business continued to outperform strong SCIg market growth fueled by market share gains in key accounts. The addition of the new label expansion for Empaveli will provide an opportunity to further grow our patient base. Internationally, we continue to deliver significant growth fueled by expansion into new geographies and our first prefilled syringe market conversion in Europe, an early step in what we believe is a much larger long-term strategy. We expect even further contribution from our prefill efforts in the back half. You'll notice we've updated our pipeline slide distinguishing between core Ig opportunities and new drugs added to our label. I'll cover the latter on the next slide. We believe this view more clearly illustrates how device innovation, label expansion and strategic collaborations are driving share gains and targeted geographic expansion for our core Ig business. Within our Ig partnerships, we made 2 key advances this quarter. First, we completed all pump and consumable registrations in Japan, paving the way for sales alongside 2 leading Ig therapies. We expect to realize sales in the back half of this year. The final step, clearance of our flow controller with the third Ig drug is expected in 2026. In addition, one of our Ig drug collaborations progressed to a combined Phase II/III trial. More broadly, we continue to make strong progress across our Ig device and drug partnerships with a major milestone on the horizon, multiple anticipated clearance for our next-generation pump in 2026, which will unlock new market share and geographic expansion opportunities. Moving to our third growth pillar. We continue to see good progress in our opportunity to enable the delivery of more drugs and ultimately bring more patients to our platform. Our pipeline includes 5 new drugs that we expect to be commercialized on our Freedom Infusion platform by the end of 2026 and 10 total pipeline drugs, a mix of independent 510(k) submissions and formal pharmaceutical collaborations. Notably, we named 2 drugs we are pursuing independently, deferoxamine for inoculation and vancomycin, an antibiotic with both now expected to receive clearance by 2026. In total, these 2 drugs represent approximately 1 million total infusions, of which we expect to realize about $500,000 in incremental revenue next year. Through our relationships with specialty pharmacies, we're in the process of identifying and potentially pursuing additional drugs that fit into this category to drive additional annual infusions into our core business. As noted in my opening remarks, the FDA recently approved an expanded indication for Empaveli, representing approximately 100,000 annual infusions. We estimate KORU's opportunity to be around 20,000 of those infusions. We've also submitted ahead of schedule a 510(k) for a rare disease biologic representing 40,000 annual infusions. We hope to receive clearance on this by the end of this year. Our revised total addressable market for new drugs now stands at approximately $1.8 billion based on estimated patient populations and dosing schedules and ASPs from our prior $2.2 billion. As our new drug pipeline continues to evolve, we will assess each therapy's infusion volume to determine KORU's serviceable opportunity. We are encouraged by our robust and growing pipeline with some near-term commercial opportunities. Moving to product development. Our initiatives are progressing well and will be drivers of near-term growth. I'm pleased to report that we launched our Phase I flow controller in Q2 ahead of schedule. Phase II flow controller submission is expected by the first half of 2026 and will provide enhanced performance and expanded label indications that will expand our access to new patients in new markets. Our next-gen pump development is on track with the 510(k) submission expected by Q4 of 2025 to Q1 of 2026. This pump will accommodate all available prefilled syringes, will be vial and syringe compatible and offer patients improved mobility and usability. We now expect to file a 510(k) for our new consumable sets in the second half of 2026, allowing us the time and opportunity to incorporate further market feedback. We do not expect this to have any negative impact on revenue figures in 2025 or 2026. We are prioritizing the pump development, a decision that has the potential to accelerate our international growth. Overall, I'm very pleased with the momentum we built in the first half of the year and remain confident in our ability to carry this trajectory through the remainder of 2025. We've established a strong foundation to execute across all of our growth pillars, and our teams continue to deliver steady, focused progress every day. With that, I'll turn the call over to Tom to walk through our financial results and share our updated 2025 guidance.

Thomas Adams, Chief Financial Officer

Thank you, Linda. Starting with revenue, we were pleased to deliver record revenues of $10.2 million in the second quarter, representing 21% growth over the prior year period. Our domestic core revenues were $7.1 million, a 15% increase over the prior year. This performance continues to demonstrate our ability to outpace the overall SCIg market growth driven by new patient starts and market share gains, leading to continued strength in consumable volumes. In our international core business, we delivered revenues of $2.2 million, representing growth of 34% over the prior year. This growth was driven by expansion into new geographies and the continued success of our prefilled syringe strategy in Europe. Our Pharma Services and Clinical Trials revenues were $900,000, representing 42% growth over the prior year, driven by strength in clinical trial orders from a non-Ig partner, demonstrating the diversification of our PST business beyond SCIg. Moving over to our gross margin performance. Starting with the chart on the left side, our second quarter margins were 63.5%, representing a 150-basis point decline year-over-year. This decline was primarily driven by 2 specific factors, tariff impacts this year of 90 basis points and a prior year favorable inventory revaluation adjustments of 90 basis points. These headwinds were partially offset by volume efficiencies and improved PST margins. For the second half of the year, we expect gross margins in the 61% to 63% range, impacted by increased revenue and lower average selling price markets and ongoing tariff impacts. We are reiterating our guidance range of 61% to 63% for the full year 2025. Turning to cash. We finished the quarter with an $8.1 million cash balance, representing cash usage of $600,000 during the second quarter, driven by lower net losses resulting from higher revenues, sustained gross margins and disciplined operating expense spending. From the net loss, we removed noncash-related items of $600,000, driven primarily by stock compensation expenses and depreciation. Our working capital was higher in the quarter, driven by inventory replenishment and timing of accounts receivable collections. We also had an investment in the quarter for manufacturing equipment related to our new products. Looking at our cash usage strategy trajectory over the past 3 years, we've made significant progress in reducing our cash consumption. We improved from $5.9 million in cash usage in 2023 to $1.9 million in 2024. With the majority of our significant infrastructure investments behind us, we continue to trend favorably. Cash usage for the first half was $1.5 million. And for the second half of 2025, we expect our usage to be neutral to positive, putting us on track to achieve our goal of positive cash flow from operations for the full year 2025 and ending the year with at least $8.1 million in cash. Our first half financial highlights demonstrate strength across our P&L. Revenue grew 19% to $19.8 million compared to $16.6 million in the first half of 2024, with a corresponding operating expense increase of 3%. This demonstrates our ability to run a disciplined capital allocation process and edge closer towards profitability. Gross margin remained strong at 63.1%, down 50 basis points year-over-year. Our adjusted EBITDA improved 101% to be slightly positive compared to a negative $1.3 million in the first half of '24 and adjusted earnings per share of $0.00 per share versus a loss of $0.02 per share in the same period last year. Looking ahead, we are raising our revenue guidance to $39.5 million to $40.5 million, representing 18% to 20% growth, an increase from our prior range of $38.5 million to $39.5 million, driven by significant opportunities for further growth from prefilled conversions internationally, partially offset by an expected inventory reduction from a large distributor in the U.S. in Q3. We are reiterating our gross margins in the range of 61% to 63%. We anticipate gross margin pressures from the first half to second half, driven by a stronger mix of growth in the international markets with lower average selling prices. In addition to supply chain inflationary and tariff pressures. We expect pricing and manufacturing efficiencies to mitigate some of these unfavorable impacts. For cash flow generation, we are reiterating our expectation of positive cash flow from operations for the full year 2025. We anticipate operating expenses exclusive of stock compensation in the range of $26 million to $27 million, with higher operating expenses spend occurring in the second half of 2025, driven largely by R&D project work. Additionally, we still expect less than $2 million of investing activities and capital expenditures for new production lines. I'll now turn the call back over to Linda for some closing commentary on future milestones and our vision for continued growth.

Linda M. Tharby, President and CEO

Thank you, Tom. We're very pleased with our second quarter performance and the momentum across all of our strategic growth pillars. Our strong results, expanding pipeline and profitability trajectory demonstrate the strength of our business model and the significant opportunities ahead. Key milestones ahead include advancing our Phase II flow controller and next-gen pump submissions, continuing our international expansion with a focus on the prefill opportunity and pipeline progression with expected filing of 3 new drugs by Q1 of 2026. As for the longer-term vision for the company, our goal is to sustain over 20% growth through investments in core international and new product and new drug pipeline initiatives. 2025 has been a pivotal year in setting that foundation. To close, a few key takeaways that we believe make KORU a compelling growth story. We delivered another strong quarter with revenue growing over 20%, fueled by recurring core revenue and continued patient growth in our core Ig business, further strengthened by international expansion. We are starting to see the tailwinds of macro trends favoring subcutaneous delivery. Our pipeline of 10 new drugs with more on the horizon meaningfully expands our long-term opportunity. Our raised guidance reflects the confidence we have in our strategy and execution. And finally, a sincere thank you to the entire KORU team for showing up with purpose and passion every day to help patients around the world. Operator, please open the line for questions.

Operator, Operator

Our first question comes from Frank Takkinen of Lake Street Capital Markets.

Frank James Takkinen, Analyst

Congrats on the solid quarter and guide. I was hoping to start with the guide. It looks like you flowed through the beat. It looks like you've got good momentum in the core business. OUS is clearly trending favorably as well. I'm just curious if you could kind of parse out expectations domestic versus OUS and then maybe cadence in Q3 versus Q4 expectations.

Linda M. Tharby, President and CEO

Yes. Frank, thank you. We're very pleased with the quarter and obviously, in the momentum we expect with the $1 million raise in the overall guidance range. What I would say on the guidance range is, obviously, the international is driving tremendous growth for us, and we expect that to continue at even an accelerated pace in the back half, offset by what Tom talked about on the U.S. side. I'll turn it over to Tom for further comments on Q3 versus Q4.

Thomas Adams, Chief Financial Officer

Yes. So Frank, the way we're looking at our business is with the $1 million raise, as Linda mentioned correctly, most of that raise, we will see in our international markets. We're seeing some really nice revenue growth with the prefilled opportunity that we both recognized in our prepared remarks. And so you can expect really steady and strong growth outpacing what you'd see in the first 2 quarters. And then as Linda mentioned domestically, yes, we did receive some work from a large U.S. distributor that they're going through an inventory reduction program here in Q3. So we see a little bit of drop-off in Q3 from that, but then we should see a bounce back up in Q4. And then on the PST side, we continue to see stable growth in our PST, which is our clinical trials and services business. So you can expect more of what you saw in the first half of the year in the back half.

Frank James Takkinen, Analyst

Got it. That's helpful. And then maybe just to follow up on kind of something you guys both referenced, prefilled syringes in Europe. I know that's just getting started, and that's a large growth opportunity. So, any incremental color you can provide on what's driving that success? And then kind of how we should think about the durability of that growth and how large of an opportunity that can be for you guys?

Linda M. Tharby, President and CEO

Yes. We are quite excited to see the progress with prefilled syringes this quarter. The broad opportunity lies in the pharmaceutical sector, where our Ig partners are shifting from vials to prefilled syringes. Our Freedom system is designed to work seamlessly with these syringes; the patient simply inserts the syringe into the pump, closes the device, and is ready for infusion. This process eliminates several steps, achieving over a 40% reduction in complexity, along with a 75% preference among patients for prefilled options. In terms of international opportunities, we historically hold a market share of 10% to 15% in Europe. As the market transitions to prefilled syringes, we find that our device is increasingly preferred. The current conversion that you see is happening in just one country and is partially reflected in our Q2 results. We anticipate more conversions in the latter half of the year, as we are collaborating with all our pharmaceutical partners, particularly focusing on one regarding their prefilled syringe transition program. We believe several additional markets will be ready for conversion by 2026. Furthermore, we expect to launch a new pump opportunity with them by mid-2026 in various new markets globally.

Operator, Operator

The next question comes from Chase Knickerbocker with Craig-Hallum.

Chase Richard Knickerbocker, Analyst

Congratulations on a strong quarter. I want to follow up on something Frank mentioned. In that international market, what is your expected market share there compared to the market share rate you just discussed for Europe?

Linda M. Tharby, President and CEO

Yes. So, we know that our share position coming into the year was probably somewhere between 10% and 15%. We think now it's in the low 20 percentage. That market is a top 5 market in Europe. And we believe that there are 4 or 5 other markets that we can go to for further conversions. So, we're just getting started. We don't think the conversion is fully complete. You'll see more on that, which is giving us the confidence to raise our guidance by the $1 million range due to what we anticipate will be further conversions in the back half.

Chase Richard Knickerbocker, Analyst

Got it. So, when you mention that low 20s number, are you referring specifically to Europe or that market? And you believe it represents 10% of market share?

Linda M. Tharby, President and CEO

Yes. In Europe, we still lack complete details about our position in that specific market, and we don't yet have a clear understanding of the range for it. The team will be in Europe and will collaborate more closely with the pharmaceutical partner to determine this over the next few months. There is a significant untapped opportunity, and we have identified that our market share in this area is likely lower than in others. This is where we encounter our main competitor in electronic pumps. We are optimistic about this initial market and expect to share more updates soon.

Chase Richard Knickerbocker, Analyst

Got it. Just on domestic SCIg market in the quarter. Can you share what the growth rate was and kind of any commentary you're hearing about kind of how your pharma partners are thinking about the remainder of the year for the SCIg market in the U.S.?

Linda M. Tharby, President and CEO

Yes. I would say we've seen the growth rates continue in that high single-digit, low double digit through the first half of the year. If we look at who has reported thus far in Ig, they're all reporting strong double-digit growth in their SCIg franchises. So, we're encouraged by that. And that is really just we continue to see further new patient starts on SCIg, which is really driving a lot of growth. We continue to see new patients being diagnosed. And then finally, we know that there is a trial occurring now for secondary immunodeficiency, which has prior been a very strong driver in Europe for SCIg. And when that trial is concluded, we believe will be another growth driver for the SCIg market in the U.S.

Chase Richard Knickerbocker, Analyst

Got it. And maybe last couple for me. Maybe just on the consumable delay. Can you just speak to specifically what kind of product design elements you're looking to add to that, that kind of caused that delay? And then kind of along the same lines on the next-gen pump. What's left to do before the submission there? How kind of confident are you in that timeline, call it, late '25, early '26?

Linda M. Tharby, President and CEO

Regarding the delay with the consumables, we experienced a significant shift in our consumables line. This involved two main aspects: a substantial enhancement in comfort associated with the needle technology, and a significant increase in convenience by reducing the steps needed for patients to perform infusions. Through our regular research with customers, patients, and pharmaceutical partners, we've identified a few adjustments that will better meet market demands, which is why we decided to delay the program. However, I don't anticipate this affecting our revenues in 2025 or 2026. We are excited about the insights we've gained and will implement these changes moving forward. As for the next-generation pump, we are very optimistic. We’ve conducted trials with patients, specialty pharmacies, and pharmaceutical companies, all of whom are extremely enthusiastic about the upcoming launch. At this time, we do not foresee any significant delays. We have successfully navigated all major technical challenges, and we believe that by the end of the first quarter at the latest, we will be applying for 510(k) approval.

Operator, Operator

The next question comes from Caitlin Cronin of Canaccord.

Caitlin Cronin, Analyst

Congrats on a great quarter. Just going off of the next-gen pump, just a reminder of why that is important, particularly for overseas? And then with the prioritizing of that now, what is the timing of that clearance and then launch overseas?

Linda M. Tharby, President and CEO

The next-generation pump is important because with the launch of prefills, patients will need to use multiple prefills in their weekly dosing regimen, which come in different sizes. Currently, to manage this, patients sometimes have to transfer prefill medication into a different size syringe, or they use two different pumps, which can be complicated. Our new pump will accommodate any prefill available in the market, ranging from 5 ml to 50 ml, and will also work with any vial or prefill. It offers enhanced mobility, a flexible dosing window, and ease of use, which we are very excited about. The value proposition is quite strong. In terms of timing, we plan to submit for U.S. 510(k) approval, and then we will aim to file in the EU about one quarter later, expecting to do so by mid-2026.

Caitlin Cronin, Analyst

That's great. And then with the tariff impact hitting, just any updates on the expectations of that and the cadence and how you're mitigating?

Thomas Adams, Chief Financial Officer

Caitlin, I can take that one. Regarding the tariffs, our largest supplier who has the most significant impact is our third-party contract manufacturer. We have examined their bills and materials and collaborated with them to understand the effects from a materials standpoint, including where the materials originated and the actual tariff impact based on the value added by that contractor. Over the full year, we estimate a 90-basis point impact, which translates to about 2% on each order. We conducted a thorough analysis on this. We believe we have it under control. As for mitigation, we are consistently implementing operational excellence programs in our facilities, seeking ways to create efficiencies through our volumes, and pursuing rebate programs with vendors. As our company grows and we see volume increases, we can benefit from these volume efficiencies. Therefore, we are confident that we are managing the tariff-related issues effectively.

Caitlin Cronin, Analyst

Great. And maybe just one more. Confidence on the distributor impact in the U.S. is really going to be just a Q3 event?

Linda M. Tharby, President and CEO

Yes. Maybe I'll start and then turn it to Tom. We look most importantly at our volumes relative to what we call our end user demand. So, we have data on what those distributors sell to our end user specialty pharmacies. That demand is very, very strong. So then we can deduce how much inventory they're carrying. And we know that based upon our demand and the overall market growth that we feel quite good about the end-user demand being sustained. So a one-time their overall company goal to reduce a week of inventory. We'll take a small hit in the third quarter, but won't impact us that much relative to some of the other growth drivers, i.e., international that we talked through.

Thomas Adams, Chief Financial Officer

Yes. Just to add on to what Linda was saying, Caitlin, our distributors, they keep their own safety stocks and they keep their own inventory levels. And sometimes they reduce them. They have initiatives to reduce them. They still service our customers, but if they're carrying, let's say, they're carrying 4 weeks, they might choose to carry 3 weeks during a particular period. So we just react to that because at the end of the day, we sell to distributors, and that's the sales that we record. So that's the reason for the Q3 dip that I mentioned earlier.

Operator, Operator

We'll take the next question is from Jason Bednar of Piper Sandler.

Jason M. Bednar, Analyst

Alright. Congrats on a nice quarter, everyone. Looks like you're expecting positive cash generation in the back half of the year here, Linda and Tom, it's good to see. I guess how are you thinking strategically about cash from here now that we're kind of in that cash generation mode? Are you going to build a cushion first? Are you thinking about reinvesting in the business to sustain that strong top line or maybe even accelerate it? And if it's the latter, do you see this more as an R&D push or an SG&A type investment? Any color there would be great.

Linda M. Tharby, President and CEO

Thanks, Jason, and congratulations on the quarter. We are excited to have achieved positive cash flow this quarter, and we remain optimistic about the outlook for the rest of the year, which is influenced by both our revenue growth and gross margin. About a year and a half ago, we began tightening our capital allocation and evaluating our portfolio for both short- and long-term opportunities. Our previous significant investments in infrastructure and talent have contributed to a reduction in cash burn. Going forward, our solid operating model, supported by partnerships with pharmaceutical companies and agreements with key accounts, allows us to maintain relatively low selling, general, and administrative expenses. As we proceed, we will carefully evaluate every growth opportunity. We anticipate that most of our investments will be in SG&A, with the advantage that many offer a one-year payback period, helping us sustain our $8 million cash balance. If we encounter significant opportunities for rapid international growth, those tend to have quick paybacks as well. The oncology pilot is another area we are monitoring for potential opportunities. Overall, we feel confident in our cash position and our capacity to maintain growth above 20% with our current resources.

Jason M. Bednar, Analyst

Alright, that's helpful. Linda, we're getting closer to tapping into this new pipeline with new drugs and expanded indications in almost real-time. What is the best way to think about the commercial uptake of that pipeline? Is it more of a linear adoption curve, or does it lean towards a hockey stick approach? We will all be looking to figure out how to model these as they become more real and progress further. How would you suggest we think about them collectively?

Linda M. Tharby, President and CEO

Yes. I would say that we tried hard to give now a number of potential total infusions. Of course, that doesn't represent our opportunity. We'll try and give an indication. I think I said on the last call that the 2 we're pursuing on our own, the vancomycin and deferoxamine will be about $0.5 million next year. Similar numbers for the 2, the Empaveli and the rare disease indication next year. So probably next year between those 2, just shy of $1 million in upside. And then you'll see kind of a similar linear progression over the course of the year. I would say the big pops that we see would obviously be oncology, if that one occurs, given the overall size of that market. We're excited that we're in clinics. But obviously, the value prop is proving strong here, but more work to do in terms of reimbursement and economics around that one.

Operator, Operator

The next question is from Anderson Schock of B. Riley Securities.

Anderson Schock, Analyst

Congrats on the really strong quarter and positive adjusted EBITDA. So, with the Japan launch expected to generate revenue in the back half of the year, I guess, how should we think about the back half for international growth? Is 30% still the target for 2025? It looks like if you remain flat sequentially on international revenue, you'd be closer to 50% growth year-over-year. Is there any seasonality we should be thinking about in the back half?

Linda M. Tharby, President and CEO

Yes. Maybe I'll just touch on Japan, and then I'll turn it to Tom for some of the more detailed questions on international. So overall, in Japan, we still believe that it is a top 10 Ig market. We're excited. SCIg is just getting started there. We just recorded our first sales. It is included in the guidance that we see, but we see a bigger impact in Japan for 2026 than 2025. Tom, maybe I'll hand it to you for the specifics around growth on international.

Thomas Adams, Chief Financial Officer

Yes, Anderson. So, if you think about the back half, as we mentioned, we've had a very strong front half of about 35-or-so percent growth. You can expect that to increase significantly over that number. As we mentioned, when we think about the $1 million increase, I'd say that's primarily all into the international business. So, as you think about your model and where that goes, I would say you'd want to layer that into Q3, Q4 almost evenly across the international business.

Anderson Schock, Analyst

Okay. Got it. And then on the last call, you mentioned you anticipate another order from the first quarter's tender win in the back half of the year. Do you have any updates on the timing or size of this?

Linda M. Tharby, President and CEO

I would say it is included in the guidance we provided. We do have visibility to it. I'm not going to give the exact numbers, but I would mention that what began to be fulfilled in the second quarter indicates we will see equally strong orders in the second half of the year.

Anderson Schock, Analyst

Okay. Got it. And then on the Pharma Services and Clinical Trial side, I guess what drove this increase? Is this just onetime NREs? Or should we expect to see this quarter's revenue kind of as the new norm?

Linda M. Tharby, President and CEO

I wouldn't expect this quarter's revenues to be typical. It was influenced by clinical trial orders for a non-Ig drug, which is positive for us. These clinical trials usually indicate that the drug is in a clinical trial, and in this case, it is in Phase III, so we will receive clearance soon. Regarding Pharma Services, as Tom previously mentioned, you can expect the first and second half revenues for PST to be roughly equal, with the possibility of a slight increase if we encounter more opportunities than currently expected.

Operator, Operator

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

Linda M. Tharby, President and CEO

Thank you all for joining us this afternoon. We look forward to providing you with further updates on additional opportunities as we make progress against our 2025 milestones. Have a great rest of your day.

Operator, Operator

This concludes today's conference. You may now disconnect your lines and enjoy the rest of your day.