Verona Pharma PLC

NASDAQ:VRNA

Greetings, and welcome to the KORU Medical Systems Fourth Quarter and Full Year 2024 Financial Results Conference Call and Webcast. [Operator Instructions] 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.

Thank you, Julian, 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 fourth quarter ended December 31, 2024. 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 further support our 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, March 12, 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.

Thank you, Louisa. Good afternoon, everyone, and thank you to all of the investors and analysts joining us on our earnings call today.

I'll begin with commentary on our strategic progress, including fourth quarter and full year updates, followed by Tom, who will review our financials and 2025 guidance. We will then open the line for your questions.

2024 marked a significant year for KORU Medical with several advancements in our strategy to become a global leader in large-volume subcutaneous drug delivery in the home and in the clinic. Today, the majority of this large volume subcutaneous market is made up of immunoglobulins, which accounts for approximately 90% of our current patient base. The SCIg market grew more than 10% in 2024 as a result of rising global infection rates, driving increased patient diagnosis. And with only 20% to 30% global penetration of SCIg into the broader Ig market, we see significant growth potential ahead. In addition to this core SCIg market, the broader large volume subcutaneous market is rapidly growing. There are over 18 large volume drugs in development as we continue to see pharmaceutical companies drive their portfolios to the subcutaneous format, supporting the broader trend of movement of care away from the hospital setting. These novel therapies represent a significant opportunity and the growing potential to bring new patients onto the KORU Freedom Infusion System.

We also delivered strong financial performance in the year. Fourth quarter results saw record-setting revenues, continued gross margin expansion and positive cash flow. Q4 revenues grew 23% and full year revenues totaled $33.6 million, representing 18% growth. Each of our businesses saw double-digit increases. Our core business grew by 16% on the year, outperforming robust SCIg market growth as a result of great work by our team to drive increased market share capture and enter new international geographies. Novel Therapies also had a strong quarter and year with an increased number of pharmaceutical collaborations and increased clinical trial supply orders. This strong Novel Therapies performance was highlighted by the addition of 4 new collaborations to our pipeline in 2024 and the announcement of an additional 2 collaborations in the first 2 months of this year.

From an operational standpoint, we expanded our gross margins, which led us to a record-setting gross profit for the full year 2024. Year-end cash balance of $9.6 million exceeded our previously communicated expectations, and we generated positive cash flows in the fourth quarter. These accomplishments paired with disciplined operating expense management throughout the year have allowed us to drive further leverage within the business as we drive to profitability.

Lastly, we are initiating our 2025 guidance to include the following: net revenues between $38 million and $39 million, representing growth of 13% to 16%; full year gross margin between 61% and 63%; and operational cash flow positive for the full year 2025. Tom will go into greater detail on each of these metrics and their assumptions towards the end of our prepared remarks. So overall, a very good year of performance across the entire company, and we have carried that into a strong start to 2025.

Moving to Slide 4. We have made meaningful progress during the year on each of our strategic growth pillars. Within our Domestic Core business, and as I mentioned on the previous slide, the U.S. SCIg market grew about 10% in 2024. This marks the eighth consecutive quarter of year-over-year U.S. market growth and serves as a strong catalyst to our base business as more chronic patients are diagnosed with immunodeficiencies and begin therapy utilizing the KORU system. We delivered another record quarter as Q4 Domestic Core revenues grew 20% over the prior year and full year revenues grew 12%, outpacing the overall market. This was driven by additional market share capture as we further penetrate new and existing accounts. Additionally, we've seen an accelerated transition in the domestic market towards prefilled syringes as pharmaceutical companies shift their supply to the prefilled syringe format. KORU is well positioned for this transition as our current and next-generation systems both accommodate prefilled syringes and our ongoing collaboration with SCHOTT allows us to stay agile with any additional prefilled format changes coming to the market.

Moving to international. It was a breakthrough year for us. We delivered 32% growth for the full year and 14% growth in the quarter. The international SCIg market continues to grow with strong supply volumes and continued patient growth. We're continuing to capitalize on these trends as we entered multiple new geographies through new distributors in the Middle East, North Africa and in Eastern Europe. Additionally, we have had broad strength across our established geographies where we are consistently gaining market share in large markets like the U.K., Germany and France. 2024 was a great year for our international team with strong execution on our expansion strategy, and we are excited to carry that momentum into 2025.

Moving to Novel Therapies. Our NT pipeline was further diversified after entering 4 agreements in 2024, bringing our total collaboration number to 15, which spans a wide range of therapy areas. This includes 2 additions to the pipelines, which we announced in the first quarter of this year. The first comes in the form of a new device collaboration for next-gen SCIg system in collaboration with our SCHOTT partnership. The second is a new nephrology drug candidate that has the potential to bring an additional 300,000 annual infusions onto the KORU system. In the near term, we have 7 opportunities with potential commercial launches by 2026.

Finally, as you may have noted in our press release, we are renaming our Novel Therapies business to Pharma Services and Clinical Trials starting in the first quarter of 2025. This change will have no impact on our reporting our financial statements and reflects the nonrecurring nature of the business. Tom will provide some additional detail on this change later in our prepared remarks.

Before we move ahead to some future catalysts, I want to address an announcement from the FDA on Monday regarding the voluntary withdrawal of certain lots of immunoglobulins by several pharmaceutical manufacturers. Of the affected drugs included in the announcement, only one was SCIg related, Xembify. Yesterday, the manufacturer, Grifols, announced it will not have an impact on their manufacturing plants, and thus, we expect it to be short term in nature. We anticipate that any supply disruption from this manufacturer will be absorbed by the capacity of other pharmaceutical manufacturers, and we do not expect to see any disruption to our business.

Moving on to what we see as significant drivers of value for the company. One of the most attractive parts of our business is our recurring revenue base, which represents approximately 75% of our revenues. We now have approximately 49,000 patients, of which about 45,000 of these are from recurring chronic SCIg patients. This represents about 2 million annual recurring infusions, which grew about 18% on a year-over-year basis. With continued SCIg market growth, share increases driven by new product launches and international expansion, we expect to see continued mid-teens growth rate in this recurring revenue base.

Next, we continue to see our OUS business as a significant growth driver for the company as we expand our presence across various geographies outside of the U.S. This year, our growth was in excess of 30%, well above the market growth. We believe that we will be able to sustain a plus 20% growth rate as we continue to execute our international strategy and capture additional market share in new and existing regions. As it currently stands, the international market is both large and underpenetrated for KORU. We hold about 10% share of a roughly $60 million OUS SCIg market, leveraging -- leaving significant room for our business to grow. As part of our strategy to expand our international addressable market, we are targeting onetime consumable needle set sales in ePump dominant markets. ePump companies do not have a consumable needle set, and we work in collaboration to provide the market with a needle set for use with any mechanical or ePump. We plan to further capitalize on this with our next-gen consumables launch. We're excited to carry our OUS momentum into 2025 with accelerated growth driven through increased penetration in current EU and Eastern Europe markets and new geographic entries, helping to continue to transform KORU into a global infusion systems provider.

Moving to our Novel Therapies pipeline. We announced the addition of 2 new collaborations since the start of the year and updated 7 commercial opportunities by 2026 compared to the prior 6. Among these 7, 4 are within the SCIg space and will lead us to either increased domestic penetration or further international expansion opportunity, while the remaining 3 represent new drugs that will give us access to over 500,000 new potential patients and nearly 1 million potential annual infusions 3 years post drug launch. The largest opportunity within these new drugs is, of course, oncology, for which we are completing market research and go-to-market requirements for a U.S. launch and look forward to updating you on our plans in the coming quarters.

Moving to our newly announced collaborations. The first of the new opportunities is in tandem with our partner, SCHOTT and will be for an expansion of a current pharmaceutical partner's Ig drug into the prefilled syringe format and compatibility with our next-gen system. As the market continues to shift towards prefilled syringes, the partnership will allow us to further position KORU as the global leader in SCIg prefilled drug delivery.

The second collaboration is with the Phase III trial for an expanded nephrology indication for a drug that is already commercialized with KORU for another indication. The expanded label is expected to treat a rare renal disorder with a patient population of approximately 30,000 patients and will give KORU access to an additional 300,000 potential annual infusions, bringing our total potential additional infusions from new drugs to 1.2 million 3 years post launch.

Each of these opportunities reflect our continued commitment to expand into new therapy areas while also maintaining our advantage in our core business. I'm very excited for the potential that each of these 15 collaborations brings to the table as they near launch and commercial revenue opportunity for KORU in 2026 and beyond. We are excited by the progress we have made in 2024 across our strategic initiatives, and our team is engaged and focused to deliver on a strong 2025.

I will now turn the call over to Tom to review our equally strong financial results.

Thanks, Linda.

Starting with our fourth quarter results, we had an excellent finish to the year, delivering $8.8 million in revenues, representing 23% growth over the prior-year period. Our Domestic Core revenues were $6.7 million, a 20% increase over the prior year as our growth continued to outpace the overall SCIg market. Strong performance was driven by growth in both consumable and pump volumes as a result of new patient starts and market share gains during the quarter. In the International Core business, we delivered strong revenues of $1.5 million, representing growth of 14% over the prior year. Growth was driven by continued penetration in our established markets as well as geographic expansion into new territories. Novel Therapies revenues were $700,000 or 122% growth over the prior year. The growth was driven by continued progress on our NT pipeline with an increased number of collaborations generating NRE service revenue and related clinical trial product revenue.

Moving over to our full year results. We delivered strong performance with $33.6 million in revenues, representing 18% growth over the prior year. Our Domestic Core revenues were $25.2 million, a 12% increase over the prior year, outpacing SCIg market growth. Domestic Core was driven by strong pump and consumable volume growth driven by the share gains in new and existing accounts. International Core revenues were $6 million, representing growth of 32% year-over-year. Growth in our international business was driven by consistent SCIg supply, overall market growth, consumable growth across both new and existing markets and strong performance in newly entered geographies. Our Novel Therapies revenues were $2.4 million compared to $1.5 million in the prior year, also representing 62% growth. Revenue growth was driven by an increased number of NRE collaborations and increased clinical trial product revenue.

Moving to our gross margin performance. Fourth quarter gross margins were 62.9%, a 260-basis-point improvement over the prior year. Margin expansion was driven by manufacturing efficiencies as well as favorable customer sales mix resulting in higher ASPs. Our gross margin performance of greater than 60% remains consistent throughout 2024. Full year margins were 63.4%, representing a 480-basis-point improvement year-over-year and finishing with our full year guidance expectations. The margin improvement was driven by increased manufacturing productivity, favorable revenue mix and increases in our ASPs. We also successfully mitigated supply chain cost increases on raw materials during the year.

Turning to cash. As previously announced, we finished the year with $9.6 million in cash balance, representing a gain of $800,000 during the fourth quarter and exceeding our guidance of at least $8.8 million. Our cash usage included a $1.6 million net loss, significantly down from the prior year and $300,000 of investments in equipment for our next-generation consumable production line. This cash usage was offset by working capital improvements of $1.6 million, driven by lower inventory and higher accrued expenses, which was partially offset by higher accounts receivable from increased sales. Additionally, noncash items of $1 million for stock compensation, depreciation and amortization contributed towards our positive fourth quarter cash flow.

Moving to Slide 14. As we take a look at our cash over the last 3 years, we've significantly reduced our cash burn with usage of $1.9 million in 2024, a 68% improvement compared to '23. The improvement in cash burn was driven by lower net losses resulting from higher revenues, improved gross margins and operating expense leverage. Other contributors were improvements in working capital. Cash burn finished ahead of our $8.8 million ending cash balance target with $800,000 of positive cash flow in the fourth quarter. As a reminder, this cash balance is exclusive of our long-term credit facility that remains unused.

We were pleased with the strong performance across our P&L and balance sheet. As I mentioned before, we delivered high teens year-over-year growth in revenues and nearly 500 basis points improvement in gross margins, while controlling our operating expenses with a 3% increase. With a significant amount of operating investments behind us in the last 3 years, we are running a disciplined use of capital across our highest growth drivers and opportunities, achieving operating leverage and driving the business towards profitability. We also delivered a 56% improvement in the net loss and EPS and a 68% improvement in cash burn. Please note that 2023 net loss and EPS included a onetime noncash valuation allowance against deferred tax assets of $4 million.

As Linda mentioned earlier in the call, starting in the first quarter of 2025, we will be renaming our Novel Therapies segment to Pharma Services and Clinical Trials to better reflect the nonrecurring nature of the business and its service revenues. We may continue to use the term Novel Therapies going forward, but it will be reserved specifically for new drugs in our pipeline opportunities. The name change will have no impact on the composition of our business, on the preparation or disclosure of our financial information by business or on previously reported financial statements. As you can see, currently, our core business is predominantly Ig drugs with 90% of our total revenues coming from that drug class. As we continue to add new drugs onto our label, the 90-10 split will change and the non-Ig drugs category will increase. Once the drug collaboration in our pipeline is approved for use on our Freedom System, any associated sales going forward becomes part of the core.

Looking ahead to 2025, we are initiating revenue guidance in the range of $38 million to $39 million, representing 13% to 16% growth. With this range, we expect sequential quarterly growth throughout the year as our business ramps. Key drivers behind these estimates include sustained global SCIg market growth in the 8% to 10% range, continued domestic and international share gains, our flow control product line extension, Japanese market entry and the addition of 3 new collaborations to our Novel Therapies pipeline.

We expect our gross margins to remain relatively flat to 2024 and range between 61% to 63%. Our gross margin will be affected this year by onetime product line costs associated with our manufacturing ramp-up in the second half in preparation for our new consumables launch. Some impact due to a higher mix of sales in international markets and supply chain inflationary and tariff-related pressures. Despite these pressures, we continue with planned pricing and manufacturing efficiencies through our operational excellence programs throughout the year to maintain our current margin profile and mitigate the onetime impacts.

Moving to cash. We are reiterating that we expect to be operational cash flow positive for the full year of 2025. We anticipate operating expenses exclusive of stock compensation in the range of $26 million to $27 million. Our operating expenses will be weighted more heavily in the first half of the year due to higher R&D costs and project work completion. Additionally, we expect there to be less than $2 million of investments in capital equipment, driven primarily by the production lines we are setting up for our next-generation products. In summary, a strong year in 2024 supports our guidance of mid-teen double-digit revenue growth, stable gross margins and our expectations to be cash flow positive for the year.

I'll now pass the call back to Linda to review new products, our 2025 milestones and for some closing remarks.

Thanks, Tom.

Over the last several years, we have invested in our innovation capabilities, and we are excited by the pending launch of 3 new products over the next year. These are all focused on offering increased convenience, time savings and improved patient comfort for the patients and clinicians that use our products every day in the home and in the clinic. Starting with the flow controller. This is a product we offer today in very selective geographies in EU that allow clinicians and patients the ability to adjust flow rates with an easy-to-use dial. We plan to roll out the device in 2 phases. First phase is the line extension that does not require an updated 510(k) submission and is expected to launch in Q3 with an improved cost of goods sold and increase in overall production capacity, allowing us to expand to new geographies. The second phase is our next-generation product, which will have a 510(k) submission in the first quarter of 2026. The new product will come with increased performance and accuracy compared to our current offering and allow KORU to pursue expanded label indications and enter new markets.

Our second pending launch is our new consumables product. It is planned to be submitted to the FDA in the second half of 2025. The product features compatibility for an expanded range of flow rates and dosage sizes while also having a simplified user interface and providing increased comfort during infusion. The customizable platform will be compatible with mechanical and ePumps, allowing us to better serve new and existing markets as we add new drug classes to our label and continue our collaborations with pharma companies developing their new drug therapies. We plan to submit the next-generation SCIg pump for 501(k) clearance between the end of 2025 and early 2026. This pump features the capability to accommodate all sizes of prefilled syringes ranging from 5 to 50 ml, allowing patients and clinicians of all dosing schedules to use our products. Additionally, the pump has a seamless removal and loading system that enables patients with large dosing sizes requiring multiple syringes to load without interrupting their infusions. The pump will also offer enhanced mobility, ease of use and patient feedback features that improve on the overall user experience.

The next-generation product will allow KORU to penetrate new markets that are rapidly converting to prefilled syringe drug administration, which serve as a significant growth opportunity for the company. The flow controller will serve as a growth driver in the second half of 2025 with the pump and consumables driving inflection for the full year '26 as they are cleared and launched as KORU's next-generation infusion system.

Now I'd like to turn to our key 2025 milestones. These are the specific performance indicators that we have detailed throughout the presentation today for financial and guidance targets as well as for each of our 3 strategic business areas. As the year progresses, we plan to provide updates through both press releases and our quarterly earnings calls as a way to measure our progress against each of the goals we have set for the year. 2025 is a pivotal year for KORU as we continue to execute on our business strategy to become a global leader in large volume subcutaneous drug delivery and position ourselves to capitalize on the opportunities in this large and growing market. Thank you to our customers, shareholders, patients and team members who have all made 2024 a great year and positioned us for further success in 2025.

We'll now open the line for your questions.

[Operator Instructions] And our first question comes from Chase Knickerbocker with Craig-Hallum Capital Group.

Congrats again on a great quarter. Maybe just first on '25 guidance. Tom, if you could break it down just a little bit more for us on kind of your growth assumptions, specifically in domestic and international and then kind of what contribution you expect from pharma services and clinical trials in the year can be a bit lumpy and sometimes hard for us to model. So kind of a breakdown would be nice.

Yes. Thanks for the question, Chase. Yes, the way we're looking at our guidance from a domestic standpoint, you can expect between 10% and 15% revenue growth. From an international perspective, we expect over 20% growth. We continue to expand in that region, so 20% being the minimum. And then from a Novel Therapies standpoint, you can always expect between around $2 million to $3 million between our NRE and our clinical product sales of revenue for the year.

Got it. And then just on the domestic side and internationally as well. I mean, kind of help us think about the breakdown between kind of, call it, new wins and kind of expansion, other drugs and other opportunities versus kind of just continued share taking with existing drugs and existing indications broadly in 2025, both domestically and internationally, kind of what drives the above-market growth kind of as the share of those 2?

Yes. So let me start with the exciting part, which would be the international space. So as you can see with the performance that we had last year, we entered into many new geographies. So as we think about those new geographies and the annualization impact of those geographies, we see some nice upside with those markets. In addition, some of the new geographies we're entering into such as Japan and some other countries that we are continuing to expand on, we expect to see some nice upside in those areas. And just to note, too, we do expect sequential growth from a cadence perspective, quarterly sequential growth in those -- in that geography.

From an OUS standpoint, yes, we continue to push. We continue to add new customers through our distribution accounts. We have seen a nice traction since last year with respect to market growth. As Linda mentioned earlier in the remarks, diagnosis of infections have gone up. The market is still very strong heading into the first quarter here. So we continue to see some nice upside in the U.S. as well.

Maybe just -- Tom said OUS, but I think he meant to say U.S. market in his last set of remarks. The only thing that I would add, Tom, excellent summary is that we continue to see increased traction OUS with our ePump collaborations with our needle set. That is driving some significant growth for us with the commercial team there really focusing on that in the back half of '24, and we've seen some nice progress into 2025 in that area, so.

Helpful. And then Linda, just if I could sneak one more in. On the oncology opportunity, can you remind us what's left to do on the filing there and when we could be in the infusion clinic there?

Yes. I would say on the filing, we actually feel pretty confident about what it takes to get an FDA approval here. More of the work we're doing is on the market assessment side. So we've got 3 things we're looking at proving out here, our value proposition, the product and saving nursing time, increasing patient satisfaction. So we're actively working today with clinics to generate that data. Second is understanding reimbursement and ensuring that the increase in costs that we see about $10 on average per infusion can be absorbed with reimbursement and also that it drives the savings and efficiencies in the clinic that we are anticipating. And then the third is establishing a new distribution partner for ourselves in the U.S. market. Making good progress on all of those and look forward to giving you updates as the year progresses.

And our next question comes from Frank Takkinen with Lake Street Capital Markets.

Congrats on a really solid finish to the year. I was hoping we could talk a little bit more about the core domestic business. Clearly, that business outperformed really well in the fourth quarter. I don't think we've seen you outperform market growth as much as you did this quarter. So just curious if there was something different that occurred that kind of is maybe allowing you to take more market share and if that 20% growth or 20% plus growth in the core business is something that you could replicate beyond kind of your thoughts around the 10% to 15% growth that you've laid out?

Yes. So first, I would say that the team has been focused all year on really a go-to-market model where they use some AI to understand which accounts to call on and to further focus on for increased penetration. That led to some nice growth opportunity for us that picked up and carried steam throughout the year. We also signed some new agreements with some of our accounts, which preferred KORU for their new patient starts. So I think we're seeing some uptick relative to that. We had a little bit of price impact in the fourth quarter that we carried from a price increase we did in July of this year. So all of those things combined, we are extremely pleased with, as you know, our U.S. business is the biggest part of our business and the overall market growth continuing to accelerate -- accelerated each quarter.

And I don't know about you, but everyone I know has had been sick for a long period of time this season. And of course, while we don't like that for humans, it is good for our business because increased infections lead to increased diagnosis of immune-deficient populations, and that is really -- we're seeing a lot of uptick there. So as for your question, well, we can anticipate 20% growth, we do feel confident in that 10% to 15% growth ongoing for this is an area. But it's an area we'll watch for continued upside, which could be driven by continued SCIg market growth beyond the 10% level, 8% to 10% is in our guidance and also based upon new account wins that we could see would drive increased U.S. performance.

Okay. Really helpful. Maybe talking a little bit more about the ePump opportunity. Maybe explain that market a little bit more to us in relation to kind of where you feel your penetration is into that with partnering your disposable with the existing ePumps out there and maybe an analogy and what inning we're in, into your penetration, and that would kind of help us understand how much more there is to go in penetrating that ePump opportunity?

Sure. So maybe just as context, in Europe, the subcutaneous Ig market is dominated by ePumps. We have our mechanical pumps in one region, which is the Nordic region where that therapy tends to dominate driven by a KOL that started with mechanical pumps several years ago. In the remainder of the markets, I think kudos to our commercial team really said this year, let's try to forge new partnerships and go after the consumables, which really drive 85% of our business. So that strategy, I would say we really started in earnest in about second quarter of last year. So I'd say we're in the early innings, and we see it as a potential significant growth driver for us moving forward. We've already seen upsides to our numbers that we are anticipating in 2024. We've had some nice wins early in 2025 in that area. And as I said, we have just over 10% market share. So a lot of room to grow there into that population. None of those manufacturers have their own consumables. So happy to partner with us. And with our new consumables launch, we think we'll have opportunity for even more upside.

Okay. Great. And then just maybe one last one on gross margin. Maybe think about gross margin a little bit longer term. I heard the comments about there's some onetime expenses related to the scale-up in this year. Maybe longer term, how do you feel the new product portfolio allows you to expand gross margins? And where could we see that shake out over time?

Yes. Maybe I'll start, and then I'll hand it to Tom. So one of the things we're most excited about is our new consumables launch. We work really hard on increasing efficiencies driven primarily through automation as we ramp to that line. So we expect that, that new manufacturing strategy will drive us to that 65% plus gross margin range.

Tom, any further comments?

Yes. And of course, Frank, we are constantly reviewing our manufacturing footprint. We have operational excellence programs. And so yield improvements are constantly looked at. As we grow in size and we sell more volume, we will continue to find margin improvements within our manufacturing space. And then, of course, as Linda mentioned, with the new product launches that are coming out, we expect to have some price premium on those products on the longer term.

Our next question comes from Jason Bednar with Piper Sandler.

Linda, I want to start with -- I think you made some comments just on the press release and here today just that the strength that you had in '24 continued into '25. That's really good to hear. But your guidance is calling for a deceleration in revenue growth versus '24 and also versus where you finished in the fourth quarter. So I guess how should we reconcile those comments that you made within -- in the context of the financial guidance? And even -- and in response to that, could you maybe compare and contrast the factors that are maybe within your control versus those that are more market dependent when we think about that $1 million range in your revenue guidance?

So what I would say around our guidance is the primary reason for that is due to our Novel Therapies. And remember, that business, we could support a really big trial in 2024, which we did. We had a really big Phase III trial that we announced in 2024, and that drove significant revenues. And you start from ground zero with those revenues every single year. So we anticipate some lumpiness in those revenues in that guidance range that I talked about.

With respect to our core business, I think our U.S. business that we saw grow this year overall in that 12% range. As we said to Tom, we anticipate increased performance in that area this year. And in our OUS business, international, we expect -- this year, we saw 30%. We're anticipating plus 20%, a little bit of a higher base, but that could be opportunity for outperformance. So really, the difference there that you see is just that Novel Therapies space and the lumpiness that we see there. But both other areas of the business, Jason, I would say, are stronger and overall, the guidance that we discussed is in line with what we saw in 2024.

Okay. And then Linda, that's helpful. Then maybe the swing factor, high end, low end in your guide and how much is in your control versus market dependent?

Yes. Thank you. I missed that second part of the question. I would say that first of all, the biggest swing factor then, of course, is our Novel Therapies revenues and how much we can accelerate into 2025 based upon various movements with pharmaceutical manufacturers. We feel good about our guidance range today relative to the commitments that we have with pharmaceutical manufacturers. And then obviously, further international growth and some wins that we haven't anticipated, faster growth in Japan become big opportunities for us on the upside. Continued U.S. market share growth is big for us. Obviously, that overall market is not within our control. But based upon all of the earnings reports and forward-looking analysis presented by all of the Ig manufacturers, they all grew those franchises in the 15-plus percent range this year. which is they're all highlighting in as areas for continued growth for them. So we feel quite good that all 4 of those manufacturers are reporting strong forward-looking growth in that Ig market.

Yes. absolutely. That's encouraging. Tom, if I could shift over to you, maybe a couple of questions here, and I'll ask them both upfront. One, as we think about the international expansion, typically, this tends to be a working capital use for companies when they go through this process. You've got more inventory you have to carry, you have longer receivable terms. How is this factored into your view on cash flow positivity for the year? And then related to that point, the second part of the question is as we transition to this cash flow positivity, which is great to see, just how do you think about deployment from here? How aggressive do you look to get with internal investments to further support top line growth and maybe even take some riskier bets out there?

Yes. Great question. Thanks for that, Jason. Yes. So just on the first one, in terms of the OUS expansion, it's all within our planning. We realized that we grew 30% OUS last year. We do realize that payment terms are generally 15 to 30 days higher than likely our U.S. business. That's all planned in our guidance from that growth perspective. So I would say from that perspective, we feel pretty good. We feel also pretty good about our inventory levels and the respective planning around building those inventories for those markets. So all planned out in part of our operational cash flow guidance, I'd say.

Just from a deployment standpoint of future capital as we continue to grow, yes, of course, we expect to be operational cash flow breakeven. We do have a means to reinvest up to a certain level, I would say, of cash. We still hold a line of credit, if needed, for larger ROI opportunities internationally. And so we feel with our current strategic plan that we have enough capital to deploy in those areas if need be for opportunities. Obviously, if a very large opportunity comes our way, we would, of course, revisit those opportunities in line with our debt and in line with any other types of cash raises.

And our next question comes from Anderson Schock with B. Riley Securities.

Congrats on the great quarter. So first, with your agreement with SCHOTT Pharma, is this integrating the next-gen pump you're submitting a 510(k) or submitting for 510(k) clearance later this year with their prefilled syringes? Or are you developing another pump alongside SCHOTT?

So the pump is being developed in collaboration with SCHOTT in so much as they are sharing all of their pipeline relative to prefilled syringes. They're sharing all of their advancements in those areas so that we can ensure the interaction of those syringes with our pump. It will be, however, a KORU-owned IP pump, and it will be a KORU submitted for 510(k) separate from their prefilled submissions. The real beauty of it is we get a really early read on everything happening in the prefilled syringe environment.

Okay. Got it. And this is the pump you plan on submitting later this year?

Correct. Later this year or first quarter of 2026.

Okay. Got it. And then will the next-gen consumables be compatible with the existing FreedomEdge and FREEDOM60 pumps?

They will. They will be compatible, obviously, with that. And with our new pump, our new pump will not be compatible with anyone else's consumable.

Okay. And then finally, how many of your 15 novel therapy partners right now are in Phase III clinical trials?

That is a great question. I'm going to have a quick look at -- but I believe it is 4 that we have in there, but it could be one more than that. Let me have a look. Yes. So 1, 2, 3 -- sorry, 5 in total. I missed one of the Ig candidates.

Congrats again on all the progress.

Thank you, Anderson.

And our next question comes from Michaela Smith with Canaccord.

It's Michaela filling in for Caitlin Cronin today. Congrats on a great quarter and strong end to the year. I was wondering if you could talk a little bit about any expected business impacts from tariffs? And do you have any thoughts on how the tariffs might affect manufacturing, supply chain costs, potential headwinds or challenges to the OUS business, especially with your focus on expansion?

Sure. Michaela, I'll take that one. So we did have a comprehensive review on tariff impacts. As you know, our assembly production is here in the U.S. and our consumable production is down in Nicaragua. Obviously, those countries are not impacted. We do have a slight impact on some assembly parts that we procure out of Mainland China. And so we have factored that into our guidance. But the -- I would say it's relatively immaterial because they are not main components for those assembly of our pumps. So we're assuming about 0.5 point for the tariff impact on full year gross margin.

It doesn't look like there are any further questions at this time. I'd like to turn the floor back to Linda Tharby for closing remarks.

So again, I'd like to 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.

Thank you. This does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time.