Q1 2024 KORU Medical Systems Inc Earnings Call

Okay.

Operator: Greetings and welcome to the Corrie Medical System's first quarter 2024 financial results conference call and webcast. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Louisa, of the Gilmartin Group. Please go ahead, Louisa.

Speaker Change: Greetings and welcome to the car medical systems first quarter 'twenty 'twenty four financial results conference call and webcast.

Speaker Change: This time, all participants are in a listen only mode.

Speaker Change: A question and answer session will follow the formal presentation.

Speaker Change: As a reminder, this conference is being recorded.

Speaker Change: I would now like to turn the conference over to your host Melissa I don't think you're marching group. Please go ahead Luisa.

Louisa: Thank you, Rachel, and good afternoon, everyone. Earlier today, Coru Medical Systems released financial results for the first quarter ended March 31st, 2024. A copy of the press release is available on the company's 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. However, actual events or results could differ materially due to many 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.

Thank you Rachel and good afternoon, everyone earlier today core medical systems released financial results for the first quarter ended March 31st 2020 for a copy of the press release, it's available on the company's website.

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

Luisa: His comments are based on our predictions and expectations as of today and actual events or results could differ materially due to many risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC.

Luisa: We assume no obligation to update any forward looking statements.

Louisa: I encourage listeners to have our press release in front of them, which includes our financial results as well as commentary on the quarter. During the call, management will discuss certain non-GAAP financial measures in our press release and accompanying investor presentation and in our filings with the SEC, each of which are posted on our website. You will find additional disclosure regarding these non-GAAP measures, including reconciliation of these measures with comparable gap measures in our press release.

Luisa: I encourage listeners to have our press release in front of you which includes our financial results.

Luisa: Well, it's commentary on the quarter.

Luisa: During the call management will discuss certain non-GAAP financial measures in our press release and accompanying investor presentation and in our filings with the SEC each of which are posted on our website.

Luisa: You will find this additional disclosure regarding these non-GAAP measures, including reconciliations of these measures.

Luisa: With comparable GAAP measures in our press release for.

Louisa: For the benefit of those listening to the replay, this call was held and recorded on Wednesday, May 1st, 2024, at approximately 4.30 p.m. Eastern Time. Since then, the company may have made additional comments related to the topics discussed; please refer to the company's most recent press release. Joining us on the call today are Linda Tharby, President and CEO of Kovu Medical Systems, and Tom Adams, Kovu Medical's Chief Financial Officer. Linda, please go ahead. Thank you.

Luisa: For the benefit of those listening to the replay. This call was held and reported on Wednesday may 1st 2024, and approximately 430 P M Eastern time.

Luisa: Since then the company May have made additional comments related to the topics discussed.

Luisa: Please reference the company's most recent press releases joining.

Speaker Change: Joining us on the call today are Linda <unk>, President and CEO of <unk> Medical systems, and Tom Adams, Our room Medical's Chief Financial Officer.

Speaker Change: Linda. Please go ahead, thank you Luisa and good afternoon, everyone and thank you for joining us today.

Linda M. Tharby: Thank you, Louisa. Good afternoon, everyone, and thank you for joining us today. During our call today, we will use slides to support our commentary. I will begin with our first quarter 2024 results and key business updates, followed by Tom, who will review our financials and 2024 guidance. After the prepared remarks, we will open the line for questions.

Linda: During our call today will use slides to support our commentary I will begin with our first quarter 2024 results and key business update followed by Tom who will review, our financials and 2020 for guidance.

Speaker Change: Following the prepared remarks, we will open the line for questions.

Linda M. Tharby: I'm very pleased with our first quarter results, with progress against multiple key milestones of our Vision 26 growth strategy. We started the year with an $8.2 million quarter and double-digit revenue, delivering the highest quarterly revenue in the company's history. The core business grew 14% overall, driven by double-digit growth in consumables and strong performance internationally.

Speaker Change: I'm very pleased with our first quarter results.

Progress against small multiple key milestones of our vision twenty-six growth strategy.

Speaker Change: We had started the year with an $8 $2 million quarter and double digit revenue delivering the highest quarterly revenue in the company's history.

Speaker Change: Our core business grew 14% overall, driven by double digit growth in consumables and strong performance internationally.

Linda M. Tharby: Underlying this was another solid quarter in the global aminoglobulin market. We also continued to make great progress in our novel therapies business, which is the catalyst for getting new drugs approved on our Freedom Infusion System and for new patients in our core business. Year-to-date, we have signed three new collaborations, and I'm also very excited to announce the addition of a new oncology collaboration, which I will discuss in more detail later. From an operational perspective, we have hit several key milestones.

Speaker Change: Underlying this was another solid quarter and the global I mean, all globulin market.

Speaker Change: We also continued with great progress in our novel therapies business, which is the catalyst for getting new drugs approved on our freedom infusion system.

Speaker Change: For new patients in our core business.

Speaker Change: Year to date, we have signed three new collaborations and I'm also very excited to announce the addition of a new oncology collaboration.

Speaker Change: Which I will discuss in more detail later.

From an operational perspective, we have hit several key milestones I'm pleased to report our third consecutive quarter of gross margin above 60% hitting 62, 3%. We finished the quarter with a cash burn of 700000, a significant decrease from $5 $2 million burn and the same peer.

Linda M. Tharby: I am pleased to report our third consecutive quarter of gross margin above 60%, hitting 62.3%. We finished the quarter with a cash burn of $700,000, a significant decrease from a $5.2 million burn in the same period of the prior year.

The prior year.

Linda M. Tharby: This reduction is the outcome of disciplined operating expense management and continued efforts to decrease our working capital, further evidence of our meaningful headway towards cash flow breakeven and profitability. Finally, we are reaffirming our 2024 guidance method. Overall, I'm very pleased with our performance this quarter as we continue to execute on our Vision 26 growth agenda. Moving to the next slide, I'd like to detail the progress we are making and our strategy across our three growth pillars. Increasing penetration in our Domestic Core, International Expansion, and Adding Multiple Large Volume Subcutaneous Drugs to our Label, our Novel Therapy. Starting with our Domestic Core, we saw a growth of 4% over the first quarter of 2023.

Speaker Change: This reduction is the outcome of disciplined operating expense management and continued efforts to decrease our working capital.

Speaker Change: Further evidence of our meaningful headway towards cash flow breakeven and profitability.

Speaker Change: Finally, we are reaffirming our 2024 our guidance metrics.

Speaker Change: Overall, I'm very pleased with our performance this quarter as we continue to execute on our vision twenty-six growth agenda.

Speaker Change: Moving to the next slide I'd like to detail the progress we're making.

Speaker Change: And our strategy across our three growth pillars, increasing penetration on our domestic core international expansion.

Speaker Change: And adding multiple large volume subcutaneous drugstore label, our novel therapies business.

Speaker Change: Starting with domestic core we saw growth of 4% over the first quarter of 2023 I want to highlight that similar to last quarter. We saw a double digit increase in our sales from our distributors to end user specialty pharmacies.

Linda M. Tharby: I want to highlight that, similar to last quarter, we saw a double-digit increase in our sales from our distributors to end-user specialty pharmacies. This is indicative of strong patient demand in our core business. Our growth was largely attributable to competitive share gains and growth in new patient starts, driving double-digit growth and recurring consumable volume. Our consumables growth following strong pump volumes in prior quarters represents a recurring revenue stream and becomes increasingly valuable as we continue to expand our customer base and when new patients start.

Speaker Change: This is indicative of strong patient demand and our core business.

Speaker Change: Our growth was largely attributable to competitive share gains and growth in new patient starts.

Speaker Change: Driving double digit growth in recurring consumable volumes, our consumables growth following strong pump volumes in prior quarters represents a recurring revenue stream.

Speaker Change: And becomes increasingly valuable as we continue to expand our customer base and win new patient starts.

Linda M. Tharby: Q1 was the fifth consecutive quarter of sequential market growth for immunoglobulin, indicating growing patient diagnosis. Pre-filled syringes continue to drive penetration into the IG market, remaining the fastest growing segment in subcutaneous immunoglobulin, a key catalyst for potential increased levels of sub-Q penetration and growth in 24 and beyond. We also continue to make good progress towards a Q4 510K submission for our new consumables designed for a more convenient and comfortable experience for our patients.

Speaker Change: Q1 was the fifth consecutive quarter of sequential market growth for immunoglobulin.

Speaker Change: Indicating growing patient diagnosis.

Speaker Change: Prefilled syringes continue to drive penetration into the I G market remains the fastest growing segment and subcutaneous immunoglobulin.

Catalyst for a potential increase levels of sub acute penetration and growth in 'twenty four and beyond.

We also continue to make good progress towards the Q4 or five 10-K submission for our new consumables designed for more convenient and comfortable experience for our patients.

Speaker Change: Yeah.

Linda M. Tharby: Moving to International Corps, we saw explosive growth in the quarter, with a 63% year-over-year increase in revenue. I want to begin the international results with great news. We were successful in a previously communicated appeal regarding ongoing certification of our products in Europe by our international notified body, PSI. As a result, we intend to proceed with a routine BSI assessment process.

Speaker Change: Moving to international core we saw explosive growth in the quarter with a 63% year over year increase in revenue.

Speaker Change: I want to begin the international results with Great News.

Speaker Change: We were successful in the previously communicated appeal regarding ongoing certification of our products in Europe or international notified body BSI.

Speaker Change: As a result, we intend to proceed with the routine BSI assessment process.

Linda M. Tharby: In the quarter, we saw strong IG supply versus the prior year, continued geographic expansion and increased penetration, and an Approved Indication. We saw strength in our established ex-U.S. geographic markets as we penetrated deeper into these markets and into targeted indications, specifically in CIDP, a neurological condition requiring large subcutaneous volumes and a typical twice-per-week dosing schedule, and SID secondary immunodecision. During the quarter, we entered multiple new markets, including the Middle East and North Africa, increasing our global footprint and patient base, and onboarded multiple new distributors.

Speaker Change: In the quarter, we saw strong IGT supply versus the prior year continued geographic expansion and increased penetration.

Speaker Change: Unapproved indications we.

Speaker Change: We saw strength in our established ex U S geographic markets as we penetrate deeper into these markets and into targeted indications specifically M. C. I D. P. A neurological condition, requiring large subcutaneous volume in a typical twice per week dosing schedule.

Speaker Change: And outside the secondary immunodeficiency.

Speaker Change: During the quarter, we entered multiple new markets, including the Middle East and North Africa, increasing our global footprint and patient base and onboard and multiple new distributors.

Linda M. Tharby: Expansion and further geographies remain a key focus for our business for the remainder of the year, namely Japan, where we remain optimistic that we will receive clearance for the Freedom Edge and consumables by Q2 or Q3.

Speaker Change: Expansion and further geographies remains a key focus for our business for the remainder of the year, namely, Japan, where we remain optimistic that we will receive clearance for the freedom match and consumables by Q2 or three.

Linda M. Tharby: Within novel therapies, we now have a total of 16 collaborations and have already hit our goal of three new deals signed within 2024, highlighted this quarter by the addition of the first drug therapy in oncology. The Oncology Collaboration is exciting for many reasons. First, the oncology therapy patient population is large, with up to 500,000 patients as an addressable population for this drug therapy. Second, it will be our first entry into oncology infusion centers with administration by a healthcare professional. This is a large and growing market, as several launched sub-Q oncology drugs require healthcare professional administration due to potential side effects post-administration.

Speaker Change: Within novel therapies, we now have a total of 16 collaborations and I've already hit our goal of three new deal fine within 2024 highlighted this quarter by the addition of the first drug therapy in oncology.

Speaker Change: The oncology collaboration is exciting for many reasons.

Speaker Change: First you're.

The oncology therapy patient population is large with up to 500000 patients as an addressable population for that drug therapy.

Speaker Change: Second it will be our first entry into oncology infusion centers with administration by health care professionals.

Speaker Change: This is a large and growing market as several launch sub Q oncology drugs require a health care professional administration does the potential side effects post administration.

Linda M. Tharby: Finally, this new collaboration is with a launch drug, which removes the risk and time related to the drug's approval. We are currently in feasibility testing of the drug with the Repro Med Infusion System prior to an FDA 510K submission, which we anticipate in the next 6 to 12 months. I am also pleased to report ongoing progress within our PIPE.

Finally, this new collaboration is with the launch drug which removes the risk and time related to the drug's approval.

Speaker Change: We are currently in feasibility testing of the drug with the freedom infusion system.

Speaker Change: Prior to an FDA five 10-K submission, which we anticipate in the next six to 12 months.

Speaker Change: I'm also pleased to report ongoing progress within our pipeline the endocrinology drug, which we first announced last year has successfully passed validation and will enter phase III trials with the freedom infusion system, another pivotal step towards commercialization.

Linda M. Tharby: The endocrinology drug, which we first announced last year, has successfully passed validation and will enter phase three trials with the Freedom Infusion System, another pivotal step towards commercialization. We have also progressed the development of our efforts with the previously announced collaboration with Launch Rare Disease Biology. This drug has successfully passed its feasibility testing and will be moving into product development with a customized Freedom infusion system. We anticipate a 510k submission for the use of the drug with the Freedom System in the fourth quarter of this year. Overall, it was a successful quarter across all three strategic growth areas. Moving on to slide five.

Speaker Change: We also progressed the development of our efforts with the previously announced collaboration with the launch rare disease biologic.

Speaker Change: This drug has successfully passed its usability testing and well be moving into product development with a customized freedom infusion system.

Speaker Change: We anticipate a five 10-K submission for the use of the drug with the freedom system in the fourth quarter of this year.

Speaker Change: Overall, it was a successful quarter.

Speaker Change: Across all three strategic growth areas.

Speaker Change: Moving on to slide five.

Linda M. Tharby: This slide depicts our Novel Therapies Collaborations, representing opportunities for new drugs on our label and or new innovations with launched on-label drugs. Although many of these drugs will take several years to attain regulatory approval, all 16 represent opportunities to bring new patients into our core freedom infusion system. A few key highlights.

Speaker Change: This slide depicts our novel therapies collaborations representing opportunities for new drugs on our label and or new innovations with launched on label drugs. Although many of these drugs will take several years to attain regulatory approval all 16 represent opportunities to bring new patients into our core.

Speaker Change: And freedom infusion system.

Thomas Adams: First, 16 total collaborations represent our largest number of collaborations to date, and with 19 new opportunities we're pursuing, this represents our broadest pipeline to date. Second, the addition of the Ecology Asset has expanded our global patient population by approximately half a million patients, bringing our total addressable population to approximately 2.1 million patients. Third, the highlighted collaborations indicate the progress we are making with our pharmaceutical partners. And most importantly, the last column with potential CORU FDA clearance dates indicates there are seven opportunities within our Vision 26 timeline for new to CORU drug label expansions, launch drugs in new geographies, and or drug product lifestyle expansions with Quorum.

Speaker Change: A few key highlights first 16 total collaborations represents our largest number of collaborations to date and.

Speaker Change: And with 19, new opportunities we're pursuing this represents our broadest pipeline to date.

Speaker Change: Second. The addition of the oncology asset has expanded our global patient population by approximately half a million patients bringing.

Speaker Change: Bringing our total addressable population towards approximately two 1 million patients.

Speaker Change: Third the highlighted collaborations and to create the progress, we're making with our pharmaceutical partners and most importantly, the last column with potential Corey.

Speaker Change: D. A clearance data indicate there are seven opportunities within our vision twenty-six timeline for new core Nucor, who drug label expansions.

Speaker Change: Launch drugs in new geographies and or drug product lifestyle co expansions with Corp.

Thomas Adams: For example, this year, we expect a clearance for Takeda's Qubit 2 dog in Japan, opening a new market per course. I'm very excited to see the novel therapies pipeline continue to get deeper and more diverse with opportunities for multiple pharmaceuticals. I'd now like to turn the call over to Tom to review our financial performance.

Speaker Change: For example, this year, we expect to clearance for Takeda as Cupid, two dog in Japan opening a new market for cars.

Speaker Change: I'm very excited to see the novel therapies pipeline continue to get deeper and more diverse with opportunities with multiple pharmaceutical partner.

Speaker Change: I'd now like to turn the call over to Tom to review our financial performance. Thank.

Thomas Adams: Thank you, Linda, and thanks to everyone joining us this afternoon. We are pleased with our first quarter results, as we saw a return of double-digit top line growth in our record setting quarter. Net revenues for the first quarter were $8.2 million, an 11% increase compared to the prior year period. Domestic chlora grew 4% with net revenues of $6 million, driven by double-digit consumable volume growth due to new patient starts and share gain.

Thomas Adams: Thank you Linda and thanks to everyone joining us this afternoon.

Thomas Adams: We are pleased with our first quarter results as we saw a return of double digit topline growth and a record setting quarter net revenues for the first quarter were $8 2 million, an 11% increase compared to the prior year period.

Thomas Adams: Domestic core grew 4% with net revenues of $6 million driven by double digit consumable volume growth due to new patient starts and share gains.

Thomas Adams: Our international core business group grew 63% year over year with revenues of $1.8 million driven by an improved IG supply versus the prior year, increased sales and improved indications, and strong growth in our geographic expansion strategy. The 63% growth rate for International Corp. consisted of approximately $260,000 of revenue for expedited inventory orders relating to the BSI regulatory determination as Linda addressed earlier. Normalized growth, excluding these orders, was approximately 40% in the OUS business.

Thomas Adams: Our international core business grew 63% year over year with revenues of $1 8 million driven by an improved I'd use supply versus the prior year increased sales and improved indications and the strong growth in our geographic expansion strategy.

Thomas Adams: The 63% growth rate for international core consisted of approximately $260000 of revenue for expedited inventory orders relating to the BSI.

Thomas Adams: Regulatory determination as long as I addressed earlier.

Thomas Adams: Normalized growth excluding these orders was approximately 40%.

Thomas Adams: Our U S business novel therapies revenue was 500000% to 21% decline compared to Q1 2023, driven by a major collaboration milestone that occurred in the prior periods. It's important to note that our novel therapies business consists primarily of nonrecurring revenues, which are variable.

Thomas Adams: NovelTherapy's revenue was $500,000, a 21% decline compared to Q1 2023, driven by a major collaboration milestone that occurred in the prior period. It's important to note that our NovelTherapy business consists primarily of non-recurring revenues, which are variable in nature, and our generally unachievable. The compensation of our revenue mix has diversified with an expanded customer base highlighted by two additional novel therapies, agreements, and advancements in pipeline progress for multiple drugs in the pipeline.

Thomas Adams: Sure.

Thomas Adams: Generally milestone based.

Thomas Adams: The compensation of our revenue mix has diversified with an expanded customer base highlighted by two additional novel therapies agreements and advancements in pipeline progress for multiple drugs in the quarter.

Thomas Adams: Our first quarter gross margin improved to 62.3%, a 620 basis point increase compared to the prior year, as indicated in the bar graph on the right side. This strong improvement was largely due to the consolidation of our U.S. manufacturing sites.

Thomas Adams: Our first quarter gross margin improved to 62.3%, a 620 basis point increase compared to the prior year as indicated on the bar graph on the right side. The strong improvement was largely due to the consolidation of our U S manufacturing sites.

Thomas Adams: This marks the third consecutive quarter that we have achieved margins greater than 60%, and we continue to work diligently to realize manufacturing improvements and efficiencies across our operations. Additionally, we have improved gross margins in our novel therapies business through the insourcing of service revenue costs at lower rates. Moving over to cash, as of March 31, we had an ending cash balance of $10.8 million, representing cash usage of $700,000 in the, a substantial reduction from the 5.2 million spans incurred during the prior year period.

Thomas Adams: This marks the third consecutive quarter that we have achieved margins greater than 60% and we continue to work diligently to realize manufacturing improvements and efficiencies across our operations <unk>.

Thomas Adams: Additionally, we have improved gross margins realized in our novel therapies business through the insourcing of service revenue cost at lower rates.

Thomas Adams: Moving over to cash as of March 31, we had an ending cash balance of $10 8 million, representing cash usage of $700000 in the quarter.

Thomas Adams: Abstention reduction from the $5 2 million spend.

Thomas Adams: During the prior year period this.

Thomas Adams: This year, our cash spending will be lighter than previous years as we continue to achieve operating leverage. Our cash deployment in the first quarter came primarily from our cash basis net loss of $1 million, which was nearly 50% lower than the prior year.

Thomas Adams: This year, our cash spending will be later than previous years as we continue to achieve operating leverage.

Thomas Adams: Cash deployment in the first quarter came primarily from our cash basis net loss of $1 million, which was nearly 50% lower than prior year.

Thomas Adams: Other drivers include investing in financing activities of $300,000 for new production line capital expenditures and financing for insurance. This was offset by a significant improvement in working capital, driven by reductions in inventory levels resulting from operational efficiencies in manufacturing and higher accounts payable due to time and. We remain focused on our cash and cash flow targets. We've substantially reduced spending since the beginning of 2023.

Thomas Adams: Other drivers of it.

Thomas Adams: Other drivers include investing in financing activities of 300000 for new production line capital expenditures and financing for insurance premiums.

Thomas Adams: This was offset by a significant improvement in working capital driven by reductions in inventory levels, resulting from operational efficiencies in manufacturing and higher accounts payable due to timing of receipts.

Thomas Adams: We remain focused on our cash and cash flow targets.

Thomas Adams: Essentially reduced spending since the beginning of 2023, we expect the first half of 2020 for cash usage pattern to remain consistent to the prior year with higher spend relative to the second half, but at a significantly lower burn rate.

Thomas Adams: We expect the first half of 2024 cash usage pattern to remain consistent with the prior year with higher spend relative to the second half, but at a significantly lower burden. The spend will be driven by equipment for our new production. We remain confident that we will hit our goals of at least $8 million in ending cash balance as well as being cash flow positive in the fourth quarter of 2024 and for the full year of 2025.

Thomas Adams: That will be driven by equipment for our new production lines.

We remain confident that we will hit our goals of at least $8 million and ending cash balance as well as being cash flow positive in the fourth quarter of 2024 and for the full year of 2025.

Thomas Adams: Moving on to guidance, we are reaffirming each aspect of our 2024 Outlook, expecting the following for the remainder of the year: revenues of $31.2 to $32.2 million, representing a 10 to 13% growth, driven by growth in a mid to high single-digit SCIG market, three new novel therapy collaborations, and an approximately pre-filled syringe penetration of 20 to 25%.

Thomas Adams: Moving onto guidance, we are reaffirming each aspect of our 2024 outlook expecting the following for the remainder of the year revenues of 31.2 to $32 2 million, representing a 10% to 13% growth.

Thomas Adams: By growth of a mid to high single digit Sci G market.

Thomas Adams: Three new novel therapy collaborations and then approximately pre filled syringe penetration of 20% to 25%.

Linda M. Tharby: We anticipate a full-year gross margin between 59% and 61% as we expand into lower ASP regions. We will also face and manage inflationary pressures within our supply chain and incur a production line startup cost later. Lastly, as I mentioned before, we expect to finish with an ending cash balance of more than $8 million, which includes approximately $23.5 to $24 million in operating expenses. This ending balance is exclusive of stock compensation and includes the expectation that we will reach cash flow breakeven in the fourth quarter of 2024 and cash flow positivity for the full year of 2020-25.

Thomas Adams: We intend we anticipate our full year gross margin between 59, and 61% as we expand into lower E. S. P. A regions.

Thomas Adams: We also will face and manage inflationary pressures within our supply chain.

Thomas Adams: And in car production line start up costs later in the year.

Thomas Adams: Lastly, as I mentioned before we expect to finish with an ending cash balance of more than $8 million, which includes approximately 23, and a half to $24 million and operating expenses.

Thomas Adams: This ending balances exclusive of stock compensation and includes the expectation that we will reach cash flow breakeven in the fourth quarter of 2024 and cash flow positivity for the full year of 2000 2025.

Linda M. Tharby: Our credit facility remains available to us for strategic growth opportunities but is not included in our estimates for the 2024 ending cash balance. I will now turn the call back over to Linda for closing remarks. Thanks, Tom.

Thomas Adams: Our credit facility remains available to us for strategic growth opportunities, but does not include in our estimates for 2024 ending cash balance.

Thomas Adams: I will now turn the call back over to Linda for closing remarks. Thanks, Tom.

Linda M. Tharby: I am very pleased by our first quarter results and the momentum ensuing across all businesses. We remain committed to the milestones I highlighted in our last earnings call. We have achieved one quarter of double-digit net revenue growth with a commitment to this type of growth for the remainder of the year. We continue to see accelerating levels of growth in our core business driven by share gains, new patient starts, international expansion, and increasing pre-bill penetration.

Linda: I'm very pleased by our first quarter results and the momentum ensuing across all businesses. We remain committed to the milestones I highlighted in our last earnings call. We have achieved one quarter of double digit net revenue growth.

Linda: <unk> to this type of growth for the remainder of the year.

Linda: We continue to see accelerating levels of growth in our core business driven by share gains new patient starts international expansion and increasing presale penetration.

Linda M. Tharby: We've completed our goal of three new novel therapies collaboration and will continue to actively pursue new opportunities as we work to move our collaboration closer to commercialization. We are projecting the submission of two 510Ks, one for a new product and the other for a new drunk indication on the Freedom platform by the end of the year. And finally, it is our commitment to break even cash flows in Q4 of 2024 and be cash flow positive for the full year.

Linda: This completed our goal of three new novel therapies collaborations and we will continue to actively pursue new opportunities as we work to move our current collaborations closer to commercialization.

Linda: We are projecting that submission of two five 10-K, one for a new product and the other for a new drunk indication on our freedom platform by the end of the year and finally it is our commitment to breakeven cash flows in Q4 of 2024 and cash flow positive for full year 'twenty five each.

Linda M. Tharby: Each of these milestones is a strong indicator of the progress we are making toward Quorra's overarching Vision 26 goal. I'm strongly encouraged by our start of the year as we continue to evolve our company into a global leader in subcutaneous drug delivery in both the clinic and at-home setting. In closing, I am incredibly proud of the team at Coro Medical and the effort they put into their work each day, as we strive to improve the patient experience and deliver increasing value to our customers, patients, and shareholders. Operator, I will now turn the call over to you for Q&A.

Linda: Each of these milestones is a strong indicator of the progress we are making.

Linda: Toward course overarching vision 26 schools.

Linda: I'm strongly encourage buyers start for the year as we continue to evolve our company into a global leader in subcutaneous drug delivery and both the clinic and at home setting.

Speaker Change: In closing I'm incredibly proud of the team at <unk> medical and the effort they put into their work each day as we strive to improve the patient experience and deliver increasing value to our customers patients and shareholders. Operator, I will now turn the call over to you for Q&A.

Operator: Thank you. 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 question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start key. Your first question comes from Frank Takkinen with Blake Street Capital Markets. Please go ahead.

Thank you well now be conducting a question and answer session.

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

Speaker Change: [noise] formation times will indicate your line is in the question Katy.

Speaker Change: They start to if you would like to have maybe a question from the queue.

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

Speaker Change: Your first question comes from Frank ticketing, it's like straight capital market. Please go ahead.

Frank James Takkinen: Great Thanks for taking the questions. Congratulations on a solid first quarter. I was just hoping to start with the guidance reiteration. Obviously, really strong start to Q1, understanding it's early in the year, but also understanding if you kind of annualize what happened in Q2, even after adjusting out some of the one-time stuff that happened internationally, it looks like the guide is very de-risked and maybe a little bit conservative. So maybe just kind of walk through some of the different elements you considered when reiterating the guide versus bringing that up a little bit, given the strong momentum year-to-date.

Frank: Great. Thanks for taking my questions. Congrats on a solid first quarter I was just hoping to start with the guidance reiteration, obviously really strong start to Q1 understanding it's early in the year, but also understanding you kind of annualize what happened in Q2, even after adjusting out some of the one <unk>.

Frank: That's what happened internationally it looks like that the guide is very derisked and maybe a little bit conservative. So maybe just kind of walk through some of the different elements you considered when reiterating the guide versus bringing that up a little bit given the strong momentum year to date.

Linda M. Tharby: Sure, so thanks Frank. We're excited about the first quarter. The way that we see the guidance overall is that we're within our guidance range at 11% in that first quarter, so we anticipate the start of the year to be in the lower end of that guidance range with the back half of the year slightly at the top end of that guidance range, so coming in somewhere in that guidance range. So overall, obviously, what we're looking at for potential upside would be international expansion would certainly be at the top of that list. We certainly saw in our first quarter that we had the one time with BSI, and Tom was able to break that out.

Frank: Sure.

Speaker Change: So thanks, Frank we're excited by the first quarter are the way that we see the guidance. Overall is is were within our guidance range of 11% in that first quarter.

Speaker Change: So we anticipate that started the year to be in the lower end of that guidance range with the back half of the year are slightly at the top end of that guidance range, so coming in somewhere in that guidance range. So overall, obviously, what we're looking at for potential upside would be international expansion would be certainly at the top.

Speaker Change: Off of that last.

Speaker Change: We certainly see in our first quarter that we had the one time I would be outside which Tom was able to break that out and we're also seeing we had a number of our initial orders from new distributors. So we have to see how all that shakes out before we're comfortable relative to doing anything to guidance a novel.

Linda M. Tharby: And we're also seeing that we have had a number of initial orders from new distributors. So we have to see how all that shakes out before we're comfortable relative to doing anything on guidance. Novel therapies are excited by the progress, and again, more deals could mean upside there. However, we do have to finish the work in those areas. And then finally, on our U.S. core business, really starting to see some nice uptick in share, but still not seeing our distributor inventories keep up with our end-user sales results. So those are the positives and watchouts that we're looking at. But overall, a strong start to the year, and we're pleased to be reaffirming guidance, and we'll update it when we think it's prudent.

Speaker Change: Therapies excited by the progress and and again more deals could mean upside. There. However, we do have to finish the work on in those areas and then finally on on our U S core business really starting to see some some nice uptick in share, but still not seeing our distributor inventories to keep up with.

Speaker Change: Our end user sales results. So so those are the positives and and and watch outs that we're looking at but overall a strong start to the year end and pleased to be reaffirming guidance and we'll update when we think it's.

Speaker Change: It's prudent.

Linda M. Tharby: Got it. That's helpful. Thank you. And then maybe just for my second one, any update on the 15 milliliter pre-fill? I don't think I heard an update in the prepared remarks. So maybe just explain to us how that's going, positive and negative expectations versus reality versus expectations year to date and looking at 2024. Yeah.

Speaker Change: Got it that's helpful. Thank you and then maybe just for my second one any.

Speaker Change: Any update on the 50 milliliter Prefill I don't think I heard a update in the prepared remarks. So maybe just explain to us how that's going positive negative expectations versus reality versus expectations year to date and are.

Looking at 'twenty 'twenty four.

Linda M. Tharby: Yeah, so if you recall, we launched that product into the market, and we did our initial load-in inventories in Q4. In Q1, we've started to see a conversion of patients to pre-fill therapy, but it is the first quarter of the product's launch, so we anticipate those increased penetration levels as we move through the year. It continues to be off a small base but the fastest-growing area of sub-Q therapy. And we also believe that over the longer term, what we're really watching out for is a tipping point to get more people on subcutaneous.

Speaker Change: Yeah. So if you recall, we launched that product into the market that our initial load in inventories in Q4 on Q1, we started to see a conversion of patients to Prefill therapy.

Speaker Change: But it is the first quarter of the product's launch. So we anticipate that was increased penetration levels as we move through the year. It continues to be off a small base, but the fastest growing area of sub Q therapy.

Speaker Change:

Speaker Change: And we also believe that over the longer term, what we're really watching out for is at a tipping point to get more people on subcutaneous therapy.

Linda M. Tharby: I guess maybe the only other update I would make is that CSL, which is the leader in pre-fills and the only company to date to have pre-fills in the market for SCIG, has announced its intention to discontinue their vials. So that, I think, will be another big impetus for pre-fills.

Speaker Change: Perfect.

Speaker Change: Maybe even if you're on the other only other update I would make is that a C. S. L, which is the leader in pre sells and and the only company to date have pre sells in the market for S. P. I G. A has announced their intention to discontinue their vials so that I.

Speaker Change: It will be another big emphasis for yourself.

Speaker Change: Yeah.

Frank James Takkinen: Got it. Helpful. Thank you.

Speaker Change: Got it helpful. Thank you.

Speaker Change: Okay.

Chase Knickerbocker: Your next question comes from Chase Knickerbocker with Craig Callum. Please go ahead.

Speaker Change: The next question comes from Chase Knickerbocker with Craig Hallum. Please go ahead.

Linda M. Tharby: Afternoon, Linda and Tom. Congratulations on the strong progress, you know, from me as well. Maybe just first, if we kind of look at that commercial rare disease product and then now that commercial oncology asset, those sort of already approved products are obviously particularly exciting when we think about near-term impact. Seems like from engagement, you know, the formal collaboration to approval for the use of your system.

Chase Knickerbocker: Afternoon, Linda and Tom Congrats on the strong progress you know for me as well maybe just first if we kind of look at that commercial rare disease product and then now that commercial oncology asset they'll sort of already approved products are obviously, particularly exciting when we think about nearer.

Chase Knickerbocker: Term impact it seems like from engagement you know the form of collaboration to approval for the use of your on the use of your system. It's about a year as far as kind of what you were kind of thing for that rare disease product is that the right way for us to think about kind of that oncology asset as well and then just kind of longer term you know any sort of commercial drug product that you know us.

Linda M. Tharby: It's about a year as far as kind of what you're kind of saying for that rare disease product. Is that the right way for us to think about kind of that oncology asset as well? And then, just kind of longer term, you know, any sort of commercial drug product that is already approved and you just need to do your kind of regulatory steps.

Chase Knickerbocker: I already approved and you just need to do here kind of regulatory steps.

Linda M. Tharby: Yes, provided the FDA cooperates, which is the unknown part of the equation, but our internal process generally would take about six months and sometimes nine months if there's customization required, and then an FDA approval process somewhere, somewhere between three and six months. That would be what we're lucky to have.

Speaker Change: Yes provided the FDA cooperates, what you'll see on that.

Speaker Change: Part of the equation, but our internal process generally would take about six and sometimes nine months. If there's customization required and then an FDA approval process somewhere in somewhere between three and six months would be what we're looking at.

Linda M. Tharby: I know you're not going to give names, certainly, but should we think of this oncology drug as being, you know, sort of a recently launched asset or one that's more mature and has some meaningful volume, you know, out in the market already, maybe in a different kind of dosage medium?

Speaker Change: Got it and I know, you're not going to give names certainly but should we think of this oncology drug is being you know sort of our recently launched asset or one that's more mature and that has some meaningful volume you know out in the market already maybe in a different kind of dosage medium.

Linda M. Tharby: Most of the subcutaneous therapies in oncology have moved from IV to subcu, so most of them have been launched within the last three to five years, so it is a fairly recent launch, I would say.

Speaker Change: Yeah, most of the subcutaneous therapies in oncology have moved from IV to subcutaneous most of them have launched within the last three to five years. So it is a fairly recent launch.

Speaker Change: <unk> is what I would say.

Linda M. Tharby: But there is some volume there already where you won't be launching the kind of the drug new with, you know, obviously with your system. So there's some kind of volume to chase down already. Correct. I got it. And if we think about those open collabs kind of in the pipeline, so to speak, can you give us a sense if there's any more of these kind of quickly impactful collaborations around kind of already approved therapies and kind of along those same lines, you know, you had previously guided towards, you know, three for the year, and I know you've got a lot to chew on with your current formal collaborations.

Speaker Change: But there is some volume already where you won't be launching kind of the drug newly with you know obviously with your system. So there is some some kind of volume to chase down already.

Speaker Change: Correct.

Linda M. Tharby: And sorry, if I missed this in your prepared remarks, but I mean, seems like a lot in the pipeline there to not add a couple more kind of through the last nine months of the year here to kind of help us think about it. Yeah.

Speaker Change: Got it and if we think about those open collab just kind of in the pipeline. So to speak can you give us a sense. If there's any more of these kind of quickly impactful collaborations around kind of already approved therapies and kind of along those same lines. You know you had previously guided towards you know three for the year and I know you've got a lot to chew on with your current like formal collab.

Speaker Change: <unk> and sorry, if I missed this in your prepared remarks, but I mean, it seems like a lot in the pipeline there to not add a couple more kind of through the last nine months of the year here kind of help us think about it.

Linda M. Tharby: Yeah, so our business development team within Novel Therapies has their sights set on phase three and launch drugs. That is one of the key reasons why I am so excited about the oncology asset because there are multiple drugs that have launched that have the same sort of unmet needs that we're going to capitalize on with this drug. So I see a lot of further potential there. We also are working on geographic expansion opportunities where some of the prior innovations we've done with some of our IG partners, they are now looking to consolidate their base of consumables with us on a global basis. So that's also exciting.

Speaker Change: Yeah, So our ER.

Speaker Change: Business development team within novel therapies has their sights set on phase III and launch drugs that is one of the key reasons why I am so excited about the oncology asset because there are multiple drugs that have launched that have the same sort of unmet needs that we're going to capitalize on what they're strong.

Speaker Change: So I see a lot further potential there. We also are working on.

Speaker Change: Geographic expansion opportunities, where some of the prior innovations we've done with some of our I G partners, they're now looking to consolidate their base of consumables to ourselves on a global basis. So that's also exciting for us.

Chase Knickerbocker: And maybe just one more on guidance to kind of piggyback off Frank there. If we look kind of at that commentary, is it kind of fair to say that Q1 was kind of in line with your expectations and hence the reiteration of guidance, but it just seems like we're still seeing a very small impact from the kind of 50 milliliter launch. Unknown Attendee The second half, you know, could look pretty good as that accelerates.

Speaker Change: Got it.

Speaker Change: And maybe just one more on on guidance to kind of piggyback off Frank there. If we look kind of at that commentary is that kind of is it kind of fair to say that you know Q1 was kind of in line with your expectations and hence the reiteration of guide, but it just kind of seems if we're seeing still seeing a very small impact from the kind of 50 milliliter launch.

Speaker Change: That you know second half you know could look pretty good as that accelerates and then on gross margins I'm, Tom I'm, just kind of help us there from a standpoint of kind of the sequential decline that's kind of assumed in guidance is that you know around kind of that expected Japan launch.

Chase Knickerbocker: And then on gross margins, Tom, just kind of help us there from a standpoint of kind of the sequential decline that's kind of assumed in guidance is that, you know, around that expected Japanese launch.

Thomas Adams: Let me start with so so just on the guidance I'm not sure that I heard a question there chase them, but what I would say is we obviously, yes, you are correct that the year first quarter kind of came in about what we were expecting so at this point, we see several shots on.

Chase Knickerbocker: So just on the guidance, I'm not sure that I heard a question there, Chase, but what I would say is we obviously, yes, you are correct that the year, the first quarter kind of came in about what we were expecting. So at this point, we see several shots on goal to outperform.

Our goal to outperform but at this point, we're also watching several areas.

Linda M. Tharby: But at this point, we're also watching several areas, including overall growth in the domestic core market. And we're looking at, frankly, how our distributors fill what we see as strong end user demand. We also have to see what the recurring underlying international growth is once we get through what we saw as a lot of distributors, new distributors coming into our network in the

Thomas Adams: Including overall growth in the domestic core Mark at and we're looking at frankly, how our distributors are Phil what we see a strong end user demand. We also have to see what the recurring underlying international growth is once we get through.

Thomas Adams: What we saw is a lot of distributors, new distributors coming into our network in the first quarter.

Thomas Adams: Yeah, and then on the Chase, on the gross margin question, I'd say, you know, our gross margins start out the year very strong. We do have some product launches, as I mentioned, that are in the back plan for the back half of the year. So, typically, when you have these product launches, you have some inefficiencies at the startup phase of that.

Thomas Adams: Yeah.

Speaker Change: Yeah, and then on the chase on the gross margin question I'd say you know our gross margins sort of your very strong we do have some product launches as I as I mentioned that are in the back plan for the back half of the year. So typically when you have these these product launches you have some inefficiencies at the startup.

Speaker Change: Phase of that and then as production volumes ramp up you know you start to see those those margins get.

Thomas Adams: And then, as production and volumes ramp up, you start to see those margins get back to normal. And I'd say, on top of that, margins have been stronger on the novel therapies side. Just to offset that, we've been insourcing a lot of the work for our novel Unravel Therapy Services Agreements, so that's been on the upside. And then another aspect of gross margin is that as we expand into these international markets, you do see a little bit of a mix change on the ASPs as you get into some of these new markets. So if you pull all those things together, along with some of the manufacturing improvements we're doing, we're pretty much holding to guidance right now.

Speaker Change: Get back to normal stages, and I'd say on top of that you know margins had been stronger on the novel therapies sides, just to offset that we've been in sourcing a lot of the the work for our novel.

Speaker Change: Our unravel therapy services agreements so that's been on the upside.

Speaker Change: And then another aspect from a gross margin is as we expand into these international markets you do see a little bit of a mix change on the Asps as you get into some of these new markets. So if you do you pull all those things together.

Speaker Change: Along with some of the the.

Speaker Change: The manufacturing improvements, we're doing where we're pretty much holding to the guidance right now one of our markets.

Chase Knickerbocker: Understood. Thanks for the question.

Speaker Change: Understood. Thanks for the question.

Yeah.

William Wood: Your next question comes from William Wood of BYO Security. Please go ahead.

Speaker Change: Your next question comes from Citi.

Citi: Please go ahead.

William Wood: Hi, Yes. Thank you so much.

Citi: Hi, yes. Thank you so much.

Citi: Congratulations on a very nice quarter and I appreciate you taking our questions.

William Wood: Really, congratulations on a very nice quarter, and I appreciate you taking our questions. Just to get a quick update on Japan and Canadian growth there or... I know you touched on Japan earlier, but I was just curious, it seems like that might be sort of slipping. I know we were sort of expecting it, or at least maybe I was, sort of imminently, and now it's sort of 2Q, 3Q. I mean, is there anything specifically that might be holding that up or that might be more required there?

Citi: Just to get a quick update on the Japan, Inc. A Canadian growth there or expansion I know you touched on Japan earlier, but I was just curious it seems like that might be a sort of slipping I know, we were sort of expecting it or at least maybe I was a sort of imminently now sort of.

Citi: Two Q3 Q I mean is there is there anything specifically that might be holding that up or you know the.

Citi: It might be more required there and then additionally on the Canadian I was just any updates on the Canadian pilot study I know there were some delays related to customers, but it just to get an update on that and how we should think about that the potential launch of that program. Thank you.

William Wood: And additionally, on the Canadian pilot study, I was just wondering any updates on the Canadian pilot study? I know there were some delays related to customs, but just to get an update on that and how we should think about that, the potential launch of that.

Linda M. Tharby: So Canada, or sorry, I'll start with Japan. Japan, we anticipate, as I said, by the regulatory body there within the coming quarters. We received...

Speaker Change: So Canada, sorry, I'll start with Japan.

Speaker Change: Japan, we anticipate as I said.

Speaker Change: And approval by the regulatory body there.

Speaker Change: Within the coming quarters, we received.

Linda M. Tharby: Final round of questions. Some months ago, they were all very easily answered questions, so we don't see any concerns. I think it's just the regulatory backup that we tend to see in ex-U.S. markets. So no, we had anticipated, though. What I would say is there is some slippage just in that regulatory timeframe, but we had not put any big numbers for Japan into our forecast for the year. Regarding Canada, all is going well. The product is in the country, and we anticipate that the trial will begin soon. It is not a clinical trial, but it is a study that the nursing, [inaudible]

Speaker Change: Final round of questions and some months ago are they wrong Barry.

Speaker Change: Usually answered questions. We don't see any concern I think it's just the regulatory backup that we tend to see.

Speaker Change: In ex U S market.

Speaker Change: So no.

Speaker Change: We had anticipated, though what I would say is there is some slippage just isn't that regulatory time frame, we had not put in any big numbers for Japan into our forecast for the year.

Speaker Change: Regarding Canada, all is going well the product is in the country and we anticipate that the trial will begin soon and then say a not a clinical trial, but it is a study that the nursing.

Speaker Change: Our body will undergo with the product and then eventually patients. So we anticipate I will continue.

Speaker Change: Date, you on on that study as the quarters progress.

William Wood: And then one more, if I may. You said you successfully appealed to the EU notified body earlier as well as today, but you still have to go through sort of the regulatory process there. I'm just curious if you could give a brief update on what that entails and what potential headwinds you still might be expecting to continue that international EU expansion.

Interviewer: Awesome and then one more if I may I. Just you know you said you're successfully appealed the EU notified body earlier and as well as today.

Interviewer: But you still have to go through a sort of the regulatory process. There just curious if you could give a brief update of what that entails and what potential.

Interviewer: Headwinds you still might be expecting to continue that our international EU expansion.

Linda M. Tharby: Yeah, so we undergo a regular review process with them, which we successfully passed an audit of our internal facilities, and then they review all of your technical files for all of your products. And so we have one product with an outstanding finding that we feel confident we can resolve in due course. And we're working with them through their normal process, which is generally three rounds of questions. We've just completed our first round. So we anticipate closing that in the coming months and having a pathway to our MDR certification.

Interviewer: Yeah. So so we undergo a regular review process with them, which we successfully passed an audit of our internal facilities and then they review all of your technical files for all of your products.

Interviewer: And so we have one product with and outstanding finding that we feel confident we can resolve in due course, and we're working with them in their normal process, which is generally three rounds of questions are we just completed our first round. So we anticipate closing that.

Interviewer: In the coming months and having a pathway to our M D. Our certification.

Speaker Change: Got it I appreciate it.

William Wood: I appreciate the extra color there, and congratulations again on a very nice quarter. We'll hop back in queue. Thank you.

Speaker Change: The extra color there and congratulations again on a very nice quarter and I will hop back in queue. Thank you.

Speaker Change: Thank you.

Caitlin Cronin: The next question comes from Caitlin Cronin with Canaccord Genetics.

Thailand Carden: The next question comes from Thailand, Carden with Canaccord Genuity.

Thailand Carden: Go ahead.

Caitlin Cronin: Hi, thanks for taking the questions and congrats on a great quarter. Maybe just to dig into U.S. Core a bit more, what is really driving the share gains there? And on the core SIG market, any updated growth expectations this year?

Thailand, Carden: Hi, Thanks for taking my questions and congrats on a great quarter.

Linda M. Tharby: Okay, I got the first part. When I answer the first part, you can give me the second part.

Thailand, Carden: I think just keep taking two U S core a bit more what that's really driving the share gains there and on the core I think any market any updated growth expectations. This year.

Linda M. Tharby: So the US core gains are really being driven by increased focus and penetration into our key accounts. First of all, our key accounts, which can compose about 65% of our business, have just gone in and understood where we, where our share position stood with each one of them, and did focused and targeted programs for every one of those accounts. In addition, we have realigned all of our sales territories and have our reps focused on areas where we feel we have the greatest opportunity.

Speaker Change: Okay I got the first part when I answered the first part you can.

Speaker Change: Give me the second part so that you have core gains.

Speaker Change: Gains are really being driven by increased focus and penetration into our key accounts first of all of our key accounts that could compel.

Speaker Change: Compose about 65% of our business are just gone in and understood where are we where our share position stood with each one of them and did focused and targeted programs for every one of those accounts. In addition, we have realigned all of our sales territories and.

Speaker Change: And have our reps focused on areas, where we feel we have the greatest opportunity.

Speaker Change:

Linda M. Tharby: I think your second question was on growth expectations in the overall FDIG market. We continue to see that globally on a mid to high single-digit basis. So obviously, our core business is performing at 14%. This quarter is greatly outperforming that underlying.

Speaker Change: Your second question was on growth expectations in the overall F. C. H I G market, we continue to see that and globally in the mid to high single digit basis, though obviously, our core business performing at 414%.

Speaker Change: This quarter is greatly outperforming that underlying.

Speaker Change: Yeah.

Linda M. Tharby: Got it. Okay, awesome. And then just a quick one on the electronic pump trial that's still set to close in the first half of the year.

Speaker Change: Got it Okay Awesome and then just a quick one on the electronic pump trial is that still set to close in the first half of this year.

Linda M. Tharby: No, we have seen that pump trial slip a little bit, and that's mostly due to the fact that we're trying to get patients enrolled in multiple countries, and every country has a different system for those clinical trials, so it's caused a little bit of delay. However, what I would say is it's not stopping our progress overall in international markets. So we're seeing, as you can see in the first quarter, an underlying growth rate of well over 40%, which has been great.

Speaker Change: No we have seen that pump trial slip a little bit and that's mostly due we're trying to get patients enrolled in multiple countries and every country has a different.

Speaker Change: A different system for for those clinical trials. So it's caused a little bit of a delay. However, what I would say is it's not stopping our progress overall in international markets, we're seeing.

Speaker Change: As you see in the first quarter and the underlying growth rate of well over 40%, which has been great.

Speaker Change: Mhm.

Caitlin Cronin: Awesome. Thanks so much. Thanks, Caitlin.

Speaker Change: Awesome. Thanks, so much.

Speaker Change: Thanks Caitlin.

Joseph Daniel Downing: Your next question comes from Joseph Downing with Piper Sandler.

Speaker Change: Your next question comes from Joseph Danny with Piper Sandler. Please go ahead.

Joseph Daniel Downing: Hey, Linda and Tom, how's it going? Appreciate the question in the quarter, I guess just piggybacking off the US market and the previous question and thinking a bit longer term. Can you frame what kind of growth you need to see from the US market in order for the company to hit the 2026 revenue targets?

Joseph Daniel Downing: Hey, Linda and Tom How's it going I appreciate the question and address it in the quarter I guess, just piggybacking off the U S market on the previous question I'm thinking a bit longer term, but can you frame what kind of growth you need to see from the U S market in order for the company that had the 2026 revenue targets.

Speaker Change: Yeah. So clearly this this year is a landmark year for us and in the U S business in terms of we're looking to take that business into double digit growth territory.

Linda M. Tharby: So, clearly, this year is a landmark year for us in the U.S. business in terms of looking to take that business into double-digit growth territory. So how do we intend to do that? Obviously, new products will be a tremendous driver of that. I mentioned the new consumables and the new pump launch, which we anticipate certainly happening within the next 6 to 12 months.

Speaker Change: So how do we intend to do that is obviously new products will be a tremendous driver of that so I mentioned, the new consumables and a new pump launch, which we anticipate certainly happening within the next six to 12 months. So both of those drivers I think will allow us to increase our share position.

Linda M. Tharby: So both of those drivers, I think, will allow us to increase our share position, and we intend to get some ASP overall growth drive from there. In addition, expanded indications, particularly in CIDP and SID, which I mentioned in Europe, continue to be a key focus area for us in the U.S. And as those new drugs launch that I mentioned in the novel therapies business, those automatically go into our core business. So our novel therapies business is just recording revenue for the nonrecurring engineering revenues, but several of those new products, which I laid out on one slide, seven new shots on goal to launch before 2026, will all be factored into our core business. So all of those, in combination, would be how we expect to see the overall business growing, in that double-digit range that we anticipate with the biggest lever over time being new drugs added to the label.

Joseph Daniel Downing: And we intend to get some a S. P. Overall growth drive from there. In addition expanded indications, particularly in C. I D. P. N S. I D, which I mentioned in Europe continued to be a key focus area for us in the U S.

Joseph Daniel Downing: And as those new drugs.

Joseph Daniel Downing: Launched that I mentioned in the novel therapies business those automatically go into our core business. So our novel therapies business. Its just recording the revenue for the nonrecurring engineering revenue, but several of those new products, which I laid out on on one slide seven new shots on goal.

Joseph Daniel Downing: A launch before 2026, well all be factored into our core business. So all of those in combination would be how we expect to see the overall business growing.

Joseph Daniel Downing: And that double digit range that we anticipate with the biggest lever over time being new drugs attitude label.

Joseph Daniel Downing: Yes.

Joseph Daniel Downing: Great. That's helpful, Linda. Thank you. And then it looks like SDIG trends are obviously improving here. Can you just comment on your level of visibility and confidence looking out over the next few quarters?

Speaker Change: Great. That's helpful. Thank you and then it looks like Oh Gee trends are obviously, improving here can you just comment on your level of visibility confidence looking out over the next few quarters here.

Linda M. Tharby: So we anticipate, I mean, it's been fantastic just to see the sequential growth and overall steady levels of IG supply. So the IG drug companies have been projecting this, saying they have built their vertical capabilities and are not concerned about overall IG supply. And now we're starting to see that in the market.

Speaker Change: So we anticipate I mean, it's been fantastic just to see the sequential growth and overall steady levels of I G supply. So the I G drug companies have been projecting that saying they had built their vertical capabilities and we're not concerned.

Joseph Daniel Downing: About overall I G supply and now we're starting to see that in the market.

Linda M. Tharby: We're also seeing increasing patient diagnosis. So I mentioned a couple of quarters back that patient diagnosis had decreased overall due to a COVID lag effect where our patients require multiple infections in order to be diagnosed with the underlying condition that requires meeting IG. And because we had a period where everyone was sheltered for a while, we had that lock-in patient diagnosed. So now everybody's out enjoying themselves, and as a result, and I hate to say it, but we see more sickness occurring.

Joseph Daniel Downing: We're also seeing increasing patient diagnosis. So I had mentioned a couple of quarters back that patient diagnosis had decreased overall due to COVID-19 lag effect, where are our patients require multiple infections in order to be diagnosed with the.

Joseph Daniel Downing: Lying condition that requires meeting I G and because we.

Joseph Daniel Downing: We had a period, where everyone was sheltered for awhile.

Joseph Daniel Downing: Had that lock in patient diagnosis, so now everybody's out enjoying themselves and as a result of and I hate to say it but we see more more sickness occurring you probably saw yourself on multiple friends get Flus and infections are this past this past season, and we're seeing the impact of that now.

Linda M. Tharby: You probably saw yourself or multiple friends get flus and infections this past season, and we're seeing the effect of that now in increased diagnosis. So we see a continued healthy outlook for that IG market. And as I said, the big unknown for us is whether pre-fills will lead to even greater growth in sub-Q because we see a huge flip from IV. That's yet to be seen, but that's what we'll watch.

Joseph Daniel Downing: Increase in diagnosis. So we see a continued healthy outlook for that market and as I said the big unlock.

Joseph Daniel Downing: And for us as well pre sales lead to even greater growth in Sop Q, because we see a huge flipped from IV, that's yet to be seen but that's what we're watching for.

Joseph Daniel Downing: Great. I appreciate that, Linda.

Speaker Change: Great I appreciate that Linda.

Joseph Daniel Downing: Okay.

Speaker Change: Thank you.

Operator: Thank you. There are no further questions at this time. That concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Speaker Change: There are no further questions at this time.

Music: ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??

Speaker Change: That concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

Joseph Daniel Downing: Yeah.

Joseph Daniel Downing: Okay.

Joseph Daniel Downing: Uh huh.

Joseph Daniel Downing: Yeah.

Joseph Daniel Downing: [noise].

Joseph Daniel Downing: Yeah.

Joseph Daniel Downing: Okay.

Joseph Daniel Downing: [music].

Joseph Daniel Downing: Yeah.

Joseph Daniel Downing: [music].

Music: Yeah.

Music: Okay.

Music: Yeah.

Music: [music].

Music: Okay.

Music: Okay.

Music: [music].

Music: Yeah.

Music: Yeah.