Q3 2024 Merit Medical Systems Inc Earnings Call
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Good day and thank you for standing by.
Welcome to the Married Medical Q3, 2024, Ernest Conference Call. At this time, all participants on a listen-only mode. After the speaker's presentation, they'll be a question and answer session. To ask a question drawn session, you'll need to press star 1 on your telephone.
You will then hear an automated message and advising your hand is raised. To withdraw your question, please press star one one again. Please be advised, this is a day's conference is being recorded. I would now like to turn the conference over to your speaker for today, Fred, and then poppers, please go ahead.
Fred: Thank you, operator and welcome everyone. I am joined on the Call today by Raul Parra, our chief financial officer and treasurer, Joe Wright, our president, and Brian Lloyd, our chief legal officer in corporate secretary.
and Brian, would you mind taking us through the safe harbor statement, please?
Brian Lloyd: Thank you, Fred. I would like to remind everyone that this presentation contains forward-looking statements that receive safe harbor protection under federal security slons.
Although we believe these four-looking statements are based upon reasonable assumptions, they are subject to risks and uncertainties.
Fred: The realization of any of these risks or uncertainties, as well as extraordinary events or transactions impacting our company, could cause actual results to differ materially from the expectations and projections expressed to implied by our forward-looking statements.
In addition, any Ford-looking statements represent our views only as of today, October 30, 2024, and should not be relied upon as represented our views as of any other date.
We specifically describe any obligation to update such statements, except as required by applicable law.
Fred: Please refer to the sections in Title of cautionary statement regarding forward-looking statements in today's press release and presentation for important information regarding such statements.
For discussion of factors which could cause, actually results to differ from these forward-looking statements.
Please also refer to our most recent times with the SEC which are available on our website.
Fred: Our financial statements are prepared in accordance with the County principles which are generally accepted in the United States.
However, we believe certain non-gap financial measures providing vests with useful information regarding the underlying business trends and performance of our ongoing operations and can be useful for period over period comparisons of such operations.
This presentation also contains certain non-gap financial measures.
A reconciliation of non-gap financial measures to the most directly comparable U.S. Gap measures is included in today's press release and presentation furnished to the SEC under Form 8K.
Fred: and the
Rear should consider non-gap financial measures in addition to not as a substitute for financial reporting measures prepared in accordance with Gap.
Please note that these calculations may not be comparable with similarly titled measures of other companies.
Both today's press release and our presentation are available on the Investors page of our website.
I will now turn the call back to Fred.
Fred: Thank you Brian and let me start with a brief agenda of what we will cover during our proposed or prepared remarks.
I will start with an overview of our third quarter financial results and a discussion of the strategic acquisition we announced on September 17th.
After my opening remarks, Joe Wright will provide an update on the notable progress we have achieved in recent months on our U.S. Rhapsody program, as well as the summary of our revenue results for the third quarter.
and Raul will provide a more in-depth review of our Quarterly Penantual results and our financial guidance for 2024, which we updated today in the press release.
and then we will open the call for your questions.
Now, beginning with a review of our third quarter result.
We reported total revenue of 339.8 million, up to 7.8% year over year on a gap basis and up to 7.9% year over year on a constant currency basis.
The constant currency revenue growth we delivered in the third quarter modestly exceeded the high end of the range of growth expectations that we outlined on our quarter two call.
Fred: Specifically, we expected constant currency revenue growth for the third quarter in the range of 6.4 to 7.8 year over year.
Importantly, the 7.9 Constant Currency Revenue Growth in the 3rd quarter was driven by strong organic growth and contributions from acquired products both of which came in at the high end of our growth expectations.
With respect to our profitability performance in the third quarter, we delivered financial results that exceeded our expectations.
We leveraged the solid revenue results to deliver non-gap operating profit growth of 19%.
and a non-gap operating margin of 19 to excuse me, 19.2% of sales, approximately 175 basis points year over year.
We also delivered 21% growth in our non-gap EPS which exceeded the high end of our expectations as well.
Perhaps most notably, we generated $38 million of free cash for all in the quarter.
Fred: and have generated more than $120 million of free cash flow over the first nine months of 2024, representing an increase of 116% year over year.
We believe our third quarter results reflect continued strong momentum in the business and we remain confident in our team's ability to deliver the updated financial guidance for 2024 that Raul will review later on the call.
Fred: We are focused on delivering continued strong execution, solid constant currency growth, improving profitability and strong free cash flow in 2024.
as well as continued progress in our continued growth initiative program and related financial targets for the three year period ending December 31, 2026.
Now, before turning the time over to Joe, I would like to take a few minutes to discuss the important acquisition we announced on September 17.
Fred: We announced the signing of a definitive asset agreement to purchase cook-medicals lead management portfolio for a total cash consideration of approximately 210 million and the assumption of certain liabilities.
Fred: We believe this acquisition represents multiple strategic and financial positives and importantly, this acquisition is consistent with and will not distract us from our continued growth initiatives.
Fred: This proposed transaction represents another example of merits, selectivity, investing to expand our product portfolio and key strategic markets that leverage our existing commercial footprint.
Stratasia Clay, we believe the proposed acquisition will position merit to offer clinicians an increasingly comprehensive set of solutions to support cardiac intervention patients from diagnosis, to therapy and intervention to post-procedure care.
Cook Medical Lead Management Business has many years of operating history and provides a comprehensive and an product portfolio of medical devices and accessories used in the lead management procedures.
for patients who need a pacemaker or an implorable cardiovascular defibrator, and I should be, lead removed or replaced. The assets we proposed to acquire from Cropoulos.
Cook includes a full portfolio of tools for complete case support including hand-for-the-wroteating extraction devices, sheets and snares for manual extraction, and leads control tools for grasping and removing leads.
We believe these assets generated approximately $37 million of revenue over the 12-month period ended December 31, 2023, were sales to customers in the U.S.
EMA, APAC
Fred: and Rest of World, representing Approximate 41, 42, 11 and 6% respectively.
Fred: We believe this transaction will strengthen our fast growing high marginal electrophysiology and cardiac rhythm management or CRM business with the addition of differentiated products and an established commercial infrastructure.
Fred: We believe the transaction will enhance our position in the cardiac intervention market, particularly in Europe, which is strategically attractive and has our commercial team very excited.
We estimate this transaction represents an annual addressable opportunity of more than $900 million in the US, EMA, APA and APAC regions.
Specifically, we anticipate that beginning in fiscal year 2025, the addition of coax lead management business will position merit.
to represent more than $100 million in combined, annualized electro-physiology and CRM revenue serving the global cardiac intervention market.
Fred: In addition to the strong strategic rationale, we believe the financial profile of the proposed acquisition is extremely compelling. Raul will share some additional color on the favorable financial profile of the acquisition later on in the call.
In the interim, I'll share that we expect sales contributions from the acquisition post-closing in the range of 46 million over the balance of 2024.
Fred: and we expect this acquisition to add approximately $40 million of revenue on an annualized basis beginning in fiscal year 2025.
Now with that said, let me turn the time over to Joe for an update on our US Raptor program and a review of our third quarter revenue performance. Joe?
Thank you, Fred. I share Fred's sentiment to the release to the notable progress we have made on our U.S. Raptor program in recent months.
First, with respect to our progress in the areas of clinical validation and raising awareness of the compelling safety and efficacy profile for apps that are among clinicians.
On September 16th, we announced positive six-month findings from the randomized arteriobinus or av-fichil arm of our RAP-City Wave Pivotal trial.
The data were shown at the cardiovascular and interventional radiological society of Europe, or Cersei Annual Congress in Lisbon, Portugal.
Dr. Machmoud, Raul Zavie, the co-principle investigator of the Wade trial, presented the extremely compelling results. Specifically, the primary efficacy endpoint was target-leasion primary patency.
which represents the percentage of patients that did not need a clinical rebasturization or have thrombosis.
and patients treated with rapsteak was 89.8%. This was 27% of the patients treated with the control, percutaneous, transluminal, and geoplasty, or PTA, which is the current standard of care.
with respect to the primary safety endpoint in the pivotal study, there were fewer adverse events for patients treated with rapidate. However, the difference in proportion of patients who experienced an adverse event was not statistically significant between the two cohorts.
Dr. Ruzave was quoted saying the superiority of the six-month F.C. data is compelling and provides clinicians the chance to evaluate how rapesity can help us prolong the vacular access from our patients. Raul Parra, for the first time, rapesity should be the new standard of care for these patients.
We were also pleased at the positive response and feedback from participants of the 2024 controversies in dialysis access or CEDA meeting in Washington DC on October 5, including positive commentary related to our wave trial for many participants at the meeting.
We expect further increases in awareness of Rhapsody's safety and efficacy among clinicians, including more clinical data results, and look forward to Rhapsody being featured in scientific sessions at the VEAP meeting on November 23rd in New York City.
Second, we have made considerable progress in our U.S. regulatory and reimbursement strategies and in developing our post-approval commercial strategy for Rhapsody.
As discussed on our last earnings call, we completed the clinical study report and filed the final module with the FDA for premarket approval, or PMA, by the end of the second quarter of 2024, as expected.
We are ready and willing to engage with FDA during their review as they review our PMA application for this innovative technology.
Fred: We believe this technology can extend long-term vessel patency rates and reduce the complications associated with existing treatment options on the market today, including the need for repeated interventions, frequent trips to the hospital, and inadequate dialysis treatments.
Our renal therapies group has been working through intensive rhapsody training covering a range of important areas including technical story, anatomy and physiology, and deployment technique.
Clinical data training and live hands-on training are scheduled to increase in the coming months.
Fred: We are focused on ensuring we are ready to enter the U.S. market following PMA approval.
The team has completed a thorough evaluation of the U.S. market opportunity and is developing a comprehensive U.S. commercial strategy.
Importantly, our plans for U.S. commercialization post-PMA approval are part of a broader commercial strategy for our renal therapies group.
Fred: We have an experienced, dedicated sales and customer support team offering a strong portfolio of dialysis products that address the entire end-stage renal disease continuum of care.
including our HeroGraft, our Surfacer Inside-Out Axis Catheter System and our portfolio of acute, chronic, and peritoneal dialysis catheters.
Fred: We are excited to add Rhapsody to this offering following PMA approval.
The team is also focused on developing and executing our reimbursement strategy for Rhapsody.
Earlier this month we submitted our application requesting a new technology APC assignment for Medicare's acute inpatient prospective payment system.
The New Technology Add-on Payment, or NTAP, designation enables new medical service or technology meeting certain eligibility criteria to receive additional reimbursement payment for a period up to three years.
We believe that Rhapsody meets the eligibility criteria, particularly as it relates to the requirement that the technology represents an advance that substantially improves, relative to technologies previously available, the treatment of Medicare beneficiaries.
Fred: The application is currently under review, and we look forward to participating in the New Technology Town Hall Meeting on December 11, 2024, which is the annual meeting held to provide a mechanism for public input on the eligibility criteria for NTAP applications before final decisions are made.
We are targeting submission of an application for transitional pass-through payment under the Medicare Hospital Outpatient Prospective Payment System or OPPS.
The Transitional Pass-Through Payment, or TPT, program is intended to facilitate access for Medicare beneficiaries to the advantages of new and innovative devices by allowing for adequate payment for these new devices while the requisite cost data is collected.
We believe Rhapsody meets the Substantial Clinical Improvement Threshold.
for new category eligibility for a pass-through payment.
Fred: Post-PMA approval, if awarded pass-through status, Rhapsody would be eligible for this additional payment as early as Q3 2025 and would continue for at least two years thereafter.
Fred: It is fair to say that we have made significant progress in our Rhapsody program this year and I applaud our team's efforts to ensure we are prepared and well positioned to introduce Rhapsody to the U.S. market following PMA approval.
Fred: For avoidance of doubt, we intend to continue providing updates as we achieve material milestones in our Rhapsody program going forward.
We also intend to host a Rhapsody-specific virtual investor event in advance of our U.S. commercial introductions.
Details for this event will be shared once we secure PMA approval.
I will now provide a detailed review of our revenue results in the third quarter, beginning with the sales performance in each of our primary reportable product categories.
Note, unless otherwise stated, all growth rates are approximated and present on both a year-over-year and constant currency basis.
Third quarter total revenue growth was driven by 6% growth in our cardiovascular segment and 86% growth in our endoscopy segment, both of which modestly exceeded the high end of the expectations we outlined on our second quarter call.
Our total revenue results included approximately $6.8 million of revenue from our acquisition of Endogastric Solutions, Inc.
Fred: Excluding sales of acquired products, our total revenue growth in the third quarter was 5.7 percent and our endoscopy segment revenue growth was 11.5 percent on an organic constant currency basis.
Fred: Deals of our peripheral intervention or PI products increased 7.7% representing nearly 60% of total cardiovascular segment growth in the period.
Fred: Growth in the PI product category was driven by sales of our radar localization products which increased 17% and sales of our drainage products which increased 10%.
Together they represented more than a half of total PI cells growth in Q3.
Sales of our Custom Procedural Solutions, or CPS, products increased 4%, which was slightly better than the low single-digit increase we expected in Q3.
Growth was driven by strong sales of critical care products, offset partially by more modest sales of kits and trays as expected due to the ongoing SKU rationalization efforts discussed on prior calls.
Fred: Cardiac intervention product sales increased 2%, slightly above the high end of our growth expectations, driven primarily by strong sales of EPCRM products and, to a lesser extent, growth in sales of fluid management products.
Both of our OEM products increased 8.5% in Q3 and were the only area of our cardiovascular segment that came in softer than our growth expectations heading into the quarter.
Notably, demand trends from customers in the U.S. improved from Q2 as expected. Product sales to OEM customers outside the U.S., however, were significantly lower than expected in Q3.
We had a discrete logistics-related issue that impacted our Q3 OEM results, but the softer-than-expected product sales to OEM customers outside the U.S. is primarily related to navigating a more challenging raw material and supply chain environment.
Our updated revenue guidance for 2024 reflects the softer than expected OEM sales in Q3 and modestly lower OEM sales expectations in Q4 as compared to what our prior guidance range assumed.
Demand remains strong, but as a result of supply chain challenges, we now expect OEM sales growth of approximately 7% in 2024, compared to 10% in 2015.
Fred: previously expected.
Turning to a brief summary of our sales performance on a geographic basis.
Our third quarter sales in the U.S. increased 10% on a constant currency basis and 7% on an organic constant currency basis.
We were pleased to see improving trends in our U.S. business as we outlined on our second quarter call. We continue to expect to deliver approximately 6% organic growth in the U.S. at the midpoint of our 2024 guidance range.
Note this growth assumption contemplates our updated expectations for OEM growth in the second half of 2024.
offset by stronger organic growth in the non-OEM portions of our business, which by way of reminder are expected to represent approximately 87% of our total organic constant currency revenue in 2024.
Speaker Change: International sales increased 4.5 percent year-over-year and increased 4.4 percent on an organic constant currency basis, exceeding the low end of our growth expectations.
Sales results in rest of world and APAC exceeded the high end of our expectations, while sales in the EMEA region were softer than expected, largely related to the aforementioned OEM challenges in the quarter.
With respect to China specifically, sales decreased 5.1%, modestly better than what our guidance had assumed.
Fred: We continue to see quarter-to-quarter variability in growth trends related to volume-based purchasing tenders as expected.
By way of reminder, while we are not providing country-specific growth assumptions in our guidance messaging,
The midpoint of our 2024 Constant Currency Growth Guidance Range now assumes our total international sales will increase 4.8% year-over-year, driven by
Fred: 2% growth in APAC, 6% growth in EMEA, and 15% growth in the rest-of-world region compared to 0%, 7%, and 11% respectively assumed in our prior guidance range.
The improving growth trends in APAC, assumed in our updated guidance, is served by better-than-expected results in China over the first nine months of 2024.
driven primarily by better-than-expected sales of units, which are now expected to modestly offset continued pricing headwinds related to volume-based purchasing.
With that, let me turn the call over to Raul, who will take you through a detailed review of our third quarter financial results, balance sheet, and financial condition at September 30th.
Raul Parra: Thank you, Joe.
Beginning with a review of our P&L performance, for the avoidance of doubt unless otherwise noted, my commentary will focus on the company's non-GAAP results during the third quarter of fiscal year 2024 and all growth rates are approximated and presented on a year-over-year basis.
Raul Parra: We have included reconciliations from our GAAP-reported results to the related non-GAAP item in our press release and presentation available on our website.
Gross profit increased approximately 10% in the third quarter.
Our gross margin was 50.9% of 108 basis points. The increase in gross margin year-over-year was driven by pricing uplift, favorable product and geographic revenue mix, and improvement in freight and distribution costs.
offset partially by manufacturing variances compared to the prior period.
operating expenses increased 6% from the third quarter of 2023. The increase in operating expenses was driven by a 5% increase in SG&A expense and an 8% increase in R&D expense compared to the prior year period.
Total operating income in the third quarter increased $10.2 million, or 19% from the third quarter of 2023, to $65.1 million.
Our operating margin was 19.2% compared to 17.4% in the prior year period.
Fred: The 175 basis point increase in operating margin was driven by a 108 basis point increase in our non-GAAP gross margin and by a 67 basis point decrease in our non-GAAP OPEX margin compared to the prior year period.
Third quarter other expense net was a benefit of $0.9 million compared to expense of $4.5 million last year.
Fred: The change in other expense net was driven by an increase in interest income associated with our higher cash balances, partially offset by an increase in net interest expense associated with increased borrowings.
Third quarter net income was $51.2 million or $0.86 per share compared to $41.4 million or $0.71 per share in the prior year period.
We are pleased with our profitability performance in the third quarter, where we leveraged stronger-than-expected revenue results to drive significant expansion in operating margins and strong growth in non-GAAP diluted earnings per share, both of which exceeded the high end of our expectations.
Note, our third quarter non-GAAP EPS results included incremental dilution related to our convertible debt that represented approximately one cent to Q3 EPS versus what our guidance had assumed.
turning to a review of our balance sheet and financial condition.
Fred: As of September 30, 2024, we had cash and cash equivalents of $523.1 million, total debt obligations of $770.5 million, and available borrowing capacity of approximately $697 million.
Fred: compared to cash and cash equivalents of $587 million, total debt obligations of $846.6 million, and available borrowing capacity of approximately $626 million as of December 31, 2023.
Our net leverage ratio as of September 30th was 2.08 times on an adjusted basis.
We generated $38 million of free cash flow in the third quarter, and have generated more than $120 million of free cash flow over the first nine months of 2024, up 116%.
The improvement in free cash flow generation is a result of growth in net income and significant improvement in cash used in working capital compared to the first nine months of 2023.
Fred: We now expect to generate approximately $150 million of free cash flow in 2024, compared to our prior guidance of $130 million, and importantly, we continue to believe our CGI program will generate more than $400 million of free cash flow in the three-year period ending December 31, 2026.
Fred: for reference.
We have included a table in our earnings press release, which details each of our updated formal financial guidance items and how those ranges compared to the prior ranges as of September 17, 2024, when we updated our guidance to reflect the projected impact.
of our proposed acquisition of lead management assets from Cooke Medical.
By way of a reminder,
Our updated financial guidance assumes the Cook Medical Transaction closes on November 1st, 2024.
Our updated guidance ranges now assume the following.
gap net revenue growth of 6.9 percent to 7.6 percent.
Fred: Net revenue growth of approximately 5% to 6% in our cardiovascular segment.
and net revenue growth of approximately 49% to 52% in our endoscopy segment and a headwind from changes in foreign currency exchange rates of approximately 7 million or approximately 60 basis points in growth year-over-year.
excluding the impact of changes in foreign currency exchange rates, we expect total net revenue growth on a constant currency basis in a range of 7.4% to 8.1% in 2024.
Note the increase in constant currency growth expectations at the low end of the guidance range reflects the flow-through of the better than expected revenue results in Q3.
$2 million lower FX headwind to GAAP revenue and the contributions from our acquisition of assets from Cook Medical from the expected closing date of November 1st to December 31st.
Fred: offset partially by our revised expectations for our OEM business in the fourth quarter. All other assumptions supporting our Q4 growth expectations remain unchanged versus what our prior guidance had assumed.
Fred: finally
Fred: Our total net revenue guidance for the fiscal year 2024 now assumes inorganic revenue contributions from the acquisitions announced on June 8, 2023, July 1, 2024, and September 17, 2024, in the range of $29.5 million.
Fred: to $32.5 million in the aggregate.
Fred: For avoidance of doubt, this aggregate range consists of approximately $11.6 million of inorganic revenue related to our acquisition of assets from AngioDynamics, Inc.
in Q1 and Q2, plus the contributions from acquisition of assets from endogastric solutions in Q3 and Q4 in the range of approximately $14 million to $15 million, plus
The contributions from our acquisition of assets from Cook Medical post-closing in the range of approximately four million to six million
Excluding inorganic revenue, our updated guidance reflects total net revenue growth on a constant currency organic basis in the range of approximately 5.1 percent to 5.5 percent.
With respect to our updated profitability guidance for 2024, we now expect non-GAAP diluted earnings per share in the range of $3.33 to $3.38, representing an increase of 17 to 19 percent.
Fred: Note, this updated range reflects the better than expected EPS results in Q3 and includes the expected dilution related to our acquisition of assets from Cook Medical, which, as disclosed on September 17th, is expected to be in the range of 1 to 2 cents.
As Fred discussed earlier, we believe the Cooke Medical Acquisition offers a very attractive financial profile.
Fred: While we believe the proposed acquisition will be modestly dilutive to our full year 2024 non-GAAP profitability given the partial year contribution and the impact of approximately $1.8 million of lower interest income on cash balances used for the total purchase consideration, we expect the acquisition to be accretive to our non-GAAP gross and operating margins in the first full year post-closing.
We expect the acquisition to be accretive to our non-GAAP net income and non-GAAP EPS in the second full year post-closing.
Fred: For modeling purposes, our updated fiscal year 2024 financial guidance now assumes non-GAAP operating margins in the range of approximately 18.5% to 18.8% of 130 to 160 basis points.
Fred: non-GAAP interest and other expense net of approximately 0.9 million of income.
Fred: non-GAAP tax rate of approximately 21.3 percent, diluted shares outstanding of approximately 59.1 million compared to 58.8 million previously, and we now expect CAPEX of approximately 50 million and free cash flow of at least 150 million.
We would also like to provide additional transparency related to our growth and profitability expectations for the fourth quarter of 2024.
Specifically, we expect our total revenue to increase in the range of approximately 5.5 to 8.2 percent on a gap basis and up approximately 6.1 percent to 8.8 percent on a constant currency basis.
The midpoint of our fourth quarter constant currency sales growth expectation assumes approximately 12 percent growth in the U.S. and 2 percent growth in international markets.
Note, our fourth quarter constant currency sales growth expectations include inorganic revenue in the range of $11 million to $14 million.
excluding inorganic contributions, our fourth quarter total revenue is expected to increase in the range of approximately three to four percent on an organic, constant currency basis.
With respect to our profitability expectations for the fourth quarter of 2024, we expect non-GAAP operating margins in the range of approximately 17.8% to 18.8% and we expect non-GAAP EPS in the range of 80 cents to 86 cents.
That wraps up our prepared remarks. Operator, we would now like to open up the line for questions.
Thank you. As a reminder, if you would like to ask a question, please press star 1 1 on your telephone.
We also ask that you please wait for your name and company to be announced before you proceed with your question.
One moment while we prepare for the first question.
And the first question that we have for the day is coming from John Young of Canaccord. Your line is open.
Hi, everyone. Thanks for taking our questions tonight and congrats on the quarter. You know, first with the Cook acquisition, I just wanted to ask, you know, a bit of a 2025 question. Not sure if you can totally answer it, but just are you expecting a halo effect essentially with, you know, the other products in the CI segment?
Yes, this is Joe. I think that's exactly the rationale behind the acquisition. We have a number of very good EPCRM focused products.
but not really an anchor portfolio.
Some of the products we have already, whether it be transeptal crossing products or some that we have in our product roadmap.
Speaker Change: And Joe, can I add that just like RTG, we've seen success in aligning and having the focus to get deeper into those specific products, John. It'll add about $40 million in annualized revenue starting in fiscal year 2025, John.
That's all very helpful. And then just a point of clarification on Rhapsody for the add-on payment. Do you also expect NTAP to go live Q3 25, if you got that, or is that just TPT? And also when it comes to pricing a product, will you price the product with NTAP in mind? Thanks again for taking our questions.
The answer is we have submitted for NTAP, and yes, we will price as if we are going to get that NTAP, but of course we won't know for several months. As far as the add-on payment, that will be submitted.
or that application will be submitted after we receive FDA approval.
Great, thanks again.
Speaker Change: Thank you. One moment for the next question.
Speaker Change: And our next question will be coming from Jason Bedford of Raymond James. Your line is open.
Hi, good afternoon. Thanks for taking the questions and congrats on the progress. Maybe just two to keep it moving here. With the wave results on Rhapsody, has the data impacted faction in Europe at all?
Speaker Change: Yeah, I think it's a little bit too early to say, Jason. Of course, we released the six-month data at the Lisbon conference or the Lisbon CIRCE. Thank you, Fred.
And that was very well received. Of course, there are a lot of European physicians there, but I think it will take some time for that to really take hold. We have made great progress, though, in pushing awareness of the product and particularly that excellent data we released.
Okay, and then maybe for Raul or others, the three to four percent organic growth guide for 4Q, I realize it's a tougher comp, but what's the expected weight on growth to get to that level?
Yeah, I mean, I think, you know, generally, I'll start, Jason, by just highlighting kind of, you know, the overall performance of, you know, that we're going to, that we've guided to.
I think, you know, for the year it's going to be, you know, a solid execution on the revenue front, you know, operating margin expansion, and really strong earnings growth. You know, we called 17 and 19 percent growth on the EPS side.
But, look, I think when we look at our guidance for the fourth quarter, it's really not materially different than what we've been guiding to, you know, since Q3 or even before that. It's right in line with kind of our expectations. Really the delta that we're kind of, you know, adjusting for is just the OEM expectations.
We had, you know, a little bit of a supply chain challenge.
Speaker Change: that could impact the fourth quarter, which we've accounted for. Obviously, everybody knows about the Baxter IV impacting procedures. And I think we've tried to account for any disruption that may happen there. But generally speaking, we feel really strong about the year that we're putting together. And then obviously, the fourth quarter is going to be, you know, strong too, just from a growth perspective overall and just an earnings perspective.
All right, thank you.
Thank you.
Thank you. One moment for the next question, please.
Speaker Change: And our next question will be coming from Larry Beagleson of Wells Fargo. Your line is open.
Speaker Change: Hey guys, this is Simran on for Larry. Thanks for taking the questions here
Speaker Change: Maybe just to start off on Rhapsody, congrats on the results there. The data looked really strong and.
I appreciate all the color on the reimbursement pathway. I guess just to ask the question in a more pointed way, is it reasonable to assume Rhapsody will be priced at a significant premium to the competitive sense in order to meet that cross-cost criteria for the add-on payment?
Yeah, typically that's how it would work. So, we'll see as we get closer to launch and we'll give more detail at an Investor Day post-approval. But yeah, that's a fair assumption.
Okay, great. And then just any additional color on the commercial strategy? You know, how are you positioning the sales force to add Rapsody to the bag? And are you going to be able to launch the product right away after FDA approval?
So, this is Fred. Look, we are preparing on the clinical side, regulatory, reimbursement, and the commercial side, and we will follow all this up.
Shortly after our approval, we'll have a virtual meeting and go through all these details at that time when all these things play out and come together, and we will share that publicly in a virtual meeting.
Got it. Thank you.
Thank you. One moment for the next question please.
And our next question will be coming from Jason Bednar of Piper Sandler. Your line is open.
Speaker Change: Thank you.
Hey, good afternoon. Thanks for taking the questions. Fred, I'll preface this by saying, you know, please don't shoot me for asking this, because I'm going to ask it anyways.
You've got the NTAP, the TPT you're pursuing on Rhapsody. You sound confident securing each. Both maybe could take it back next year. TPT, I guess, on NTAP. But you're launching next year, presumably after approval. I'll take a stab here.
How do you want the analyst community thinking about the volume and or revenue opportunity for Rhapsody in 25? You like to take an imprudent approach with...
Speaker Change: setting guidance and expectations, but I think all of us are trying to feel out how much this could actually add in 2025 or the first full year of launch, and you've got a lot of different variables to consider. So how do you want us thinking about that?
You know, first of all, these are all good comments that we're receiving today. We're very excited about the product as we have been. We'll provide more at the appropriate time. We're going to hold steady to the course, as we've said.
and we'll be as conservative as always but again you're going to have to wait Jason I wish we could do it faster but that's not what we're going to do we've given you it's we've given you everything we have but we want you to have now we'll look forward to talking to that to you in the virtual meeting
Okay, all right, fair enough. Nice try. It's all been very helpful today, so we do appreciate it. We hope so. We're working hard and we're progressing. We're doing things that have to be done. And Jason, as we've talked, you know, our intent is to provide material updates every quarter as they happen. So, you know, we provided a pretty good amount of color, you know, today and, you know, more to come.
You did, and more than I think a lot of us were expecting, so it's all been helpful.
Maybe I'll shift over to
you know, the margin side. This has been, you know, extremely successful and impressive here the last few years.
Speaker Change: Thank you.
Speaker Change: over the next few quarters or next year, or maybe just bigger picture as we start thinking about our models for next year. Any other considerations that we should think about in sustaining this margin improvement? Not looking for specific guidance, of course, but big picture items that we should have in mind.
Yeah, look, I mean, I'll take you know, the question is pretty broad, Jason. So I'm going to take, you know, just
a minute to highlight, you know, the 108 basis point improvement year over year, you know, we hit 50.9. Obviously, you know, the sales team is working really hard on pricing uplift. They've been working really hard on the favorable, you know, kind of product and geography revenue mix.
And our operations group has been doing a great job on the freight and distribution side. So, you know, that's all driving the...
the gross margin improvement, and as we talked about, you know, in CGI when we laid out those goals for 2026
significant portion of the improvement.
comes from gross margin, right, on the low end. And as we get to the higher end, obviously there's an incremental gross margin improvement there too, with additional leverage to the operating expense line. So generally speaking, I think this gives us a,
Big vote of confidence for us, you know, that we're heading in the right direction, we're making the right improvements, but it's, you know, it's progressing, I guess, as we planned and, you know, it's part of the CGI program to increase the gross margin and let it flow through to the operating margin.
Speaker Change: All right. Thank you.
Yep, and maybe just one more thing, Jason. I didn't hit on the SKU rationalization piece, so let me answer that here real quick. But generally speaking, our commitment there hasn't changed. You know, there's two aspects to the SKU rationalization. One is just replacing our legacy products with newer products.
that are, you know, the same but just improve improvements and also obviously lower cost to manufacture. And then the second piece, the more material one that I think people generally ask about, is whether we're going to exit businesses or exit products.
and you know generally we'll give color and we'll give people a heads-up when those material kind of you know items come up. We don't anticipate anything for 2025. It'll be more of the internal stuff that you guys won't really notice.
or we hope you don't notice other than through the incremental margin improvement.
Speaker Change: Perfect, appreciate it.
Thank you. One moment for the next question.
Speaker Change: And our next question will be coming from David Rescott of RW Byrd. Your line is open.
Great, thanks for taking the questions. Congrats on the quarter and appreciate all the color on Rhapsody. Just a couple on Rhapsody from us.
David Rescott: Maybe attacking some of the market opportunity questions a little bit of a different way. You know, you look at the, we'll call it the scent-covered graft market out there, where
David Rescott: PTA, and so I'm curious when you think about the opportunities to enter these markets, is the stunt covered grass kind of the lowest hanging fruit out there and going after kind of what you looked at in the control arm is more upside, or do you think that both of those markets are kind of up for grabs with Rhapsody once you get out there?
Yeah, David, first of all, a very thoughtful question and we appreciate why you're asking.
and we look forward and we're going to share all of the thoughts on all of these issues in the future.
David Rescott: As everything plays out, we're focused on preparing for the commercial launch as we speak.
And then we will talk about all of this stuff at our virtual meeting. I'm sorry to have to repeat that. And I appreciate you guys trying. But listen, we are focused.
David Rescott: on CGI, we're focused on launching this product, we're focused on operating margins, free cash flow, all the things we've talked about. So the Rhapsody is important to us, but we have a big business we have to run and we'll talk to you.
As soon as we get to that closing time and get ready, in the meantime, we're getting ready to go to the market.
Speaker Change: All right, thanks. And then just maybe as a follow-up on that and some of the prior comments, you know, you talked about, again, the out-year margin expansion story, just, I'm not sure you're going to...
provide much on it, but just curious on the assumptions around not necessarily the impact Rhapsody would have, but assuming that the Rhapsody contribution on a margin perspective should be aligned with the expansion story over the CGI. Thank you.
Speaker Change: Yeah, I...
Again, thanks for the question, but we're obviously focused on the PMA approval, getting through that process, and we're excited about the product just as everybody is.
But, you know, clearly we're focused on delivering at least 20% operating margins per CGI. That's the goal. That's what everybody's focused on.
We're also focused on making sure that we get, you know...
the Rhapsody product line across the finish line from a PMA approval.
Speaker Change: there's a lot of work that's being done internally. We're just as excited as everybody but you know we're just going to hold off on kind of the financial you know modeling questions until we actually you know that post approval meeting that we have. So again I appreciate the question.
Speaker Change: [inaudible]
Thank you. One moment for the next question.
Speaker Change: Thank you.
And our next question is coming from Mike Mattson of Needham. Your line is open.
Yeah, thanks. So just kind of a higher level question, you know, Merit's been sort of making this move from, you know, more kind of basic accessory type products into these more physician preference item, therapeutic products like Rhapsody, the Cook Lead Management devices, and then the endogastric solution products.
you know kind of more of the purchasing or C-suite side of the hospital.
Speaker Change: Yeah, I think those are fair questions. I'm very confident in our sales team.
have been selling a lot of more accessory-type devices, that's for sure, but that's really built the company to where it is today and has enabled us to make these select bets on therapeutic products.
There's clearly a change in selling. I'll be clear about that, but we're
We are confident that we can get our attract and retain top sales talent that know how to sell therapeutics.
We're already, this year, we've been training up our renal therapies group in preparation for Rhapsody. They're already selling physician preference.
products in that portfolio, and we're confident they can take on Rhapsody. And we'll do the same with the cardiac therapies group, really anchored by Cook's weed management business.
and our EGS, you know, our endoscopy group too. Yeah.
Okay, got it. And then just one more. I got to try one more on Rhapsody. I know you may not answer this, but one more stab at the market opportunity here. I mean, can you just tell us, like, what the kind of TAM is for the indications you're expecting to get here? So, in other words, covered stints used specifically for AVGs or AVFs. I mean, I've ballparked it kind of in the...
300 to 600 million dollar range, but it's not very scientific. So I don't, is that reasonable? And sorry, that's a U.S. number specifically.
Mike, we are not going to confirm or deny anything, what we are going to say is yes, we can provide it at the virtual meeting right after we get approved.
Okay, fair enough. We look forward to discussing it. Yeah, it'll be good to get on to, yeah, anyway, thank you very much, Mike.
Thank you.
Thank you. One moment for the next question.
Speaker Change: Thank you.
And our next question will be coming from Craig Baiju, Bank of America Securities. Your line is open.
Good afternoon guys, thanks for taking the questions. I wanted to start with the OEM business and you know maybe just
I guess the question is, you know, any of these logistical challenges...
You know, can that, you know, bleed into 25 and...
Speaker Change: and I guess that's the first part, and then...
just how to think about that business going forward in terms of a growth rate. Obviously, over the last couple of years, it's been
a pretty strong grower for you. Maybe it slowed down a little bit this year, but would love any thoughts you had on that business and any potential disruption kind of bleeding into early 25.
Yeah, no, great, great, great question. You know, first of all, I think
just to highlight, right? I mean, I think, you know, Q3 revenue came in, you know, above our, you know, the high end of our guidance. So generally speaking, even though we did have a little bit, you know, we weren't as
high on the revenue growth and OEM as we expected, we were still able to beat the high end of our guidance. And also, I just I want to make sure that it's clear like
you know, we're not concerned here, you know, internally about OEM. I mean, you know, if you look at Q1, they were, you know, down 5%.
They were up 5% in Q2, and they were up 8.5% in Q3. So the demand is there. The logistics issue is really isolated to Q3. Is a customer.
Speaker Change: that couldn't arrange pickup for Q3. Then you ran into kind of the Chinese New Year that led into some delays. So it was really kind of a discreet.
Speaker Change: Item.
And it's Golden Week, just for clarification. Yes, Golden Week. Yeah, thank you. And so, you know, we can put that one kind of behind us. I think what we've tried to accommodate for is really the supply chain. You know, that's something that kind of, that we, you know,
We don't really have control over, as we've talked before in multiple quarters, there are still some areas that haven't recovered from a supply chain standpoint, and this just happens to be, you know, one of the areas that, you know, that's
Speaker Change: that's limiting us to be able to deliver on the demand that we're seeing from customers.
Speaker Change: So the demand is there. We have visibility to that. We continue to be excited about OEM. And again, we're still talking about 7% growth in 2024 for OEM, which is at the high end of our CGI guidance.
So, again, we have good visibility into the business. We're confident in the expectations. We're not going to provide anything for 2025. But I want to make sure that everybody understands that the
kind of the...
The impacts that we were seeing in Q1 are, you know, and coming out of into Q2.
are really different from what we're seeing, you know, heading into Q4.
they're discreet. So again, super confident in the overall business. I think if you look at the U.S. growth on a constant currency basis, organic, we were approaching almost seven percent. Really solid number for the U.S.
Speaker Change: You know, the rest of our U.S. business is almost 86%, 87%. So we're really talking about a small portion of our business. But continue to be excited about the demand we're seeing in OEM.
Speaker Change: Got it. Thanks, Raul. And maybe for Fred or Joe, obviously, you know, we're all excited about Rhapsody. I'm going to spare you a question on Rhapsody specifically.
I don't mean to look past it, but you know, you guys have talked about the Cook deal.
the product roadmap. Fred, I think in past quarters you've even teased that there's, you know, you have other pipeline products, you know, beyond Rhapsody. So, you know, maybe just, you know, help us understand when we may
hear about some of these new products or what the pipeline looks like or when you would disclose that to us or just how we should think about the pipeline other than Rhapsody over the next couple of years.
Yeah, well, listen, again, these have all been really good questions, which we appreciate.
Look, we're not revealing the details. I will say that we're focused on the CGI as we've been talking about on the call.
I think in terms of new product development, it continues to be a priority at Merit.
We have certain technologies here that we developed.
over the last several years, and when appropriate, we'll bring it forth. So we just want to keep focused on the things that are in front of us, but in the meantime, there's ongoing product development.
Speaker Change: Great. Thanks, guys.
Speaker Change: Thank you.
Thank you. One moment for the next question.
Speaker Change: Our next question will be coming from Jim Sidoti of Sidoti & Company. Your line is open.
Jim Sidoti: Hi, good afternoon. Thanks for taking the questions. Can you talk a little bit more about the integration of the Cook Medical products? Are you bringing on any of their sales folks? And will you move the manufacturing to your facilities?
Speaker Change: Yes, we are planning on taking on some sales professionals in the transaction, and yes, we will be transferring the manufacturing of that product to a merit facility. In the meantime, however, we will have a TSA to bridge the time between close and
Speaker Change: transfer to a merit site.
So once that transfer is complete...
What will the impact be on gross margins?
Speaker Change: We'll talk about that, Jim, when it's complete. Yeah, I mean, again, I think if you look at our original guidance that we gave out when the acquisition came out, we said it was going to be accretive to non-gap gross margins, accretive to non-gap operating margins in the first full year post-close.
If you look at the business now compared to where you were 7-8 years ago, the cash flow has improved dramatically.
What's the plan long term with cash? Do you anticipate continuing to use cash for acquisitions? Or would you ever consider, are there other options out there?
You know, we've made acquisitions because we have not only a line, that line comes from our ability to generate cash.
I think we've done a great job. You can see the numbers that we're talking about for this year. And as someone told me that lives in New York City...
Cash is King, and you might know that guy quite well.
Speaker Change: Thank you.
Speaker Change: Thank you for the question. First of all, we're working really hard to, you know, to make those improvements. I think it's, you know, it's obviously shown.
Speaker Change: and the performance that we've generated. You know, obviously...
We're off to a really good start under our CGI program, you know, Jim, we're at $120 million of free cash flow for the year. We're going to do a minimum of $400 million under the CGI program, so we're off to a good start. We've got plenty of capacity, our balance sheet is strong, and we continue to work on our working capital, so all solid points that are generating that free cash flow.
Speaker Change: Thank you.
All right and then with Rhapsody I know you don't want to answer a lot of questions but when it does get approved is this something that you think you can get in the market with relatively quickly or you think there'll be significant amount of training involved to launch the product?
Great question. The training has started this year, so we've had ongoing training sessions with our sales groups, and we'll be ready to go from that perspective.
adoption out of the gate keep in mind this is this like most
new medical devices will require a VAC committee in most cases, so that takes time.
Speaker Change: But I don't think it's any greater than any other product, and of course with the data we have, we expect that process to be certainly not easy, but easier than it would be without such great data.
Thank you for taking the questions.
Thank you, Tim.
Thank you. One moment for the next question.
The next question will be coming from Michael Piscussie of Barrington Research. Your line is open.
Michael Piscussie: Good evening. I've challenged myself to try to ask a Rhapsody question you guys can't answer.
Michael Piscussie: So, let's see how it works. I'm just curious, in terms of your communication with the FDA, have there been, I guess the clock started at the end of June or the first of July, have there been any stoppages during your, you know, any communication with the FDA since then?
Speaker Change: Yeah, so as you know Mike we promised or we indicated that we would file by the end of the second quarter which we did there's a hundred and eighty FDA days and We have had no stoppages
Speaker Change: So we'll leave it at that.
I'm going to try my luck with a second one.
In terms of website traffic or inquiries, have you noticed any pickup in people clicking around and trying to learn about Rhapsody since the day in Portugal?
I haven't. I haven't candidly looked at it, but guys, you want to speak to that, Joe? Yeah, I mean, look, I think it continues to track well in multiple markets, you know, where it's available commercially. Obviously, there's a lot of...
positive feedback from clinicians. And there continues to be a lot of data released, you know, that in the coming months, Mike, so, I mean, I think that's all generating a buzz. Generally speaking, as you saw just today alone, you know, just what the questions we're getting. So that's probably the best way to answer it.
Absolutely. All right, last one real quickly. In terms of M&A, you guys for a few years there were pretty quiet. You've picked up a little bit, not doing anything huge, but doing some deals that seem meaningful, both strategically and even financially. I'm just curious, in terms of
Speaker Change: Comfort with leverage, I mean, is there a number, and forgive me if you put this out either tonight or recently, but I'm just not sure I heard it, is there sort of a leverage ratio you guys are comfortable with going up to?
Speaker Change: Yeah, Mike, you know, I think, you know, had you asked me this year, you know, this question, you know, three years ago when the interest rates were low, you know, we'd probably say a higher number, right? We'd probably go up to four times.
I think generally speaking in this interest rate environment, you know, we're probably somewhere around three.
unless we can deliver really quick, right?
Look, I think we're disciplined on the transactions that we're...
that we're showing right now, I think they're real, right? I mean, I think you're looking at the transactions. You can pick up on the theme pretty easily. We're looking at areas that we can go deeper into the bag, that we can make investments in sales forces to make sure that they can get deeper into the bags that we already have.
including the new products that we're bringing on with these acquisitions.
Speaker Change: And, you know, we're sitting right now at 2.08.
times, you know, Levered. We've got plenty of cash on the balance sheet. We have a strong balance sheet and we've got plenty of firepower, but we're going to continue to remain disciplined. We've got our crosshairs on the CGI program.
Speaker Change: and you know that that's our that's our goal is to execute to the CGI program that we've that we've promised and everything that you know falls under that scope I guess you know we're making sure that you know any transaction that we do generally you know meets or exceeds those targets
Outstanding. Thanks, guys. Appreciate it. Thanks, Mike.
Thank you. One moment for the next question.
Speaker Change: Thank you.
Speaker Change: And our next question will be coming from Steve Littman of Oppenheimer. Your line is open.
Thank you. Evening, guys, and congrats on the progress. I guess first on Koch.
Where do you see the biggest sales synergy opportunities with your legacy TRM franchise, whether it's a cross-sell in the U.S., door opening in other countries? Any thoughts on that would be helpful.
Thank you.
Speaker Change: Yeah.
Speaker Change: So globally, it really helps our global franchises. As far as product...
products we have. We have the Worley, we have the SNAP splittable sheet, we have the Ventrax, which will be coming out soon. We have transeptal crossing catheters.
dedicated feet on the street, we're confident that'll happen.
Speaker Change: Great, thanks.
Just a follow-up on China. Good to see growth continuing to hold up for you guys there. Can you talk about the environment overall there?
How much BVP are you absorbing? Your confidence on procedure volume growth? I thought that would be great as well.
Yeah, look, I think, you know, Steve, look, I think it's, you know, for us, you know, first of all, volume-based purchasing has kind of come in as expected. I think the nice thing that we've seen is we've seen a strong demand and an increase in units.
Speaker Change: which is why you're seeing the better than expected results, you know, in China. So, I think for us, you know, the business continues to be strong.
Speaker Change: were stronger than we anticipated.
Speaker Change: volatile, I would say. But generally speaking, you know, the we're outpacing it with the unit growth. And so I think we continue to be excited about, you know, the performance of our Chinese team, and generally speaking, just the APAC region.
Speaker Change: Great. Thank you, guys.
Thank you. And this does conclude the Q&A session for today. I would now like to turn the call back over to Fred for closing remarks. Please go ahead.
Fred: Well listen, it's been a long call. We appreciate all the questions. Raul and I and Joe will be around for the next couple of hours. Best wishes. It's cold out in Salt Lake City. Warm us up with your questions. Thanks again for taking the time. We appreciate it and good evening from Salt Lake City. Good night.
Thank you for participating in today's conference call. You may all disconnect.
and the rest of us. Thank you. Thank you.