Merit Medical Systems [MMSI] Conference call transcript for 2022 q3
2022-10-26 23:15:02
Fiscal: 2022 q3
Operator: Good day and thank you for standing by. Welcome to the Merit Medical Systems Third Quarter 2022 Earnings Conference Call. Please be aware that todayâs conference is being recorded. I would now like to hand the conference over to your speaker today Fred Lampropoulos. Please go ahead.
Fred Lampropoulos: Thank you and welcome, everyone, to Merit Medical Systemâs third quarter of fiscal year 2022 earnings conference call. Iâm joined on the call today by Raul Parra, our Chief Financial Officer and Treasurer; and Brian Lloyd, our Chief Legal Officer and Corporate Secretary. Brian, would you mind taking us through the Safe Harbor provisions, 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 securities laws. Although we believe these forward-looking statements are based upon reasonable assumptions, they are subject to unknown risks and uncertainties. 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 those currently anticipated. In addition, any forward-looking statements represent our views only as of today, October 26, 2022 and should not be relied upon as representing our views as of any other date. We specifically disclaim any obligation to update such statements, except as required by applicable law. Please refer to the section entitled Cautionary Statement Regarding Forward-Looking Statements in todayâs presentation for important information regarding such statements. Please also refer to our most recent filings with the SEC for a discussion of factors that could cause actual results to differ from these forward-looking statements. Our financial statements are prepared in accordance with accounting principles which are generally accepted in the United States. However, we believe certain non-GAAP financial measures provide investors 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-GAAP financial measures. A reconciliation of non-GAAP financial measures to the most directly comparable U.S. GAAP measures is included in todayâs press release and presentation furnished to the SEC under Form 8-K. Please refer to the section of our presentation entitled Non-GAAP Financial Measures for important information regarding non-GAAP financial measures discussed on this call. Readers should consider non-GAAP financial measures in addition to, not as a substitute for, financial reporting measures prepared in accordance with GAAP. Please note that these calculations may not be comparable with similarly titled measures of other companies. Both todayâs press release and our presentation are available on the Investors page of our website. I will now turn the call back to Fred.
Fred Lampropoulos: Thank you, Brian. And let me start with a brief agenda of what we will cover during our prepared remarks. I will start with an overview of our better-than-expected revenue results for the third quarter. After my opening remarks, Raul will provide you with a more in-depth review of our quarterly financial results and the formal financial guidance for 2022 that we updated in todayâs press release, as well as a summary of our balance sheet and financial condition. We will then open the call for your questions. Beginning with a review of our second quarter revenue performance, we reported total GAAP revenues of $287 million in the third quarter, up 7.5% year-over-year. Our total GAAP revenue growth was driven by a 8.6% growth in U.S. sales and 6.1% growth in international sales. Our total revenue increased 10.5% year-over-year in the third quarter on an organic constant currency basis, excluding the headwind to our GAAP revenue growth related to changes in exchange rates compared to the prior year period. We delivered constant currency revenue results that exceeded the growth expectations that we discussed in our second quarter earnings call. Specifically, we shared our expectation for constant currency revenue growth in the range of a 4% to 6% year-over-year in quarter 3. The better than expected constant currency revenue results were driven by solid execution from our team, stronger than anticipated demand in the U.S. and more favorable than anticipated international sales trends, particularly in EMEA and the APAC reasons. Now, let me provide you with a more detailed review of our revenue results in the third quarter, beginning with a sales performance in each of our primary reportable product categories. Unless otherwise stated, all growth rates are approximated and are on a year-over-year and constant currency basis. Weâve included reconciliations from our GAAP reported results to related non-GAAP item in our press release and presentation available on our website. Third quarter total revenue growth was driven by 10% growth in our cardiovascular segment and 14% growth in our endoscopy segment. Sales of our peripheral intervention products increased 12%, representing the largest driver of total cardiovascular segment growth again in this quarter. Within the PI category, sales of our embolics and access products, increased 18% and 24%, respectively, and together represented nearly half of total PI growth and sales of our SCOUT Radar Localization angiography and biopsy products each increase in the low double digits year-over-year and together represented roughly 1/3 of our total PI growth. Within our cardiac intervention business sales increased 12% in quarter 3 representing the second largest contributor to total cardiovascular segment growth year-over-year. Cardiac intervention growth was primarily driven by 26% growth in sales of intervention products, and 25% growth in the sales of our products. Intervention products are the largest portion of our PI product category, which makes the 26% growth and quarter 3 even more impressive. Intervention products growth was driven by a notable increase in the sales of our map angioplasty packs, and mid teams growth in sales of our basic inflation devices. We also saw strong demand for our PhD hemostatic valve products in quarter 3. The 25% growth in sales of our EP CRM products was driven by strong demand for our snap sheets, and our hearts band sheets and transseptal needles. Sales of our OEM products increased 23% and outperformed our expectations more than anywhere else in the business in quarter 3. Some of this is a function of the challenge in predicting this type of business with quarterly precision. But we believe that third quarter revenue performance reflects continued improvement demand from larger customers in multiple categories including kits, cardiac access coatings and fluid management. While OEM growth was certainly a positive surprise, sales of our CPS products declined 3% modestly and reforming relative to the flattish growth assumed in our guidance. Finally, sales in our endoscopy segment increased 14% in quarter 3 at the high end of the growth range, we provided on our quarter to call. Recall that our quarter 3 guidance had assumed a notably wider range of sales in our endoscopy segment, given the potential business disruption issues with a third party contract manufacturer. As indicated on our quarter 2 call we viewed this disruption is transitory and indeed it was. We managed to the transition delivered sales results at the high end of the growth range. Of note endoscopy growth was driven by strong demand for both our Elation esophageal balloon product and our endo Max fully covered esophageal stance. Now turning to a brief summary of our sales performance on a geographic basis. Our third quarter sales in the U.S. increased 7% year-over-year. Sales to U.S. customers came in above the high end of our growth expectations and represented 36% of our total company constant currency growth this quarter. OEM standout performance represent the largest contributor to the better than expected U.S. growth this quarter, PI, CI and endoscopy revenue all came in at the high end of our expectations, reflecting continued strong execution and overall improving trends in the U.S. Our third quarter international sales increased 16% year-over-year which is strong performance in light of the challenging global macro environment in quarter 3. All three of our major regions posted growth in the mid to high teens in the third quarter, specifically, sales in APAC, EMEA and the rest of the world regions increased 14%, 17% and 19% respectively year-over-year. While all three regions exceeded the high end of our guidance expectations, EMEA and APAC grow more than 80% of the upside. EMEA growth was driven by demand from customers in Eastern Europe, the Middle East and Western Europe, specifically in the UK, France, Germany, and Italy. APAC growth was driven primarily by mid teens growth in China, where we are seeing strong demand for our PI and CI product, which is more than offsetting the continued headwind related to volume based purchasing. And lastly in our rest of world region with delivered 19% growth year-over-year which was also ahead of expectations, driven by strong demand from customers in Canada, and Brazil. In summary, we are encouraged by the improving growth trends and proud of our team strong execution despite another quarter marked by challenging operating environment, particularly in the international markets. Now before I turn the call over to Raul, I wanted to comment on a few other noteworthy items in the quarter. First, we delivered another quarter of impressive profitability improvement margin expansion and free cash flow generation in quarter 3. Our non-GAAP gross profit, non-GAAP operating income and non-GAAP net income increased 6%, 17% and 23% year-over-year respectively in quarter 3. Our non-GAAP operating margin increased 130 basis points year-over-year to 16.1%. And we generated $20 million of free cash flow in the quarter. We believe our financial results over the first nine months of 2022 represent clear evidence that we are executing towards our goal of enhancing Meritâs long term growth and profitability profile. We remain committed to the financial targets that we outlined in the foundationâs for growth program for the three year period ending December 31, 2023 which by way of reminder call for constant currency organic revenue to increase at a CAGR of at least 5% non-GAAP operating margins of at least 18% and cumulative free cash flow generated of more than $300 million. Second, I wanted to highlight another area where our team has been executing well towards one of our key strategic initiatives, specifically, the development clearance and commercialization of new products. In addition to the four new products updates, discussion of quarter 2 call we highlighted our continued progress in these areas, with four notable press releases in the third quarter. In July, we announced the launch of a new version of our Elation pulmonary balloon dilator. One that happens to be the smallest and shortage configuration offered in our range of multistage pulmonary balloon configurations. The unique balloon size fits a critical need in the pulmonary care space. Historically, physicians have relied on single stage cardiovascular balloons that were often too large and too long for use in smaller airways. This new configuration allows physicians to accurately match balloon diameter and length to specific small airways in the lungs, bringing treatment options to more patients. In August, we announced the launch of our safeguard focus cool compression device. This new compression device builds upon the original safeguard focus, revolutionary idea that provides compression over post surgical sites which can assist hemostasis in patients with pacemaker and implantable cardioverter sefibrillator pocket. The safeguard focus cool offers the same high performance, but with an easy to prepare cooling solution that does not require refrigeration, making it ideal for the lab environment. In September, we announced the launch of our Prelude roadster guide sheet. The Prelude roadster is the newest addition to marriage basket and peripheral access portfolio, which includes introducers and other products including access kit, vessel dilators and accessories. The Roadster is designed for deliverability, visibility and resilience and torturous peripheral vascular anatomies indicated for use in a variety of procedures we believe this device will also help deliver devices used to diagnose and treat the estimated 6.5 million people aged 40 and older in the U.S. suffering from peripheral artery disease or PAD. PAD is a serious condition where there is a narrowing or blockage of the vessels, mainly in the legs and lower extremities that prevents blood flow to these areas. PAD is associated with a twofold increased prevalence of heart failure, as well as the risk of limb amputation. To diagnose and treat PAD procedures are performed to detect an open blocked vessel. Prelude Rowson can help make these procedures available to more patients. And finally, in late September, we announced the launch of our terminal elite soft tissue biopsy system. The terminal elite is the latest addition to marriage comprehensive portfolio of biopsy devices, and as a single use device indicated for use in various soft tissue locations such as liver, lung, lymph nodes, kidney and other soft tissue suspect lesions. We believe that terminal elite represents another example of merits ongoing commitment to the advancement of biopsy procedures with its broad portfolio of products aimed at improving diagnostic accuracy and pathology labs across the nation. Iâm proud of the teamâs continued commitment to strong execution, the areas of development, clearance and commercialization of new products. Now with that said, let me turn the call over to Raul, who will take you through a detailed review of our third quarter financial results and our 2022 financial guidance which we updated in todayâs press release. Mr. Parra?
Raul Parra: Thank you, Fred. Given Fredâs detailed discussion of our revenue results, I will begin with a review of our financial performance across the rest of the P&L. For the avoidance of doubt unless otherwise noted, my commentary will focus on the companyâs non-GAAP results during the third quarter of fiscal year 2022. We have included reconciliations from our GAAP reporting results to the related non-GAAP items in our press release and presentation available on our website. Gross profit increased approximately 6% year-over-year in third quarter. Our gross margin for the third quarter was 48.4% compared to 49.1% in the prior year period. The 66 basis point decrease in gross margins year-over-year was primarily due to unfavorable manufacturing variances specifically purchase price variances. As expected, we experienced higher freight costs compared to the prior year period. We continue to prioritize meeting customer demand and mandating back orders which has led to a higher mix of air shipments and delayed the transition back to a more cost effective ocean alternative. As expected, our third quarter results reflect the inflationary headwinds we are seeing in freight, logistics, labor and increasingly in raw materials. Similar to what we experienced in Q2 while our guidance assumed higher raw material costs and freight logistics expense year-over-year our third quarter results included incremental headwinds from higher than expected raw materials, and freight and logistics expenses, each of which represented headwinds to our non-GAAP gross margins of roughly 30 basis points on a year-over-year basis. Third quarter operating expenses increased 1% compared to the third quarter of 2021. The year-over-year increase in operating expense was driven by a 2% increase in SG&A expense and a 3% decrease in R&D expense. Compared to the prior period. Our operating expense performance in Q3 was better than expected and reflects continued prudent expense management. Total operating income in the third quarter increased 6.7 million, or 17% year-over-year to 46.2 million. Our operating margin for Q3 was 16.1% compared to 14.8% in the prior period. The year-over-year change in operating margin was driven by 128 basis point reduction in our non-GAAP operating expense margin compared to the prior year period, offset partially by the 66 basis point decreased in our non-GAAP gross margin. Third quarter other expense net was 800,000 compared to 1.6 million last year, the change in other expense net was primarily related to decreased expense from realized and unrealized foreign currency losses compared to the prior period, partially offset by increased interest expense due to a higher effective interest rate year-over-year. Third quarter net income was 37 million or $0.64 per share, compared to 30.2 million point or $0.52 per share in the prior year period. We are very pleased with our profitability performance in the third quarter, where we delivered year-over-year growth in both non GAAP net income and diluted earnings per share of 23% exceeded the high end of our guidance range, which calls for low single digit net income and EPS. Turning to brief review of our financials returning to a brief review of our financial results over the first nine months of 2022. Total revenue for the nine months ended September 30, was 856.6 million, up to 61.3 million year-over-year, or 10% growth on a constant currency basis. Gross profit increased 7% year-over-year to approximately 416 million representing 48.5% of sales compared to 49% of sales in the prior period, a 50 basis point decrease year-over-year. Now compared to the first -- that we have experienced incremental headwinds to our gross margin of more than 250 basis points related to inflationary pressures and raw materials, freight and logistics. The early benefits we were seeing as a result of the teamâs hard work and dedication to our foundations for growth program are the primary reason we have managed to offset the majority of these inflationary headwinds to our gross margins this year. Operating profit increased 50% year-over-year to 142.8 million representing 16.7% of sales compared to 15.6% of sales in the prior year period. A 110 basis point increase year-over-year. We are driving strong operational leverage through prudent expense management, which is resulting in operating profit growing faster than revenue growth over the first nine months of 2022. Net income increased 10% year-over-year to 109. 7 million or $1.91 per share compared to 95.4 million or $1.67 per share in the prior period. Turning into a review of our balance sheet and financial condition, as of September 30, 2022 we had cash and cash equivalents of 51.5 million long term debt obligations of approximately 270 million and available borrowing capacity of approximately 509 million. This compares to cash on hand of 67.8 million long term debt obligations of approximately 243 million and available borrowing capacity of approximately 490 million as of December 31, 2021. Our net leverage ratio as of September 30, was 0.7 times on an adjusted basis. With respect to our cash flow generation in the third quarter our strong profitability performance in the third quarter of 2022 combined with strategic working capital investments resulted in strong free cash flow generation of $20 million in the third quarter. As expected, our use of free cash for working capital increase compared to the prior periods. In recent quarters we have discussed our strategy to proactively invest in our inventory balances to build the requisite safety stock and ensure high customer service levels. We generated $54 million of free cash flow during the nine months ended September 30, 2022. We continue to expect strong free cash flow generation this year and remain on track to deliver our goal of generating at least 75 million of free cash flow in 2022. Of note, this free cash flow target assumes planned investments related to the foundations for growth programs that are expected to drive our CapEx and investments in the range of 55 million to 60 million in 2022. Turning to review of our fiscal year 2022 financial guidance, which we updated in todayâs press release. For the 12 months ended December 31, 2022 we now expect GAAP net revenue growth of approximately 6.5% to 7.1%. year-over-year. This GAAP net revenue range now seems a headwind from the changes in foreign currency exchange rates in the range of approximately 23.7 million representing a headwind of approximately 220 basis points to our forecast at GAAP growth rate this year. This FX impact reflects an incremental headwind of 5 million as compared to our prior 2022 guidance. Note roughly 2 million of this incremental FX headwind was realized in Q3 with a balance of the increase expected to impact our GAAP revenue results in Q4. The GAAP net revenue guidance range now assumes net revenue growth of approximately 6.6% to 7.1% in our cardiovascular segment, compared to 5% to 6% in our prior guidance range and net revenue growth of approximately 3.8% to 5.4% in our industry segment compared to our prior guidance which assumed a range of a 5% decline to an increase of 8% year-over-year. With respect to profitability guidance for 2022 we now expect GAAP net income in the range of approximately 64.8 million to 68.3 million or $1.13 to $1.90 per diluted share. This compares to our prior guidance range which is GAAP net income in the range of 62.4 million to 68.3 million or $1.08 to $1.18 per diluted share, non-GAAP net income in the range of approximately 146.9 million to 150.4 million, or $2.55 to $2.61 per diluted share. This compares to our prior guidance range which assumed to GAAP net income, non GAAP net income in the range of approximately 139.6 million to 145.5 million or $2.42 to $2.52 per diluted share. For modeling purposes, our fiscal year 2022 financial guidance now assumes non-GAAP gross margins in the range of approximately 48.5% to 48.8% compared to a range of 49% to 49.15% previously. While we are pleased with our continued progress, we are seeing it as a result of our FFT initiatives in the area of pricing, we continue to see significant increases in the areas of raw materials and freight logistics. The 40 or 50 basis point revision to our non GAAP gross margin expectations just reflects the impacts of rising raw material costs and freight and logistics expenses over the second half of 2022 which are incremental to the increases contemplated in our prior guidance assumptions. Note roughly 20 basis points of change in our gross margin expectations were related to Q3 with the balance expected to impact our Q4 financial results. Finally, while impact of higher raw material cost is largely outside of our control, the impact on our gross margins in the second half of 2022 comes from a higher rate versus shipping freight, which is a direct result of our strategic decision to respond to the stronger than expected demand for our products around the world. Returning to a review of other key modeling assumptions supporting our updated financial guidance for 2022. We now expect non GAAP operating margins in the range of approximately 16.8% to 17.1% compared to a range of 16.6% to 17.1% previously. GAAP and non-GAAP other expenses of approximately 6.1 million and 4.2 million respectively, compared to 6.5 million and 4.8 million previously, a full year 2022 tax rate of approximately 22% versus 24% previously, and diluted shares outstanding of approximately 57.6 million. Lastly, given the continued uncertainty in the global macro environment, we would like to provide additional transparency related to our growth and profitability expectations for the fourth quarter of 2022. Specifically, we expect our total revenue to increase in the range of approximately 3% to 5% increase year-over-year on a GAAP basis and up approximately 6% to 8% year-over-year on a constant currency basis. Note the midpoint of our fourth quarter constant currency sales growth expectations assumes approximately 5% growth year-over-year in the U.S. and approximately 10% growth year-over-year in all U.S. markets. With respect to our profitability expectations for the fourth quarter, we expect to see non-GAAP gross margins in the range of flat to up 100 basis points on a sequential basis. We also expect to see non-GAAP operating margins increase in the range of 120 basis points to 240 basis points on a sequential basis. These margin expectations combined with a notable increase in our non-GAAP tax rate compared to last year, specifically 23% versus 13% in Q4, â21, are expected to drive a change in non-GAAP net income and EPs in the range of down high single digits year-over-year on a low end to flat year-over-year on the high end of the range. With that, Iâll turn the call back to Fred.
Fred Lampropoulos: Well, thank you Raul. A lot of numbers and a lot of work done there. So I appreciate very much. In closing our third quarter growth and profitability performance exceeded our expectations. But we believe as a direct result of our team has continued strong execution and relentless focus on our strategic initiatives. We now know how hard they are working and how that they are delivering these strong results despite the continued challenging operating environment around the world. Weâd like to thank all of our team members around the world that made our performance over the first nine months of 2022 possible. Importantly, weâre not resting on our prior success, we remain committed to continued progress. Weâre confident in our 2022 guidance which now calls for the total revenue growth on a constant currency basis of 9% year-over-year. We also continue to expect to report improving non-GAAP operating margins and strong free cash flow in 2022. Now that wraps up are prepared remarks. And weâll turn the time back over now to our administrator for questions. And then following that Raul and I will be available for the next couple of hours to visit and get into more detail if necessary. We will now turn it over to the administrator, thank you very much.
Operator: All right, our first question comes from the line of Jayson Bedford from Raymond James. Your line is open.
Jayson Bedford: Good afternoon, and congratulations on the quarter, you guys are doing a nice job. So I guess just a few for me. First, fourth quarter guidance specifically on the implied organic growth there, I guess the question is, and I can appreciate itâs dynamic market out there. But was there anything one time-ish in the third quarter result that kind of propped up the organic growth in the quarter?
Fred Lampropoulos: Jason, the answer is no.
Jayson Bedford: Maybe for Raul or Fred some of the gross margin dynamics, you stress kind of the ocean versus air in terms of freight? When does that dynamic slip? Iâm guessing some time in â23. But any kind of framing on that will be great.
Fred Lampropoulos: Yes, we wonât get ahead of ourselves to talk about 2023 Jason, but I think what weâre looking for is reliability. I think things are definitely opening up and thereâs more capacity. Itâs just not reliable enough for our customers needs, quite frankly. And so, to the extent we continue to see the demand that weâre seeing. Weâll continue to kind of use the current air versus ocean mix that we have. So I guess itâs dependent a little bit on that reliability of the carriers, and the demand from our customers.
Raul Parra: Yes. And I would just say thatâs correct. And I think you saw that international result. And that was a result of making decisions to meet customer needs. Itâs as simple as that.
Jayson Bedford: And maybe just the last one from a product related. Can you comment on Rhapsody in Europe, and then just a reminder as to where we stand in terms of U.S. timing for that product? Thanks.
Raul Parra: Sure. Rhapsody is in terms of timing, weâre about halfway through, pretty close to halfway through the trial. Again, there was a number of we have the whole COVID thing and then, but it has been accelerating in terms of that enrollment. So Iâm going to still say its two and a half years out for that approval. We still continue to be very pleased and weâve also seen a lot of interests that continued to build a business over in Europe, as well as Brazil.
Operator: Thank you. One moment for our next question. Our next question comes line of Larry Biegelsen from Wells Fargo. Your line is open.
Larry Biegelsen: Good afternoon. Thanks for taking the question. And Iâll echo my congratulations on a really nice quarter here, Fred and Raul. Fred. I just wanted to start maybe on 2022 year-to-date OpEx is relatively flat R&D spending itâs actually down a little bit. So how are you holding up x flat in an inflationary environment?
Fred Lampropoulos: Yes, itâs good question, Larry. Iâm going to Raul, and I were talking about this, and I think he has a better explanation that I would have, Iâll let him pick this up. And then Iâll come back and comment if I need anything for further. Raul?
Raul Parra: Yes , I mean, I think weâve a lot of the right investments this year, Larry in certain things like trade shows, and travel some of that some of the expenses up and youâll, youâll see it in the SG&A line. I think on the R&D line, quite frankly, there is thereâs cost initiatives and things that that are ongoing from that standpoint, including R&D and clinical, I think on the clinical side things have been a little bit slower than we anticipated on the enrollment. So that helps. And also, just as we shift and move on priorities within R&D, that tends to push expenses out one way or the other. So, again, I think itâs just prudent expense management on our side, making sure that we understood that weâre still in a choppy environment on the way to kind of normalized recovery. So just being patient with our expenditures, and then some of itâs just kind of outside of our scope.
Fred Lampropoulos: And let me just add to that youâve heard me say this many, many times, our vertical integration, allows us to control our production and to adapt to the conditions. And that continues to be a very big deal for us, Merritt. Just doesnât really well, I mean, we made those investments a long time and over the years, but itâs made a difference. Raul?
Raul Parra: I think, lastly to I just want to make sure that I point out our executive team and our employees, weâre all really committed to achieving the 18%, non-GAAP operating margin as we head into 2023. So, I think thereâs a broad commitment from the executive team and the employees on making sure that weâre frugal in our expenses.
Larry Biegelsen: Thatâs helpful. How do you, if I think about 2023, you guys, could have flat sales essentially and still meet your foundations for growth 5% CAGR because youâve done so well since you gave those goals in 2020. Fred, how do you want people to think about the momentum you have here? I mean the guidance implies about 9% organic growth in 2022, the momentum and how do you want people to just think about the growth algorithm for Merit going forward. Thanks for taking the question.
Fred Lampropoulos: Youâre welcome. Thanks, Larry. Larry, we want them to think about February of 2023 when we will go through our entire program. Thatâs what we want people, we want to finish the year, we want to stick to the goals that weâve set, and then 2023 and around February-ish, we will go through and we will lay out our plan from there.
Operator: Thank you. One moment for our next question. Our next question from the line of Mike Matson from Needham. Your line is open.
Mike Matson: Yes, thanks for taking my questions. I want to ask one on currency. I understand the youâre pretty clear with the impact on your top line, but I just wanted to maybe talk about the impact on the expense side or the P&L. Has it had a material impact on your earnings? How well hedged are you and as we head into 2023 is there a risk of any surprises there in terms of hedges rolling off or anything like that?
Fred Lampropoulos: Yes. So we obviously have a hedging program in place that that buffers, some of the impact that weâre seeing. We also have natural hedges in place, as you know we have operations in Europe. And then also some level of expenses in the APAC region that help also with our hedging. So I say, generally, we donât disclose the impact to the rest of the P&L. I would say that we might have some geography mixes within gross margin and OpEx because of the effects. But our hedging program is really designed to minimize the impact on EPS. And so I think thatâs why youâre seeing a kind of a minimal impact on the earnings side.
Mike Matson: And just as we head into 2023 and when thereâs no reason to expect that to change at all, that you should be able to continue to offset most of the impact from EPS.
Raul Parra: I think weâre going to be like most people, right from an FX standpoint, I think most people as things lapse, youâre probably looking at the first half of the year, next year, the people are going to be challenged with FX, but again, for us, I think itâs kind of business as usual.
Fred Lampropoulos: Well, and I think Raul to your point, we have what we think is a successful program, and weâll stick with that program.
Mike Matson: And then just one on China. So I think you said you saw mid teens growth there. But you did call out some impacts some of the VVP program. So I donât know, if youâre willing to quantify like how much better your growth would have been without VVP and then just whatâs the longer term outlook there in terms of VVP do you expect continue headwinds from that over the next few years as they expand into more product categories?
Fred Lampropoulos: Yes. Mike, volume based purchasing tenders are happening, but they are contemplating in our guidance. So weâve taken that. We donât stop and talk specifically about this, that or the other, but we have contemplated those and those are part of our guidance that weâve provided, and will be part of our discussion in February.
Operator: Thank you. One moment for next question. Our next question comes from the line of William Plovanic from Canaccord. Your line is open.
William Plovanic: Great, thanks. Good evening. A question on guidance for this year. If Iâm doing my math right, and please correct me if Iâm not, youâre basically saying revenue is going to be flat sequentially in Q4 and EPS will be about flat sequentially when we get to the low end to guidance. What are you contemplating in that low end guidance? Fourth quarter is typically a much bigger quarter for everything. So Iâm just trying to understand what gets us to the low end versus the high end?
Raul Parra: Sure, for sure. Look, I think, first of all, we had a great Q3. I think our Q4 growth really reflects kind of the continued improvement in the operating environment, as weâve talked about over the last year and a half. So, again, a chop, kind of a recovery a choppy recovery to normal is kind of how we see things. So we expect Q4 total revenue growth of approximately 6% to 8% year-over-year on a constant currency basis. The midpoint of our fourth quarter constant currency sales growth, expectations assumes roughly approximately 5%, constant currency growth year-over-year in the U.S. markets, and approximately 10%, constant currency growth year-over-year our O-U.S. markets. So, again, I think those are pretty, pretty solid growth numbers when you look at it on a year-over-year basis.
William Plovanic: And then how does FX the hedging impact your gross margins? Obviously, youâre taking a hit to revenue. Help us understand because the question really lies is, okay, so you havenât your gross margins have actually come down a little, it doesnât seem like you get to benefit from it depending on where you put your FX into the P&L and Iâm just trying to understand, okay, as rates kind of the dollar peak strengthening and search weakening again, how does that flow through into next year in terms of gross margin as weâre looking at it?
Raul Parra: Yes, again, I guess weâre not going to get into the details of that, as you know Bill, I mean, these things are pretty complex especially companies from company to company. I would just generally say that we have operations in Ireland so as the Euro drops obviously, that helps us, but also as revenue drops, that hurts us. So thereâs a lot of offsets and hedging that goes in place, along with intercompany balances that also kind of feed into that from a hedging standpoint. So, Iâd say itâs pretty complicated stuff, but which is why we donât get into all the details of what it does to the rest of the P&L. Iâll just end with saying that that our hedging program is made to really minimize the impact on EPS. Right. So thatâs the ultimate test for us is how is our EPS moving one way or the other. And so far, I think itâs done a pretty good job of keeping us within our original.
William Plovanic: Last question, if I may. Just on China. I mean, you guys have a significant exposure to China. I think itâs 13% of your sales or something like that. Itâs pretty big piece of your business. Help us understand obviously, in this day and age, thereâs just a lot more protectionism coming in. And how are you protected from a top line and bottom line perspective in terms of that business?
Fred Lampropoulos: Well, I mean look, I think if you look at our growth for one, I mean we had outstanding growth in almost every region. So I would say that weâre not overly dependent on China. I mean our APAC growth was pretty stellar. So I would say that generally, China is a big part of our business, but and we continue to invest there we continue to register products. But I think thereâs other areas that weâre investing also that can help minimize the impact from that standpoint.
Operator: Thank you. One moment for next question. Our next question will come the line of Jason Bednar from Piper Sandler. Your line is open.
Jason Bednar: Congrats on the solid quarter. You got so down here on producing. So bigger picture question on pricing dynamics. It sounds like some of the initiatives from the company are having some real positive effects and a few intertwine questions here. But could you give us a sense as to where youâre having the most success taking price in this environment on a product level or country level basis? And then how sticky do you think this price increase trend can be as we look forward to â23?
Fred Lampropoulos: Yes, let me just say that pricing is part of one of the pillars of our foundations for growth. And I think that is, generally the area I donât Iâm not going to address specifically, but it is one of those issues that we identified a long time ago. And itâs helping a lot. So Iâll just leave it at that. And it helps to offset, of course, the inflationary pressures, and itâs part of the reason we delivered the financial results in the third quarter. So itâs an important part of our overall program. And again, weâll talk about maybe these factors sometime in February.
Jason Bednar: So one more from us. So I have in my notes that you wreck sitting in some product line transfers from your Texas facility down to Mexico. And weâre wondering if you could update us here on the progress youâve made with that initiative as a complete, and whatâs the right way to think about the cost savings from this --
Fred Lampropoulos: Yes, Iâm going to let Raul pick that one up.
Raul Parra: Yes, itâs obviously one of our foundations for growth targets. We donât give detailed kind of status of where things stand, I would say itâs in progress. It is a multiyear effort as you can imagine, moving them any product lines that are registered all over the world just takes time, and which is why we donât call out the specific details, but I would say the work is ongoing, and theyâre still want to jump there.
Fred Lampropoulos: And part of our another pillar and our foundation for growth. These are the things that we identified and we talked about when we came out with our program, in terms of footprint, and consolidations. Itâs an important part of our overall program of improving the operations of the company.
Operator: One moment for our next question. Our next question comes from the line of Jim Sidoti from Sidoti. Your line is open.
Jim Sidoti: Hi, good afternoon. Thanks for taking the question.
Speaker: Welcome Jim.
Jim Sidoti: So you increase your revenue guidance, despite a increase in the currency headwind. So are you doing that because youâre seeing share gains, are you getting better traction with the new products? Or the price increase is starting to take effect?
Fred Lampropoulos: That was a good answer.
Raul Parra: I mean, I donât want to be a wise guy. But I think the performance is always as you know, Jim, a function of a lot of factors.
Fred Lampropoulos: Yes, I mean, Iâll take a minute to maybe thank our sales force for the efforts and the execution on their part, not just one region. I mean, itâs across multiple regions, and then also our operations group for being able to deliver the product. I think itâs a challenging environment right now procuring raw materials and getting people to show up to work. And theyâre doing a magnificent job, not only on execution on the sales side, but then being able to also deliver the product. So weâre pretty excited about the efforts on their part, and want to just thank them, I think publicly.
Jim Sidoti: Well done. It sounds like the supply chain issues with the endovascular business are behind you at this point. Do you see any of the other supply chain issues starting to improve? Or do you think theyâre still going to be affected going into next year?
Fred Lampropoulos: Jim, thatâs a great question. We continue to see kind of modest disruption. I think itâs hard to predict that thatâs what I would say. I think things are generally getting better. But we have a hard time predicting whether things are going to be stable or not. And itâs just one thatâs the problem that we see. Itâs a little plastic part that you wouldnât have thought of and itâs just, its random things, and itâs still difficult. But again, I think weâre doing a pretty good job. Obviously, you can see the sales numbers. We are executing a very high level, and thatâs not possible without our operations through delivering the product. So I think itâs going to I donât know how long itâll stick around. But what we want to be able to see before we are comfortable with it, is just getting a little bit forecasting those raw material purchases a little bit better and not getting surprises is what weâre looking for.
Jim Sidoti: And you highlighted a few of the new products that benefited during the quarter. And then you mentioned that youâre about 50% enrolled on Rhapsody. When Rhapsody gets approved, do you think thatâll be a contributor on the same order of magnitude as new products you have now? Or do you think thatâll be something thatâll be a much larger contributor?
Fred Lampropoulos: Well, Iâm not going to go into that number, Jim, in terms of matching it up on something that we have a belief in earnest that weâll wait to see how this develops. And, again, itâll be maybe part of our discussion down the road. But I think what really is important is that merits ability to work through the supply chain, meet the demands of customers and continue are the same thing that Merit has been known for so long. And thatâs coming out with a new products whether it be breakthrough designations, or the new scout BX delivery system, the mini reflector, the resolve, pneumothorax tray, all of those things all add up, and I think part of Meritâs heritage.
Jim Sidoti: And then the last one for me if we do hit, if it is a recessionary environment next year, are there any product lines that youâre concerned about in particular? Or do you think youâll be able to file to that?
Fred Lampropoulos: Itâs a good question, Jim. And itâs one that Iâm happy to answer. And that is, generally speaking over the years, our business does not suffer from as you might have other consumer types and other product lines, and businesses, people still get sick, people still need to be treated. And so recessions are not a big factor at Merit. Itâs just as simple as that. I think history would go back and look at it, youâll find that Merit has done quite well during these economic pullbacks.
Operator: One moment for our next question. Our next question will come from the line of Michael Petuski from Barrington Research. Your line is open.
Michael Petuski: So I guess, Fred first of all, impressive Q3. When you sort of think about all the macro issues that are out there, whether itâs labor retention, inflation, shipping challenges, currency headwinds, as the previous question, possible recession, flu, COVID, possibly coming back heavy in the winter. I mean what are the two or three things if you get narrowed down to two or three things that you really are, are sort of like, this concerns me or this is going to be a challenge or weâre really going to have to be bringing our A game to this particular area, this particular headwind? I mean, how do you sort of I canât remember a time when thereâs been more to think about on a macro level than right now. Thanks.
Fred Lampropoulos: I think when you were talking about Raul said war, I mean, thatâs another factor. Whatâs that going to do? And what goes on all these places. I think maybe the better way to answer the best way to answer that question is, if we look over the 35, years of Meritâs history whether it be financial meltdowns, whether it be threats here and there, whether it be wars, whether it be terrorism, I mean, when you really kind of look at all of this COVID we canât forget all those other things that happened. What it did to slow down 9/11 war in Iraq, war and Afghanistan, I mean, all of these things. Weâve been hit by all of these things over the years. So Mike, I guess, to answer the best way to answer your question is the ones weâve already been hit with we know how to deal with those generally, itâs always the one that you donât see coming. But even with that, as COVID came through, Merit adapted, our workforce adapted our sales force adapted to meet customer needs. We found products that we can build, like the swabs that were temporary, but it helped the business to keep 200 people employed. We helped people, we helped the nation. So I think that a success of a business and Iâm going to speak military for 30 seconds, you adapt to the conditions. Thatâs the key to it and its one American strong suits. It always has been. So taken up whatever it has been.
Raul Parra: It is a lot of it too we talked a lot of a lot about all the issues that are out there, Mike, I think you could lose focus very quick if you just focus on those issues right there. But the reality is a lot of thatâs outside of our control. And so really being focused on what we can control and execute on is what weâve been doing really the last few years. And I think itâs helped us tremendously, obviously.
Fred Lampropoulos: And I think thatâs a terrific answer. Weâll work on the things that we can and will adapt to the things that we canât.
Michael Petuski: Fair enough. So then sort of pivot off that question. I suspect that some other companies, maybe havenât managed through all of this quite as cleanly as you guys have, and Iâm not minimizing. I know, itâs been a Herculean effort on your part. But there are probably some other companies out there, that maybe are looking to divest product lines or that sort of thing. And really what Iâm getting around to is youâre generating a lot of cash balance sheets, de-levered in great shape. I mean, I would assume valuations for assets are coming down as far as the type of assets you guys look at. I mean what are you seeing and what are your thoughts?
Fred Lampropoulos: Well, I think youâre right, I think those things are out there. But I want to make sure that I emphasize again, that Meritâs goal is to finish that third year of foundations for growth, while keeping their eyes open. We understand that we do and are in a position to look at things. So but they have to fit, and weâre very patient in the business I think is doing fine. Itâs just the discipline, and the focus. And I think thatâs whatâs helped us to be able to deliver these kinds of results. So we know theyâre out there. Weâve talked about them. There are opportunities. But again, they have to be consistent with the long term goals that weâve set out in our foundations for growth, Mike. So I mean, that may sound like a canned answer. It kind of is because we have a camp program. We are focused, laser focused on what we want to accomplish and what we promised.
Michael Petuski: I suspect a lot of investors are giving us standing out for that answer. Hey, last quick question on just this idea that flu could be heavy this winter, and maybe COVID comes back. Are you hearing anything from your contacts in hospital systems, about concerns about staffing of hospitals or anything that would sort of really curtail surgical volumes? Thanks.
Fred Lampropoulos: Yes. Not specifically into surgical but staffing. We have a member of our board that runs a hospital system. And staffing is a problem for everybody. Until we get the participation rate higher and things like this. Itâs a challenge for everybody Mike. Itâs not going away. So what weâre not hearing are things that we were hearing before, like, elective procedures and that sort of stuff. Iâm not hearing that language, just staffing in general, is a problem, but not in terms of procedural rights at this point.
Operator: Thank you. And that will conclude Q&A. Iâll turn it over to Fred for any closing remarks.
Fred Lampropoulos: Well, ladies and gentlemen, thank you very much for your time. Itâs a busy day. And just one closing note. Itâs snowing like crazy out here. Come out and see us. Weâd love to host you here in Salt Lake City. Thank you again for the time and weâll look forward to talking to you again soon. Best wishes. And good night from Salt Lake.
Operator: This concludes todayâs conference call. Thank you for participating. You may now disconnect. Everyone good day.
