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Good afternoon, and welcome to the ShockWave's First Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes.
I would now like to turn the call over to Debbie Kaster, Vice President of Investor Relations at ShockWave, for a few introductory comments.
Thank you all for participating in today's call. Joining me today from ShockWave Medical are Doug Godshall, President and Chief Executive Officer; Isaac Zacharias, Chief Commercial Officer; and Dan Puckett, Chief Financial Officer.
Earlier today, ShockWave released financial results for the quarter ended March 31, 2022. A copy of the press release is available on ShockWave's website.
Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to the expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including, without limitation, statements relating to our sales and operating trends, business and hiring prospects, financial and revenue expectations, and future product developments and approvals are based upon our current estimates of various assumptions. These statements involve material risks and uncertainties, including the impact of the COVID-19 pandemic that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.
Accordingly, you should not place any undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our annual report on Form 10-K on file with the SEC and available on EDGAR and in our other reports filed periodically with the SEC.
ShockWave disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise.
This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 9, 2022.
And with that, I'll turn the call over to Doug.
Thanks, Debbie. Good afternoon, everyone, and thank you for taking the time to join us to review ShockWave's results for the first quarter of 2022.
While the quarter started out solely with a fairly significant COVID surge, omicron now seems like a distant memory as procedures recovered steadily since January. Our team has remained focused, which has enabled us to sustain our high level of performance as evidenced by our first quarter revenues of $93.6 million, a 194% increase from the first quarter of 2021.
At a high level, U.S. coronary continues to account for the majority of our growth. However, both our international business and our U.S. peripheral franchise continue to be strong contributors to growth.
Later in the call, Isaac will provide additional details regarding market dynamics. But first I would like to discuss some key recent accomplishments and drivers of our business. Starting with peripheral, there has been increasing attention paid to our peripheral business of late, and we are encouraged that the significant upside potential of this franchise is being better appreciated.
Last month, we announced the transition from a limited to a full launch of M5+ product and the customer response continues to be very positive. As a quick reminder, the M5+, which will replace our legacy M5 product over time, has three major improvements, size, reach and speed. By now offering a larger eight-millimeter version, doctors are noting that they feel better equipped to treat a significant portion of the iliac arteries, where our seven millimeter device felt a bit undersized to them. The longer catheter shaft gives our customers the length they need to reach lesions above the knee via radial access from the wrist, which our old shaft length could not quite accommodate.
And lastly, by doubling the speed of the pulses from one to two per second, the procedure takes half the time. And no one wants to go back to the old version once they have done one case with M5 fast. Size, reach and speed are all resonating strongly during the early days of the launch and confirms that our team is doing an excellent job at identifying the needs of our customers and incorporating them efficiently into our new product development efforts.
The big news on the international front is the recent approval of coronary IVL in Japan. There are over 250,000 PCIs performed in Japan each year. And physicians there perform intervascular imaging, particularly IVUS, on almost all their cases as standard practice, which enables them to identify calcium more accurately than relying on X-ray. By comparison, less than 10% of U.S. cases use intervascular imaging.
As we have seen in every geography, our safety profile resonates strongly with the Japanese cardiologist. And remarkably, our CAD IV study in Japan had even lower event rates than the very low rates we have seen in previous studies. So the combination of their use of intravascular imaging to better identify calcium and our consistently low adverse event rates are two of the many reasons why we anticipate that Japan will be amongst our strongest markets.
Our leadership team in Japan is quite strong and they are now in the process of building out our sales organization to ensure that we are poised and ready as soon as we receive reimbursement, which we believe should come by the end of this year. In order to help the clinical community appreciate the benefits of IVL, we continue to mine the substantial data sets we have created through the rigorous trials we have conducted. We were pleased to have two publications in the inaugural issue of the journal of the Society for Cardiovascular Angiography & Interventions, or JSCAI, which just launched in January. Featured in this issue were our CAD III, one year results, as well as our CAD pooled outcomes by gender. The gender studies have been particularly interesting and insightful as they have helped us to highlight the safety and effectiveness of IVL on frail patients with smaller vessels as are generally found in female coronary patients. These data showed that IVL was equally safe and effective in men and women unlike previous studies of atherectomy to devices.
In February CAD III IVUS outcomes were presented at CRT and shortly thereafter in March, the CAD IV one year outcomes were presented at the Japanese Circulation Society by Dr. Shigeru Saito, who was the PI of CAD IV. We anticipate a continued healthy cadence of data being presented and published as our studies continue to prove the acute and long-term benefits of our technology.
Finally, a few words on the macroeconomic and global environment. We believe the next several quarters will be more stable for our customers than the COVID whipsaws that they have lived through over the past two years. And our continued acceleration as evidenced by the strong Q1 performance, suggests that we will likely deliver results in a higher range than our prior guidance. We now anticipate delivering top line revenues in the range of $435 million to $455 million for the full year of 2022, representing growth of 83% to 92% from 2021.
As our company is matured, we have increasingly made it a priority to be active in sharing our good fortune with those who are not as fortunate. Our philanthropic priority has recently shifted to supporting the people of the Ukraine as best we can. In addition to other Ukraine specific donations, our team in Europe has partnered with our distributor in Poland and established their relationship with a hotel near the Ukrainian border, whereby ShockWave is helping to fund the hotel as a temporary housing facility for Ukrainian refugees, almost exclusively women and their children. I've been so impressed by the outpouring of support from our employees across the globe to help personally and financially support this cause.
The ShockWave team is not just extraordinary in the ability to pull together and deliver results, but it is extraordinary in the sense of purpose and community demonstrated by the individual team members.
With that, I will turn the call over to Isaac to provide more color on the commercial front. Then Dan will share more details on the broader business and financial results. Isaac?
Thank you, Doug. As Doug mentioned earlier, the year started out with some lingering challenges due to COVID across the globe. However, there was a nice rebound in the second half of the first quarter that has continued into Q2. Our team finished the quarter strong with solid results across the board from U.S. coronary, U.S. peripheral and our international business. Our U.S. sales team continues to execute at a high level.
Regarding the broader environment we certainly saw an impact to procedures, especially peripheral cases but it was largely contained to January. Our U.S. hospital-based peripheral business recovered well after the January slump. Our customers are continuing to treat their heavily calcified product and critical ischemia patients and experience a return of healthy procedural volumes. Further they are increasingly choosing IVL as their tool choice for their patients. These monthly dynamics seem consistent with most other companies in our space have reported a soft January followed by a strong February and March.
In fact, in February we had the highest U.S. average daily sales in our history for both the coronary and peripheral products. Fortunately, this record was surpassed in March. During the quarter 62% of our U.S. accounts purchased both coronary and peripheral products. 21% purchased only coronary, and 17% purchased only peripheral. We are pleased to see the continued increase in the proportion of our accounts purchasing both coronary and peripheral products. Our data show that peripheral IVL use is higher in accounts that also use coronary IVL than it is in accounts that only use peripheral IVL. The same is true of coronary use in accounts that also use peripheral IVL compared to those who do not use peripheral IVL. It is our goal to have all of our customers using both coronary and peripheral IVL.
During the first quarter reorders represented 92% of the C2 revenue in the U.S. indicating that the use of IVL continues to grow with existing customers. We expect this reorder metric to grow as the number of available new accounts diminishes. We have now launched C2 and over three quarters of our target accounts, most of which are comprised of high volume facilities that perform over 750 PCIs per year. Throughout the rest of this year, we will focus on launching the remaining target accounts.
To be clear these centers have not yet been launched. Said differently they are not accounts that have used IVL and stopped using the products. These un-launched accounts will continue to be a tailwind for our coronary business throughout the year. Meanwhile, the focus in our launched accounts will be ongoing customer education and training to help ensure that the entire group of physicians and staff are comfortable with IVL. This will help drive for their penetration in those accounts.
Our U.S. peripheral business saw strong quarter-on-quarter growth of 10% and was supported by the increased reimbursement for outpatient above the knee peripheral IVL procedures that went into effect on January 1st. While it is hard to quantify the impact of our increased reimbursement which is now equivalent to the atherectomy reimbursement, the payment uplifts certainly removes the economic barrier for our customers and will allow them to use IVL whenever clinically appropriate.
As Doug mentioned earlier, we transitioned to a full commercial launch of M5+ in April. Our launch strategy with M5+ is similar to what you saw with C2. We are working in a very controlled deliberate manner to roll this product out to the field. Again, the results in the quarter give us confidence that our hospital customers have returned to treating calcified PAD at levels similar to the pre-pandemic period.
On the international side, we also delivered record growth. Again, our new teams in the UK and France drove excellent growth to lead these results. Coronary IV represents the bulk of our international business. However, we continue to increase our focus and efforts on driving peripheral IVL adoption. The international peripheral market dynamics are different in the U.S. mainly in the peripheral atherectomy use outside the U.S. is uncommon.
So our teams spend their time building a new segment of peripheral calcium modification in those countries. We have traditionally done well in Germany and Italy, and more recently our new teams in France and the UK have made significant progress building our peripheral IVL business. The launch of M5+ will serve as a further catalyst for our international business, both our symptomatic peripheral disease and for S4 access. We have also increased our marketing efforts for peripheral IVL in Europe, and are establishing more programs to teach customers about the mechanism and benefits of IVL.
As an example, the team recently performed a workshop with surgeons to demonstrate the impact of IVL in a heavily calcified cadaver model. The physicians were able to see and feel the impact of IVL on these calcified peripheral arteries. It's a remarkable demonstration of how significantly IVL changes the compliance of heavily calcified artery and the surgeons were able to feel the change with their own hands. We expect these efforts will increase our customer base and usage of IVL over time.
Turning to Asia, we are excited about the recent approval of C2 in Japan. We plan to launch the product in Q4, after receiving reimbursement. In the interim we will perform cases on a limited-basis in key centers to help ensure that that we are prepared for the full launch. We will approach the launch in Japan in the same method as we have done in other countries with a focus on training and education on appropriate use. We expect the launch in Japan to be slower than in the U.S. primarily because of the relatively smaller size of our team in Japan and the lack of existing IVL business in those accounts.
And finally, the IVL business in India continues to perform very well as they've emerged from the pandemic. In a short-time they have already enrolled more than 100 patients and what will be a 1,000 patient registry. These data along with the data being collected in post-market registries in other countries including Spain, Italy, France, and the Netherlands will be significant additions to the compendium of IVL data.
With that, I will turn the call to Dan to review the financials.
Thank you, Isaac, good afternoon, everyone.
ShockWave Medical's revenue for the first quarter ended March 31, 2022 was $93.6 million, 194% increase from $31.9 million in the first quarter of 2021. U.S. revenue is $78.5 million in the first quarter of 2022, growing 273% and $21 million in the first quarter of 2021. The increase included $51.3 million from the coronary product Shockwave C2, which is launched in the U.S. in February of 2021. The growth in the U.S. was also enhanced by continued sales force expansion.
International revenue was $15.1 million in the first quarter of 2022, representing a 39% increase from $10.9 million in the first quarter of 2021. The increase in international revenue over the prior year reflects continued growth in customer demand and expansion of direct sales force in Europe. Looking at product lines, our peripheral products Shockwave M5, Shockwave M5+ and Shockwave S4 accounted for $22.9 million of the total revenue in the first quarter of 2022, compared to $16.1 million in the first quarter of 2021, a 42% increase. Our coronary product Shockwave C2 accounted for $70.3 million in total revenue in the first quarter of 2022, compared to $$15.3 million in the first quota of 2021, representing that 359% increase.
In addition that sales of generators yielded $0.4 million in revenue in first quota of 2022, compared to $0.5 million in the first quarter of 2021. Gross profit for the first quarter of 2022 was $80.7 million compared to $24 million in the first quarter of 2021. Gross margin for the first quarter of 2022 was 86% as compared to 75% in the first quarter of 2021. Improvement in gross margin was primarily driven by product mix as well as continued improvements in productivity and process efficiencies.
Total operating expenses for the first quarter of 2022 were at $65.4 million, a 58% increase from $41.5 million in the first quarter of 2021. Sales and marketing expenses for the first quarter of 2022 were $36 million compared to $24 million in the first quarter of 2021. The increase is primarily driven by sales force expansion. R&D expenses for the first quarter of 2022 were $17 million compared to $10.3 million in the first quarter of 2021. The increase was primarily driven by headcount growth.
General and administrative expenses for the first quarter of 2022 were $12.4 million compared to $7.2 million in the first quarter of 2021. The increase of primary driven by higher head count to support the growth of the business. Net income for the first quarter of 2022 is $14.5 million compared to a net loss of $23.6 million in the first quarter of 2021. Basic net income per share for the period was $0.41. Diluted net income per share for the period was $0.39. We ended the first quarter of 2022 with $201.1 million in cash, cash equivalents and short-term investments.
At this point, I'd like to turn the call back to Doug for closing comments.
Thank you, Dan.
There's no shortage of progress and exciting news at ShockWave. We're making great strides towards providing patient's access to both peripheral and coronary IVL. We have an impressive body of acute and now increasingly long-term evidence supporting the safety and effectiveness of our products. And we have established infrastructure and capabilities across the globe to support a large and growing customer base. We look forward to sharing more successes throughout this year, driven by continued execution and innovation.
Thank you all for joining us today and for your support.
[Operator Instructions] And our first question comes from Adam Maeder, actually I apologize. Our first question comes from Bill Plavonic from Canaccord.
Great. Thanks. Good evening. Can you hear me okay?
Sure. Hey Bill.
Wow. Just trying to some pretty big numbers and just make sure I'm clear. So U.S. coronary was $51.3 million is that correct?
Sub components Dan, do you have it right off the top of your head?
U.S. coronary?
Each $51.3 million?
$57.9 million.
Yes, $57 9 million. Yes. I just want to make sure the number...
Okay, $57.9 million?
Yes.
Okay. That makes a little more sense. Okay. Just checking. Okay, so a couple of questions here, first, congratulations on another solid quarter especially given January was tough. I was wondering just a couple of things is in Isaac's commentary, there was comment regarding the target accounts you're in three quarters. Can you remind us the number of target accounts that you have? And as you continue to expand kind of, I think, how, how should we think about that going forward? And then as we think about the guidance, it was a pretty big jumping guidance kind of just directionally if you have any color on that? Thanks.
Doug, why don't you take the guidance first?
Yes, yes. So as we sort of look at the run rate of the business and continue acceleration of both, well, really are three drivers of U.S. Coronary, U.S. Peripheral, and then broadly the international business taking into account that to your point. The January into early February is a little softish and what we – and as we don't anticipate really ongoing any – ongoing COVID downdrafts it's we – we see all, all three contributing, very nicely to growth over the course of the year? And so jump at having a jumping off point of close to $94 million, which was obviously meaningfully ahead of where we – where we in the street initially thought we were going to be for the quarter strike us that 2.30 to 2.35 or 4.35, 455 was the right range, given the trajectory of the business.
Yes. And then on the account side, we have probably 1,100 or so target accounts and on top of that there's a number of accounts that we've launched that are kind of satellite hospitals to a target account. So you open up a big account and then they want us to launch into their three or four hospitals that they use that are partners in the area. So that's a, and I think the key for us Bill is, is we're getting great reorders from our last customers and we've still got a chunk, a decent chunk of accounts that we plan on launching throughout this year to drive kind of new customer growth.
Yes. And we anticipate we'll be in virtually every cath lab over-time. So north of 1,500 total it's just the sort of where do you draw the line for? Who's a target versus who is sort of opportunistic and that's sort of an account size cut-off?
Got you. And then the one thing I didn't hear anything on, and I'll jump into queue is just C2+ in Europe, I know you're going through the MDR pathway, any update on that? And thanks for taking my questions.
I would say the MDR process needs an update because it's torture for any company that's going through it. But we think we're nearing the tail end and anticipate we'll be first with a limited launch, and then a broader launch rolling that in Europe in the back half of this year. We've not – we've not determined what our timing is going to be for U.S. launch? We want to get some experience in Europe before we launch in the U.S. approval process.
Great. Thank you.
Yes.
And thank you. And our next question comes from Adam Maeder from Piper Jaffray. Your line is now open.
Hi, good afternoon. Thanks for taking the questions and congrats on the great quarter to start the year. Wanted to dig in a little bit more on the peripheral business? Isaac did I hear correctly sequential growth 10% quarter-over-quarter. Just wanted to clarify that remark and then just any finer point that you can put on, BTK versus ATK? Thanks.
Yes. So the 10% was a U.S. sequential growth quarter-on-quarter for all peripheral, and color on the ATK, BTK. We see it's generally been pretty well proportioned since we've gotten out of the gates with the S4 product line, which is the product that is mostly used below the knee. And, and so as we see growth – the proportion of growth between, if you look at the total per peripheral number in the U.S. the proportion of above the need or below the knee has been relatively stable over the last four to six quarters. And it was last quarter as well.
And it'll be interesting to see the added shaft length of the M5+ will actually enable that device to be used when you go sort of up and over the – you'll be able to use it in below the knee cases. So the smaller size of M5+ we anticipate will be used in the sort of proximal vessels below the knee. Because it's a – it has a longer treatment zone and a faster treatment time. So we anticipate, and I got to be watching to see if it's – if we see some sort of complimentary M5+ S4 below the knee strategies.
Got it. That's helpful color guys. And if I can sneak in actually two more; one follow-up on peripheral. Just wanted to ask about the ATK reimbursement change that went into effect your parody to atherectomy Jan 1, 2022. It sounds like that's having a nice impact. Isaac, I think you talked about removing economic barriers, but just wanted to, I guess, hear a little bit more about kind of the observations in the field that you're seeing from customers, is that changing customer behavior and then I had one follow up? Thanks.
Sure. Yes. I think it's – we've talked about this in the past, as it relates to TPT and the NTAP on the coronary side, the customers – customer behavior takes a little while to change because it's – you need to both kind of get the administration who cares about the revenue that the hospital has associated with procedures, aligned – generally with the cath lab manager and they tend to focus on the expense of procedures, not necessarily the revenue. So our team's just kind of an ongoing education with the physicians. Cath lab managers and the administration on what this change means in terms of revenue and as those conversations happen and then generally you go into a hospital and the rep had been in there a couple weeks ago talking to them about it and they it won't have sunk in yet.
It won't have sunk in yet to one of those constituents that there is actually a payment change for the shock wave procedure this year. So I think my observation is this is going to be an ongoing educational effort by the team – by our field reimbursement team and the field team themselves. With those constituents and over time we'll continue to see the alignment between the revenue side of the hospital and the cost out of the hospital saying, okay, we no longer need to really try to put a break on the physicians for using ShockWave. They can use this now. Whenever they think it's appropriate, but I think it's going to be a build.
Okay. That's helpful. And just for the last one, thanks again for taking the questions here. Not sure if it's for Doug or Dan, but I know the focus is on driving top line growth, Q1 result, strong healthy guidance raise, gross margin is continued to improve, OpEx spend has been well controlled. So the question is just around kind of future leveraging models going forward. How do we think about that? Just any color there would be much appreciated? Thanks again.
Yes. We'll – we can probably tag team on this. Fortunately our thesis going into the coronary launch was that we would have one of the more leverageable field teams given that we believe we'd be able to sell both coronary and peripheral through the same channel and that it would actually be complimentary versus the experience many companies had where they can't – they can't effectively call on both peripheral and coronary customers. I think so far so good. A year into the launch that we're encouraged that our team is operating at an extremely high level in terms of providing a high level of service to both peripheral and coronary customers. Many of whom are overlapping on the cardiology side, obviously and we don't – we don't think that's going to be going backwards.
We think that, that will only get better, frankly over time as we complete the launch into our target accounts of coronary and then work on a penetration model for both coronary and peripheral. We'll be building out some of the supporting infrastructure. So we're – our IT team is getting strong – strong, and getting stronger. Our finance team is strong and getting stronger. So some of the areas that that you view, there aren't as obvious to the outside world were sort of our, which are critical backbones to the company to support this – support the sales – and the sales efforts those might not be quite as leveraged right now, but as the – as sales ramp through this year you'll see sort of top line far outpacing some of that that G&A expansion and Dan, I don’t know if I probably said before you were going to say, sorry.
I know. I think it's a good summary. Like Doug said, I mean want we expect more leverage out of the business towards back half of the year for sure. In sales and marketing and G&A and R&D we're going to continue to invest. And we're investing in infrastructure as well, but we still see some upside on leverage this year and we're very satisfied with the direction we're going.
Great. Thanks so much.
Thank you. And our next question comes from Larry Biegelsen with Wells Fargo. Your line is now open
Good afternoon. Thanks for taking the question and congrats on a nice quarter guys. Okay. Just maybe the follow-up on Adam's question because profitability has become a little bit more of an important topic recently. So basically Dan, it sounds like the message is you're going to be above 16% operating margin for 2022, given that you are 16% this quarter and you expect more leverage in the second half? And that mid-30s Doug operating margin goal that you've talked about when do you think you can get there? Maybe just talk a little bit more beyond 2022? And I had just a couple follow-ups.
I agree with the first part, Larry. We've always said probably longer range at full scale, upper-20s, lower-30s I mean, we want to continue to invest in the business, but we see a path to kind of best in class for sure.
And we aspire to. Aspire to that not to commit to a specific number. But yes, I mean, it's were we feel very fortunate that we – that we're able to kind of walk and chew gum of improving profitability and sustaining a high growth rate, which I know is a tricky balance. But so far we haven't had to make trade-offs on the growth side in order to drive profitability.
Okay. Yes. Clearly you guys are in a unique position. So Doug back to the top line Japan reimbursement, is it possible that you get it by how much visibility do you have on that? And from a timing standpoint, could you get it by October where you would get revenue this year? And why the slower growth than the U.S. given the IVUS use, the higher awareness and imbursement it's just going to be reimbursed from day one and I did want to ask about China after that.
Sure. So I guess the, the way we expect Japan to have reimbursement put in place by the end of September. So that's the current expectation. It's a fairly steady process. So there's not a lot of guesswork associated with understanding is – end of September we should get that. We don't yet know what that reimbursement about will be, and regarding the launch and the – I think in the relative speed of the launch compared to the U.S., you are exactly right hitting on the tailwinds, there's really high degree of imaging, which helps identify the calcium or intravascular imaging to help identify the calcium. It's nice to have reimbursement out of the gate, but just in terms of account coverage there with the sales team, we do not have nearly the team on-the ground that we had in the U.S. And we were in hundreds and hundreds and hundreds of PCI accounts already with our peripheral business in the U.S. So just – it's really just solely the ability to go in and turn on accounts and then the speed with which we'll do that in Japan is going to be limited by the personnel and the lack of existing business.
Okay. That's helpful. And lastly, just on China, I don't think I heard any update on this call, on the last call I think you said you expect approval by the end of this year. So any update there, please? Thanks for taking the questions.
I think we said mid-year for, or maybe this year...
No you said this year.
Yes. So what we expect, I'd say it's probably a midyear look now for approval Larry, and then work on starting to sell as you know, there, it's still a real mess over there with COVID. So I think we have, you know, modest expectations for China this year. But expect to get all three of the products, the coronary and the two peripheral products approved midyear and then start launching into that market.
So it just sounds like, just sorry to follow-up. It sounds like you do have a little bit of revenue in for Japan and China in 2022 in the guidance?
There's a little bit, yes. But it's not much at all. I think we want to be conservative on that front until we get out there.
Got it. Thanks guys.
Thank you. And our next question comes from Danielle Antalffy from SVB Securities. Your line is now open.
Hey, good afternoon, everyone. Thanks so much for taking the question. Congrats on a really good quarter and good start to the year. I guess, just to follow-up on the U.S. and coronary. And just you are in three quarters of accounts already, just curious to see how the different accounts are ramping? And I guess maybe a good way to sort of characterize it if you could even qualitatively some of your sort of best accounts, what are you seeing there from a penetration perspective or how the market for vessel prep has grown in those accounts versus some of your less penetrated accounts?
And then when you look at the less penetrated accounts, what are you doing to get, whether it's more users at those accounts are just – the users that are using to use it more? What are you doing to get that going? Thanks so much.
Yes, Isaac and I can tag team on this. On a macro level, we are not close to if 30% of the patients have calcium and some people like to use 20% as a sort of realizable number for IVL use at 20% of the PCI procedures, we aren't scratching the surface of full penetration hardly anywhere. The highest penetration is probably at some handful of small centers that don't have atherectomy. And so this is the only tool they have for calcium treatment. But at our larger centers we're not in the double digit sort of penetration of PCI volume. So we have meaningful upside across the board. And I could say the same thing about peripheral, but certainly focus on coronary.
And Isaac, I don’t know if you want to tag team on the inserts?
Yes, I think, the way we're thinking about it, Daniel this year is we just annualized the launch. So we still have accounts that have only been open a quarter or two quarters. And like I said, there is more accounts to go. I think this is a year of the team just kind of doing the usual blocking and tackling. And while we gather data on what the distribution and the way we're going to look at it is what's the distribution of penetration across our accounts. And as we get more data on that and track it, we'll work to understand why do some accounts have higher penetration than others. And once we really understand that at the customer level, then we'll develop tactics specific tactics to go after bringing the kind of the lower penetration accounts closer towards the higher penetration accounts.
But right now, I think, it's, we're doing the same stuff we've done throughout the launch, which has only been a year. And that is going in making sure they know how to use the product, getting more people to use it, who haven't been using it. And then as we've kind of shifted towards the M5+ launch, which is an important launch, spending time on the peripheral side of the house and making sure that's getting the attention it needs.
Got it. Thank you for that. And then just one quick follow-up on the guidance. And you're increasing the guide by $30 million at the midpoint. I know you guys don't give quarterly guidance, but you beat consensus by $7 million, annualizing that gets you close to that $30 million. But I guess just, what if you could talk a little bit qualitatively about what is looking better within the business, is it coronary, is it peripheral, is it all of it, is it U.S., is it Japan? Maybe just help us understand where in the guidance you are seeing better trends versus where we were in mid-February
Well, Asia broadly China, Japan is not different so that that's not affecting our guide. We anticipated launching Japan next year, we're still anticipating launching Japan next year. China, as Isaac indicated, is a small – we have a sort of small plug number in for this year. We think we'll sell some. So it's really driven by the same three drivers that we had anticipated from as we started the year, which was international, but more so U.S. peripheral, U.S. coronary.
And the M5+ like, you always hope that your limited launch is broad enough and that you are rigorous enough to be able to interpret what you see in a limited launch, and extrapolate it to a full launch and so far so good. It isn't just the early folks who really, really liked M5+ it seems to be everybody really, really likes M5+, and sees it as a sort of meaningful new product, not just an upgrade of an old product. It's really resonating very well. The team did a great job developing it and now launching it so far.
And then coronary just continues to sort of outpace adoption expectations. I'm sure you've heard it in your physician call Danielle, like the, a full year into launch where people will still be referring to it as a game changer. I actually had the pleasure of going with my dad to get a stent last week, and the doc there said, oh, the Shockwave that thing is a game-changer.
So, on a personal level, glad my dad didn't need Shockwave, because he didn't have calcified arteries, but it's nice that the consistency with which folks response a positive device.
And just maybe to tack on, you did the guidance in February for the year, we were maybe two weeks of positive trend out of January. And January was bad, especially in the U.S.
Yes.
We didn't have enough of a quarter under our belt check to feel great about the year.
Okay. Fair point. And Doug I hope your dad is doing well. Thanks guys.
Yes, he is crushing it. Thanks.
Thank you. And our next question comes from Travis Steed from Bank of America. Your line is now open.
Hey guys, congrats on a great quarter. Doug, most of those have been asked, so I'll just love to get your views on kind of like the update on the pipeline progress potential for an R&D date at some point this year.
And I'll ask my second question now as well, since it's getting late. And just any update on the competitive environment as you see it? Thank you.
Yes, those two are actually intertwined, Travis. Thanks. We were tentatively looking at doing a full Investor Day towards the middle of this year, but with the sort of competitive noise or sort of future sort of distant future competitive noise, we've decided that we're going to be a little bit more judicious about how much we share about our next product development. I mean, folks have folks have talked about C2+ a little on this call. That will be a late or second half 2022 international product, 2023 U.S. product. The L6 has also been talked about a bit that's our larger peripheral catheter sort of larger than what M5+ is able to achieve in terms of diameter. And beyond that we have a sort of multiple products a year product launch plan out well into sort of the next three, four, five years. But what we don't want to do is provide a roadmap to folks who are looking to try to figure out what's working for us and make it easy for them to try to try to just copy us.
We're spending a lot of money on R&D. Obviously, we continue to expand our team. We in our last call we talked about being north of a 100 R&D folks by the end of this year. The hiring plan is going well. And while we feel fortunate that we're able to both invest heavily and drive profitability, we still – even though today's tape, doesn't suggest that growth is very popular, we still think growth is long-term going to be what rewards our customers, because it's going to mean we've brought them better solutions and it'll reward our shareholders. So we're going to continue focusing on growth and try to maintain that profitability.
So right now we'll meet our products when they are more visible closer to market and not provide a multi-year product roadmap.
Right. Great. Thanks, Doug. Congrats again on, on the great quarter.
Thanks Travis.
Thank you. And our next question comes from Cecilia Furlong with Morgan Stanley. Your line is now open.
Good afternoon, and thank you for taking the questions, Doug I wanted to continue just on R&D specifically, and really what you are contemplating to the back half of 2022 versus Q1 levels, either from a hiring clinical or pipeline product focus, and really how we should think about R&D investment focus beyond 2022 as well?
The ramp will slow because we'll continue adding heads, but not at this sort of aggressive pace. We'll start – we've got the BTK trial up now, but 2023, we’ll start because we're in a bit of a lull on big trials, but we'll have our BTK trial running into 2023 and we'll on all likelihood to have a coronary trial that'll spool up into 2023, so you'll have a bit more clinical expense. And then as some of our more advanced new product development activities start to hit the clinic, then we'll start shifting into also augmenting with preapproval studies. And that will be probably parallel into 2023-2024 preapproval studies. Some will be feasibility and some will be sort of pivotal preapproval studies.
In terms of the, sort of what people think of as R&D sort of people designing and building new products that spend is not likely to change if you do a run rate after Q4, because we'll just keep churning through sort of – the team will finish one project and they will roll onto the next project. And so that'll be a modest increase in spend after Q4.
Okay. And if I could follow-up just quickly on Japan, but how you are thinking right now, from a timeline perspective around bringing your peripheral product into the region? And thank you.
Sure. Hi Cecilia. We are working right now with – our team in Japan is working with our consultants and starting to have conversations with regulators on what the appropriate trial is and to get a product, our peripheral products approved in Japan. So I don't have timeline yet, but they started turning the crank on that early this year. So hopefully we'll have more clarity on that as we exit the year.
Great. Thank you for taking the questions.
Yes.
And thank you. And our next question comes from Michael Polark with Wolfe Research.
Hey, good afternoon. Thank you. Just in Japan, as we peer out to 2023 and 2024, trying to make sure I have the inputs in the ballpark 250,000 PCIs we know our calcification rates are probably similar and high IVIS adoption there. What's the ASP for coronary in Japan, give or take relative to the U.S.? Can you frame that up so we can kind of consider Japan we're not [indiscernible]?
Yes. So we're still negotiating with the MHLW on the reimbursement. Reimbursement, it's an ongoing process. It could be in a reasonably wide range of where it might land. So I prefer not to comment now, but once we have the reimbursement decision that will drive ASP roughly – ASP will be close to the reimbursed amount.
Okay.
Yes. It will be interesting to see the Japan uses atherectomy at a slightly higher rate than the U.S., which is at a 2x the rate of Europe. So it'll be interesting to see is that in part because they do use imaging, so they see more? And you've got a decent chunk of hospitals who don't have atherectomies because they don't have surgical backup and yet they do use IVIS. So, it strikes us as a really interesting alignment of clinical practice and our product capabilities. So, we're excited about Japan, obviously.
If I can ask one more, just on the a fine point on coronary center activation in the U.S., I'm trying to track that quarter-to-quarter here as you ramp towards close to full market penetration in the U.S. Is it fair to say that new accounts activated in the first quarter, given the lingering Omicron challenges were de minimis and that the focus for the rest of the year will be bringing on board that one quarter of accounts that you haven't opened yet? Basically, I had you at the end of the fourth quarter, give or take at 1100 accounts. And I'm just curious what the first quarter kind of ended at, so I can build the rest of the year in a reasonable way. Thank you so much.
Yes, I was just grabbing some rough feedback. But I'd say to answer part of your question of what's the focus, I mean, as the launch has progressed, we've already migrated towards a stronger blend of better penetration of existing accounts with the addition of new accounts. Obviously, if you've got a territory where you're in 50% of your target accounts, you might spend a little more time trying to pick up new accounts. If you're in a territory where you've been there from day one, you're at 90% in your territory, you're going to be already shifted very heavily towards getting more physicians at each center using the device and getting more utilization amongst the physicians who do use the device already.
And we added to it, it was a slower quarter for adding new accounts for coronary, mostly because there is fewer accounts to add. So, you've kind of seen, given statistics last year, you saw the number of accounts per territory, adds in the quarter, going down progressively. That's still going down, but we did a pretty good job of bringing on new accounts even with the January hit by Omicron. So we're pleased with kind of the account growth we had in the quarter.
Yes. And it's getting harder to do. We used to do an account per territory, per quarter, and we keep adding more territories so that it's getting harder. At it's like where do you draw the line at the beginning of the quarter number of account territories end of the quarter number of accounts. And so that was one of the reasons we shifted to the Isaac shifted to the percent of targets metric versus the accounts per territory, per quarter metric.
Thank you so much.
And thank you. And I'm showing no further questions. I would not like to turn the call back over to Doug Godshall for closing remarks.
Thanks very much. And thanks everybody for joining us today. We appreciate the interest and attention. And certainly look forward to catching up with you over the coming weeks. Have a good rest of your evening. And take care.
This concludes today's conference call. Thank you for participating. You may now disconnect.