MiMedx Group, Inc

Ladies and gentlemen, thank you for standing by and welcome to MiMedx 4th Quarter 2021 Operating and Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. I would now like to hand the conference over to your speaker, Mr. Jack Haworth, Senior Vice President of Investor Relations. Please go ahead, sir.

Thank you, Operator, and good afternoon, everyone. Welcome to the memetics fourth quarter 2021 operating and financial results conference call. With me on today's call are Chief Executive Officer Tim Wright, Chief Financial Officer Pete Carlson, Executive Vice President and Chief Commercial Officer Dr. Rohit Keshav, and Executive Vice President Research and Development Dr. Robert Stein. Tim and Pete will provide a summary of our operating and financial results for the quarter. And at the conclusion of their remarks, Tim, Pete, and Doctors Kashup and Stein will be available for your questions. Before we begin, I would like to remind you that our comments today will include forward-looking statements, including potential timelines for our ongoing clinical trials and FDA submissions and approvals, and expected market size for these products. These expectations are subject to risks and uncertainties, and actual results may differ materially from those anticipated due to many factors. Actual timing and FDA approval will depend on a number of factors, including the results of our clinical trials, our interpretation of those results, the impact of COVID-19, actions by others that affect our timelines, and other factors that the FDA deems important. Additional factors that could impact outcomes and our results include those described in risk factors section of our annual report on Form 10-K and our quarterly reports on Form 10-Q. Also, our comments today include non-GAAP financial measures, and we provide a reconciliation to GAAP in our press release, which is available on our website at www.memetics.com. With that, I'm now pleased to turn the call over to Tim Wright. Tim?

Thank you, Jack. Good afternoon, everyone, and thank you for joining us on the call today. 21 was a defining year for Memetics. In 21, we advanced our understanding of our periodon process, placental tissue, both scientifically and clinically. We delivered above-market double-digit growth in our continuing tissue and cord commercial portfolio despite COVID and the impact of the end of enforcement discretion. We are well positioned to execute against our goals and objectives for 2022. We are innovating by introducing new purpose-designed and developed products. We are expanding into areas of surgical recovery and across the globe with our anticipated launch of EpiFix in Japan. And we are advancing the body of scientific evidence to support expanded applications of our placental biologic platform. The unmet clinical need across the markets we address today is significant. Ten percent of the U.S. population have diabetes with calculated annual costs exceeding $300 billion. A key driver of cost for patients with diabetes is lower extremity diabetic ulcers, which present a substantial financial burden to payers and a significant burden to patients. Patients with these lower extremity ulcers face challenges with mobility, the risk of infection, the risk of amputation, decreased quality of life, and a shortened lifespan. many of which are exacerbated should amputation actually be required. It is estimated that up to 85% of amputations are avoidable with the adoption of best practices of treatment. Results of our recent peer-reviewed study clearly demonstrate that memetics' proprietary Purion-processed epifix should always be considered as part of a best practice treatment regimen. When following these guidelines, EpiFix was shown to provide better clinical outcomes by reducing major amputations, emergency room visits, inpatient admissions, and readmissions, all with statistically significant P values less than .0001. Not only was EpiFix noted as a dominant treatment strategy, it was also found to be cost-effective, providing increased quality of life at a lower willingness-to-pay threshold. The results of this recent peer-reviewed study are meaningful for patients, physicians, and payers. Memetics will continue to pursue evidence-based approaches to support the clinical use of our products. We can only do this by substantiating the clinical and economic attributes of our foundational placental biologics platform. We are advancing not only scientifically, but we are also delivering revenue growth. I'm extremely pleased to report another outstanding quarter of growth. Fourth quarter net sales from our tissue and cord products, also known as our 361 products, were 66.9 million, reflecting a 13% increase versus the same period one year ago. Net sales of the same portfolio of products increase an impressive 15% year-over-year for the full year 2021. We exceeded our stated 21 objective of greater than 10% growth. as well as beat the market average growth, which is estimated to be between 6% and 8%. Despite the end of enforcement discretion this past May, total net sales in 2021 grew 4% versus the full year of 2020, and adjusted net sales grew 7%. These strong results are a direct reflection of our investment we've made to support our sales professionals and our medical science liaisons. In addition, our territories are designed to focus on high growth areas. We are equipping our teams with meaningful clinical, scientific, and economic evidence and reinforcing their efforts with medical education initiatives designed to amplify the important benefits of our products to patients, clinical decision makers, and payers. Our commercial business is getting stronger, and we are expanding into new markets. Our strategic expansion into surgical recovery markets is one component that propels our continued growth. Here, our direct and agency sales professionals are laser-focused, on identified areas where our tissue products can help reduce complications across several specialties such as Mohs procedures, colorectal anastomosis, spinal decompressions, complex surgical reconstructions, and lower extremity repairs where a patient may have an increased likelihood of complications. Complications such as dehiscence, adhesions, hypertrophic scarring, and others may affect both the recovery of the patient and the outcome of the surgery. We are targeting certain procedures for use of our products based on an unmet clinical need, potential procedural complication rates, clinical relevance, and economic factors, plus overall business priorities. As in advanced wound care, we believe the surgical recovery market is expanding due to the demographic trends, such as aging, obesity, diabetes, and other comorbidities that can complicate healing and increase a patient's susceptibility to non-healing chronic wounds. At our recent Company Investor Day, we outlined our strategy for achieving sustainable annual growth of 11 to 14% in our continuing commercial portfolio. This above market growth rate includes growth in our existing products, EpiFix and EpiCord, along with an increase in our surgical recovery setting using our AmnioFix and AmnioCord products. I'd like to spend a moment on two additional contributors to our anticipated growth, our global expansion into Japan and our robust near-term organic product pipeline. First, Japan. As we had previously discussed, Memetics received regulatory approval from the Japanese Ministry of Health, Labor, and Welfare in June 2021 to market EpiFix in Japan. As the first amniotic tissue approved for hard-to-heal chronic wounds, such as diabetic foot ulcers and venous leg ulcers, which do not respond to conventional therapy. We expect to secure reimbursement approval mid-2020, too, subject to the government's ability to continue to progress our application in light of COVID constraints. Our commercial team is establishing the necessary structure, medical education programs, and market development initiatives to operationalize our commercial strategy. As of today, we have already trained more than 200 Japanese clinicians on the use of EpiFix, and we are working to build consensus on establishing a treatment practice guideline, as well as leveraging the power of peer-to-peer education in partnerships with expert key opinion leaders. We believe these results could lead to the treatment of as many as 100,000 patients annually. Success in Japan is an important step in our aspirations to grow our business geographically outside the U.S. I'd like also to highlight an area I'm personally excited about. We are innovating. I've asked the organization to develop two substantial new products every year, and we are well on our way to achieving this goal. The native and multimodal therapeutic properties of our Purion process placental tissue provide an almost unlimited range of new organic product innovations, including 361 products as well as 510K products. We have outstanding scientists in our research and product development organization. We have the capital to invest in these important product development initiatives that broaden our portfolio and expand our addressable markets. The first two of these product innovations are planned to be introduced later this year. and our placental collagen matrix product. Amniofect is a membrane product similar to EpiFix and AmnioFix, but is uniquely processed to produce a thicker, more robust graft. The initial feedback we have amassed through multiple focus groups, customer preference testing, and key opinion leader dialogue indicates that this new platform has the applicability for operative procedures where a surgeon needs to anchor or suture the graft, such as in a rotor cuff repair or a complex wound reconstruction. Our placental collagen matrix product is made from the placental disc. It is a placental extracellular matrix in a particulate format. Its clinical utility will be in complex wounds that are deep or tunneling or simply difficult to reach with conventional products. We see this as an additional platform into which we can incorporate innovations and iterations that have the potential to improve the process of care and patient outcomes. Our commercial team will be well prepared to bring these new products to the market later this year, benefited by an armamentarium of evidence and medical education support designed to facilitate clinical adoption. Overall, we made great progress in 2021 and we're putting the company in a solid position to achieve a number of significant milestones in 2022. Let me reiterate Mometix's commitment to developing new products, our commitment to expanding the market opportunities, and our commitment to generating science-based evidence. These three things all position us to achieve 11% to 14% growth in our commercial business in 2022. Transitioning to another area I'm excited about, our late-stage musculoskeletal pipelines, We're advancing in this area as well with our clinical operations team. We are confident in the therapeutic potential of micronized D-HACM and are methodically focused on initiating our phase three KOA program in order to demonstrate its effectiveness in the clinic and its potential to remodel soft tissue, demonstrating a demode characteristic or disease-modifying characteristic. We are diligently working on site selection, clinical trial protocols and design, and the final analysis of the 12-month readout from our Phase IIb KOA study. This may provide an important look into the durability of patient response to micronized DHAKM, and these studies will be considered as we advance our plans for Phase III. We intend to hold confirmatory meetings with the FDA to review our statistical analysis plan as well, as well as finalize our study protocols as soon as possible. Our Phase IIb study results provided important insights into the properties and behavior of our AmioFix injectable product. The number one thing we discovered from the first 190 patients was that our placental biologic is both safe and effective. The p-values for these 190 patients were statistically significant and clinically meaningful, consistent with published retrospective studies and real-world experience amassed from more than 138,000 vials that have been used in the clinic prior to enforcement discretion. I would encourage you to read both our press releases on these results and also watch this segment of our investor day presentation available on our website for additional detail. The piece of the puzzle we had to solve is what went right in the first 190 patients and why that result wasn't continued through the remaining 256 patients. Fortunately, after an extensive root cause analysis, we learned that the potency of the investigational product faded as it aged from time of manufacture and that our proprietary biochemical and biological tests can detect this reduction in potency. Possibly the best news is that, from what we have learned, this is fixable. The scientific and financial benefits from this root cause analysis are potentially enormous, and I believe the findings from our Phase IIb trial have increased our probability of technical and regulatory success as we commence our phase three KOA clinical study program later this year. The cash we are generating from our growing commercial business is going back into advancing this important program, and I'm excited about the potential these investments have to transform the treatment of KOA by providing rheumatologists and orthopedic surgeons a safe, effective, and novel placental biologic modality. I will now turn the call over to Pete who will take you through our fourth quarter and full financial results.

Pete? Thank you, Tim, and good afternoon, everyone. As Tim mentioned earlier, we had a great quarter and peeling the onion a strong year. This is the second full quarter following the end of FDA enforcement discretion in which the company is no longer able to market Section 351 products in the United States. As we have previously disclosed, These products represented approximately 13% of total sales in 2020, and the team is working hard to grow back into our pre-enforcement discretion revenue levels. We reported net sales for the fourth quarter of 2021 of $67.4 million, a $1.1 million decrease compared to the three months ended December 31, 2020, in which we recognized revenue of $68.5 million. Fourth quarter 2021 net sales included revenue recognized on the remaining contracts of $100,000 compared to $500,000 for the same period one year ago. As a reminder, these are the remaining contracts relating to the historical pattern of revenue recognition. Adjusted net sales, which excludes the cash collected on the remaining contracts, were $67.3 million for the three months ended December 31st, 2021, compared to $68 million for the fourth quarter of 2020, declining 1%, a strong result given the headwind from our inability to sell or market the Section 351 products in the U.S. Sales of our tissue and cord products were $66.9 million in the fourth quarter, compared to $59.3 million in the prior year, growing a double-digit 13%. Net sales for the full year 2021 were $258.6 million compared to $248.2 million, an increase of 4.2% versus the full year 2020. Adjusted net sales grew 7.1% to $257.6 million in 2021 versus $240.5 million in 2020. For the full year 2021, tissue and cord products grew 15% to $240 million versus $208.6 million in 2020 a year impacted by restrictions implemented at the onset of the COVID-19 pandemic. Results in 2021 reflect the initial progress of our commercial efforts to focus strategically on areas of surgical recovery, growth in our EpiFix sheet portfolio, and a positive impact in sales of our EpiCord expandable product launched in September 2020. Overall, our strategic initiatives are taking shape, and as Tim mentioned earlier, expansion into Japan and the launch of two new products in the U.S. this year should further help drive growth above the industry average. Gross margin for the three months ended December 31st, 2021 was 84.0% compared to 84.2% for the fourth quarter of 2020. For the full year, gross margin was 83.3% in 2021 compared to 84.2% for 2020. I will remind you that we recorded reserves related to products impacted by the end of enforcement discretion in 2021, which have a 0.4% impact on 2021 gross margin. As I have said, we expect gross margin to decline slightly in 2022 from our recent levels. Selling general and administrative expenses, or SG&A, for the fourth quarter 2021 were $53.1 million, compared to $48.7 million for the fourth quarter 2020. The increase in SG&A expenses during the period was driven by higher professional fees as well as increases in travel expenses over the prior year period when the company continued to have restrictions in place due to the pandemic. For the full year ended December 31st, 2021, SG&A expenses were $198.4 million compared to $181 million in 2020. The full year 2021 increase reflects restoration of full salary levels and merit increases, which were restricted for a portion of 2020 as part of our response to COVID-19 pandemic, along with increased commissions from higher sales volumes as access to hospitals and other healthcare facilities increased. The company also incurred $3.9 million of expenses associated with the proxy contest during the second quarter of 2021. Research and development expenses were $4.6 million for the fourth quarter of 2021 compared to $3.4 million for the same period in 2020. The increase reflects higher personnel costs driven by growth in headcount to support clinical research efforts. These expenses were $17.3 million for the full year at the bottom end of the range we previously provided, though we do expect these costs to increase in 2022. Investigation, restatement, and related results were a benefit of $4.5 million for the three months ended December 31st, 2021, compared to an expense of $20.4 million for the three months ended December 31, 2020. For the full year, these results were an expense of $3.8 million, reflecting expenses incurred toward the advancement of legal fees of certain former officers and directors of the company, offset by recoveries from our directors' and officers' insurance programs. While we expect to continue to incur some litigation costs moving forward, we anticipate continued low levels of investigation, restatement, and related expenses. Turning to the bottom line, net income was $2.2 million for the fourth quarter of 2021 compared to a net loss of $16.6 million in the same period a year ago. For the full year 2021, net loss was $10.3 million compared to a net loss of $49.3 million in 2020 when investigation, restatement and related expenses were $59.5 million. Adjusted EBITDA was $3.5 million or 5.2% of adjusted net sales in the fourth quarter of 2021 compared to $10.3 million or 15.2% of adjusted net sales in the same period a year ago. For full year 2021, adjusted EBITDA was $17.9 million or 6.9% of adjusted net sales compared to $30.6 million or 12.7% in 2020. As of December 31st, the company had $87.1 million of cash and cash equivalents compared to $95.8 million as of December 31st, 2020. In summary, despite the loss of Section 351 product sales in the back half of 2021, as well as some of the COVID challenges facing the industry, our tissue and cord business has returned to growth based upon multiple initiatives designed to reinforce the differentiation of our products and convey the clinical and economic value of our brands. We aim to be free cash flow break even in the next 12 months and expect overall revenue to return to pre-enforcement discretion levels during that period as well. With respect to annual revenue growth in 2022, we provided our outlook at the J.P. Morgan Conference last month, which highlighted 11% to 14% growth in our advanced wound care products and reflects our mid-year expectation of launching EpiFix in Japan and the launch of Amnio Effect and our Placental Collagen Matrix product this year. Let me remind you that the 11 to 14% growth percentage is based on the Advanced Wound Care Section 361 Tissue and Cord Products Only, which totaled $240 million in 2021. We also provided quarterly breakouts of revenue for modeling purposes to help clarify for our investors both the cadence of our business, typically impacted by seasonality in the first quarter, with the reset of patient deductibles, as well as the timing of our planned product launches that we anticipate contributing in the back half of this year. For 2022, we expect mid single digit growth in the first quarter, building to a high teens or 20% growth in the fourth quarter. Slide 16 in our JP Morgan presentation includes the specific ranges we provided, For further reference, this is available on our website. From a gross margin standpoint, we believe gross margins in 2022 will be slightly lower due to competitive dynamics, product mix focused on surgical recovery, and the launch in Japan. As I mentioned, we expect R&D spend to increase over 2021 with the initiation of our Phase III KOA clinical trial program, estimated at approximately $30 million for two trials, representing $15 million per trial incurred over a period of three years. 2022 R&D spend additionally includes the new product development initiatives Tim referenced in his remarks. Importantly, I want to reemphasize that we expect to be free cash flow neutral in 2022, including the investments we are making to initiate our phase three knee OA program. Lomedics has made extraordinary progress over the last two years, restoring the company's financial credibility, reputation, and overall foundation. I would like to take a moment to acknowledge the progress the team made to strengthen our internal control environment. Remediation of the remaining material weaknesses was a defined priority for us in 2021. I am proud of the team involved in these efforts and I'm pleased to share on their behalf that management, in partnership with our internal and external auditors, has evaluated these controls and has determined them to be effective as of December 31, 2021. Finally, as disclosed in the 10-K, we amended our loan agreement to add a financial covenant based on minimum levels of net sales, replacing the adjusted EBITDA leverage covenant. The amendment also includes an increase in the minimum liquidity covenant to $20 million. This is a strong net positive for the company that provides continued financial flexibility to invest in our commercial business and our pipeline. I will now turn the call back to Tim.

Thanks, Pete. In closing, I'd like to thank our memetics team for their exemplary contributions. Over the past three years, we've been rebuilding and securing the foundation of memetics. Three years of innovating, expanding, and advancing have redefined who we are and what we hope to do to transform medicine. We have made significant and necessary improvements to our infrastructure, processes, and systems to support our robust growth strategy and invested heavily in our commercial organization as well as other essential sales enabling support functions. Memetics is a unique business with a unique business model that begins with a unique miraculous organ, the placenta. Our placental biologics have the potential to transform medicine in patients' lives today and tomorrow. We are well positioned to advance the understanding and clinical application of placental science across advanced wound care, surgical recovery, including most surgery, musculoskeletal diseases, and sports medicine. From donation to innovation to commercialization, We aim to be unmatched and unrivaled. As always, I thank you for joining our Q4 earnings call. Your interest and support are appreciated. Operator, you may now open the lines for questions.

Thank you. Ladies and gentlemen, we will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. For participants who are not MiMedx covering research analysts, please limit to one question and one follow-up, and then please return to the queue. One moment, please, while we poll for questions. Our first question comes from Carl Burns with Northland Capital Markets. Please proceed.

Great. Thank you. Thanks for the question, and congratulations on the progress. I'm just wanting to know if you can drill down a little bit in terms of the increase in R&D given the anticipation of new product development, you know, two per year, and then also the timing of the inception of the pivotal phase three trials for NEOA.

Thanks.

Carl, good to talk to you. We will see an increase in those expenses. They've been artificially low in the past couple of years. We did think they'd be higher this year, but the way the trial schedule played out, it wasn't the increase we thought. We haven't given specific numbers, but it's certainly going to increase As we go through 2022, how much is a little dependent on the timing of some of the aspects. But, you know, this is an important investment in our business, and we're focused on making sure the team has the right resources to do the work they need to do.

This is Bob Steinkopf. We do plan to initiate our Phase 3 DOA program in the second half of the year, and we anticipate being on time in the... BLA filing in the late part of 2025. Got it.

Great. That's helpful. I'm going to cheat a little bit and just squeeze one more question. It looks like in terms of the advanced wound care products on an adjusted basis, you were up 15% year over year for the full year, up 13% for the quarter year over year, and up 7% sequentially. With respect to the sequential increased 7%. Was there any seasonality or any uniqueness in terms of, I wouldn't say buy-in, but anything that would have translated there? Thanks.

Hey, Rohit, I think that would be a great question for you to respond to.

Carl, while Rohit's getting his phone ready, it's Pete. There is seasonality, and even between the third and the fourth quarter, similar to people waiting until their co-pays are paid up in the first part of the year, we do think there's a little bit of activity at the end of the year. So in the fourth quarter, people electing procedures when they decide But while their co-pays are all used up, so, you know.

I can answer that for the phone issues. But, Carl, that's a great question. Like as Pete mentioned, we do see some seasonality from Q3 to Q4. And it's related to, like Pete said, as people have met their deductibles for the year, there's a run towards getting some of the things that they might have ignored done. We also saw that coming out of Q3 into Q4, Q3 was, at the beginning of Q3 was impacted definitely by the Delta variant of the virus. And then we saw that we had more robust access in Q4. So those were the contributing factors. And also we continue to build momentum in our execution as we, as more and more of our team, we had a big bolus of hiring done in the first half of the year. We also trained our salespeople in the first half of the year. So it takes a good six months for them to become more and more productive. And we also started picking up that pace towards the end of the year. So all of those are contributing factors to what I would think is a pretty good, robust set of results in Q4. Great.

Thank you. That's very helpful.

Our next question comes from with HC Rainright. Please proceed.

Thank you. This is from HC Rainright. Good afternoon. So just trying to understand the guidance so that you would have, you would expect 11 to 14% growth over the net sales of $240 million. So what's the push and pull on this number? And how should we think? I mean, you already gave us the guidance between quarters or through the year. But I'm just trying to understand the range.

Hey, RK, this is Tim. I'm going to let Rohit address that question.

Yes, good question again. In terms of the overall guidance, 11% to 14% and the flow throughout the year in the quarters, I think the beginning of the year is impacted by these insurance resets. So typically we get out of the gate a little bit slower in Q1 with that impact as we had already answered in the prior question. As we think about what are the drivers for growth in our business, we've talked a lot about innovation and the expansion into Japan. Both of those things start impacting the business in Q3 and Q4. And as a result, the growth rates that we expect in the second half of the year are significantly higher. And overall, the combined effect of that is the 11% to 14% of growth. Okay.

Thank you. Tim, I apologize if you already discussed this during the commentary because I got late onto this call. Talking about Japan, is there anything that you can add in terms of certainty of when you would have a decision from them? And then I'm just going to throw in a quick question to Bob. On the NEOA, I heard that you're planning to start this program for sure in the second half. What is required of your team to get done so that you can get this BLA, I'm sorry, not BLA, the study and get enrollment started in the second half?

Yeah. RK, this is Tim. Reimbursement approval in Japan is certainly going to be predicated on the ability of the government to process our application. We don't really have any additional information. We still feel that mid-year approval around reimbursement is certainly feasible, but we also have to consider that COVID may impact the government's ability to process our application. So If we get any updates on that, obviously, we'll get that out.

Bob, do you want to address RK's question around the clinic? Yes. Hi, RK. It's Bob Stein. Before we initiate the Phase 3, we'll need to meet with the FDA, go over our Phase 2B trial results, and also we want to share with them our protocol design for the Phase 3 so that we get their buy-in to what we plan to do. And we'll continue to work on addressing the issue that led to the fading of potency over time with the investigational product. And we believe we have that all under control.

Perfect. Thank you very much, gentlemen. Thanks for taking all my questions.

Take care. Thank you. Take care, RK.

Ladies and gentlemen, as a reminder, if you would like to ask a question, it's star 1 on your telephone keypad. Our next question comes from John Vandermoson with XSCR. Please proceed.

Hey, good evening, everyone. First question is on the recent study you guys put out on lower extremity diabetic ulcer and the demonstration of cost effectiveness there. Are there any other indications that merit this kind of study? Because it certainly seems to make a strong argument for, you know, in addition to the dependencies of the patient, there's also an economic argument to make Any other work that you or others might do there in other indications to help make the case to physicians?

This is Tim. I think this whole area of wounds that do not heal, these chronic wounds, so this happened to focus on VFUs. The other area could be venous leg ulcers. And I think this is what the Agency for Healthcare and Research, some of their commentary around there's a lack of strong clinical work in this area as well as health economic work. So I think the whole field of wound care would benefit from the approach that we have taken to combine the looking at the clinical efficacy and safety as well as health economic outcomes. I think that's where all this is headed and we're committed to generating data, not only efficacy data, but this economic type of data

Okay. Yeah, thank you, Tim. And another question on your targets for growth this year. You know, there's a couple components to it. There's, I guess, the base same-store sales or same-product sales component of it, and then there's the, you know, regional expansion and then new products on top of that. How would you break down that 11% to 14% into those categories? And obviously, you know, some of that second half waited. I'm not exactly sure where you are with sales right now for the two new products you announced, if that's going to start in 2Q. But how would you break that down as we look at that 11% to 14% number?

You want to break that down? Okay. Yeah, John, it's Pete. Good afternoon. What we've talked about is over the course of several years, those pieces are seven to eight percent growth in the existing products two to three percent from these two new products we're introducing this year and then two to three percent from the international expansion that's how you get to the 11 to 14 percent as rohit said you know a lot of the growth or the impact of both the new products in japan is in the back half of the year um so those that That ratio we have is not necessarily this year's ratio. You would certainly get to the lower end of those ranges for both Japan and the new products. And on the upper end, if not above the range on the existing products just for this year, given their second half, the mid-year to second half impact of the revenues.

Okay. I mean, it almost seems like maybe that mid-single-digit number you give in the first quarter will kind of continue through as the same-store sales, and then the other additions will kind of add on to that, perhaps, as you get to the 20% target for the Q. Not exactly.

Because of that seasonality, there is an odd growth you wouldn't think would be seasonal. There is just more opportunity to grow even the existing business as the year progresses. It's not as distinct in the first half, second half as things like those new products, but I would think it would be more high single digits across the year.

Very good. And last one for me is on just the COVID restrictions. It seems like in recent days even that a lot of the restrictions have kind of fallen off and I was wondering if there was any observations that you've made so far in sales and marketing activities as a result of that change.

Certainly, the restrictions are lowering. I'm going to let Rohit give you his perspective since he's interacting with our folks on the ground every day.

Thanks, Tim. That's a great question. When we keep a close eye on this, I think as we began this quarter in January, obviously these restrictions are pretty high, probably the peak of restrictions we have seen during the course of the last at least 12 months. As As things have developed and you hear it in the news every day, those restrictions have come down, improving the access for both patients and for our sales teams to be in front of customers. We still see pockets where these restrictions are high. For example, in VA hospitals and things like that, and in pockets and specific zip codes, but we adapt to them. One of the great things is that we have adapted through the last two years of having to live through it And our business model, which serves a continuum of care across the three care settings of a hospital, a wound care clinic, as well as the private office, allows us to approach patients in balance where we might see them during those different phases of access issues and so on. So we have adapted our business model and are flexible in being able to address the needs of the market accordingly. Okay. Yeah. Thank you, Arit. That's good.

That's all for me.

Thank you.

Ladies and gentlemen, we have reached the end of the question and answer session. I'd like to turn the call back to Tim Wright for any closing comments.

Well, I certainly do appreciate everyone joining. Your continued interest is important. I think we're off to an exciting 2022 and look forward to continuing dialogue with our investor base. Thank you.

Thank you. This concludes today's conference. You may now disconnect your lines.