Feb 28, 2022
Operator
Ladies and gentlemen, thank you for standing by and welcome to MiMedx Fourth Quarter 2021 Operating and Financial Results Conference Call. [Operator Instructions] I would now like to hand the conference over to your speaker, Mr.
Jack Howarth, Senior Vice President of Investor Relations. Please go ahead, sir.
Jack Howarth
Thank you, operator and good afternoon everyone. Welcome to the MiMedx 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 Kashyap; 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 Drs. Kashyap 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.mimedx.com. With that, I am now pleased to turn the call over to Tim Wright.
Tim?
Tim Wright
Thank you, Jack. Good afternoon, everyone and thank you for joining us on the call today.
‘21 was a defining year for MiMedx. In ‘21, we advanced our understanding of our PURION process placental tissue, both scientifically and clinically.
We delivered above-market double-digit growth in our continuing tissue and core 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 biologics platform. The unmet clinical need across the markets we address today is significant.
10% of the U.S. population have diabetes, with calculated annual cost 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-based challenges with mobility, the risk of infection, the risk of amputation, decreased quality of life and a shortened lifespan, many of which are exacerbated to an 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 MiMedx is proprietary PURION-processed EPIFIX, it 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 0.0001. 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. MiMedx will continue to pursue evident-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 1 year ago.
Net sales of the same portfolio of products increased 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 most procedures, colorectal anastomoses, 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 the 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 2 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, MiMedx 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-2022, 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 and 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 510(k) 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 2 of these product innovations are planned to be introduced later this year, AMNIOEFFECT and our placental collagen matrix product.
AMNIOEFFECT 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 rotator cuff pair 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 deeper 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 the 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 MiMedx’ 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 am excited about our late-stage musculoskeletal pipeline.
We’re advancing in this area as well with our clinical operations team. We are confident in the therapeutic potential of micronized dHACM and are methodically focused on initiating our Phase 3 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 2b KOA study. This may provide an important look into the durability of patient response to micronized dHACM, and these studies will be considered as we advance our plans for Phase 3.
We intend to hold confirmatory meetings with the FDA to review our statistical analysis plan as well as finalize our study protocol as soon as possible. Our Phase 2b study results provide an important insight into the properties and behavior of our AmnioFix 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 for 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 test 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 2b trial have increased our probability of technical and regulatory success as we commence our Phase 3 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 of 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?
Pete Carlson
Thank you, Tim, and good afternoon, everyone. As Tim mentioned earlier, we had a great quarter in 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 3 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 1 year ago.
As a reminder, these are the remaining contracts relating to the historical pattern of revenue recognition. Adjusted net sales, which exclude the cash collected on the remaining contracts, were $67.3 million for the 3 months ended December 31, 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 3 months ended December 31, 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 had 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 31, 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 the 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 3 months ended December 31, 2021, compared to an expense of $20.4 million for the 3 months ended December 31, 2020. For the full year, these results were an expense of $3.8 million, reflecting expenses incurred towards the advancement of legal fees of certain former officers and directors of the company, offset by recoveries from our directors and officers’ insurance program.
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 31, the company had $87.1 million of cash and cash equivalents compared to $95.8 million as of December 31, 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 breakeven 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 JPMorgan conference last month, which highlighted 11% to 14% growth in our advanced wound care products and reflects our midyear expectation of launching EPIFIX in Japan and the launch of AMNIOEFFECT 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 JPMorgan 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 3 KOA clinical trial program estimated at approximately $30 million for two trials, representing $15 million per trial incurred over a period of 3 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 3 Knee OA program.
MiMedx has made extraordinary progress over the last 2 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 define 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.
Tim Wright
Thanks, Pete. In closing, I’d like to thank our MiMedx team for their exemplary contributions.
Over the past 3 years, we’ve been rebuilding and securing the foundation of MiMedx. 3 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. MiMedx 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.
Operator
Thank you. [Operator Instructions] Our first question comes from Carl Byrnes with Northland Capital Markets.
Please proceed.
Carl Byrnes
Hi. Thank you.
Thanks for the questions and congratulations on the progress. I am 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, two per year.
And then also the timing of the inception of the pivotal Phase 3 trials for knee OA?
Tim Wright
Pete, do you want to cover that?
Pete Carlson
Yes. Carl, good to talk to you.
We will see an increase in those expenses. They have been artificially low in the past couple of years.
We did think they would 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 this is an important investment in our business. And we are focused on making sure the team has the right resources to do the work they need to do.
Robert Stein
This is Bob Stein, Carl. We do plan to initiate our Phase 3 knee OA program in the second half of the year, and we anticipate being on time in the BLA filing in the late part of 2025.
Carl Byrnes
Got it. Great.
That’s helpful. I am 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.
Tim Wright
Rohit, I think that would be a great question for you to respond to.
Pete Carlson
Carl, while Rohit is getting his phone ready, it’s Pete. There is seasonality and even between the third quarter and the fourth quarter, there – similar to people waiting until their co-pays are paid up in the first part of the year, we do think there is a little bit of activity at the end of the year.
So, in the fourth quarter people electing procedures when they – but while their co-pays are all used up, so…
Rohit Kashyap
Pete, I can handle it.
Pete Carlson
Go ahead, Rohit.
Rohit Kashyap
Thanks for that. I had some 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 is 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, a 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 continued to build momentum in our execution as we – it’s 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.
Carl Byrnes
Thank you. Very helpful.
Operator
Our next question comes from Swayampakula Ramakanth with H.C. Wainwright.
Please proceed.
Swayampakula Ramakanth
Thank you. This is RK from H.C.
Wainwright. Good afternoon Tim, Pete and Bob.
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 am just trying to understand the range.
Tim Wright
RK, this is Tim. I am going to let Rohit address that.
Rohit Kashyap
Yes. RK, good question again.
In terms of the overall guidance of 11% to 14% and the flow throughout the year and 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 have 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, they have – 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.
Swayampakula Ramakanth
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 am just going to throw in a quick question to Bob. On the knee OA, I heard that you are planning to start this program for sure, but in the second half, what is required of your team to get done so that you can get this BLA?
And – I mean, sorry, not BLA, the study and get the enrollment started in the second half?
Tim Wright
Yes. RK, this is Tim.
The 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 midyear 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 will get that out. Bob, do you want to address RK’s question around clinic?
Robert Stein
Yes. Hi RK, it’s Bob Stein.
Before we initiate the Phase 3, we will need to meet with the FDA to 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 into what we plan to do.
And we will 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 well under control.
Swayampakula Ramakanth
Okay. Thank you very much gentlemen.
Thanks for taking all my questions.
Tim Wright
Take care. Thank you.
Operator
[Operator Instructions] Our next question comes from John Vandermosten with Zacks SCR. Please proceed.
John Vandermosten
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 – in addition to the benefits of the patient, there is also an economic argument to make, any other work that you or others might do there? And are there indications to help make the case to physicians?
Tim Wright
This is Tim. I think this whole area of wounds that do not heal, these chronic wounds.
So, this happened to focus on DFUs. 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 is a lack of clinical – 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 are committed to generating data, not only efficacy data, but this economic type of data.
John Vandermosten
Okay. Yes.
Thank you, Tim. And another question on your targets for growth this year.
There is a couple of components to it. There is, I guess the base same-store sales or same product sales component of it, and then there is the regional expansion and then new products on top of that.
How would you break down that 11% to 14% into those categories? And obviously, some of that is second half weighted.
I am 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%?
Tim Wright
Pete, you want to break that down?
Pete Carlson
Okay. Yes, John, it’s Pete.
Good afternoon. What we have talked about is over the course of several years, those pieces are 7% to 8% growth in the existing products, 2% to 3% from these two new products we are introducing this year and then 2% to 3% from the international expansion.
That’s how you get to the 11% to 14%. As Rohit said, a lot of the growth – or the impact of both the new products in Japan is in the back half of the year.
So, those – that ratio we have does not – 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 midyear to second half impact of the revenues.
John Vandermosten
Okay. I mean, it almost seems like maybe that mid-single digit number you gave 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 2Q?
Pete Carlson
Not exactly. Because of that seasonality, there is an odd – well, growth you wouldn’t think would be seasonal.
There is just more opportunity to grow even the existing business as the year progresses. It is not as distinct in the first half, second half as things like those new products.
But I would think that the mid – it would be more high-single digits across the year.
John Vandermosten
Okay. 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 is any observations that you have made so far in sales and marketing activities as a result of that change?
Tim Wright
Well, certainly, the restrictions are lowering. I am going to let Rohit give you his perspective since he is interacting with our folks on the ground every day.
Rohit Kashyap
Thanks, Tim. And 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 for the peak of restrictions we have seen during the course of the last at least 12 months. And 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 2 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, the 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.
John Vandermosten
Okay. Thank you, Rohit.
That’s good. That’s all for me.
Tim Wright
Thank you.
Operator
Ladies and gentlemen, there are – we have reached the end of the question-and-answer session. I would like to turn the call back to Tim Wright for any closing comments.
Tim Wright
Well, I certainly do appreciate everyone joining. Your continued interest is important.
I think we are off to an exciting 2022 and look forward to continuing dialogue with our investor base. Thank you.
Operator
Thank you. This concludes today’s conference.
You may now disconnect your lines.