Earnings Call Transcript - MDXG Q2 2023

Operator, Operator

Good afternoon and thank you for standing by. Welcome to the MiMedx Second Quarter 2023 Operating and Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to Mr. Matt Notarianni, Head of Investor Relations for MiMedx. Matt, please go ahead.

Matt Notarianni, Head of Investor Relations

Thank you, operator and good afternoon everyone. Welcome to the MiMedx second quarter 2023 operating and financial results conference call. With me on today's call are Chief Executive Officer, Joe Capper; and Chief Financial Officer, Doug Rice. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from our Investor Relations website at mimedx.com. Joe will kick us off with some opening remarks and Doug will provide a summary of our operating highlights and financial results for the quarter, and then Joe will conclude with some additional updates, including the discussion of our financial goals. We will then be available for your questions. Before we begin, I would like to remind you that our comments today will include forward-looking statements, including statements regarding future sales growth, future margin and expenses, expected market sizes for our products, and potential timelines for clinical trials and FDA submissions and reviews. These expectations are subject to risks and uncertainties, and actual results may differ materially from those anticipated due to many factors. Actual results, market sizes, timing, and FDA review will depend on a number of factors, including competition, access to customers, the reimbursement environment, unforeseen circumstances and delays, and other factors. Additional factors that could impact outcomes and our results include those described in the 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 measures in our press release, which is available on our website at www.mimedx.com. With that, I'm now pleased to turn the call over to Joe Capper. Joe?

Joe Capper, CEO

Thanks Matt. Good afternoon everyone. Thank you all for joining us on today's call. It is my pleasure to report on another outstanding quarter of solid financial performance and operational excellence. In short, our momentum is strong and we expect it to continue. As you will hear today, Q2 exceeded even our lofty expectations for the business. I am particularly proud of the team's tremendous progress on delivering adjusted EBITDA approaching levels this company has not seen for several years due to the numerous enhancements we have set in motion. Our recent decision to increase focus on our Wound & Surgical businesses was driven by the substantial opportunity in those markets and our highly competitive offerings in the space. Our distinct advantages stem from our gold standard technology and industry-leading sales and operations infrastructure. That powerful combination gives us a strong foundation from which to build, enabling us to outpace market growth for what we believe will be years to come. We anticipate that the company is at the front end of a multiyear growth base with the needs to capitalize on the numerous opportunities before us. The focused go-to-market strategy and disciplined execution that drove our strong first half performance is certainly repeatable. Before we provide you with more detail on how we envision our long-term growth plan unfolding, let me first touch on some of the more noteworthy accomplishments from the second quarter. Q2 year-over-year net sales grew by approximately 21.5% to $81.3 million, the highest quarterly net sales performance we have delivered in nearly four years. Gross profit margin improved to 83.3%, another nice step-up sequentially. Adjusted EBITDA was $14.1 million, up from an adjusted EBITDA loss of almost $1 million a year ago, representing a $15 million improvement. We ended the quarter with $68.7 million in cash, up $7.5 million from the end of Q1. We announced the suspension of our Knee Osteoarthritis development project, an important strategic pivot, which hones our focus in the wound and surgical markets. And we are pleased to welcome Doug Rice to the team as our new Chief Financial Officer. Doug is a highly accomplished and seasoned healthcare executive whose considerable experience makes him ideally suited for our next stage of growth. In fact, we are already seeing the value of his contributions in the brief time he's been on board. This second consecutive quarter of exceptional performance was driven by an incredibly high level of execution across the entire company. Moreover, any business that is going to win in the market has to have a solid financial foundation, great products, attractive opportunities and a team that can execute. I am confident we have that at MiMedx. While our Q2 financial performance exceeded our expectations from top to bottom, our adjusted EBITDA margin, again, rates additional attention. As anticipated, the business is starting to generate fairly dramatic margin improvement with scale. The Q2 adjusted EBITDA of $14.1 million represents a 17% return on net sales. However, if we pro forma out the Q2 spend on the knee OA trial, things start to look significantly better as our adjusted EBITDA margin would have been in excess of 20%. As you can see, we are starting to unlock the leverage in the business, which, as I mentioned last quarter, will increase free cash flow generation, improve our balance sheet, lead to growth funding optionality, and accelerate value creation. As is my practice, I will provide a quick update on the company's progress on the three key elements of our strategic focus. As a reminder, these are the areas in which we are concentrating our time and resources in order to drive growth and ensure long-term success. Our top priority is to build on our leadership position in the Wound & Surgical markets by enhancing our product portfolio and expanding geographically. To that end, the second quarter represented another period of commercial excellence, during which we once again experienced growth in all sites of service. The two products we launched in September of last year continued to gain wide market acceptance in various surgical settings, helping to grow our Q2 sales in the hospitals by 17%. As we work to refine our approach in surgical markets, we are making significant investments in clinical research and our medical affairs efforts. We believe our success in the surgical sector will be greatly enhanced with a growing body of real-world evidence supporting a wide range of surgical applications. In the private office sector, we recorded another strong quarterly performance, growing at 25% year-over-year. The positive trend we saw here in Q1 continued into the second quarter, which is likely being driven in part by the OIG's guidance for companies to register the products on the CMS price list and adhere to the ASP reimbursement methodology. We anticipate this transition could continue to provide us with revenue growth support into the second half of the year. We also hope to be in a position to launch another new product later this year, likely in Q4 and into the private office setting. As you may have seen, CMS proposed physician fee schedule for calendar year 2024 was published a few weeks ago. The proposal indicates that CMS has decided not to make any major modifications to how skin substitutes are currently reimbursed but continues to drive enforcement of the current policy per the OIG's guidance. If this position holds through the comment period, we would not expect to see any potentially disruptive policy changes, at least throughout 2024, which would be a net positive for us in the near term. We will continue to provide input and work with various stakeholders as CMS strives to develop a reimbursement model that ensures patient access to these critical products and safeguards against abuse leading to overpayment. Finally, we were encouraged by the strides we are making in Japan as we work through the early market development phase. During the quarter, we continued to see an increased level of interest in and utilization of this first-of-a-kind product in the Japanese market. As such, we expect adoption to ramp in the coming months and quarters. Our next priority is to develop opportunities in adjacent markets to create additional growth drivers for the company. With our strategic focus now firmly concentrated on the wound and surgical business, one of the more obvious opportunities is to expand our skin substitute offering beyond amniotic tissue. According to market data, amniotic allografts account for less than 43% of the skin substitute market with xenografts and synthetics making up the balance. An expansion of our skin substitute offering beyond amniotic tissue immediately more than doubles our total addressable market while leveraging our entire commercial infrastructure. As such, we have concerted efforts, both internally and externally toward the expansion of our product portfolio. Additionally, we continue to look for ways to leverage our technology and commercial strength to develop opportunities adjacent to the skin substitute market. Our final objective is to build a corporate discipline around expense management, rationalization, and continuous process improvement. As the Q2 results indicate, this approach continues to take hold within the organization. Our efforts to enhance efficiencies, production yields, and operations resulted in another sequential improvement in gross margin, and we continue to get leverage from our overall operating expenses. As a reminder, we've highlighted two efficiency goals, which we have been striving to achieve by year-end. One is to get a wound and surgical contribution margin above 30% of sales and the second is to get corporate G&A below 20% of sales. For Q2, we more than achieved both of these targets well ahead of schedule. I anticipate that we will continue to execute on our plan, resulting in further margin improvement and an enhanced ability to scale over time. It seems the team certainly turned in another great performance in Q2, executing against this three-point strategy and building on the momentum established as we enter the year. Our plan is to continue to identify and execute against the most relevant growth drivers for our business. If you stick to this formula, I have no doubt we will build on this franchise, have the opportunity to create tremendous value and move MiMedx into the ranks of healthcare's most admired companies. I'd also like to mention that shortly after the end of the quarter, the 11th Circuit Court of Appeals ruled in our favor by affirming the dismissal of the punitive securities class action lawsuit brought against the company and others in 2019. The case was on appeal with the United States District Court of the Northern District of Georgia. We were obviously glad to receive this positive news, as it should put to rest one of the largest remaining potential claims against the company stemming from past challenges. Now let me turn the call over to Doug for more detail on our financial results on what is inaugural call as the Chief Financial Officer for MiMedx. Doug?

Doug Rice, CFO

Thank you, Joe. Good afternoon, everyone, and thanks for joining us today. I'm very pleased to be a part of the MiMedx team at this exciting time in the company's history. I've spent much of my career in med tech, and I have seen numerous growth stories unfold. I believe MiMedx has the essential key characteristics for growth and value creation. I look forward to meeting and working with those of you in the investment community with whom I have not met before in my prior roles. Moving on now to our second quarter, as many of the financial measures covered in today's call are on a non-GAAP basis, please refer to today's earnings release for further information regarding our non-GAAP reconciliations and disclosures. First, as Joe mentioned, our second quarter 2023 net sales were over $81 million, up 21.5% year-over-year. Joe outlined many of the growth drivers in his remarks, but I would reiterate that the strong performance was balanced across our sites of service and also continued to benefit from contributions of our newer products, which are still in their first year of launch. Moving to gross profit and gross margins. Our second quarter gross profit was $67.7 million compared to $55.1 million last year. And our gross margin was 83.3% compared to 82.3% last year, up 100 basis points. Our gross margin improvement was driven in part by favorable product mix as well as the ongoing accomplishments that our quality, operations, and regulatory team has made this year to help improve our production yields and efficiencies. We continue to work on driving our gross margin percentage back into the mid-80s over the long term. GAAP selling, general and administrative expenses, or SG&A, were $51.9 million compared to $55.8 million in the prior year period. The decrease in SG&A spend was driven primarily by the cost savings activities the company actioned late last year as well as other expense management items, partially offset by higher commissions due to higher sales volumes. Our GAAP R&D expenses were $8.5 million compared to $5.5 million in the prior year period. The increase over the prior year period was driven primarily by increased EOA clinical trial program spending as well as the dissolution of this segment and the costs associated with that decision. Investigation, restatement, and related expenses were $1 million compared to $3.2 million in the prior year period and a step down sequentially, which was expected based upon the conclusion of some of the company's outstanding legal matters. As part of the decision to focus the business on Wound & Surgical, which we announced in late June, we also recognized a restructuring expense totaling $3.3 million in the second quarter, which reflects certain write-offs and other wind-down expenses. GAAP net income was $1.2 million compared to a net loss of $10.9 million in the prior year period. Adjusted EBITDA was $14.1 million or 17.4% of net sales compared to an adjusted EBITDA loss of $1 million or 1% of net sales in the prior year period. On a segment basis, net sales in Wound & Surgical totaled $80.5 million compared to $66.1 million last year, reflecting growth of 21.7%. The Wound & Surgical segment contribution of $27.6 million represented 34.3% of Wound & Surgical net sales compared to a segment contribution of $14.2 million or 21.5% of Wound & Surgical net sales during the second quarter last year. You will recall one of our goals over the last several quarters has been for Wound & Surgical to achieve contribution margin in excess of 30%, and we are pleased to report this achievement this quarter. Turning to Regenerative Medicine, operating expenses totaled $10.1 million compared to $3.1 million last year. This increase was driven primarily by costs associated with our strategic realignment as well as expenses that have been incurred prior to that announcement for the Knee OA clinical trial program. Finally, our SG&A expenses in Corporate and Other totaled $13.4 million, representing 16.5% of our total net sales compared to $17.1 million last year or 25.6% of total net sales in the prior year period. As you will recall, getting these corporate and other SG&A expenses below 20% of net sales has been a focus of the company, so we're pleased to be reporting this achievement as well this quarter. At the end of Q2, the company had $68 million of cash and cash equivalents, reflecting a sequential step-up of approximately $7 million. As was noted on the first quarter conference call, our first quarter is a heavy cash use quarter and we expect to build our cash balance throughout the course of 2023, which we expect will afford us numerous opportunities for growth financing, should investment opportunities present themselves to us. I will now turn the call back to Joe.

Joe Capper, CEO

Thanks, Doug. As you have just heard, our strong second quarter 2023 results give us much for which to be proud. To recap, we recorded quarterly revenue of $81.3 million, up 21.5% year-over-year, gross profit margin of 83.3%, adjusted EBITDA of $14.1 million, increased our cash balance, continued rollout of our new products in the US, made additional progress developing our business in Japan and continued to realize margin improvement by driving expense rationalization throughout the organization. By any measure, the first half of 2023 was a tremendous success. Let me provide some commentary on how we now see the full year taking shape. As you may recall, at the end of Q1, we reiterated full year 2023 guidance for revenue percentage growth to be in the low double-digits. When we spoke to you about six weeks ago, we raised this guidance to the mid-teens, given the growth we were experiencing at the time. Now with another excellent quarter in the books, we are again raising our full year guidance for revenue to the mid- to high teens. So, why not just high-teens or even 20%, like we saw for the first half. While I'm certainly not ruling it out, here are some contexts. First, during the second half of 2022, we launched two new products. And the business performed much better than it had during the first half of 2022, providing for stronger comparisons for this year's second semester. Also, both Doug and I are new to the business. Having successfully run companies in the past, we know the benefits gained by living through a full business cycle. Naturally, with time, we will develop a solid feel for the ebbs, flows, seasonality, etc., of this particular category. We do anticipate second half sales cadence to be heavily weighted to the fourth quarter, consistent with healthcare market behavior. In any case, this is certainly shaping up to be an excellent year of performance and progress. With the elimination of the expenses that were associated with the Knee OA development project, we now expect our adjusted EBITDA margin in the second half of the year to be above 20%, demonstrating excellent leverage as the business scales. And if all those expectations are met, we will have a cash balance by the close of 2023 of at least $90 million, barring any unusual events. A marked improvement in our cash forecast over just the last few periods. Those who have been following the company, since I joined in January have seen the steps we've taken to reposition the company with an increased focus on Wound & Surgical and to improve our financial profile. The first half results indicate these steps are having the desired effect. I have no doubt, we will continue to execute our plan, turn in an excellent second half and set the business up for sustained growth for the foreseeable future. In closing, I would like to thank the entire MiMedx team for the excellent Q2 results, and for their continued dedication to our company, and the many healthcare providers and patients we serve. There is definitely an excitement around the company that our best days are ahead. With that, I would like to open the call to questions. Operator, we are ready for our first question. Please proceed.

Operator, Operator

Thank you. Our first question is coming from Anthony Petrone from Mizuho Group. Your line is now live.

Anthony Petrone, Analyst

Thank and congratulations here to the team and congratulations, Doug, to the new role here with MiMedx. We go to work with you again. Maybe…

Doug Rice, CFO

Thanks, Anthony.

Anthony Petrone, Analyst

Absolutely. Maybe Joe and Doug, we could start off with top line and kind of toggle through the two segments and the two end channels. And I guess what we're looking for is just where is the underlying growth profile for the surgical end-markets in which you compete today? And where is the underlying growth profile for Wound Care? And when we think of the delta here with MiMedx growing over 20%, what amount of the spread versus market is from share gains? And is there any price levers in there that we should be observing of? And I'll have a couple of follow-ups.

Doug Rice, CFO

There's certainly no price advantage; it's all about volume. We believe procedure volumes are continuing to rise and are higher than they were last year. This suggests a tailwind in the market that we, like others, are experiencing. We also think we're benefiting from improved execution within our organization, particularly in our sales and operations divisions, which have seen significant enhancements over the last few years. New leadership has introduced new behaviors from which we believe we have gained. In the surgical setting, we launched two new products in September last year, so we won't be able to fully evaluate their impact for a few more months, but we are noticing good acceptance of these products in various applications. Surgical recovery is not a well-defined market, offering many opportunities for product use, and our sales team is becoming more effective in this channel. In the private office setting, we may be benefiting from a shift in the market away from pricing, influenced by pressure from the OIG. Regarding how we differentiate between market growth and market share gain, it’s challenging to pinpoint this within a quarter, as most market data we receive is somewhat outdated. However, there is a clear indication that both growth and market share gains are occurring. We are likely experiencing high single-digit growth in the market while also expanding our share, which ties back to our overall execution across the organization. I hope that addresses your question.

Anthony Petrone, Analyst

No, that's helpful. And maybe the follow-ups here and I'll hop in the queue. First, Joe, you mentioned on the wound care side, some benefit from sort of CMS recommending that providers adhere or stay closely in line with the OIG recommendations? Do you have a sense of how many wound care products have dropped out of the market based on these recommendations to date and maybe looking into the second half, how many may drop out? And then lastly, just on adjusted EBITDA, clearly trending well ahead of expectations. Was a touch over 20% blended for the quarter, the guidance in the second half is for 2020? So maybe just any areas of reinvestment in the business. Is there a signal there that you're perhaps adding maybe a little bit more to the sales force, either on the wound care or surgical side? Again, congratulations on the good quarter.

Joe Capper, CEO

Thank you. So the second part of your question was really about reinvestments and are we hedging a little bit if I read your question on the adjusted EBITDA margin growth, probably because we would like to invest in different parts of the business, and we think there's a lot of opportunity to do so. Look, I think it's going to be very difficult for us not to be north of 20%, the way this business is growing and the kind of leverage we're starting to get from it. I think productivity is way up. We're seeing leverage in the sales expense, and I expect to continue to see that improve. As far as companies that are dropping off or dropping out of the market, hard to say. The only thing we can point to is there are certainly a lot more companies with products listed on the CMS price list this year than there were last year. That number has increased significantly. And so, that's likely driving some of the behavior that we're seeing in the market, but difficult to say, hey, who's going to survive and who's not going to survive. That we'll see over the long-term what happens. But I don't think the story is over here. It's been punted down the road a bit, but I think CMS will still do something to address some of these anomalies.

Anthony Petrone, Analyst

Thanks, again.

Operator, Operator

Thank you. Next question is coming from Carl Byrnes from Northland Capital Markets. Your line is now live.

Carl Byrnes, Analyst

Thank you and thank you for the question. Congratulations on the results. I was just wondering if you see a significant drop in investigation-related expenses. Do you expect that the third and fourth quarters will have similarly low levels? Also, regarding R&D on a normalized basis, where do you anticipate R&D expenses will be in the second half of the year?

Doug Rice, CFO

Good question, Carl. This is Doug. With regards to a drop in the investigation costs, we would expect those to taper off with some of the favorable resolutions that we've seen in the last few weeks. And so yes, you're spot on there, of course, we'll adjust for those, and those wouldn't be included in our adjusted EBITDA guidance. But from a cash perspective, we would definitely expect those to taper over time. Your next question was to split, remind me.

Carl Byrnes, Analyst

R&D normalization.

Doug Rice, CFO

In the quarter, our R&D normalized at 10% on a GAAP basis, excluding knee osteoarthritis costs. This figure includes a couple of million dollars in wind-down costs related to the Regen decision. As knee OA expenses decrease, we expect an additional reduction of around $4 million to $5 million based on our spending pattern from the first half of the year. I anticipate that R&D will likely decline to the low to mid-single digits.

Joe Capper, CEO

Yes. The remaining focus will be on our Wound & Surgical division. We have a solid product pipeline that we are continuing to fund, mostly involving product line extensions for our amniotic tissue product, which keeps our R&D costs low. We can manage our expenses effectively, but I may choose to increase spending in the future as new opportunities arise. While the total dollar amount may go up as the organization expands, the percentage of sales attributed to R&D is unlikely to increase significantly.

Carl Byrnes, Analyst

Got it. Thanks.

Operator, Operator

Thank you. Next question today is coming from RK from H.C. Wainwright. Your line is now live.

RK, Analyst

Thank you. Good afternoon and congratulations on a very good quarter. I have a couple of quick questions. Regarding the growth in in-office sales that you've experienced this quarter and expect to continue in the second half, how do you see this evolving into 2024 and beyond? Will that growth slow down, or do you plan to maintain it by introducing additional products for in-office sales, as mentioned on the call?

Joe Capper, CEO

Yes. RK, Joe. It's obviously early to be talking about 2024 and beyond. I would answer it by saying that we believe we have the fundamentals within the organization that are strengthening that would tell me that we have the ability to continue to grow the business somewhere in the double digits for the foreseeable future. And I can't give you a number. Some of that depends on what happens within the market. Some of it depends on our ability to continue to expand our product portfolio. We have a lot of plans to do so. But I do think that the foundation of the business, the pipes of the company are such that we are in pretty good shape to continue to grow this business for quite some time. There are no major limitations to scale that I can identify.

RK, Analyst

Very good. Regarding Japan, I understand you mentioned there is an increasing interest and adoption. Do you foresee a significant contribution from Japan in the second half of the year, or will we only have a preliminary idea of how the product might perform in 2024, with substantial contributions likely coming in 2024 and later?

Joe Capper, CEO

Yes, I think you have that right. In terms of a percentage of sales, Japan in the second half will likely still be not a meaningful contributor. I do think; however, we're making a lot of good progress. We have to keep in mind that this is a first of its kind product in the Japanese market, which means it requires a lot of market development. We have to train key opinion leaders. We have to train our partner. We have to work with those folks to get procurement requirements in place. We have to work with those folks that get reimbursement set in place. We've made a tremendous amount of progress in those areas. We've hosted numerous KOL advisory meetings. Most major KOLs in Japan have used the product and they're seeing its ability to heal some of the more complex wounds. So, the uptick is there. It's just going to take a while before they start to use it on more patients. They see more progress with those complex wounds and reimbursement starts to flow through at reasonable levels. All that is just the early stage of market development. So, we remain optimistic. I can't tell you when we're going to hit that magic tipping point where this thing is just going to start to grow at a much higher rate. We did have growth in the quarter. We felt good about that on a percentage basis, it looks wonderful because the basis is still relatively small. But we'll keep you posted. We're still pretty excited about it.

RK, Analyst

Very good. And for my last question, you mentioned the potential for acquiring a skin substitute to expand that market beyond what you currently offer with amniotic tissues. If you proceed with an acquisition, will that be factored into the $90 million cash estimate for the end of the year, or is that amount exclusive of any potential acquisitions?

Doug Rice, CFO

This is Doug. All our forward-looking statements are based solely on organic growth and the momentum we currently have. At this point, we cannot predict any inorganic growth from an investment perspective. However, I will say that we are excited about our free cash flow, positive EBITDA, and the momentum we have in generating cash. This provides us with the opportunity to take advantage of significant opportunities and opens up many doors for us.

RK, Analyst

Thank you. Thank you. Joe and Doug.

Joe Capper, CEO

Thank you.

Doug Rice, CFO

Thanks, RK.

Operator, Operator

Thank you. Our next question is coming from John Vandermosten from Zacks SCR. Your line is now live.