Anika Therapeutics Inc (ANIK) 2020 Q4 法說會逐字稿

Good evening, ladies and gentlemen, and welcome to Anika's Fourth Quarter and Full Year 2020 Earnings Conference Call. (Operator Instructions) The conference is being recorded. (Operator Instructions)

I will now turn the call over to Mark Namaroff, Executive Director of Investor Relations and Corporate Communications. Please go ahead.

Thank you, Therese. Good evening, everyone. And thank you for joining us for Anika's fourth quarter and year-end conference call and webcast. Our Q4 and year-end earnings press release was issued after the close of the market today and is available on our Investor Relations website located at www.anika.com as well as the supplementary PowerPoint slides that will be used for the discussion today.

So with me on the call today is Dr. Cheryl Blanchard, President and Chief Executive Officer; and Mike Levitz, Executive Vice President, Chief Financial Officer and Treasurer. During today's call, Cheryl and Mike will review Anika's fourth quarter and year-end 2020 financial results with key business highlights as well as discuss our view of 2021, and then we'll have time for questions.

Please take a moment to open the slide presentation and refer to Slide #2. Before we begin, please understand that certain statements made during the call today constitute forward-looking statements as defined by the Securities Exchange Act of 1934. These statements are based on our current beliefs and expectations, including statements with respect to the impact of the COVID pandemic on Anika, and are subject to certain risks and uncertainties. The company's actual results could differ materially from any anticipated future results, performance or achievements. We make no obligation to update these statements should future financial data or events occur that differ from the forward-looking statements presented today. Please also see our SEC filings and our most recent Form 10-K and 10-Q for more information about risk factors that could affect our performance.

In addition, during the call, we may refer to a number of adjusted or non-GAAP financial measures, which are used in addition to results presented in accordance with GAAP or generally accepted accounting principles. We believe that non-GAAP measures provide an additional way of viewing aspects of our operation and performance. But when considered with GAAP financial measures, and the reconciliation of GAAP, they provided even more complete understanding of our business. A reconciliation of these adjusted non-GAAP financial results to the most comparable GAAP measurements are available at the end of the presentation slides and on our fourth quarter press release.

And now I'd like to turn the call over to our President and CEO, Dr. Cheryl Blanchard. Cheryl?

Thanks, Mark, and good evening, everyone. 2020 was a critical year in Anika's transformation from largely a single technology and customer company into a global joint preservation company that creates and delivers truly meaningful advancements in early intervention orthopedic care.

Starting with the late 2019 launch of our innovative hyaluronic acid, our HA-based regenerative solution, TACTOSET, which is a differentiated product designed to treat insufficiency fractures that is gaining real momentum; followed in early 2020 with the acquisitions of Arthrosurface and Parcus within days of one another; and the tremendous work integrating our business in 2020 through COVID, Anika is positioned to become a leader in high-opportunity spaces within orthopedics, including osteoarthritis pain management, regenerative solutions, soft tissue repair and bone-preserving joint technologies. We're still in the midst of this transformation and are very excited about our future plans for value creation for all of our stakeholders.

Let's dive into the quarter and 2020 highlights, please turn to Slide 3. We successfully navigated the year through COVID, ending with revenue in the quarter up 10% compared with 2019 driven by our Joint Preservation & Restoration business following the acquisitions of Arthrosurface Surface and Parcus Medical that closed in Q1 of 2020. We saw continued momentum in Joint Preservation & Restoration through our commercial efforts and delivered sequential growth as well, despite further COVID headwinds from the post-holiday COVID surge that attenuated elective procedures in late Q4. We see strong demand for our joint preservation products and believe we have a right to win as orthopedic surgeons view our minimally invasive and regenerative portfolios favorably, particularly in the ambulatory surgical center setting.

Our Joint Pain Management business had lower revenue for the quarter as a result of COVID dynamics impacting J&J Mitek's ordering patterns in the second half of 2020, as we've stated in our last couple of earnings calls, as well as the impact in the fourth quarter of the post-holiday COVID increase on in-office injection procedures. We see this business stabilizing into 2021.

On the bottom line, we delivered positive adjusted EBITDA and positive operating cash flow as we continue to invest in the businesses we acquired last year. We continue to make investments in integrating and implementing back-office systems and commercial operations and infrastructure to structure the business for efficient scaling over the coming years. We also see greater potential for growth of the sports medicine soft tissue repair and bone-preserving joint technologies businesses, and we plan to continue to invest in them throughout this year.

I'm pleased to say that we are debt-free as we were able to pay down the remaining $25 million outstanding under our line of credit and end the quarter with $98 million of cash and investments. Mike will take you through the details of the financials shortly.

It's clear that COVID had a significant impact to our business, like so many other orthopedic companies and businesses that serve elective procedures in general. The post-holiday surge in COVID cases during the latter half of the fourth quarter was especially challenging to our Joint Preservation & Restoration business as elective procedures were delayed. But there are signs that things are beginning to improve. Note that we are still seeing softness into the first quarter of 2021 due to COVID and the recent winter storms that most significantly impacted the southern states like Texas. In the fourth quarter, elective surgical procedures, in our estimates, were approaching pre-COVID levels. And we expect that we should see a return to pre-COVID procedure levels in the second half of the year, if the predictions with the vaccine rollout continue to hold true. We also estimate that clinic capacity for elective injection procedures was between 70% to 85%.

Now turn to Slide 4 for our full year review. We were able to accomplish so much during such a challenging year. Following the unexpected passing of Anika's former CEO, Joe Darling, in January of 2020, we successfully navigated the business through one of the worst pandemics in our collective history with minimal operational disruption. At the same time, we acquired and then integrated 2 new businesses and strengthened our management team while delivering 14% revenue growth for the year. I'd like to spend a few minutes reviewing how these accomplishments inform our new strategy.

The acquisitions of Arthrosurface and Parcus in Q1 of 2020 enabled Anika to enter the faster-growing spaces of joint preservation and restoration, including sports medicine and bone-preserving joint technologies, which, in combination with Anika's synergistic regenerative solutions, expanded our global market opportunity to over $8 billion. Our focus will now encompass 4 areas in the early orthopedic continuum of care: osteoarthritis pain management, regenerative solutions, soft tissue repair and bone-preserving joint technologies. We have made substantial progress with integrating the business into one Anika. The next phase of integration in 2021 will focus on systems integration and implementation that will facilitate scaling the business over the coming years.

As part of the acquisitions, we also integrated our global commercial channels, which include a large network of dedicated distributors focused on our targeted surgical call points. This hybrid commercial model, and the expansion of our market presence beyond our partnership with J&J Mitek, will allow Anika to achieve its growth goals.

We strengthened our senior management team and our Board of Directors with a combined 9 new additions, adding tremendous experience and leadership from some of the world's top orthopedic and med tech companies. For example, Mike has 18 years of financial leadership at med tech companies such as Hologic and most recently, Insulet, that have executed successful transformational growth stories. Our GC comes to us from medical device and drug delivery firms, including Insulet and Medtronic. Our 3 seasoned commercial leaders come to us with experience from leading orthopedic companies, including Biomet, Zimmer-Biomet and Smith & Nephew in sports medicine and extremities leadership roles, with a focus on delivering innovation and commercial excellence and building out successful sales and marketing teams. Anika's Head of R&D was the Co-Founder of and led Arthrosurface and has over 30 years of experience in orthopedic product development focused on sports medicine, extremities and developing truly innovative, minimally invasive solutions. Our 2 new Board members bring significant health care experience from Becton, Dickinson and Integra LifeSciences.

As you can see, in 2020, we've been focused on building out a top-notch team that has the right experience, knowledge and energy to execute our transformational growth strategy.

During the year, as we discussed during our Q3 call, we launched 7 new joint preservation products, mainly for the sports medicine and extremities markets, further expanding our portfolio in these spaces. These products include several new suture anchor solutions for rotator cuff repair, knotless syndesmosis repair solutions for the ankle, a device to treat arthritis at the CMC joint in the hand as well as ligament retention devices for ACL reconstruction. Our total arthroplasty system for the wrists, called WristMotion, received 510(k) clearance in Q4, and we are planning for an initial release of this product in the second half of 2021. Its unique design is intended to preserve as much natural wrist joint motion as possible and, ideally, has the potential to begin to shift surgeon treatments away from wrist fusion, thus expanding the wrist implant market.

Lastly, I'd like to stress that many companies of our size would have struggled to complete even a portion of this list. And at the same time, we delivered our products to our customers and their patients with a continued high level of quality they expect, allowing us to exit the year with strong financial footing for 2021.

Before I hand the call over to Mike to review the financial details, I'd like to walk you through our strategic direction and how we see the business performing over the coming years. Please turn to Slide 5. We set a course and are focused on achieving our stated goal from our 2019 Investor Day of doubling the revenue of the company by 2024 with double-digit adjusted EBITDA growth. How are we going to do this? Our market opportunity today is 8x larger than it was 1 year ago. We now have an $8 billion global market opportunity beyond the legacy Anika osteoarthritis pain management business, including regenerative solutions, soft tissue repair and bone-preserving joint technologies. These joint preservation solutions position us well in the faster-growing areas of sports medicine and extremities compared with the more traditional total joint replacement orthopedic markets.

We'll continue to leverage our strength with ORTHOVISC and MONOVISC, remaining as the #1 combined choice for osteoarthritis pain management in the U.S. with our marketing partner, J&J Mitek. Our worldwide commercial organization is now established to deliver our innovative, minimally invasive surgical solutions to clinicians so their patients can resume active living faster. And we'll continue to invest in developing meaningful products, including new products using our differentiated HA-based regenerative platform, further leveraging our commercial organization.

Please refer to Slide 6. We've already touched on the over $1 billion market opportunity in osteoarthritis pain management, continuing to sell our market-leading ORTHOVISC and MONOVISC HA injectables through J&J Mitek in the United States and through global distributors outside the United States. In addition, we remain excited about the new opportunities with our next-generation combination steroid plus viscosupplement injectable, CINGAL, and our HA-based regenerative solution for cartilage repair, HYALOFAST, both currently being sold outside the United States. We initiated enrollment in our pilot study for CINGAL toward U.S. FDA approval and resumed enrollment in our clinical trial for HYALOFAST U.S. approval. Enrollment in both of these studies is proceeding but has been slowed due to COVID. As we are currently projecting them, COVID has pushed these U.S. launch time lines past 2024.

That said, I would like to point out that even though we currently sell both CINGAL and HYALOFAST outside the United States in over 30 countries, incremental revenue following approval for CINGAL and HYALOFAST in the U.S. is not currently in our model or necessary to support achievement of our stated 2024 goals of doubling the revenue of the company. We will continue to provide updates on these clinical studies during our upcoming calls and during our Investor Day we're planning for late spring. We view both of these products has tremendous upside after 2024 as we believe we're just getting started in driving value creation over the long term.

In the more than $1 billion regenerative solutions market, our current product portfolio includes our single-stage HA-based cartilage repair solution, HYALOFAST, and our HA-based solution to treat insufficiency fractures, TACTOSET, which was released in late 2019. TACTOSET is showing real traction by offering advantages over currently available treatments and is highly competitive in the insufficiency fracture treatment space. Leveraging our HA technology to develop new products for rotator cuff and other soft tissue repair represents another example of how Anika plans to bring together its expertise in HA with new regenerative surgical products. The intersection and synergy of HA and our joint preservation products will be a key catalyst for growth for Anika over the coming years. The over $2 billion soft tissue repair market in sports medicine represents a fast-growing opportunity, as I previously mentioned. We have a growing portfolio of products for soft tissue fixation, including suture anchors and instrumentation for rotator cuff repair and kits to treat upper and lower extremities.

Lastly, the over $4 billion bone-preserving joint solutions space addresses areas of unmet need where the osteoarthritic disease process has further progressed and an implant is needed. These specialized implants treat progressive arthritis in multiple joints, including the shoulder, hand, wrist and elbow and the foot and ankle. This technology includes partial joint and joint resurfacing implants that are minimally invasive and bone-sparing and is intended to allow patients with further OA progression the ability to live actively. This year, in this category, we're excited to be launching our WristMotion product with additional products and development.

Now I'd like to turn the call over to Mike to review the financials for the quarter and the year and talk about how we're seeing 2021. And then I'll provide some closing comments. Mike?

Thank you, Cheryl. I'll now walk you through our results for the fourth quarter and full year 2020.

Please turn to Slide 7. Total revenue for the fourth quarter of 2020 increased to $32.7 million, up 10% year-over-year and up 3% from the third quarter due primarily to the growing Joint Preservation & Restoration revenue streams of legacy Arthrosurface and Parcus, which we acquired in early 2020, offset by lower Joint Pain Management revenue due to the negative impact of COVID and related ordering patterns of J&J Mitek, our largest customer.

Joint Preservation & Restoration revenues totaled $13.1 million in the quarter, up $12.6 million year-over-year, primarily due to the acquisitions of Arthrosurface and Parcus Medical. On a sequential basis, our Joint Preservation & Restoration revenues increased 12% from the third quarter in spite of incremental post-holiday COVID headwinds and continued strong recovery from the initial COVID impact earlier in 2020. Despite those headwinds in the latter half of the fourth quarter and into early 2021 associated with the COVID spikes and winter storms, the momentum in this business in this part of our business remained strong. In the fourth quarter, before the COVID spike, underlying demand approached pre-COVID pro forma levels as procedure volumes recovered and our integrated sales team continued to gain traction.

Joint Pain Management revenue totaled $16.9 million in the fourth quarter, down 36% year-over-year and down 9% sequentially from the third quarter. As we mentioned in previous earnings calls, we expect that the product shipments to Johnson & Johnson Mitek, who markets and distributes our MONOVISC and ORTHOVISC products in the United States, would be lower in the second half of 2020 than in the first half as a result of COVID and Mitek's related ordering pattern, which pushed a significant portion of the initial COVID impact from the second quarter into the second half of 2020.

This second half impact was greater in the fourth quarter than in the third quarter for a number of reasons, including Mitek's order timing between Q3 and Q4; lowered derived product transfer pricing to Mitek in the fourth quarter, which I'll explain in a moment; and lastly, lower Mitek end-user sales and therefore -- and thereby, lower royalties to us, down both year-over-year and, to a lesser extent, sequentially due to the impact of COVID spikes on elective procedure. As a reminder, our revenue from Mitek is based on both a royalty on their end-user sales of ORTHOVISC and MONOVISC in the quarter as well as the product shipments we make to Mitek to supply those end-user sales. The transfer pricing of our shipments is derived from Mitek's end user average selling price 2 quarters earlier. Therefore, the significant initial COVID impact in the second quarter, which included lower end user average selling price on the low volumes in that quarter, had a trailing incremental negative impact on our fourth quarter product revenue.

Overall, while our pricing and volume in Joint Pain Management are both down from pre-COVID levels, reflecting both COVID and changing market dynamics, based on our discussions with our commercial partner, Mitek, the belief is that both pricing and volume have now largely stabilized as of the end of 2020, and we are pleased that, together, remain the market leader in U.S. viscosupplements with MONOVISC and ORTHOVISC.

As a result of the acquisitions of Arthrosurface and Parcus, the continued growth of Joint Preservation & Restoration and lower Joint Pain Management revenue, our overall revenue mix diversification increased in the fourth quarter, with Joint Pain Management revenue decreasing to 50% of Anika's total revenue, down from 89% of revenue in the same period last year. Further, revenue from J&J Mitek decreased to 40% of total revenue in the fourth quarter, down from 72% in the same period last year. For the full year, our total revenue reached $130.5 million. That's an increase of 14% compared to $114.5 million in 2019 due to Joint Preservation & Restoration revenue, largely from the addition of Arthrosurface and Parcus, which offset lower Joint Pain Management and other revenue due primarily to COVID.

Our gross margin in the fourth quarter was 51% compared to 71% in the fourth quarter of 2019 due primarily to the unfavorable 16-point impact of $5.2 million of noncash acquisition accounting-related expenses and the unfavorable COVID impact on revenue mix and volume.

With regards to operating expenses, our research and development and SG&A expenses together totaled $22.8 million in the fourth quarter, up from $16.3 million in the same period of 2019, reflecting the acquisitions of Arthrosurface and Parcus as well as expenses to support future growth, such as clinical trial costs, incentive compensation and investments in our commercial and related support organization.

During the fourth quarter, we also recorded certain fair value adjustments to reduce the goodwill associated with the acquisitions at the beginning of 2020 of Arthrosurface and Parcus and to reduce the expected contingent consideration payments due in future periods for those acquisitions. Specifically, we reduced goodwill by $24.4 million in the fourth quarter, and we reduced the fair value of contingent consideration by $12.5 million.

As a reminder, Anika previously reduced both goodwill and the value of contingent consideration in the first quarter of 2020 at the beginning of COVID based on the estimated impact of COVID at that time. In the fourth quarter, we revised our estimates based on the continued impact of COVID as well as our planned incremental investments to support the strong growth we expect out of these legacy businesses.

Our net loss for the quarter was $15.7 million or $1.10 loss per share compared to net income of $4.1 million or $0.28 per diluted share in the fourth quarter of last year. Excluding the noncash charges discussed earlier and other adjustments described both in our earnings release and our online earnings presentation, we achieved adjusted net income of $1.7 million or $0.12 per diluted share compared to $6.3 million or $0.43 per diluted share in the same period last year.

Despite the impact of COVID, we generated adjusted EBITDA in the fourth quarter of $4 million. That was down from $11.1 million for the fourth quarter of last year. The decrease in profitability was primarily due to the unfavorable COVID impact as well as the addition of Arthrosurface and Parcus and incremental investments supporting our future growth.

For the full year 2020, our net loss was $24 million or $1.69 loss per share, down from net income of $27.2 million or $1.89 per diluted share in 2019. This included a number of acquisition-related expenses and adjustments. Our adjusted net income for 2020 was $10.1 million or $0.71 per share, and our adjusted EBITDA was $23.9 million, both down from 2019 due primarily to the unfavorable COVID impact as well as investments supporting our future growth.

As a reminder, adjusted net income, adjusted net income per share and adjusted EBITDA are non-GAAP measures. Please refer to the reconciliations of those measures to the corresponding GAAP-reported figures in either our fourth quarter press release or our fourth quarter earnings presentation in the Investors section of our website.

Lastly, with regards to our financial position, Anika's balance sheet remains strong with $98.3 million in cash and investments at the end of the year. As a reminder, in April, out of an abundance of caution, we drew down $50 million on our outstanding credit facility to strengthen liquidity in light of COVID-19. Based on performance recovery and stabilization of our business through the pandemic thus far, we repaid the $50 million in full, with the final $25 million repaid during the fourth quarter. While we remain focused on controlling costs, we are also balancing that with reinvesting to support growth and long-term profitability, consistent with our strategic objectives.

Please turn to Slide 8. We would now like to walk you through our directional outlook for 2021. Due to the continued uncertainty associated with COVID-19, we will not be providing detailed financial guidance for the full year and the first quarter of 2021 at this time. At the same time, we would like to share with you more qualitative and directionally quantitative insights into our current expectations.

We believe that market trends are pointing to a second half of 2021 recovery, depending on the timing and nature, in the United States and globally, of vaccine rollout; additional COVID spikes; and other dynamics, such as variants of the COVID disease. These dynamics remain very fluid and could have a material impact on our results and expectations. For example, in the latter half of the fourth quarter of 2020 and thus far into early 2021, elective procedures have been significantly impacted by both increased COVID spikes across the U.S. and globally as well as by recent storms, most recently and most prominently in the southern United States. This has impacted our results in the first quarter, and we expect there to be continued uncertainty through the remainder of 2021 as the timing and the extent of the recovery remains unclear.

That being said, despite the impact of COVID spikes, in our Joint Preservation & Restoration business, we are seeing strengthening demand for our Arthrosurface and Parcus products in extremities and sports medicine as well as our HA-based regenerative products, including TACTOSET in the United States and HYALOFAST outside the United States. Based on this growing demand, we expect strong growth as COVID lifts in 2021. And overall, for the full year of 2021, we expect Joint Preservation & Restoration revenue growth in the upper 20s to low 30s percent range over 2020. Continued strong growth in Joint Preservation & Restoration is an important element of our multiyear growth strategy, and we look forward to updating you on progress through the year as COVID lifts.

We also believe our Joint Pain Management business has stabilized, and most of the order timing that impacted us between the first and second halves of 2020 is behind us. While we expect the COVID impact to remain more prominent for a longer period in the joint pain management injections area as compared to surgical procedures in joint preservation and restoration, we do expect low single-digit growth in 2021 of joint pain management revenues over 2020. We also expect our other revenues outside of our main product families to decrease mid-single digits, primarily as a result of increased competition for long-standing mature product lines. On a total company basis, we, therefore, expect revenues in 2021 to grow between the high single digits and low double digits as compared to 2020.

Moving down to P&L. Directionally, we expect gross margins to remain fairly consistent between 2020 and 2021, excluding the impact of Parcus and Arthrosurface acquisition-related expenses which continue into 2021. Specifically, in addition to approximately $6 million in annual amortization of Parcus and Arthrosurface acquisition-related intangibles that flows through cost of revenue, there remains approximately $7 million of acquisition-related inventory step-up costs, which we expect to be charged to cost of revenue through 2021.

With regards to spending, as Cheryl mentioned, in 2021, we are increasing our investment in commercial infrastructure and capabilities, including people, systems and processes that support our transformation and will enable us to scale as we grow. We also will continue to invest in research and development, including the clinical trials that Cheryl described, required to ultimately bring our existing outside-the-U. S. product to the U.S. Further, as COVID lifts, we expect marketing- and sales-related expenses to increase accordingly. Overall, as we invest ahead of growth in support of our longer-term growth and profitability targets, we expect operating expenses to increase over 2020 as a percentage of revenue.

With the continued weight of COVID during the year and our incremental investments for growth, we expect our adjusted EBITDA to remain positive and healthy but to decrease as a percentage of revenue in 2021. We remain laser-focused on our multiyear targets of doubling 2019 revenues by 2024 and delivering double-digit adjusted EBITDA growth as well as continued strong growth beyond 2024. We believe there is significant opportunity for Anika within the large and faster-growing segments of early intervention orthopedics that comprise our now over $8 billion addressable market. We are in the early stages of Anika's transformation and are laying the groundwork for an exciting future.

I will now turn the call back over to Cheryl.

Thank you, Mike. If everyone could please turn to Slide 9. I would like to let you know that we plan to host a virtual Investor Day in late spring where we'll outline our strategy, technologies and new product development road map and introduce you to our new management team. Please stay tuned for more details from Mark Namaroff, our Head of Investor Relations.

As we all know, 2020 was a challenging year on many fronts for all of us, both personally and professionally. I've now been CEO -- in the CEO role for a year, with the work-from-home order implemented just a couple of weeks after I started. I'd like to wrap up the call today by thanking the team members at Anika. As you just heard, the Anika team truly accomplished many great things during this transformational year for the company. I'm very proud of our employees working through adversity for most of the year while accomplishing so much to transform our business into a focused orthopedic solutions company.

The health and safety of our team remains our top priority at Anika. Our employees are our greatest asset. And while we continue to work remotely across most of our business locations, we are taking the necessary precautions to keep our employees safe and healthy. For those who have continued to be on-site or traveling to support our customers, I'd like to extend an extra thank you.

In closing, we're a passionate team. We're closely -- working closely with key clinicians who are equally passionate to bring solutions to their patients. We're energized to create truly meaningful advancements in early intervention orthopedic care. Quality and compliance are core values as we do this important work. And our team is driven to develop and deliver solutions that restore active living for people around the world.

Thank you all very much for your attention and support of Anika, and we can take your questions now.

(Operator Instructions) The first question comes from Jim Sidoti with Sidoti & Company.

Can you hear me?

We can. Jim, how are you?

I'm well. I'm well, I hope everyone's healthy there. It sounds like you're doing well.

We are.

A couple of questions. One, with J&J, do you have any visibility into where their inventory is now? Do you think -- I know you said low single-digit growth for the year. Is that something you think starts out right away? Or is that a back end -- back half of the year where you really see that growth?

Jim, this is Mike. We expect that the growth is going to increase through the year given COVID lifting and how that all plays out. There is still -- we believe that they got through most of the inventory through the end of the year. The COVID spike at the end of -- around the holidays didn't help, so there's a little bit coming in. But I think the important thing in terms of modeling is that we believe that business has really now stabilized. There have been a number of dynamics at play with COVID and everything else, and that really is -- we really believe that, from our conversations with J&J Mitek that, that has stabilized. So I think in terms of modeling it -- generally, I think, historically, their business tends to strengthen in the second quarter. And -- but with COVID, this is a little harder to look at normal seasonality as you go forward here.

Okay. And with regard to seasonality, typically, for orthopedic companies, Q4 is the strongest quarter of the year, and Q1 comes in a little bit lower. Would you think that will be the case for you guys as well? Should we expect Q1 to be down from Q4 of '20?

Yes, Jim, I'm not giving specific guidelines for Q1, but I think what you're saying is absolutely what we typically see, right? It's strong Q4, lower Q1. We're seeing -- we'll see that more in the joint preservation business, I think, generally, than we've seen in the Mitek business just because J&J tends to -- they manage their own inventory levels throughout the year, so it may not follow a normal seasonality on the transfer products. But yes, I think that's definitely true. Also with COVID lifting through the year, I think you're going to see the businesses continue to strengthen. We've seen a lot of demand in our joint preservation business. But as we saw at the end of Q4, and even into the beginning of Q1, procedures are just getting postponed, a place may have a COVID lockdown or people may be quarantined and then may push off the procedure for a couple of weeks. So we saw that dynamic in the latter half of Q4. We see that -- we expect to see that here in the beginning of 2021. But the demand remains very strong, and our team is very energized about the opportunity there this year.

And I guess one thing that will offset that a little bit, too, is for Q1 2021, you'll have the full quarter for Parcus and Arthrosurface whereas, in 2020, you only had, I think, about 6 or 8 weeks of those products.

Yes, that's correct. We had -- one of the acquisitions closed at the end of January, the other at the beginning of Feb. And last year, we had about 2 months of activity for the acquired companies, and now we'll have the full 3 months. So that will definitely help. There's definitely just some comp dynamics in the first half, obviously, because COVID hit in Q2. But then as we saw with the Joint Pain Management business, that impact really came into the third and fourth quarters. So there's going to be some interesting dynamics as we go through the year. But I think what we were trying to communicate is we -- while we may not have clear sight here on a quarterly basis, the business remains very strong, and our team is as excited about where we're going and how this is all coming together.

Okay. And then 2 more for me. Can you talk about the sales force, where it was in the end of the year and what are your plans for 2021?

Yes. Let me talk about that, Jim. First of all, I would tell you that we are really excited with where we landed in the year from an integration perspective. We were -- we talked in the past about the fact that we effectively accelerated our integration activities on the sales force, the commercial team side. And so we really have, especially in the U.S., a fully integrated hybrid model where we've got over 30 direct employees and then over 100 independent distributors that they also work through. So we continue to do work on the integration side around commercial and sales operations, implementing systems and processes that are going to allow us to efficiently scale that business, and we'll be working on those things into this year, into 2021. But we're really happy with where we landed on sales force integration and the strength of the sales force. They've all been cross-trained. They're selling the full bag across the legacy Parcus, legacy Arthrosurface and legacy Anika businesses. So we have a dedicated sales force that's focused on the soft tissue space, on the regenerative space and on the bone-preserving joint technologies, focused on that surgical call point with a full bag. So we're pretty excited about where we landed with that sales force.

I guess what I'm trying to get to is do you expect a significant increase in the sales force in 2021?

No, we don't. We feel really good about the fact that we were able to bring 3 legacy sales forces together. And we feel like we've got a really strong team of people that are ready to drive all of the cross-selling opportunities, especially over the next couple of years as we launch new products into their hands.

Jim, the only thing I would add is, as it relates to my comments around the sales and marketing spend, we do expect that to increase through the year because we suspended a lot of the marketing efforts last year with COVID, trade shows and the like. And so as things open up, we do expect those costs to increase. And then also, commissions are going to be increasing as the sales grow. And that's something that, in the old Anika model, you wouldn't have seen. But now that we've moved to more of a direct commercial model, you'll be seeing that coming through as the revenues grow. We're also surrounding that commercial team with more infrastructure support, in addition to the marketing side, just commercial operations. And the other thing is because we see -- going from the historic business model to this larger $8 billion market opportunity with the kind of products that we're bringing to market, we want to make sure we can capture that value. And so that's where -- when I made comments about the incremental investment, it's not in the number of salespeople, we believe, that the combination of the direct team and the distributor force that we have is entirely appropriate, but it's the rest of the support piece and the marketing that goes with it.

Okay. All right. Makes sense. And then last one for me, you mentioned a couple of times during the call that you think you're on track to double your revenue by 2024. Can you just remind me, is that -- does that include acquisitions? And at this point, I mean, are the acquisitions something that you would plan more 2 or 3 years from now? It seems like you have quite a bit on your plate for 2021, at least.

Yes. Jim, specifically, when Joe Darling, our former CEO, laid out that target in 2019 -- 2019 was the baseline year. So we had $115 million roughly in 2019. So doubling the revenue by 2024 would simply be $230 million. And in terms of how we get from where we are, where we just closed the year, at $130.5 million to the $230 million, our model behind that is entirely organic. We are not banking on any one particular product to get there. We have a number of products that Cheryl walked you through across extremities and sports medicine. The exciting parts you sell outside the United States like CINGAL and HYALOFAST are also not in that model because they will be growth drivers beyond 2024. They won't be in the U.S. market necessarily at that time. And so our model is based entirely on an organic growth trajectory driven by sales force execution, first, and then also by the exciting products that we have that leverage the regenerative capabilities into sports medicine and extremities.

That being said, we recognize we have a big opportunity here. And so we -- and we have a strong balance sheet, so we are being opportunistic. If there are bolt-on acquisitions that make sense and support our strategy for growth at both the top and the bottom line, then we are definitely open to M&A where it makes sense on a bolt-on basis. But key point is the targets that we've laid out are not dependent upon any home runs with any individual products nor are they dependent upon acquisitions. Those would all be upside.

But it really -- the starting point really is from 2019, just to be clear, Jim.

Okay. All right. But based on what you've said so far for 2021, it seems pretty clear that you think 2022, 2023, you're going to see a pretty significant acceleration in top line growth as COVID subsides and as these new products start to gain some traction.

Yes. I mean I think one of the things, just doing the math, obviously, just given the acceleration, given we're making investments, and those investments then will take time to pay off. But that being said, to get there, it takes mid-teens [CAGR]. And if you look at what we're doing, we closed last year over 10%. Here, we've got a target that, even with COVID through a good portion of the year, we've guided at double-digit growth at the midpoint. And that's driven by growth in Joint Preservation & Restoration in the 20s to 30s percent range. So we've got very robust growth there. And we really believe there's a lot of opportunity ahead of us. And now that the -- our larger business, the Joint Pain Management business has stabilized, that's a very good business for us as well, especially on the profitability side as you can see from the legacy business model. So we're excited about how this all fits together.

The next question comes from Mike Petusky with Barrington Research.

A few questions. So Mike, I guess the R&D expense in the quarter was quite a bit higher than I was anticipating. I mean is that sort of the new level? Or were there sort of one -- more sort of one-off things in there that sort of took it to sort of a $30 million run rate for a year?

Mike, a couple of things. So there were some onetime items in there, and one of which we called out in our non-GAAP reconciliation. There was a write-off of IP R&D, in-process research and development from the legacy S.r.l. acquisition a number of years ago. That was about $1.4 million. But there were some offsetting items in there as well that were onetime in nature. So in terms of thinking about how that lays out in the coming year, Cheryl gave an update a bit on what we're seeing on the clinical trials. Obviously, things are delayed because of COVID. But we do expect them to open up as COVID lifts up. And so as enrollment continues for the CINGAL pilot trial and for the HYALOFAST clinical trial, you will see potential lumpiness in the R&D line in 2021. There are a number of investments that are laid out on that page that Cheryl walked through in terms of -- from a development standpoint. And so we're really trying to be thoughtful about making the investments now to leverage the commercial opportunity that we have. And so yes, I think it's fair to expect that R&D is going to be higher in 2021, as I described, and higher as a percentage of revenue. But a lot of that is -- you've got clinical trials and the timing of those clinical trials really will play -- will impact that.

Okay. Can I ask -- since both CINGAL and HYALOFAST are now pushed out to beyond 2024, what do you guys anticipate spending in terms of R&D between now and '24 on those efforts, just those 2?

Yes. I mean I don't believe we've called that out before, Mike. I don't know that I'm prepared to walk through how much we're going to be spending on those. There's a number of different ways we are looking at approaching those opportunities. And the other thing I would say, just to help understand how we're thinking about it, it's a couple of things. I think if you kind of go back a couple of years, I think they were really -- the predominant conversation on the R&D front was really around CINGAL and HYALOFAST. I think in understanding how we're thinking about it now, there are a number of other opportunities that are -- that we're excited about across these bigger markets. And so we're working through what's the best driver of our future value and how we lay out that spend. So we're cognizant not just on driving the top line but also the bottom line. And that's why we -- our 2024 targets that we keep reiterating are not just about the doubling of revenue but also about double-digit EBITDA growth. But the phasing of that timing between now and 2024 will -- our plan is to give you more clarity around how we're thinking about all of this at our Investor Day so that you can see how we get from here to there.

Right. Are there -- and I'm not necessarily calling out these 2 products. But were there any products -- or are there any products that sort of have been on the drawing board for a while that, as you guys look at this with fresh eyes as a fresh management team, you say, wow, maybe longer term, this -- we can get a return on investment in other places and maybe some of this doesn't make sense longer term, even though maybe you're down the track? I mean are there projects like that?

Well, it's a really good question, and with the new management team coming in, you might imagine we've done a lot of detailed analysis around that. And I will tell you that we remain very bullish after a pretty detailed market assessment of the OA pain management space of CINGAL in the U.S. and we also are remaining to be very excited about HYALOFAST in the U.S. We've got experience with those 2 products outside the U.S. We sell them both in over 30 countries. And we see what they do relative to things that they may be competing with coming up in the U.S. While that landscape has certainly changed over the time period that these have been in development, those areas remain very exciting to us.

That said, the strategy of the company has really taken us in a different direction where the strategy isn't all about HYALOFAST and CINGAL as it was. And it is a more comprehensive, built-out strategy across really the continuum of care in the early intervention orthopedic space. While we like those 2 products in the U.S., they are a part of the story, and they are not needed, they're not in our model, for doubling the revenue by 2024. We continue to take a look at where we make investments, and we feel like we're structured to be able to invest in other high-opportunity spaces in the U.S. and globally, notwithstanding what we continue to do with HYALOFAST and CINGAL to get them into the U.S. We just think, in general, there are so many opportunities in these areas. And continuing to leverage the HA technology in, like, rotator cuff and other soft tissue areas, additional sports med products, additional bone-preserving joint technologies, you're going to see a good cadence of product launches in the near term. So the company is not waiting around for HYALOFAST and CINGAL in the U.S.

The other thing that I'd add, just for clarity, too, Mike, is we are deciding what we're not going to do. So there was a charge I just described to Jim in the fourth quarter -- or maybe I described it to you, forgive me, of $1.4 million of writing off in-process research and development costs. That's specifically associated with some historic programs that we decided we're no longer going to pursue. The company also wrote off certain costs in the second quarter, what we refer to as product rationalization for certain programs and things that we were no longer going to pursue. We are very cognizant of our size and the importance of focus. And so we are being very thoughtful in terms of where we're spending our time and our resources.

And we're looking at it based upon what drives the most value. And as Cheryl said, this tie-in of HA, the regenerative capability with sports medicine and extremities, is an important aspect of the different programs we're focused on. So we're in the early stages of that. As you know, there's been a lot of change in the management team. The team is really gelling together. I've been here now 6 months, and we've got a really solid team that are really looking hard at these questions of where we deploy our resources to deliver the top line growth but also to be very cognizant of the bottom line.

Got you. So I guess in terms of just general capital allocation, could you guys sort of lay out the priorities? I mean, certainly, you're investing in your business and in R&D and your commercial capabilities. But beyond that, I mean, is for the $100 million on the balance sheet and any cash flows you generate, I mean is M&A 2021 possibility, is share repurchase? But I don't know if you've ever considered a dividend, but just curious about capital allocation priorities, how you would rank them.

Sure. Mike, I'll take that one.

Go ahead, Mike, and then I can add some comments.

Great. Thank you. Our opportunity, I think, to drive the most value off of the platform that we're establishing here now that we have Parcus and Arthrosurface is organically, and that's why we're making the investments that we are, and we're sacrificing some of the profitability in the short term to do that. That being said, as we build this platform of capabilities, there are a number of things we'd like to bolt on and add to this. And acquisitions are definitely an area that could make a lot of sense for us. We've got a big market out there that we want to be able to address. Now the timing of that, is it in '21, is it -- how quickly, that remains to be seen. We're focusing a lot of '21 on building these capabilities, systems, processes, other things. If the right opportunity comes along, we're definitely openly considering those things. But it needs to make sense and it needs to be something we can execute on, not just in acquiring it but integrating it and driving value from it. So I think as we go forward into the future years, you're going to see more of that conversation. But we're not ignoring opportunities as they arise this year.

Yes. Thanks, Mike. And I would just add on, we are still very focused on completing a successful integration of the 2 deals that we did last year. We continue to look for bolt-on opportunities and other potential transformational opportunities, but still considering the right level of financial discipline and really aligning -- now that we have a commercial team, aligning to our commercial fit. So I do think there are opportunities there, and we continue to be out looking.

Mike, just one last point is, I think we're focused, obviously, on value creation for our shareholders. And we're looking at how do we deliver that greatest value creation. We've got some very fast-growing revenue streams, and we've got gross margins approaching 70% range and opportunities to expand that. And so as we think about what's going to drive value, that's why we're looking at M&A and the other things on top of the platforms we're creating because we believe we are building a very strong foundation here. And we -- and it's really around value creation for shareholders that we're looking at that capital allocation.

Got you. Got you. Okay. Just one last quick one. Cheryl, you made an allusion to HA TACTOSET, we've had it sort of in the bag for about a year at this point. You -- I think you termed that we're getting traction or getting good traction, something along those lines.

Yes.

Are you willing to quantify -- I mean has that product gone $1 million? I mean what kind of contribution is it actually making at this point?

Yes. We haven't quantified it, especially since we withdrew guidance, but it is gaining significant traction and we like where it's headed. I don't know if, at some point, we're going to be willing to break it out. But right now, we're not. But I like what that product is doing. It also gives me continued confidence in our current pipeline as we continue to leverage the HA technology platform and what we see it doing with HYALOFAST outside the United States and with TACTOSET as we currently have it launched in the U.S.

This concludes the question-and-answer session. I would like to turn the conference back over to Cheryl Blanchard for any closing remarks.

Great. Thanks, Therese. And I just want to thank everybody for your attention today and wish everybody to stay safe and healthy, and we will talk soon. Thanks again.

This concludes today's conference call. You may disconnect your lines. Thank you for participating, and have a pleasant day.