Anika Therapeutics, Inc. (ANIK) Q2 2020 Earnings Report, Transcript and Summary

Thank you for standing by. This is the conference operator. Welcome to the Q2 2020 Anika Therapeutics Earnings Conference Call. As a reminder, all participants are in listen-only mode and the conference is being recorded. After the presentation, there will be an opportunity to ask questions. [Operator Instructions] I would now like to turn the conference over to Kristen Galfetti, Executive Director of Investor Relations. Please go ahead, ma’am.

Thank you, Carl. Good evening, everyone, and thank you for joining us. With me today on the call is Dr. Cheryl Blanchard, President and Chief Executive Officer; and Sylvia Cheung, Chief Financial Officer of Anika. During today’s call, Cheryl and Sylvia will review Anika’s second quarter 2020 financial results and key business highlights, which were summarized in our earnings release today. A copy of the earnings release is available on the Investor Relations section of our website at anikatherapeutics.com. In addition, a slide presentation is posted on our website in the Investor Relations section under the Events and Presentations tab. We invite you to take a moment now to open the file and follow the presentation along with us. Please turn to Slide 2. Before we begin, please remember that certain statements made during this conference call constitute forward-looking statements, as defined in the Securities Exchange Act of 1934. These statements are based on our current beliefs and expectations, including statements with respect to impacts of the COVID-19 pandemic on Anika. These statements are subject to certain risks and uncertainties. The company’s actual results could differ materially from any anticipated future results, performance or achievements. Please also see our SEC filings for more information about factors that could affect our results. Certain financial measures we will discuss in this call are non-GAAP financial measures. We believe that providing these measures helps investors gain a more complete understanding of our results and is consistent with how management views our financial performance. A reconciliation of these non-GAAP financial results to the most comparable GAAP measurement, calculated and presented in accordance with the U.S. GAAP, is available in the Investor Relations section of our website. I will now turn the call over to our President and CEO, Dr. Cheryl Blanchard. Cheryl?

Thank you, Kristen, and good evening. We hope that everyone joining us on this call remains in good health, while we continue to navigate this ever-shifting landscape. Our thoughts and gratitude remain with all the committed healthcare workers around the world, who are on the frontlines and selflessly taking on this global pandemic. As this is our first full quarter call to report since I became President and CEO, I’m delighted to share that the Anika team executed extremely well against both internal and external expectations. As expected, the suspension of elected procedures due to COVID had a material impact on our business. Despite the COVID environment, we generated positive top and bottom line performance and surpassed aggressive organizational goals, including integration milestones, all in the environment of a global pandemic. That cross-functional execution underscores the ability of our team to adapt, overcome situational barriers and find new ways to deliver increased value to our customers, shareholders and other key stakeholders with a continued focus on the patients who benefit from Anika’s products. Please turn to Slide 3. Before diving into our second quarter results and business progress, I’d like to discuss how we are continuing to navigate the evolving COVID-19 environment. First and foremost, our steps to safeguard the health and well-being of our employees and other stakeholders have paid off. Remote and distance working, new internal policies and other measures have been effective in maintaining a healthy organization and in continuing to deliver our products to physicians and their patients safely. Manufacturing and supply chain operations have also continued with minimal disruption. And our team and distribution partners have coordinated closely with medical facilities and surgery centers to ensure patients have had uninterrupted access to the treatments and plans they need. We also maintained strong fiscal discipline during the quarter, focusing on cash preservation and strengthening our liquidity. Our continued proactive and decisive actions, including talent redeployment, acceleration of integration activities and delivering product, as procedural recovery ramps back up, drove the business results and progress we achieved in the quarter and positioned us well for the future. Please turn to Slide 4. The leadership team that is successfully navigating this unique environment is now a combination of legacy Anika executives, talented leaders that joined Anika through the recent acquisitions of Parcus Medical and Arthrosurface, and other recent additions to our team. This enhanced team positions us very well for continued success in the current environment and as we work to grow Anika in the coming quarters and years. There have been several key organizational changes and many team members who deserve recognition for their contributions, but today, I would like to highlight a few key adds to our newly formed Anika executive team. First, Bart Bracy, who is a Co-Founder and Executive at Parcus, has been appointed Senior Vice President of Sales and Marketing for the Americas region. Bart is an established orthopedic executive with a successful career in sales and marketing in sports medicine. And prior to joining Parcus, he served in commercial leadership roles at companies including Arthrex and Smith & Nephew. Steve Ek, the former President and CEO at Arthrosurface, has been appointed Vice President of Research and Development. Steve has a track record of designing and delivering breakthrough solutions in the joint preservation and restoration and sports medicine markets. He also brings a wealth of orthopedic knowledge from his prior work experience at Linvatec, now ConMed, and Smith & Nephew. Mark Brunsvold, another co-Founder and the former President of Parcus, will continue to lead the legacy Parcus operations as President of Sports Medicine. Mark brings a significant background of innovating and manufacturing in the sports medicine field from his prior work experience developing and manufacturing products for Arthrex as the owner of Machine Metals. Finally, James Chase, Senior Vice President of International Sales and Marketing, has assumed responsibility for Anika’s operations in Padua, Italy in order to fully leverage our growing international business. James brings significant sales, marketing and general management experience in the sports regenerative medicine spaces from his extensive experience at Smith & Nephew. The more time I spend with this team, the more excited I become about Anika’s future and our ability to drive growth to new levels. Now turning to Slide 5, we delivered a strong revenue performance in the quarter with total revenue growing year-over-year. This exceeded our COVID planning expectations for the quarter, even in light of the procedural slowdowns due to the pandemic. The temporary suspension of elected procedures resulted in an organic top-line decline of $5.9 million during the quarter. However, inorganic revenue contributed an increase of $6.2 million in the quarter, which more than offset the drop and resulted in year-over-year top-line growth of 1%. This speaks to the success of our strategic initiatives and the strength of our newly expanded, more diversified business. I’m also very encouraged by the improvement we experienced over the last couple of months as a result of restrictions easing on elective procedures across major markets, even with recent COVID setbacks in certain regions. Orthopedic Joint Preservation and Restoration volume were at about 25% of historical levels in April and rose to around 50% in May and over 80% in June on a pro forma basis. July’s orthopedic Joint Preservation and Restoration run rate volumes are around 75% of 2019 levels, also on a pro forma basis. The procedural recovery was particularly evident in ambulatory surgery centers, or ASCs, and office-based activity, where physicians have had the ability to implement safety protocols that have allowed certain appointments and procedures to resume. Our tracking rapid response and adaption to the shifting environment has allowed us to maintain relevance in the marketplace and even gain and train new customers during the period. It’s important to remember that the vast majority of our products are used in either office based procedures for the OA pain management injectable side of the business or surgeries performed in the ASC setting. We anticipate hospitals will continue to face special challenges with the influx of COVID patients, and we expect continued depressed levels of elective procedures in the hospital and possibly ASC and office settings, especially as COVID hotspots emerge in different geographies. Our current product mix that favors non-hospital based procedures puts us in a strong position to continue our positive momentum going forward depending on the COVID status in a given geography. An additional factor benefiting second quarter revenue was the stable order flow during the quarter for MONOVISC and ORTHOVISC from our U.S. commercial partner due to order timing and contractual terms. We expect domestic orders for ORTHOVISC and MONOVISC to ease in the second half of the year to level off inventory due to lower end market sales in Q2 as a result of COVID. Please turn to Slide 6. We made accelerated progress against our integration plan during the quarter. Most importantly, we fully integrated our U.S. commercial team, forming a single, seamless organization to support our expanded product portfolio. These changes include the senior management changes I mentioned earlier, the implementation of shared marketing and sales operations functions and an optimized direct sales representative structure and scaling plans. We entered the third quarter with 35 direct sales professionals in the U.S. in addition to a specialized group of sales support and marketing personnel. Final elements of the integration that will continue into next year include consolidation and implementation of operating systems and the prioritization of our robust product pipeline, which will be discussed on the next earnings call. Turning to Slide 7. We also made changes in our R&D team in an effort to streamline and accelerate development of our many promising new product development programs. We made progress evaluating our robust product pipeline, and we are on track to roll out our new R&D roadmap to investors on our third quarter earnings call. Q2 was a very active time for our product development and regulatory teams. We gained U.S. regulatory clearance for 6 new sports medicine surgical devices and instruments to enable procedures ranging from rotator cuff repair to arthroscopic knee repairs and treating arthritis damage in the hand and wrist. These products will be commercialized through Anika’s recently integrated sales and marketing team through the third quarter of 2020. We also expanded the TACTOSET franchise, our surgically delivered regenerative therapy, to treat bone insufficiency fractures with the launch of a small bone cannula set. This line extension was developed with input from foot and ankle surgeons to enable improved and more accurate access in small joints and extremities, and will address unmet patient needs in those joints. In addition, we achieved our first sales of CINGAL in Australia in the quarter and continued the international expansion of our joint pain management portfolio with CINGAL and MONOVISC regulatory approvals in Finland and CINGAL, MONOVISC and ORTHOVISC approvals in Serbia. With respect to clinical trials, we’ve continued to work with clinical trial sites and CRO partners to determine how and when we can safely start new or resume ongoing studies. While we’re not yet ready to provide updated timing for the CINGAL pilot study or the HYALOFAST Phase III trial, we are optimistic that we will be able to provide new guidance by the time we report our third quarter results in October. We’re ready to move ahead with these clinical trial plans as soon as it is safe to do so in the current COVID environment, and continue to be excited to pursue both of these products in the U.S. market based on our commercial experience with them internationally. I will now turn the call over to Sylvia to review our second quarter results, and I will wrap up with some additional comments on the quarter before opening the line for questions. Sylvia?

Thank you, Cheryl. Please turn to Slide #8. Total revenue for the second quarter of 2020 increased 1% and 20% year-over-year for the 3- and 6-month periods, respectively. Revenue growth for the quarter was driven primarily by orthopedic Joint Preservation and Restoration products due to the acquisitions of Parcus Medical and Arthrosurface. This was partially offset by the lower joint pain management revenue under the COVID environment. We expect U.S. purchase orders for ORTHOVISC and MONOVISC to ease in the second half of the year as a result of inventory leveling by our commercial partner due to COVID. As part of the integration of Parcus and Arthrosurface, we have decided to prioritize, and over time, discontinue certain legacy Anika products in the future. These are low volume and low margin, primarily wound care related non-core products. In the second quarter, we recorded $2.9 million of non-cash charges related to this product rationalization, of which $1.9 million was included in the cost of revenue and $1 million was included in the selling, general and administrative expenses. As expected, we also incurred non-cash acquisition-related amortization expense of $3.8 million in the quarter in cost of product revenue. The result of these non-cash charges impacted product gross margin by 19 percentage points year-over-year. COVID also negatively impacted our top-line, resulting in lower royalty revenue and lower manufacturing volumes, together impacted product gross margin by 14 percentage points for the quarter. As a result, product gross margin was 45% for the quarter compared to 78% for the second quarter of 2019 and 60% for the first quarter of 2020. The Q2 product gross margin is primarily a result of nonrecurring items and COVID environment and, therefore, should not be indicative of our future performance. Cost of product revenue R&D and SG&A expenses in the quarter were $36 million compared to $18.5 million in the second quarter of 2019. Cost of product revenue increased 1 point – increased $10.1 million due to the drivers previously discussed. Selling, general and administrative expenses increased $7 million due mostly to increased selling and marketing expenses related to the company’s extended sales infrastructure and intangible asset charges of approximately $1 million related to the rationalization of certain legacy products, which we discussed earlier. Total operating expenses for the second quarter of 2020 also included $4.2 million of increase in fair value of contingent consideration liability. These were associated with the recent acquisitions of Parcus and Arthrosurface. This charge was recorded as an expense in the second quarter. The increase in contingent liability is primarily a result of better-than-expected revenue performance in the second quarter due to easing COVID restrictions in certain regions and the related improvements in revenue. Net loss for the quarter was $7.7 million or $0.54 loss per diluted share compared to net income of $9.4 million or $0.67 per diluted share in the second quarter of 2019. Excluding the non-cash charges discussed earlier, we achieved net income and positive EBITDA for the quarter. Non-GAAP adjusted net income for the second quarter of 2020 was $1.2 million or $0.09 per diluted share. Adjusted EBITDA was $5.6 million for the quarter compared to $14.8 million for the second quarter of last year. The decrease in adjusted EBITDA was primarily due to increases in cost of product revenue and related revenue mix as well as selling and marketing expenses discussed earlier. Adjusted EBITDA is defined by the company as U.S. GAAP and net income, excluding depreciation and amortization, interest and other income or expense, income taxes, share-based compensation expense, acquisition-related expenses and other charges, non-cash charge related to goodwill impairment in the first quarter and change in fair value of contingent consideration associated with our recent acquisition and as a result of the COVID-19 pandemic. We ended the quarter with a solid $144 million in cash and investments on our balance sheet. In April, we drew down $50 million from our existing credit facility to strengthen liquidity in light of COVID-19. We have also implemented a number of short-term internal expense controls and are prioritizing business initiatives to conserve cash flow and continued selected investment in critical strategic initiatives for future growth. We are continuing to suspend our financial guidance for the remainder – for the full year of 2020 until our visibility into revenue trends impacted by COVID improves. Importantly, the long-term fundamentals of our business remain strong, and we are well positioned to navigate this period of uncertainty. That concludes my comments, and I’ll now turn the call back over to Cheryl. Cheryl?

Thank you, Sylvia. I’d like to remind you that, as previously announced, Sylvia Cheung plans to step away from her role at Anika next month. We have proceeded with a timely search to identify Sylvia’s successor and have evaluated some truly excellent candidates. I feel strongly we will be able to name a top-notch CFO in the not-too-distant future. On behalf of the Board and management team, I want to thank Sylvia for her years of service in building this company, and also for the support she has provided to me and so many of our colleagues over the years. Thank you, Sylvia, truly. We will always be grateful for your leadership. And to wrap up the second quarter, we experienced an unprecedented impact on procedure volumes in our business in general as a result of COVID. As jarring as that was, we leaned into the challenge, turning our efforts to actively tracking the situation through multiple channels with the goal of quickly returning to full commercial activity as soon as it’s safely possible. We’ve continued to aggressively monitor leading indicators of hospital, surgery center and office-based activity and engage with our customers and distributors. We also moved quickly on integrating our commercial organizations to leverage our full product portfolio across the full sales team. That vigilant analysis and rapid response allowed us to be equipped when our customers were ready. Our performance in the second quarter underscores the resolve of our leadership team and the strength, depth and new diversity of our product portfolio propelling this organization forward. While we are not providing guidance at this time due to the uncertainty presented in the current COVID environment, our business fundamentals and product pipeline remains strong, and demand for our innovative products is robust. We’re now ready to take your questions. Thank you.

Thank you. We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Jim Sidoti with Sidoti & Company, LLC. Please go ahead.

Good afternoon. Can you hear me?

We can. How are you, Jim?

Yes, we can. Good afternoon, Jim.

Great. Great. First, Sylvia, I just want to say good luck with whatever adventures are next to you and you’ll be missed.

Thank you. I appreciate it, Jim.

Now with regards to the quarter, you indicated that your U.S. partner was contractually obligated, I guess, to make some purchases. Can you just give us an order of magnitude on what that revenue was from then? And how much will that go down do you expect in the second half of the year?

Yeah. So the revenue from our ORTHOVISC and MONOVISC products in the U.S. was roughly about 55% of our Q2 revenue. And from a mix standpoint, it used to be more or less roughly between product and royalty. But due to the COVID pandemic situation, the royalty component is much smaller than before. And as Cheryl mentioned earlier, this factor had impacted our first-half of the year revenue as our U.S. partner continued with their purchase for the second quarter. They did not reduce their inventory purchase and this is due to timing of order placement as well as contractual terms. However, we did see that royalty revenue from domestic ORTHOVISC and MONOVISC sales during the quarter declined and was negatively impacted by COVID. We do expect the second half of the year for ORTHOVISC and MONOVISC in the U.S., the product purchase to be lighter in the second half of the year comparing to the first half of the year as a result of inventory leveling by our commercial partner. But at the same time, we think that the royalty of revenue will continue to pick up as office-based procedure resumes in the U.S. So at this point, we’re not really in a position to provide quantitative numbers in terms of those expectations. And I think you may remember this. We do get compensation from our partner in 2 different ways. First is the product transfer price, when we sell them products; and second is as a royalty when they sell the product into the market. And the dynamic of the 2 components that I discussed just now and what Cheryl was talking about will impact the first half and the second half from a revenue mix standpoint. So first half, we had more product revenue, less royalty revenue. The second half of the year, we’ll be seeing the reverse. But in terms of dollar size, we’re not in a position to provide that information.

Okay. But you do expect it will be lower, or the combined revenue will probably be lower in the second-half than the first-half. Is that right?

There is the potential. At this time, it’s difficult to say, because the royalty component is very much driven by the end market sales. And with the uncertainty surrounding COVID, it’s very difficult to project what that revenue trend will continue to look like.

Okay. So I think what I’m hearing is if procedures pick up significantly, that the increasing royalty revenue might be enough to offset the decline in product sales.

Yeah, that’s very much dependent upon the COVID recovery and the end-market sales. That’s correct.

Okay. And then, the acquisition-related expense, is that entirely non-cash amortization that $3.8 million or were there other expenses in there?

So there are 2 components to it. Roughly about half of it is related to amortization of intangible assets and the remaining is related to amortization of inventory markup, which we do expect to deplete between now and sometime in 2021. And the rate of that, obviously, is tied to the sales and the COVID recovery of Parcus and Arthrosurface products.

Okay. So the faster that things would recover, the quicker that step-up in inventory charge goes away. But it sounds like there will always be around $2 million per quarter of non-cash amortization going forward?

For the – yes, for the near-term related to the intangible asset amortization, that is correct. And within that bucket, there are 3 different categories of intangible assets. And the estimated economic lives ranges from 5 years to 15 years. So depending on the remaining useful life, obviously, it will impact the sizing of the amortization expense. But those are much longer term comparing to the inventory markup amortization, which are expected to be completed by sometime in 2021.

Right. And depending on how sales go, that could come sooner or later?

That’s exactly right.

All right. And then can you just repeat the monthly breakout? I think you said it was on procedures, 25%, 50%, 80%, was that what you said?

Yeah, this is Cheryl. I said, in April we were at about 25% of historical. This was for the Joint Preservation & Restoration part of the business, 25% of historical levels on a pro-forma basis. May was at 50%. June was over 80%, and then July is tracking at around 75%.

And are you seeing any physicians report increase in activity from patients, who maybe a little bit hesitant to go into the hospital and to get the total knee replacement?

Yeah. It’s a conversation we’ve had with a lot of customers and marketing partners. I think that there’s an element of that taking place, but it’s difficult to track with data. So, well, I would tell you that we believe that’s a reasonable intuitive assumption to make. We don’t have a lot of data to back it up. But we certainly hear of cases where that is happening. And I think that as COVID progresses we could be seeing that as a trend.

All right, and then the last one for me. In the quarter, SG&A was around $14.5 million, and I think you said there was about $1 million of onetime charges in that from one of the acquisition charges. So should we think of SG&A at around $13.5 million a quarter at this sales level? And, obviously, if sales go up, it would go up in there. But is $13.5 million a good baseline?

So, Jim, the baseline number is difficult to give a comment on, because we’re currently under COVID. So assuming that all the conditions are similar to this past Q2, I would say that it’s a good baseline number. The $1 million non-recurring item was related to the product rationalization activity, which we spoke about. You are correct in saying that the SG&A line will scale with top-line revenue increase, because part of that is related to commission and other sales-related expenses associated with top-line revenue. At this point, we are not providing any baseline or projection information for our operating expenses. I think we’ll be in a much better position to do so as we have – as we exit from COVID and have a more normalized business to speak of.

Okay. All right. Well, that was it for. Thank you. And again, good luck, Sylvia.

Thank you very much, Jim.

Thanks, Jim.

Thank you. [Operator Instructions] The next question comes from Mike Petusky from Barrington Research. Please go ahead.

Hi. Thank you. So I just want to clarify, the 25%, 50%, 80%, 75%, that’s procedure volume in the space or that’s your – sort of your revenue trends in Joint Preservation and Restoration?

Yes. That is our – that was our procedure volume trend. Yeah, it’s our procedure volume trend.

Got you. Okay. Great. And then on the product rationalization, Sylvia, is it $1 million for the quarter? Or is that $1 million annualized? Or is there more to come? Can you just talk about sort of the totality of what you guys are doing on rationalizations and how much revenues that can play here? Thanks.

Sure. So in total, the product rationalization-related charge was $2.9 million. $1.9 million went through cost of product revenue, and $1 million went through SG&A. So this is related to de-prioritizing or defocusing on non-core, low-margin and low-volume products, and mostly in the wound care business area. So they’re not material to our revenue, and certainly in the non-core aspects of our business. So it is a one-time event.

Okay. All right. So it’s like $1 million or $2 million a year or something less than that?

Yes, it’s much less than that.

Okay. Okay. All right. Great. What about – sometimes you guys have given sort of pricing trends in MONOVISC and ORTHOVISC. Was there any price cutting in Q2? And is there anything you can share about your best guess as to the second half?

Yeah. So from a pricing and a U.S. standpoint for ORTHOVISC and MONOVISC, what we saw was on a sequential quarter basis, there was – the pricing for ORTHOVISC was pretty stabilized. For MONOVISC, we saw a modest decline in the second quarter in the low-single-digit range. And it’s difficult to project what second half of the year would look like. As you know, we don’t have control and don’t have full visibility into that aspect of the business. The information that I shared in terms of the Q2 activities, I think, are within expectation from our standpoint.

All right, great. And then, Cheryl, I may have heard this more optimistically than you meant it. The commentary around visibility for CINGAL and other trials, it seems – you seem to be saying that you thought you would have some visibility in terms of restarting those when you guys do your Q3 conference call. Did I hear that – is that what you were saying? Or did I mishear what you were trying to get across there?

No, you heard me correctly. We feel like we’re optimistic that – for the Q3 call that we will be able to provide an update on progress and timing for those trials. It’s still obviously very dependent on the COVID environment and specific to clinical trial site geographies relative to what’s going on with COVID in a given geography. But we’ve continued to make progress with spinning up new sites with the HYALOFAST trial, as we had talked about doing on prior calls, and implementing all of the start-up work for the CINGAL pilot trial. So work has continued there. And we’re obviously staying very close to the sites through our own communications and through our CRO partner communications. And we feel like by Q3, we’ll be able to provide some updates.

Okay. I just want to be absolutely crystal clear on this that you’re making progress in terms of like site certification and that sort of thing, but there aren’t actual active trials going on in the company at this point, are there?

So the HYALOFAST trial is an active trial that has suspended enrollment because of COVID. But that trial remains active. The CINGAL pilot trial has sort of completed all the start-up activities to the point that we can take them up until we start enrolling patients, which we have not done yet, because we won’t do that until we feel like we can do it safely and execute on the trial according to the protocol. So yeah, that’s correct. We’ve either suspended or not yet started enrollment, and that’s the update we feel like we’ll be able to – we’re optimistic we can provide on the next call.

Got you. Okay. Last question. Obviously, some key sort of retiree states, Florida, Arizona, Southern California, a place like that have been hit hard with COVID the last, let’s say, 4 to 6 weeks. I would assume that those are also places where you guys have pockets of strength in your business, particularly in like MONOVISC and ORTHOVISC and so on. Do you have any sense of how much exposure you have in some of these sort of southern or – Sunbelt, southwest-type states that are heavy with retirees?

Yeah. We’ve obviously kept as close a track of those dynamics as we can. And what I can tell you is that in those states and, frankly, in other places, we have business around the world and around the United States that as these hotspots are popping, we see elective procedure shutdown in a city or a state for a week, for a month. And so there’s definitely some impact and, I would say, very active start/stop activities in some of those regions. What that impact looks like is very difficult to predict. And that’s why we felt like the best we could do was at least give you how we’re tracking in the month of July, because that’s pretty close to actual data at this point in time. And then we’re going to obviously continue to track things closely going forward.

Can I just ask one clarifying question? In July, do you actually – have you seen any sort of dip in second half of July versus first half of July? We came off a call yesterday where essentially they communicated they had seen a material dip in the second half versus first half.

I would say that we have not seen that.

Okay. All right. Very good. Thank you.

Thank you very much, Mike. Have a nice day.

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

Thank you, Carl, and thank you for your time today, everyone. We look forward to updating you as we continue to deliver progress on our strategic initiatives. Have a great evening. And please, everyone, stay well.

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