Organogenesis - Q3 2023

Transcript

Operator (participant)

Welcome, ladies and gentlemen, to the Q3 2023 earnings conference call for Organogenesis Holdings Inc. At this time, all participants have been placed in listen-only mode. Please note that this conference call is being recorded and that the recording will be available on the company's website for replay shortly. Before we begin, I would like to remind everyone that our remarks today may contain forward-looking statements that are based on the current expectations of management and involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including the risks and uncertainties described in the company's filings with the Securities and Exchange Commission, including Item 1A, Risk Factors, of the company's most recent annual report and its subsequently filed quarterly reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made.

Although it may voluntarily do so from time to time, the company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable securities laws. This call will also include references to certain financial measures that are not calculated in accordance with generally accepted accounting principles, or GAAP. We generally refer to these as non-GAAP financial measures. Reconciliations of those non-GAAP financial measures to the most comparable measures, calculated and presented in accordance with GAAP, are available in the earnings press release on the investor relations portion of our website. I would now like to turn the call over to Mr. Gary S. Gillheeney, Sr., Organogenesis Holdings President, Chief Executive Officer, and Chair of the Board. Please go ahead, sir.

Gary S. Gillheeney Sr. (President, CEO and Chair of the Board)

Thank you, operator, and welcome everyone to Organogenesis Holdings Q3 fiscal year 2023 earnings conference call. I'm joined on the call today by Dave Francisco, our Chief Financial Officer. Let me start with a brief agenda of what we'll cover during our prepared remarks. I'll begin with an overview of our Q3 revenue results and an update on our key operating and strategic developments in recent months. Dave will then provide you with an in-depth review of our Q3 financial results, our balance sheet, and financial condition at quarter end, as well as our financial guidance for 2023, which we reintroduced in our press release this afternoon. Then I will share some closing thoughts before we open the call for your questions. Let me start by reviewing our revenue for Q3.

We reported net revenue of $108.5 million for the Q3, down 7% year-over-year. Sales of our advanced wound care products decreased 7%, and sales of our surgical and sports medicine products decreased 2% compared to the prior year. Q3 sales reflects the significant business disruption we experienced as a result of the local coverage determinations, or LCDs, published by three Medicare Administrative Contractors on August third, which we discussed on our Q2 conference call. Specifically, after a strong start to the quarter and despite delivering strong year-over-year growth through August, our sales trends were materially impacted during the month of September. The impact of this business disruption was most acutely experienced in the regions of the U.S. where these MACs operate.

Q3 sales in the LCD-impacted MAC regions declined in the high teens year-over-year, and we experienced a modest decline in the non-LCD impacted regions, primarily in the office setting. We are proud of the team's execution and commitment to our mission, not just the commercial team in the field, but throughout the organization, as these teams worked tirelessly following the August 3 announcement, engaging with all relevant parties in advance of the stated effective date of the LCDs to convince these MACs to withdraw the LCDs and thereby protecting the customers and patients that we serve. As announced on September 28, all three MACs withdrew the final LCDs for skin substitute grafts, cellular and/or tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers that were scheduled to take effect on August, excuse me, on October 1.

We applaud the MACs and CMS for carefully considering the shareholders' and stakeholders' concerns regarding the LCD's potential negative impact in putting the needs of patients first in coming to this decision. We thank all of the stakeholders, including physicians, patient advocacy groups, and clinical and industry associations concerned about the negative health outcomes, including prolonged treatment and serious infections, which often lead to amputations and associated higher mortality, for their support in advocating for the withdrawal of the LCD. We also thank the stakeholders concerned about the treatment disparity and health inequity impact of the LCDs that would have had on the populations with higher rates of diabetes and other comorbidities for their support. Now clearly, we are pleased with the withdrawal of the LCDs.

But that said, the overall business disruption in the marketplace, including significant confusion and uncertainty among customers, as well as aggressive and in certain circumstances, questionable competitive response, impacted our capacity to engage with new and existing customers, affecting the adoption and utilization of our products and ultimately affecting our Q3 sales results. While we are pleased with the LCD's withdrawal, we continue to navigate through the challenging environment created by their proposed adoption. We have reintroduced our 2023 financial guidance, which reflects the impacts of business disruption in the Q3, as well as our recovery activities throughout the year. The commercial team is actively reengaging with our customers to bring our products back to the healing algorithms and formularies. These efforts are progressing well.

However, our share of voice has been focused on clarifying the misinformation in the market, limiting our resources on delivering our clinical messaging and expanding our customer base... Turning to an update on our operational progress in recent months, we continue to focus on and invest in expanding manufacturing capacity overall for our portfolio and pipeline, as well as to drive long-term efficiencies to enhance our optionality for the future. We continue to work with outside advisors to identify and evaluate potential options. We are currently targeting a final plan here by the end of calendar year 2023. Our ongoing phase III clinical trial for ReNu for the treatment of knee osteoarthritis continues to progress as planned. We continue to expect to achieve the last patient, last visit milestone by the end of the year, allowing for analysis of the data early next year.

We've also made progress with respect to our second phase III study for ReNu. We enrolled the first patient in September, as expected, and as previously discussed, we expect to have a subsequent discussion with the FDA regarding the clinical data requirements for the BLA, and we intend to propose the current phase III trial, combined with the published 200-patient RCT, as valid scientific evidence and sufficient for a BLA approval. With that, let me turn the call over to Dave.

Dave Francisco (CFO)

Thanks, Gary. I'll begin with a review of our Q3 financial results. Unless otherwise specified, all growth rates referenced during my prepared remarks are on a year-over-year basis. As Gary mentioned, net revenue for the Q3 was $108.5 million, down 7%. Our advanced wound care net revenue for the Q3 was $101.4 million, down 7%, and net revenue from surgical and sports medicine products for the Q3 was $7.2 million, down 2%. Gross profit for the Q3 was $82.7 million, or approximately 76.2% of net revenue, compared to 77.6% last year.

The decrease in gross profit and margin resulted primarily from a decrease in pricing for certain of our products, as well as a shift in product mix compared to the prior year period. Operating expenses for the Q3 were $74.7 million, compared to $88.9 million last year, a decrease of $14.2 million, or 16%. The decrease in operating expenses in the Q3 was driven by a $15.1 million, or 19% decrease in selling, general, and administrative expenses, offset partially by a $0.9 million, or 9% increase in research and development costs compared to the prior year period.

Q3 GAAP operating expenses included $0.1 million of restructuring-related activities, compared to $0.6 million in the prior year, as well as $1.6 million of legal costs and compensation costs related to our efforts to convince the MACs to withdraw the LCDs, compared to no such costs in the Q3 of 2022. Q2 2022 GAAP operating expenses also included certain two non-operating items: $4.2 million charge related to disposal of certain equipment related to the construction in progress in one of the company's Canton, Massachusetts, facilities. $0.6 million of cancellation fees incurred in connection with the company's decision to pause its manufacturing facility construction project.

Excluding these items and non-cash intangible amortization of $1.2 million in both periods, non-GAAP operating expenses for the Q3 decreased $10.5 million, or 13%. The material reduction in our non-GAAP operating expenses is related to the timing of expenses year-over-year, and a result of our proactive strategy to manage costs in light of the challenging operating environment. We have implemented additional cost reduction initiatives in recent weeks that further mitigate the impact to profitability from the lower Q4 revenue outlook. Operating income for the Q3 was $8.1 million, compared to $1.8 million last year, an increase of $6.3 million. Total other expenses net for the Q3 were $0.4 million, compared to $0.6 million last year, a decrease of $0.2 million.

Net income for the Q3 was $3.2 million, compared to $0.2 million last year, an increase of $3 million. Adjusted net income for the Q3 was $5.3 million, compared to $5.1 million last year, an increase of $0.2 million. As a reminder, adjusted net income is defined as GAAP net income, adjusted to exclude the effect of amortization and restructuring charges and the resulting income taxes on those items. Adjusted EBITDA for the Q3 was $16 million, or 14.7% of net revenue, compared to $11.6 million, or 9.9% of net revenue last year. We believe the operating leverage delivered in the Q3 is notable in light of the year-over-year decline in revenue.

We have provided a full reconciliation of our Adjusted EBITDA results in our earnings release. Turning to the balance sheet, as of September thirtieth, 2023, the company had $98.8 million in cash, cash equivalents, and restricted cash, and $67.6 million in debt obligations, compared to $103.3 million in cash, cash equivalents, and restricted cash, and $70.8 million in debt obligations as of December 31st, 2022. We have also up to $125 million of available borrowings on a revolving credit facility as of September thirtieth, 2023. Turning to a review of our 2023 financial guidance, which we reintroduced in our press release this afternoon.

For the twelve months ending December 31, 2023, the company now expects net revenue of between $433 million and $446 million, representing a year-over-year decrease in the range of 1%-4%, as compared to net revenue of $450.9 million for the year ended December 31, 2022. The 2023 net revenue guidance range assumes net revenue from advanced wound care products of between $406 million and $418 million, representing a year-over-year decrease in the range of 1% to 4. Net revenue from surgical and sports medicine products between $27 million and $29 million, representing a year-over-year decrease in the range of flat to down 6%.

In terms of profitability guidance for 2023, the company expects to generate GAAP net income of between $4 million and $9 million, and adjusted net income of between $11 million and $17 million. We also expect EBITDA between $26 million and $37 million, and Adjusted EBITDA of between $40 million and $51 million. In addition to our formal financial guidance for 2023, we are providing some considerations for modeling purposes. For the fiscal year 2023, we now expect the midpoint of our total revenue range for 2023, now assumes sales of PuraPly products to decrease approximately 23% year-over-year, and sales of our non-PuraPly products will increase approximately 21% year-over-year. Our profitability guidance now assumes gross margins of approximately 76% to 76.5.

Total GAAP operating expenses will decrease approximately 1%-2% year-over-year, and total non-GAAP operating expenses will be roughly flat year-over-year. Our 2023 non-GAAP operating expenses include non-cash and tangible amortization of approximately $4.9 million, estimated restructuring charges of $3.4 million, and $1.6 million of other non-operating items related to our efforts to convince the MAC to withdraw the LCDs. Total interest and other expenses of approximately $2.2 million. GAAP tax rate in the range of 51% to 53 at the high end and low end of our guidance range, respectively, and we continue to expect non-GAAP tax rate on adjustments of 27%.

We now expect non-cash depreciation of approximately $9.9 million, and non-cash stock comp expense of approximately $9 million, and weighted average diluted shares of approximately 133 million. We also expect full year 2023 CapEx to be approximately $25 million to 30 million. With that, I'll turn the call back over to Gary for some closing remarks.

Gary S. Gillheeney Sr. (President, CEO and Chair of the Board)

Thanks, Dave. Before we open the call to your questions, I wanted to share some additional thoughts on our near-term outlook and underlying assumptions supporting our updated guidance for 2023. The environment remains challenging as a result of the LCD having been announced, despite their withdrawal on September 28. While sales trends in October have improved as compared to September, we're experiencing significant business disruption, driven by customer confusion and uncertainty, as well as the aggressive and in certain circumstances, questionable competitive response. Our Q4 guidance assumes improvement as we move through the quarter, but we expect our sales reps to be spending more time servicing existing customers and regaining lost customers versus cultivating new customer adoptions. This is a primary driver of the lower revenue expectations reflected in our updated guidance as compared to what our prior guidance assumed for the Q4 of 2023.

While the second half growth trajectory for Organogenesis has been impacted by the LCD-related customer confusion, we believe this is largely transitory. We continue to actively engage with customers and have multiple commercial support programs underway with targeted strategies to regain lost accounts and enhance existing customer relationships. As we build our customer base back in the Q4, we are building momentum as we close out 2023. Looking ahead to 2024, we will launch new products across both advanced wound care and surgical sports medicine markets, and will continue to be a leader in the space with highly innovative, highly efficacious products that deliver on our mission to provide integrated healing solutions that substantially improve outcomes while lowering the overall cost of care. With that, I'll turn the call over to the operator to open the call up for questions. Thank you.

Operator (participant)

Thank you, sir. If you'd like to ask a question, please signal by pressing star one one on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Our first question will come from Ryan Zimmerman with BTIG. Please go ahead.

Ryan Zimmerman (Managing Director and Medical Technology Analyst)

Hey, thanks for taking the questions. I'm juggling a few calls tonight, so I apologize if this was covered earlier, Gary. But CMS's final rule came out recently for 2024. Really didn't have much change, kind of despite all the angst and speculation this year in terms of how CMS, you know, thinks about skin substitutes and so forth. And just curious kind of how we should be thinking about the market dynamics, given, you know, the continuation of a high-cost, low-cost bundle structure, and really just, you know, your view of, excuse me, of whether at some point there is gonna be a change in, you know, payment models in this area of medicine.

Gary S. Gillheeney Sr. (President, CEO and Chair of the Board)

Yeah, sure. Thanks for the question, Ryan. So you're correct, the 2024, you know, physician fee and hospital outpatient reimbursement really didn't have much change at all. I think going forward, there will be some changes, particularly in the office setting. I think the dynamics of the market right now, I think maybe the impetus behind some of the LCD changes that were rescinded was to bring discipline to the market and stability to the market, and I think that's necessary. So I do think over time there will be a change in the office, I think, and an appropriate change, I think, could be very positive, quite frankly.

So, you know, we've advocated for, you know, an ASP plus six model, which we think would bring some stability quickly to the market. But I think going forward, we're also looking at more creative bundling scenarios that I think could actually be better for patient care and more stable for the industry, and really bring some distinction between the products and the overall efficacy of those products. So I think we'll see something in the next 2-3 years.

... I think there'll be structural changes, particularly in the office, in HOPD. There may be a response, you know, to whatever changes in the office. So there aren't, you know, incentives to push more patients back into the office, excuse me, back into the hospital, which is a higher cost setting. So they need to coordinate, in my opinion, those two models, and I think they will, and I think that'll happen in the next 2-3 years.

Ryan Zimmerman (Managing Director and Medical Technology Analyst)

Very helpful. And, you know, the LCDs being pulled, I think, was a win for you guys, and it, you know, as you noted, didn't make a whole lot of sense. But there is confusion in the market, and so just help us understand, you know, beyond Q4 of this year, how you think that can... You know, does that continue? I mean, you know, how are you kind of preparing to inform the market, you know, given that there aren't these changes happening from the LCDs?

Gary S. Gillheeney Sr. (President, CEO and Chair of the Board)

Yeah, great question. And as I mentioned in the prepared remarks, a lot of our share of voice in those affected MAC areas, and even outside of the impacted MACs, there's a lot of misinformation, and we're spending a lot of our share of voice on correcting that misinformation and making sure our customers do understand that, you know, our products are, you know, reimbursed and getting them back on formulary. You know, it's particularly in HOPD, where it's a more efficient model that, you know, they'll quickly take you off, you know, their formulary if there's a reimbursement change, an expected change, particularly when you think about the treatment algorithm, you know, with a patient, it's typically not one application. So, you know, you need to address that from a reimbursement perspective early.

So that happened very quickly in HOPD, and we experienced it. Getting it back on formulary is a longer process through, you know, MAC and other processes that they have. So we're in that process, and we're addressing each and every one of those accounts. In the office area, you know, we're handling those pretty much one on one. Fortunately, we have really strong share of voice and brand loyalty in those accounts, and we're moving them back to Organogenesis accounts very quickly. But it is a, it's a Q4 effort. As I mentioned, we are seeing a nice trend. September was the worst month. We've seen improvements in October.

Even through the month of October, we're seeing improvements in November, and we expect to have a majority of those accounts, you know, back with us at the end of the year, which positions us, you know, really well for growth in 2024.

Ryan Zimmerman (Managing Director and Medical Technology Analyst)

Okay. Thanks for taking my questions.

Gary S. Gillheeney Sr. (President, CEO and Chair of the Board)

Sure. Anytime.

Operator (participant)

Thank you. As a reminder, if you'd like to ask a question at this time, please signal by pressing star one one on your telephone keypad. We are currently showing no remaining questions in the queue at this time. That does conclude our conference for today. Thank you for your participation.

Gary S. Gillheeney Sr. (President, CEO and Chair of the Board)

Thank you.