Organogenesis Q3 2023 Earnings Call Transcript

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Provided by Quartr
November 9, 2023

There are 4 speakers on the call.

Operator

Welcome, ladies and gentlemen, to the Third Quarter 2023 Earnings Conference Call for Organogenesis Holdings, Inc. At this time, all participants have been placed in a 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.

Operator

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 or GAAP. We generally refer to these as non GAAP financial measures. Reconciliations of those non GAAP financial measures 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.

Operator

Gary S. Gilhaney, Sr, Organogenesis Holdings President, Chief Executive Officer and Chair of the Board. Please go ahead, sir.

Speaker 1

Thank you, operator, and welcome everyone to Organogenesis Holdings Third Quarter 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.

Speaker 1

Let me start by reviewing our revenue for Q3, we reported net revenue of $108,500,000 for the 3rd quarter, 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 LCD published by 3 Medicare administrative contractors on August 3, 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 experienced in the regions of the U. S.

Speaker 1

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 work Hirelessly, following the August 3rd announcement, engaging with all relevant parties in advance of the stated effective date of the LCDs to convince the MAX to withdraw the LCDs and thereby protecting the customers and patients that we serve. As announced on September 28, all 3 MAX withdrew the final LCDs for skin substitute grafts, desalination and or tissue based products for the treatment of diabetic foot ulcers and venous leg ulcers that was scheduled to take effect on October 1. We applaud the MAX and CMS for carefully considering the shareholders and stakeholders concerns regarding the LCD's potential negative impact and putting the needs of patients first in coming to this decision. We thank all of the stakeholders, including physicians, patient advocacy groups And clinical industry associations concerned about the negative health outcomes, including prolonged treatment and serious infection, which often lead to amputation and associated higher mortality for their support and advocating for the withdrawal of the LTD.

Speaker 1

We also thank the stakeholders concerned about the treatment disparity and health inequity impact of the LCD that would have had on the populations with higher rates diabetes and other comorbidities for their support. Clearly, we are pleased with the withdrawal of the LCDs. With that said, the overall business disruption in the marketplace, including significant confusion and uncertainty among customers, as well as aggressive in certain circumstances questionable competitive response impacted our capacity to engage With new and existing customers affecting the adoption and utilization of our product and ultimately affecting our 3rd quarter 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 impact of business disruption in the Q3 as well as our recovery activities throughout the year.

Speaker 1

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 Overall for our portfolio and pipeline as well as to drive long term efficiencies enhance our optionality for the future. We continue to work with outside advisors to identify and evaluate potential options.

Speaker 1

We are currently targeting a final plan hereby the end of calendar year 2023. Our ongoing Phase 3 clinical trial for RENEW for the treatment of knee osteoarthritis continues progressed 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 2nd Phase 3 study for RENEW. We enrolled the 1st patient in September as expected.

Speaker 1

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 3 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.

Speaker 2

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 $108,500,000 down Our Advanced Wound Care net revenue for the Q3 was $101,400,000 down 7% and net revenue from Surgical and Sports Medicine products for the Q3 was $7,200,000 down 2%. Gross profit for the Q3 was $82,700,000 or approximately 70 0.2% of net revenue compared to 77.6% last year.

Speaker 2

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 $74,700,000 compared to $88,900,000 last year, a decrease of $14,200,000 or 16%. The decrease in operating expenses in the 3rd quarter was driven by a $15,100,000 or 19% decrease in selling, general and administrative expenses, offset partially by a $900,000 or 9% increase in research and development costs compared to the prior year period. 3rd quarter GAAP operating expenses included $100,000 of restructuring related activities compared to $600,000 in the prior year as well as $1,600,000 of legal costs and compensation costs related to our efforts to convince the MAX to withdraw the LCDs compared to no such costs in the Q3 of 2022. Q3 2022 GAAP operating expenses also included certain 2 non operating items, $4,200,000 charge related to disposal of certain equipment related to the construction in progress in one of the company's Canton, Massachusetts facilities $600,000 of cancellation fees incurred in connection with the company's decision deposits manufacturing facility construction project.

Speaker 2

Excluding these items and non cash intangible amortization of $1,200,000 in both periods, non GAAP operating expenses for the 3rd quarter decreased $10,500,000 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 further mitigate the impact to profitability from the lower 4th quarter revenue outlook. Operating income for the Q3 was $8,100,000 compared to $1,800,000 last year, an increase of $6,300,000 Total other expenses net for the Q3 were $400,000 compared to $600,000 last year, a decrease of $200,000 And net income for the Q3 was $3,200,000 compared to $200,000 last year, an increase of 3,000,000 Adjusted net income for the Q3 was $5,300,000 compared to $5,100,000 last year, an increase of 200,000 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 $16,000,000 or 14.7 percent of net revenue compared to $11,600,000 or 9.9 percent of net revenue last year.

Speaker 2

We believe the operating leverage delivered in the 3rd quarter is notable in light of the year over year We have provided a full reconciliation of our adjusted EBITDA results in our earnings release. Turning to the balance sheet. As of September 30, 20 The company had $98,800,000 in cash, cash equivalents and restricted cash and $67,600,000 in debt obligations, compared to $103,300,000 in cash, cash equivalents and restricted cash and $70,800,000 in debt obligations as of December 31, 2022. We've also up to $125,000,000 of available borrowings on our revolving credit facility as of September 30, 2023. Turning to a review of our 2023 financial guidance, which we reintroduced in our press release this afternoon.

Speaker 2

For the 12 months ending December 31, 2023, the company now expects net revenue of between $433,000,000 443,000,000 Representing a year over year decrease in the range of 1% to 4% as compared to net revenue of $450,900,000 for the year ended December 31, 2022. The 2023 net revenue guidance range assumes net revenue from Advanced Wound Care products of between $406,000,000 $418,000,000 representing a year over year decrease in the range of 1% to 4%. Net revenue from surgical and sports medicine products between $27,000,000 29,000,000 representing a year over year decrease in the range of flat to down 6%. In terms of profitability guidance for 20 The company expects to generate GAAP net income of between $4,000,000 $9,000,000 and adjusted net income of between $11,000,000 17,000,000 We also expect EBITDA between $26,000,000 $37,000,000 and adjusted EBITDA of between $40,000,000 51,000,000 In addition to our formal financial guidance for 2023, we are providing some considerations for modeling purposes. For the fiscal year 2023, we now 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.

Speaker 2

Our profitability guidance now assumes gross margins of approximately 76% to 76.5%. Total GAAP operating expenses will decrease approximately 1% to 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 intangible amortization of approximately $4,900,000 estimated restructuring charges of $3,400,000 and $1,600,000 of other non operating items related to our efforts to convince the MAX to withdraw the LCDs. Total interest and other expenses of approximately 2,200,000 GAAP tax rate in the range of 51% to 53% at the high end and low end of our guidance range respectively, and non cash stock comp expense of approximately $9,000,000 and weighted average diluted shares of approximately 133,000,000 We also expect full year 2023 CapEx to be approximately $25,000,000 to $30,000,000 With that, I'll turn the call back over to Gary for some closing remarks.

Speaker 1

Thanks, Dave. And 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 LCDs haven't 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 aggressive and in certain circumstances questionable competitive response. Our 4th quarter guidance assumes improvement as we move through the quarter, but we expect our sales reps to be spending more time servicing existing 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.

Speaker 1

While the second half growth trajectory for Organogenesis has been impacted by LCD related customer confusion, we believe this is largely transitory. We continue to actively engage with customers and have multiple commercial programs underway with targeted strategy 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 market 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.

Speaker 1

Thank you.

Operator

Thank you, sir. And our first question will come from Ryan Zimmerman with BTIG. Please go ahead.

Speaker 3

Hey, thanks for taking the questions. 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 thinks about Skin substitutes and so forth. And just curious kind of how we should be thinking about the market dynamics given The continuation of a high cost, low cost bundle structure and really just your view Of whether at some point there is going to be a change in payment models in this area of medicine?

Speaker 1

Yes. Sure. Thanks for the question, Ryan. So you're correct. The 2024 Physician fee and hospital outpatient reimbursement really Didn't have much change at all.

Speaker 1

I think going forward that 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, We've advocated for an ASP plus 6 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.

Speaker 1

So I think we'll see something in the next 2 to 3 years. I think there'll be structural changes, particularly in the office, In HOPD, there may be a response to whatever changes in the office. So there aren't 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 will happen in the next 2 to 3 years.

Speaker 3

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

Speaker 1

Yes, 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 impact at MAX, 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 our products are reimbursed and getting them back on formulary, It's particularly in HOPD where it's a more efficient model that they'll quickly take you off Their formulary, if there's a reimbursement change and expected change, particularly when you think about the treatment algorithm with a patient, It's typically not one application. So 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 the back and other Processes that they have.

Speaker 1

So we're in that process and we're addressing each and every one of those accounts. In the office area, We are handling those pretty much 1 on 1. 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 4th quarter Effort, as I mentioned, we are seeing a nice trend. September was the worst month.

Speaker 1

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 back with us At the end of the year, which positions us really well for growth in 2024.

Speaker 3

Okay. Thanks for taking my questions.

Operator

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.

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Key Takeaways

  • Organogenesis reported Q3 net revenue of $108.5 million, down 7% year-over-year in Advanced Wound Care and 2% in Surgical & Sports Medicine, largely driven by LCD-related market disruptions.
  • Three Medicare Administrative Contractors issued Local Coverage Determinations on August 3rd that significantly hurt sales in affected regions, but all LCDs were withdrawn on September 28 after engagement with CMS, physicians, and patient groups.
  • Gross margin contracted to 70.2% and GAAP operating expenses fell 16%, helping lift adjusted EBITDA to $16.0 million (14.7% of revenue) in Q3 despite the sales headwinds.
  • The company reintroduced full-year 2023 guidance of $433 million–$443 million in net revenue (down 1–4%), GAAP net income of $4 million–$9 million, and adjusted EBITDA of $40 million–$51 million, assuming a 23% decline in PuraPly sales and 21% growth in other products.
  • The ongoing Phase 3 RENEW trial for knee osteoarthritis remains on track for last patient visits by year-end, and a second Phase 3 study has begun, with plans to combine data for a BLA submission.
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Earnings Conference Call
Organogenesis Q3 2023
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