Q1 2024 Organogenesis Holdings Inc Earnings Call

May 9, 2024

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Operator: Welcome, ladies and gentlemen, to the first quarter of fiscal year 2024, IRINC's 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.

Welcome, ladies and gentlemen to the first quarter of fiscal year 2024 earnings conference call for organic Genesis Holdings, Inc.

Operator: At this time, all participants have been placed in listen only mode. Please.

Operator: Please note that this conference call is being recorded.

Operator: And that the recording will be available on the company's website for replay shortly.

Operator: 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 I indicate, as 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 report. Please use caution not to place undue reliance upon any forward-looking statements, which speak only as of the date made.

Operator: 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.

Operator: Scribed in the company's filings with the Securities and Exchange Commission, including item one a risk factors of the company's most recent annual report and it subsequently filed quarterly reports.

Operator: 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 statement, whether as a result of new information, future events, or otherwise, except as required by applicable securities law. 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.

Operator: Although it may voluntarily do so from time to time the company undertakes no commitment to update or revise the forward looking statements.

Speaker Change: Whether as a result of new information future events or otherwise, except as required by applicable securities laws.

Speaker Change: This call will also include references to certain financial measures that are not calculated in accordance with generally accepted accounting principles or GAAP.

Speaker Change: We generally refer to these as non-GAAP financial measures.

Speaker Change: 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.

Speaker Change: I would now like to turn the call over to Mr. Gary <unk> senior.

Speaker Change: Ganoe Genesis Holdings, President Chief Executive Officer, and chair of the Board. Please go ahead Sir.

Gary S. Gillheeney: Thank you, operator, and welcome everyone to Organogenesis Holdings' first quarter fiscal year 2024 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 will cover during our prepared remarks.

Speaker Change: Thank you operator, and welcome everyone to organic Genesis Holdings first quarter fiscal year 2024 earnings conference call.

Speaker Change: On the call today by Dave Francisco, our Chief Financial Officer.

Gary S. Gillheeney: I will begin with an overview of our first quarter revenue results and an update on our key operating and strategic developments in recent months. Dave will then provide an in-depth review of our first quarter financial results, our balance sheet and financial condition at quarter end, as well as our financial guidance for 2024, which we reaffirmed in our press release this afternoon. Then I will share some closing thoughts before we open the call to your questions.

Speaker Change: Let me start with a brief agenda of what we will cover during our prepared remarks.

Gary S. Gillheeney: I will begin with an overview of our first quarter revenue results and an update on our key operating and strategic developments in recent months.

Gary S. Gillheeney: Dave will then provide an in depth review of our first quarter financial results, our balance sheet and financial condition at quarter end as well as our financial guidance for 2024, which we reaffirmed in our press release this afternoon.

Gary S. Gillheeney: Then I will share some closing thoughts before we open the call for your questions.

Gary S. Gillheeney: Beginning with a review of our revenue results for Q1. Our sales results came in above the high end of the guidance range outlined on our fourth quarter call, reflecting a continuation of the positive momentum in business trends in early 2024 that we discussed on our call at the end of February. Our commercial team continues to see progress in their broad-based efforts to reengage with our customers to bring our products back into the healing algorithms and formularies.

Speaker Change: Beginning with a review of our revenue results for Q1.

Gary S. Gillheeney: Our sales results came in above the high end of the guidance range outlined on our fourth quarter call, reflecting a continuation of the positive momentum in business trends in early 2024 that we discussed on our call at the end of February.

Gary S. Gillheeney: Our commercial team continues to see progress and their broad based efforts to reengage with our customers to bring our product back to the healing algorithms and formularies.

Gary S. Gillheeney: We believe our first quarter results support our confidence that we focused our commercial team on the right strategy to navigate this challenging operating environment. We are encouraged by the evidence that the commercial support programs we implemented to enhance our existing customer relationships regained lost accounts and to drive growth in our customer base by emphasizing our differentiated products and that clinical validation is continuing to prove effective. Now, we turn to an update on our progress on our Renew program.

Gary S. Gillheeney: We believe our first quarter results support our confidence that we focused our commercial team on the right strategy to navigate this challenging operating environment.

Gary S. Gillheeney: We are encouraged by the evidence that the commercial support programs, we implemented to enhance our existing customer relationships regained lost accounts and to drive growth in our customer base by emphasizing our differentiated products and their clinical validation are continuing to prove effective.

Gary S. Gillheeney: Our ongoing Phase III clinical trial evaluating the use of RENEW for the management of symptoms associated with knee osteoarthritis has continued to progress favorably in recent months. Last week, we announced top-line results from our first phase 3 clinical trial to evaluate the safety and efficacy of RENEW for the management of symptoms associated with knee osteoarthritis. Top-line data was positive, and the primary endpoint was achieved with a p-value of The study demonstrated a statistically significant reduction in knee-away pain at six months as assessed by the Western Ontario McMaster University Arthritis Index pain scale compared to the subjects treated with saline control.

Gary S. Gillheeney: Turning to an update on our progress on our renewable program.

Gary S. Gillheeney: Our ongoing phase III clinical trial evaluating the use of renewable for the management of symptoms associated with knee osteoarthritis have continued to progress favorably in recent months.

Gary S. Gillheeney: Last week, we announced topline results from our first phase III clinical trial to evaluate the safety and efficacy of renew for the management of symptoms associated with knee osteoarthritis.

Gary S. Gillheeney: <unk> data was positive and the primary endpoint was achieved with a P value of 0.0 $1 77. The study demonstrated a statistically significant reduction in knee OA pain at six months as assessed by the Western Ontario, Mcmaster University arthritis index pain scale compared to the <unk>.

Gary S. Gillheeney: Subjects treated with saline control.

Gary S. Gillheeney: In addition to improving neo-A-pain symptoms, Renu maintained patient function compared to saline control with a P-value of less than 0.0001. Renu also showed a favorable safety profile which is consistent with our prior studies. If approved, we believe introducing RENEW to a large and growing pain management market represents a transformational opportunity for organogenesis. If approved, introducing Renew as an innovative pain management solution for the millions of patients suffering from Neo-A represents a significant new addressable market opportunity for organogenesis.

Gary S. Gillheeney: In addition to improving knee OA pain symptoms renew maintain patient function compared to saline control with a P value of less than 0.0001.

Gary S. Gillheeney: Renewed showed a favorable safety profile, which is consistent with our prior studies.

Gary S. Gillheeney: If approved we believe introducing renew to a large and growing pain management market represents a transformational opportunity for Ganoe Genesis if.

Gary S. Gillheeney: If approved introducing new and innovative pain management solution for the millions of patients suffering from knee OA represents a significant new addressable market opportunity for organogenesis.

Gary S. Gillheeney: Specifically, by 2027, an estimated 34.4 million Americans are expected to be affected by Neo-A. While there is no known treatment that completely cures knee OA, it is possible to treat the disease symptoms with the goal of avoiding or delaying costly and invasive knee replacement surgery.

Gary S. Gillheeney: Specifically by 2027% an estimated $34 4 million Americans are expected to be affected by knee OA.

Gary S. Gillheeney: While there is no known treatment that completely curious it is possible to treat disease symptoms with the goal of avoiding or delaying costly and invasive knee replacement surgery.

Gary S. Gillheeney: We believe RENEW, if approved, will address an unmet clinical need for all patients suffering from moderate to severe symptomatic knee osteoarthritis, and we are particularly excited about the unique opportunity for RENEW to serve the most severe knee OA patients who have limited non-surgical options, representing an estimated 5 million Americans. If successful, Renu would be the only FDA-approved biologic intra-articular injection to improve pain symptoms, even in the most severe cases of NeoA.

Gary S. Gillheeney: We believe renewable if approved will address an unmet clinical need for all patients suffering from moderate to severe symptomatic knee osteoarthritis and we are particularly excited about the unique opportunity for new to serve the most severe knee OA patients who have limited non surgical options representing an estimated five.

Gary S. Gillheeney: 5 million Americans.

Gary S. Gillheeney: If successful renew would be the only FDA approved biologic intra articular injection to improve pain symptoms even in the most severe cases of knee OA.

Gary S. Gillheeney: By way of reminder, 30% of the enrolled patients in the first phase 3 trial were in the most severe Neo-A patient population, also known as KL4. Based on the positive results of this clinical trial, along with our accumulated safety and efficacy data from our published 200-patient RCT and RENU's RMAT designation for NeoA, we intend to request a meeting with the FDA to discuss the clinical data requirements for a biologic license application dossier.

Gary S. Gillheeney: By way of reminder, 30% of the enrolled patients in the first phase III trial.

Gary S. Gillheeney: <unk> of the most severe knee OA patient population also known as <unk> for us.

Gary S. Gillheeney: Based on the positive results of this clinical trial, along with our accumulated safety and efficacy data from our published 200 patient RCT and renews or Matt designation for knee OA, we intend to request a meeting with the FDA to discuss the clinical data requirements for a biologic license application file.

Gary S. Gillheeney: Our team is targeting completion of data analysis by the end of May, and we look forward to sharing further information shortly thereafter on Renu's performance in this important Phase III prospective double-blinded, multi-center, saline-controlled, parallel-group clinical trial of 515 patients. We're also pleased with the notable progress we are seeing in our second phase three trial. We continue to see momentum in the pace of enrollment, and our current timeline has us achieving full enrollment by the end of the year, well ahead of our original expectation when we started enrolling patients in this study last September.

Gary S. Gillheeney: Our team is targeting completion of data analysis by the end of May and we look forward to sharing further information shortly thereafter.

Gary S. Gillheeney: <unk> performance in this important phase III perspective, double blinded multicenter saline controlled parallel group clinical trial of 515 patients.

Gary S. Gillheeney: We're also pleased with the notable progress we are seeing in our second phase III trial.

Gary S. Gillheeney: We continue to see momentum in the pace of enrollment and our current timeline has is achieving full enrollment by the end of the year well ahead of our original expectation when we started enrolling patients in this study last September.

Gary S. Gillheeney: Before turning the call over to Dave, I wanted to share a few thoughts on recent developments in the area of Medicare reimbursement and coverage. On April 25th, a collaborative proposed LCD was published by seven Medicare administrative contractors.

Speaker Change: Before turning the call over to Dave I wanted to share a few thoughts on recent developments in the area of Medicare reimbursement and coverage.

Gary S. Gillheeney: On April 25th collaborative proposed LCD was published by seven Medicare administrative contractors. The proposed LCD addresses skin substitute graphs selia cellular <unk> tissue based products for the treatment of diabetic foot ulcers and venous leg ulcers in the Medicare population.

Gary S. Gillheeney: The proposed LCD addresses skin substitute grafts, cellular, and or tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers in the Medicare population. As outlined by CMS, the LCD was issued to make sure that Medicare beneficiaries and people with Medicare have access to skin substitute products that are supported by evidence and that show they are reasonable and necessary for the treatment of diabetic foot and venous leg ulcers in the Medicare population, and that coverage aligns with professional guidelines for appropriately managing these wounds. The proposed LCD also calls for limiting the number of applications to four per case, as well as including allowances for additional treatment applications in cases where medically necessary.

Gary S. Gillheeney: As outlined by CMS. The LCD was issued to make sure that Medicare covers and people with Medicare have access to skin substitute products that are supported by evidenced in that show they are reasonable and necessary for the treatment of diabetic foot and venous leg ulcers in the Medicare population and that coverage aligns with professional guidelines.

Gary S. Gillheeney: For appropriately managing these wounds.

Gary S. Gillheeney: The proposed LCD also caused for limiting the applications to four per case as well as including allowances for additional treatment applications in cases, where medically necessary.

Gary S. Gillheeney: We applaud CMS and NMACS for continuing to prioritize coverage with demonstrated clinical efficacy for skin substitute products. We have been pushing for reform for many years and believe this proposed LCD represents a substantial step forward towards cleaning up the market. Importantly, we are confident that Organogenesis will be well positioned to gain market share now and in the future. The proposed LCD includes 15 covered skin substitute products, which the MACs believe have the requisite published, peer-reviewed clinical evidence to support reimbursement.

Gary S. Gillheeney: We applaud CMS and the Max for continuing to prioritize coverage with demonstrated clinical efficacy for skin substitute product, we have been pushing for reform for many years and believe this proposed LCD represents a substantial step forward towards cleaning up the marketplace.

Gary S. Gillheeney: Accordingly, we are confident that organogenesis will be well positioned to gain market share now and in the future.

Gary S. Gillheeney: The proposed LCD includes 15 covered skin substitute products, which the Max belief have the requisite published peer reviewed clinical evidence to support reimbursement.

Gary S. Gillheeney: Importantly, the proposed LCD also includes a list of approximately 200 skin substitutes that are currently sold in the market today that have been designated as non-covered. Two of our commercialized brands are included on the proposed LCD covered list, Applegraph and Affinity, the latter of which is the only living amniotic offering on the covered list. We have four commercialized brands, Puriply, New Shield, Novacor, and Cygnus, that were designated as non-covered as part of the proposed LCD.

Gary S. Gillheeney: Importantly, the proposed LCD also includes a list of approximately 200 skin substitutes that are currently sold in the market today that have been designated as non covered.

Gary S. Gillheeney: Two of our commercialized brands are included on the proposed LCD covered list Apograph an affinity the latter of which is the only living amniotic offering on the covered list.

Gary S. Gillheeney: We have four commercialized brands pure apply new shield <unk> and Cigna that were designated as non covered as part of the proposed LCD.

Gary S. Gillheeney: We have a strategy to leverage existing strong clinical and real-world data, including RCTs, and have already initiated new RCTs to secure additional clinical evidence. We expect to have compelling cases to present to MAX to secure coverage for additional products on the covered list later this year and into next year. We strongly believe these material changes from CMS and the MACs in reimbursement of skin substitutes will be positive for the long-term health of the wound care market.

Gary S. Gillheeney: We have a strategy to leverage existing strong clinical and real world data, including <unk> and have already initiated new RCT to secure additional clinical evidence.

Gary S. Gillheeney: We expect to have compelling cases to present to the Max this year.

Gary S. Gillheeney: Secure coverage for additional products on the covered list later this year and into next year.

Gary S. Gillheeney: We strongly believe these material changes from CMS in the Max and reimbursement of skin substitute if ultimately adopted will be positive for the long term health of the wound care market.

Gary S. Gillheeney: While it will be a period of transition and disruption if these sweeping changes are implemented, we believe that Organogenesis' strong brand equity, established commercial infrastructure, and a plan to establish additional clinical validation to secure coverage of key commercialized products, which taken together represent a substantial competitive advantage for us that has us well positioned to maximize the enormous opportunity to serve more patients with our highly innovative and highly efficacious products. With that, I'll turn the call over to Dave. Thanks, Gary.

Gary S. Gillheeney: While it will be a period of transition and disruption if the sweeping changes are implemented we believe that organogenesis strong brand equity established commercial infrastructure and our plan to establish additional clinical validation to secure coverage of key commercialized products, which taken together represent a substantial competitive advantage for us.

Dave: That has us well positioned to maximize the enormous opportunity to serve more patients with our highly innovative and highly efficacious products.

Dave: With that I'll turn the call over to date.

David C. Francisco: Thanks, Gary. I'll begin with a review of our first quarter financial results. Unless otherwise specified, all growth rates referenced during my prepared remarks are on a year-over-year basis. Net revenue for the first quarter was $110 million, up 2%. As Gary mentioned, these results were well ahead of expectations.

Dave: Thanks, Larry I'll begin with a review of our first quarter financial results.

David C. Francisco: Otherwise specified all growth rates referenced during my prepared remarks are on a year over year basis.

David C. Francisco: Net revenue for the first quarter was $110 million up 2%.

David C. Francisco: As Gary mentioned these results were well ahead of expectations, we provided on our fourth quarter call, which called for a total first quarter revenue in the range of $98 million to a $104 million as we experienced strong momentum building at the end of February that carried into March.

David C. Francisco: We provided on our fourth quarter call, which called for a total first quarter revenue in the range of $98 million to $104 million, as we experienced strong momentum building at the end of February that carried into March. Our Advanced Wound Care Net Revenue for the first quarter was $103.9 million, up 3%, and Net Revenue for Surgical and Sports Medicine Products for the first quarter was $6.1 million, down 9%. Gross profit for the first quarter was $81.3 million, or 73.9% of net revenue, compared to 75.3% last year. Gross margin was impacted year-over-year primarily due to shifts in product mix compared to the prior year period.

David C. Francisco: Operating expenses for the first quarter were $85.1 million compared to $85 million last year, an increase of $0.1 million, or less than 1%. The year-over-year change in operating expenses in the first quarter was driven by a 1.5 million, or 2%, decrease in selling general administrative expenses, offset by a 1.6 million, or 14%, increase in research and development costs compared to the prior year period. Operating loss for the first quarter was $3.9 million compared to an operating loss of $4 million last year, a decrease of $0.1 million.

David C. Francisco: Our advanced wound care net revenue for the first quarter was $103 9 million up 3% and net revenue for surgical and sports medicine products for the first quarter was $6 1 million down 9%.

David C. Francisco: Gross profit for the first quarter was $81 3 million or <unk> 73, 9% of net revenue compared to 75, 3% last year.

David C. Francisco: The gross margin was impacted year over year, primarily due to shifts in product mix compared to the prior year period.

David C. Francisco: Operating expenses for the first quarter was $85 1 million compared to $85 million last year, an increase of <unk> 1 million or less than 1%.

David C. Francisco: The year over year change in operating expenses in the first quarter was driven by a $1 5 million or 2% decrease in selling general and administrative expenses offset by a $1 6 million or 14% increase in research and development costs compared to the prior year period.

David C. Francisco: Operating loss for the first quarter was $3 9 million compared to an operating loss of $4 million last year, a decrease of <unk> 1 million.

David C. Francisco: Net loss of the first quarter was $2.1 million, compared to a net loss of $3 million last year, a decrease of $0.9 million. Adjusted net loss for the first quarter was $1.4 million, compared to $0.7 million last year, an increase in adjusted net loss of $0.8. As a reminder, adjusted net income is defined as gap net income adjusted to exclude the effects of amortization and other certain items and resulting income taxes on those.

David C. Francisco: Net loss for the first quarter was $2 1 million.

David C. Francisco: <unk> to net loss of $3 million last year, a decrease of <unk> 9 million adjusted.

David C. Francisco: Adjusted net loss for the first quarter was $1 4 million compared to <unk> $7 million last year, an increase in adjusted net loss of <unk> $8 million.

David C. Francisco: As a reminder, adjusted net income is defined as GAAP net income adjusted to exclude the effects of amortization and other certain items and resulting income taxes on those items.

David C. Francisco: Adjusted EBITDA for the first quarter was $2.6 million, or 2.3% of net revenue, compared to $3.8 million, or 3.5% of net revenue last quarter. We have provided a full reconciliation of our adjusted net income and adjusted EBITDA results in our earnings. Turning to the balance sheet, as of March 31st, 2024, the company had $89.3 million in cash and cash equivalents and restricted cash, and $64.9 million in debt. That compared to $104.3 million in cash, cash equivalents, and restricted cash, and $66.2 million in debt obligations as of December 31st, 2023. We also have up to $125 million of available borrowings on our Revolve and Credit Facility as of March 31, 2024.

David C. Francisco: Adjusted EBITDA for the first quarter was $2 6 million or two 3% of net revenue compared to $3 8 million or three 5% of net revenue last year.

David C. Francisco: We have provided a full reconciliation of our adjusted net income and adjusted EBITDA results in our earnings release.

David C. Francisco: Turning to the balance sheet as of March 31, 2024, the company had $89 3 million in cash and cash equivalents and restricted cash and $64 9 million of debt obligations that compared to $104 3 million in cash cash equivalents and restricted cash and $66 2 million in debt obligations as of December 31, 2020.

David C. Francisco: Three.

David C. Francisco: We also have up to $125 million of available borrowings on our revolving credit facility as of March 31 2024.

David C. Francisco: Turning to a review of our 2024 financial guidance, despite the strong momentum that we are experiencing in the business, we are reaffirming our prior guidance that we referenced in our press release this afternoon to account for the potential near-term disruption in the market that we expect from the LCD. For the 12 months ended December 31st, 2024, the company continues to expect net revenue between $445 million and $470 million, representing a year-over-year increase in the range of 3% to 9% as compared to net revenue of $433.1 million for the year ended December 31st, 2023.

David C. Francisco: Turning to a review of our 2024 financial guidance. Despite strong momentum that we're experiencing in the business. We are reaffirming our prior guidance that we referenced in our press release. This afternoon to account for the potential near term disruption in the market that we expect from the LCD.

David C. Francisco: For the 12 months ended December 31, 2024. The company continues to expect net revenue between $445 million and 470 million representing a year over year increase in the range of 3% to 9% as compared to net revenue of $433 1 million for the year ended December 31 2023.

David C. Francisco: The 2024 Net Revenue Guidance Range assumes net revenue from advanced wound care products between $415 million and $435 million, representing a year-over-year increase in the range of 2% to 7%. Net revenue from surgical and sports medicine products between $30 million and $35 million, representing a year-over-year increase in the range of 9% to 27%. In terms of our profitability guidance for 2024, the company expects to generate a gap net income loss in a range of $10.6 million, net loss to net income of $4.6 million, and adjusted net income loss in a range of $8.1 million, adjusted net loss to adjusted net income of $7.1 million.

David C. Francisco: The 2024 net revenue guidance range assumes net revenue from advanced wound care products between $415 million and $435 million, representing a year over year increase in the range of 2% to 7%.

David C. Francisco: Net revenue from surgical and sports medicine products of between $30 million and $35 million, representing a year over year increase in the range of 9% to 27%.

David C. Francisco: In terms of our profitability guidance for 2024, the company expects to generate GAAP net income loss in a range of $10 6 million net loss to net income of $4 6 million and adjusted net income loss in a range of $8 1 million adjusted net loss to adjusted net income of $7 1 million.

David C. Francisco: We also expect EBITDA in the range of $5.8 million to $25 million and adjusted EBITDA in the range of $15.8 million to $35 million. For modeling purposes, we expect second quarter revenue in the range of approximately $120 million to $125 million. Note that all modeling considerations outlined in the fourth quarter call remain largely unchanged. With that, I'll turn the call back over to Gary for some closing remarks.

David C. Francisco: We also expect EBITDA in the range of $5 8 million to $25 million and adjusted EBITDA in the range of $15 8 million to $35 million.

David C. Francisco: For modeling purposes, we expect the second quarter revenue in the range of approximately $120 million to $125 million.

Gary: Note that all modeling considerations outlined in the fourth quarter call remain largely unchanged.

David C. Francisco: With that I'll turn the call back over to Gary for some closing remarks.

Gary: Thanks, Dave.

Gary S. Gillheeney: As a market leader, I'm confident that the maximum prioritization of demonstrated clinical efficacy will strengthen our competitive position over the long term. Additionally, our RENEW program continues to exhibit significant promise to provide clinically meaningful benefits to millions of patients suffering from NEOA symptoms, and our intention this year is to develop a clear regulatory path supported by robust safety and efficacy data. If approved, Introducing Renew as an innovative pain management solution for the millions of patients suffering from Neo-A represents a significant new addressable market and a transformational opportunity for organogenesis.

David C. Francisco: As a market leader I'm confident that the Max prioritization of demonstrated clinical efficacy will strengthen our competitive position over the long term.

Gary S. Gillheeney: Additionally, our renew program continues to exhibit significant promise to provide clinically meaningful benefits to millions of patients suffering from symptoms.

Gary S. Gillheeney: And our attention. This year is on developing a clear regulatory path supported by robust safety and efficacy data.

Gary S. Gillheeney: Approved introducing renewable as an innovative pain management solution for the millions of patients suffering from knee OA represents a significant new addressable market and a transformational opportunity for organogenesis.

Gary S. Gillheeney: I am very pleased with our advancements in the execution of our priorities that will ultimately allow us to 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 your questions. Thank you.

Gary S. Gillheeney: I am very pleased with our advancements in the execution on our priorities that ultimately will allow us allow us to deliver on our mission to provide integrated healing solutions that substantially improve outcomes, while lowering the overall cost of care.

Gary S. Gillheeney: With that I'll turn the call over to the operator to open the call up for your questions. Thank you.

Speaker Change: Thank you Sir.

Operator: If you'd like to ask a question, please signal by pressing star 11 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. If you would like to ask additional questions, we invite you to add yourself to the queue again by pressing star 11. And our first question will come from you. Ryan Zimmerman with BTIG. Your line is now open. Hello.

Gary S. Gillheeney: If you'd like to ask a question. Please signal by pressing star one on your telephone keypad.

Ryan Benjamin Zimmerman: If youre using a speakerphone. Please make sure your mute function is turned off to allow your signal to reach our equipment.

Ryan Benjamin Zimmerman: If you would like to ask additional questions. We invite you to add yourself into the queue again by pressing star one.

Ryan Benjamin Zimmerman: And our first question will come from.

Operator: Ryan Zimmerman with <unk>. Your line is now open.

Ryan Benjamin Zimmerman: Good afternoon. Can you hear me OK? Yes, yes. All right, great.

Ryan Benjamin Zimmerman: Good afternoon.

Ryan Benjamin Zimmerman: Can you hear me okay.

Ryan Benjamin Zimmerman: Yes, yes, yes, alright.

Ryan Benjamin Zimmerman: Congratulations. It's nice to see the results this quarter. I want to ask a little bit about guidance first. There are a couple components to it.

Ryan Benjamin Zimmerman: Congrats.

Ryan Benjamin Zimmerman: Nice to see the results this quarter.

Ryan Benjamin Zimmerman: I wanted to ask a little bit about guidance first couple a couple components to it so.

David C. Francisco: Dave, just to confirm, the guidance today includes the impact of the proposed LCD. And if I look at the way you're setting it up based on the second quarter, it would suggest the second half, you know, 24 may be lower in total sales versus the first half of 24. And I assume you're kind of factoring that in from the impact of the LCDs. And I just want to kind of get your thoughts around, you know, how that plays out, whether that's all in the third quarter, and you expect that disruption in the third quarter, or you expect that to carry into the fourth quarter, just so we all kind of have an understanding around pace.

Ryan Benjamin Zimmerman: Dave just to confirm the guidance today.

David C. Francisco: <unk> the impact of the proposed LCD.

David C. Francisco: And if I look at the way you're setting it up based on the second quarter.

David C. Francisco: It would suggest second half 'twenty for maybe lower in total sales versus the first half 'twenty four in that and I assume you're kind of factoring that and from the impact of the LCD is I just wanted to kind of get your thoughts around.

David C. Francisco: How that plays out.

David C. Francisco: Whether thats all in the third quarter and you expect that disruption in the third quarter or you expect that to carry into the fourth quarter. Just so we all kind of have an understanding around pacing.

David C. Francisco: Yeah, sure. I think, you know, it's unclear as to exactly when this will be enacted. And so, you know, from our understanding, we think it'll be late Q4, maybe even to January of 2025. So what we learned last year when this happened is that customers started to pull back ahead of the enactment date. And so whether it's January or whether it's earlier than that, in Q4, we just wanted to make sure that we had some leeway there. We obviously beat them fairly handily in Q1, and wanted to have some cushion in the back half. But our expectation is that this would be disruption that we would experience in the fourth quarter.

David C. Francisco: Yes, sure I think it's unclear as to exactly when this will be enacted in so far.

David C. Francisco: Understanding we think it'll be at a late Q4, maybe even to January of 2025. So what we learned last year. When this happened is the customer is starting to pull back ahead of the enactment date and so whether it's January or whether it's earlier than that in Q4, we just wanted to make sure that we had some leeway there.

David C. Francisco: Obviously beat fairly handily in Q1 and wanted to have some some cushion into the back half, but our expectation is that would be disruption that we would experience in the fourth quarter.

Gary S. Gillheeney: Okay, very, very clear and very helpful. Two other questions for me: One, can you just talk about, Gary, kind of what products really kind of bounced back this quarter, what you saw in the trends, you know, as you kind of put that, you know, that impact of competition from last year's LCD behind you this quarter? It was certainly nice to see what stood out from a product perspective that worked. And then the last question I'll just ask now is just on Renew. You know, it looked really good on top line data coming out last week.

David C. Francisco: Okay.

David C. Francisco: <unk> clear and very helpful.

Gary S. Gillheeney: Two other questions for me one can you just talk about Gary kind of on what products really kind of bounce back this quarter, what you saw on trend.

Gary S. Gillheeney: You kind of put.

Gary S. Gillheeney: That that impact of competition from last year's LCD behind you. This quarter certainly nice to see what stood out from a product perspective that work and then.

Gary S. Gillheeney: Last question I'll, just ask now is just on renew.

Gary S. Gillheeney: It looked really good topline data coming out of last week, just curious to get your thoughts around kind of that responder rate versus maybe some of what we've seen with other.

Gary S. Gillheeney: I'm just curious to get your thoughts around kind of that responder rate versus maybe some of what we've seen with other products in the market like Syngal and kind of how you think about the benefits of, you know, amniotic suspensions versus traditional HA. Thanks for taking the questions, guys.

Gary S. Gillheeney: Other products in the market like Cingal and kind of how you're thinking about the benefits of amniotic suspension versus traditional AJ. Thanks for thanks for taking the questions guys.

Gary S. Gillheeney: So I think, you know, what was really exciting for us was the number of accounts. I'll get to the products, Ryan, to answer your question, but the number of accounts that we were able to bring back, particularly as you got into February and March, really started to accelerate, and the number of units of product that we were able to sell. So that was probably the most exciting thing for us.

Speaker Change: Sure. So I think what was really exciting for us as the number of accounts.

Gary S. Gillheeney: And I'll get to the product's Brian to answer your question, but the number of accounts that we were able to bring back, particularly as you got into February and March really started to accelerate.

Gary S. Gillheeney: And the number of units.

Gary S. Gillheeney: Product that we were able to sell so that was probably the most exciting thing for us clearly.

Gary S. Gillheeney: Clearly, our amniotic products did extremely well. And our new product with Cygnus did extremely well. We launched that product at our national sales meeting, and it definitely had a strong impact on the quarter. But fundamentally, the accounts and number of customers that we brought back really started to accelerate. You know, on the renewal side, I think what's exciting for us is when you look at HA, some of the historical data, the non-response rate is pretty high for HA products, up to 40%.

Gary S. Gillheeney: Our amniotic.

Gary S. Gillheeney: Products did extremely well.

Gary S. Gillheeney: Our new product with sickness did extremely well, we launched that product at our national sales meeting and it definitely had a strong impact on the quarter, but fundamentally the accounts.

Gary S. Gillheeney: The number of.

Gary S. Gillheeney: Customers that we brought back really started to accelerate.

Gary S. Gillheeney: On the renewable side I think what's exciting for us.

Gary S. Gillheeney: When you look at some of the historical data. The non response rate is pretty high for ha products up to 40%.

Gary S. Gillheeney: And, you know, we haven't seen that in our amniotic suspension technology. Obviously, the P value is extremely strong, which indicates that the response rate was significantly higher than what you would see in typical HA. But, you know, until it's completely finalized, we really don't have a strong comparison to discuss. But I think the response rate in our product, as clearly demonstrated in this study, was very strong.

Gary S. Gillheeney: We haven't seen that in our amniotic suspension technology.

Gary S. Gillheeney: Obviously, the P value was extremely strong which indicates that the.

Gary S. Gillheeney: The response rate was was significantly higher than what you would see in typical HCA.

Gary S. Gillheeney: But until it's completely finalized we really don't have a strong comparison really to discuss but I think the response rate.

Gary S. Gillheeney: Clearly demonstrated in this study was very strong.

Speaker Change: Thank you.

Ross Everett Osborn: Thank you. One moment for our next question. Our next question comes from Ross Osborn with Cantor Fitzgerald. Your line is now open.

Speaker Change: Thank you one moment for our next question.

Ross Everett Osborn: Our next question comes from.

Ross Everett Osborn: Ross Osborne with Cantor Fitzgerald. Your line is now open.

Gary S. Gillheeney: Hey guys, congrats on the quarter and thanks for taking our questions. So maybe starting off on the products that were not on the covered list, would you be able to walk through by product where you stand in terms of current data and where you think you'll need to collect more to get those on the covered list? Thank you.

Ross Everett Osborn: Hey, guys congrats on the quarter and thanks for taking our questions.

Gary S. Gillheeney: Maybe starting off on the products that were not on the cover glass would you be able to walk through byproduct, where you stand in terms of current data and where you would still need to collect more data on the.

Speaker Change: Thank you.

Gary S. Gillheeney: Yeah, sure. So we have a very strong RCT for our new shield product that's completed and ready for publication. And our expectation is that we will have that product ready, the publication ready for submission in our comments. We also have a significant amount of real-world data for Pure Apply, some of which has not been seen by CMS. We have an extremely large study with Puriply, over 1,500 patients, very powerful. So we'll be submitting that with comments. And we've already initiated studies with Puriply AM and Puriply XT, so we expect those studies will be coming along.

Speaker Change: Yes, sure so we have.

Gary S. Gillheeney: Yes.

Gary S. Gillheeney: Very strong RCT for our new shield product that's completed.

Gary S. Gillheeney: Ready for publication and our expectation is that we will have that product ready.

Gary S. Gillheeney: The publication ready for submission in our comments, we also have a significant amount of real world data for pure apply.

Gary S. Gillheeney: Some of which has not been seen by CMS, we have taken an extremely large.

Gary S. Gillheeney: Study.

Gary S. Gillheeney: With purify over 500 patients very powerful so we will be submitting that with comments and we've also initiated already studies with pure apply Amin pure play X T. So we expect those studies will be will be coming along.

Gary S. Gillheeney: Okay, great. And then maybe, you know, following the proposal, have you seen any attrition in your sales force? And then just kind of current plans around where you stand in terms of your comfort level, which is the size of your sales force?

Speaker Change: Okay, Great and then.

Speaker Change: Maybe following the proposal have you seen any attrition in your sales force.

Speaker Change: Current plans around where you stand in terms of.

Speaker Change: <unk> level.

Speaker Change: Switching to the fact that your sales force.

Gary S. Gillheeney: Well, it's interesting. We did see some attrition early on in the first quarter, and then it started to stabilize. Actually, the LCD change will probably continue to stabilize the sales force for obvious reasons. There are not a lot of products out there available in the market.

Speaker Change: Well its interesting we did see some attrition and early on in the first quarter and then it started to stabilize.

Gary S. Gillheeney: Actually the LCD change will probably continue to stabilize the sales force.

Gary S. Gillheeney: For obvious reasons is not a lot of products out there available in the market.

Gary S. Gillheeney: And we certainly have our, you know, our two products that we're pretty excited about in the market. So we think it will actually stabilize. We've actually already received calls from sales representatives from other companies looking for opportunities. So I think the stabilization will continue for the rest of the year. And we do expect to add reps during the year, but we'll probably pace that a bit as we see how this LCD continues to roll out and ultimately matures. But our expectation is that we will stabilize and continue to add reps, probably more so in the back half of the season.

Gary S. Gillheeney: And we certainly have our our two products that we're pretty excited about in the market. So we think it actually will stabilize.

Gary S. Gillheeney: We've actually already received calls from sales representatives from other companies already looking for opportunity. So I think the stabilization.

Gary S. Gillheeney: It will continue for the rest of the year and we do expect to add reps during the year, we will probably pace that a bit as.

Gary S. Gillheeney: As we see how this LCD continues to rollout and ultimately finalizes, but our expectation is we will stabilize and continue to add reps.

Gary S. Gillheeney: Probably more so in the back half of the year.

Gary S. Gillheeney: Okay, great. And then last one for us, would you be able to share the percent reduction from baseline on the WOMAC pain score basis at six months?

Speaker Change: Okay, Great and then last one for US would you be able to share the percent reduction from baseline on the WOMAC pain score basis at six months.

Gary S. Gillheeney: No, it's not. We don't have that data set available.

Gary S. Gillheeney: No.

Speaker Change: It's not we don't have that dataset available.

Speaker Change: Okay got it thanks for taking questions.

Ross Everett Osborn: Okay, I got it. Thanks for taking our questions.

Gary S. Gillheeney: Sure.

Operator: Thank you. As a reminder to ask a question, please press star 11 on your telephone and wait for your name to be announced. Again, that is star 11 to ask a question. Our next question comes from Drew Ranieri with Morgan Stanley. Your line is now open.

Speaker Change: Thank you.

Ross Everett Osborn: As a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced again that is star one to ask a question.

Operator: Our next question comes from drew Ranieri with Morgan Stanley. Your line is now open.

Andrew Christopher Ranieri: Hi Gary, hi Dave, thanks for taking the questions. Gary, maybe just for you to start with, we've been getting a few more questions recently on maybe expectations for the upcoming proposed PFS coming up in July. I mean, we've talked before about CMS wanting to move to a bundled payment, but I think it might be helpful for you to kind of reflect on what might happen if that is the case, if it does move to a bundled payment.

Andrew Christopher Ranieri: Hi, Gary Hi, Dave Thanks for taking my questions.

Andrew Christopher Ranieri: Can you maybe just.

Andrew Christopher Ranieri: For you to start with.

Andrew Christopher Ranieri: We've been getting a few more questions recently on.

Andrew Christopher Ranieri: Maybe expectations for the upcoming <unk>.

Andrew Christopher Ranieri: Post PFS coming up in July.

Andrew Christopher Ranieri: We've talked before about.

Andrew Christopher Ranieri: CMS wanting to move to a bundled payment but.

Andrew Christopher Ranieri: But I think it might be helpful.

Andrew Christopher Ranieri: Maybe for you to kind of reflect on.

Andrew Christopher Ranieri: What might happen if that is the case if it does move to a bundled payment I mean, if we if we look back to when the hospital settings shifted over a decade ago.

Andrew Christopher Ranieri: I mean, if we look back to when the hospital settings shifted over a decade ago, I think Orgo, at the time, was a one-product company. I mean, a lot has changed over the last decade plus, so maybe just how should investors kind of think about the potential impacts or any type of framework to think about what the bundled payment might mean for you and for the business on top of maybe this proposed LCD?

Andrew Christopher Ranieri: I think at the time was a one product company a lot has changed over the last decade, plus so maybe just how should investors kind of think about the potential impacts or any type of framework to think about what the bundled payment might mean for you and for the business on top of maybe this proposed LCD.

Gary S. Gillheeney: Sure. So I think, you know, the bundle payment system is probably the kind of final step in really putting the final pieces of controlling and managing this market together. So it will allow for, I think, a more clinically focused market where you won't have the large swings in ASP that you see out there now. So from that perspective, having a clinical focus, which is where we like to compete, we think is very positive from our perspective and, I think, positive for the space.

Andrew Christopher Ranieri: Sure.

Andrew Christopher Ranieri: I think the.

Gary S. Gillheeney: The bundled payment system is probably the kind of the final step and really putting the the.

Gary S. Gillheeney: The final pieces of controlling and managing this market.

Gary S. Gillheeney: So it will allow for I think more clinically focused market.

Gary S. Gillheeney: We won't have the large swings in asps.

Gary S. Gillheeney: You see out there now.

Gary S. Gillheeney: So from that perspective.

Gary S. Gillheeney: Having a clinical focus which is where we like to compete we think is very positive from our perspective, and I think positive for the space So that.

Gary S. Gillheeney: So that step in the process, which may not happen in 2025 with all of these changes; it may move to 26 or some other period, we don't know, but it clearly is another piece that's necessary to actually control the spending in this space. And it will make the bar higher to get into the bundle. And right now, that bar isn't very high to get on the market. It will make it a little bit higher, both clinically and from a pricing perspective. Those products are gonna have to be priced in the market, not really drive the market or disrupt the market.

Gary S. Gillheeney: Step in the process, which may not happen in 2025 with all of these changes it may.

Gary S. Gillheeney: Move to 'twenty six or some other period, we don't know, but it clearly is another piece that's necessary to actually control.

Gary S. Gillheeney: The spending in this space and it will it will make the bar higher to get into the bundle.

Gary S. Gillheeney: And right now that bar is very high to get on the market. It will make it a little bit higher both clinically and from a pricing perspective, those products going to have to be priced in the market.

Gary S. Gillheeney: And not really drives the market or disrupt the market so from that perspective I think.

Gary S. Gillheeney: So from all of that perspective, I think the bundle is an important piece. Now, it needs to be structured appropriately to provide access, so we're not eliminating patient access. Some thoughtful design that needs to go into it, but structurally, it's an important piece.

Gary S. Gillheeney: The bundle is is an important piece now it needs to be structured appropriately tools provide access so we're not eliminating patient access so.

Gary S. Gillheeney: Some thoughtful design that needs to go into it but structurally it's an important piece.

Gary S. Gillheeney: Got it. I appreciate the color there.

Speaker Change: Got it I appreciate the color there and maybe just on <unk>.

Gary S. Gillheeney: On renew.

Gary S. Gillheeney: Yes.

Speaker Change: To ask maybe kind of next steps and milestones I heard that you are.

Gary S. Gillheeney: And maybe just on Renew, to ask maybe kind of next steps and milestones. I heard that you're looking to complete the data analysis by the end of May. Can you maybe just give a date or timeframe in mind for the FDA meeting and kind of the path forward of whether the second phase three would be required or not? Just trying to get a better sense of how you're thinking about, you know, approval, commercialization, and kind of really building some commercial momentum maybe into approval. Thanks for taking the question and for other New York groups.

Gary S. Gillheeney: By the end of May you are looking to complete the data analysis can you maybe just give a date or time frame in mind for the FDA meeting.

Gary S. Gillheeney: The path forward of whether a.

Gary S. Gillheeney: The second phase III would be required or not just trying to get a better sense of how youre thinking about.

Gary S. Gillheeney: Approval commercialization and kind of really building a.

Gary S. Gillheeney: Building some commercial momentum maybe into two approval. Thanks for taking my questions.

Speaker Change: Sure drew so our expectation is that we're going to be requesting a meeting around.

Gary S. Gillheeney: So our expectation is that we're going to be requesting a meeting around June 3rd. We expect that we will have a meeting. I believe there's a 60 day requirement to establish that meeting, so sometime in early August, we would be meeting with the FDA. And then they have, I believe, 30 days to actually summarize the meeting and the meeting minutes. If that schedule holds by the end of September, we would probably be able to announce the results of that meeting, and we'll have a better sense of whether we move forward with one study or two studies.

Gary S. Gillheeney: Around June 3rd.

Gary S. Gillheeney: We expect that we would have a <unk>.

Gary S. Gillheeney: Meeting I believe there's a 60 day requirement to establish that meeting so sometime early August that we would be meeting with the FDA.

Gary S. Gillheeney: Then they have I believe 30 days to actually summarize the meeting and the meeting minutes.

Gary S. Gillheeney: If that schedule holes by the end of September we would probably be able to announce the results of that meeting.

Gary S. Gillheeney: And we will have a better sense on whether we move forward with one study or two studies.

Gary S. Gillheeney: If we move forward with two studies, I think, as we said before, our expectation is we'd be submitting the BLA in Q2 of 26, with expected approval in Q2 of 27. If we're successful in only needing one study, and perhaps an interim analysis of the second study, we would cut one year off of those timelines. So Q2 of 25 and commercializing in Q2 of 26, with again that one study or one study and an interim analysis of the second study.

Gary S. Gillheeney: If we move forward with two studies I think as we said before our expectation is we'd be submitting the BLA in Q2 of 26 with expected approval.

Andrew Christopher Ranieri: Got it. Thank you so much. Sure.

Andrew Christopher Ranieri: In Q2 of 2007, if we're successful and only needing one study.

Andrew Christopher Ranieri: And perhaps an interim analysis of the second study, we would cut one year off of those timelines.

Andrew Christopher Ranieri: Q2 of 25% and commercializing in Q2 of 26 with again that one study.

Andrew Christopher Ranieri: Or one study in an interim analysis of the second study.

Andrew Christopher Ranieri: Okay.

Speaker Change: Got it thank you so much.

Andrew Christopher Ranieri: Sure.

Speaker Change: Thank you we are currently showing no remaining questions in the queue at this time.

Operator: Thank you, are currently showing no remaining questions in the queue at this time. That does conclude our conference for today. Thank you for your participation. Thank you.

Operator: are currently showing no remaining questions in the queue at this time. That does conclude our conference for today. Thank you for your participation. Thank you.

Operator: That does conclude our conference for today. Thank you for your participation.

Operator: Thank you.

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Operator: Please note that this conference call is being recorded and that the recording will be available on the company's website for replay. 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 I indicate, including the risks and uncertainties described in the company's filing.

Operator: Welcome, ladies and gentlemen to the first quarter of fiscal year 2024 earnings Conference call for Organogenesis Holdings, Inc.

Speaker Change: At this time, all participants have been placed in listen only mode. Please.

Operator: Please note that this conference call is being recorded.

Operator: And that the recording will be available on the company's website for replay shortly.

Operator: Securities and Exchange Commission, including item 1A, risk factors, of the company's most recent annual report, caution not to place undue reliance upon any forward-looking statement 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 a forward-looking statement, whether as a result of new information, future events, or other, except as required by applicable security.

Operator: 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.

Operator: Whether as a result of new information future events or otherwise, except as required by applicable securities laws.

Operator: 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 F. Gillheeney Senior, holdings president, chief executive officer, and chair of the board. Please go ahead, sir.

Operator: This call will also include references to certain financial measures that are not calculated in accordance with generally accepted accounting principles or GAAP.

Speaker Change: We generally refer to these as non-GAAP financial measures.

Speaker Change: I would now like to turn the call over to Mr. Gary <unk> senior.

Speaker Change: Ganoe Genesis Holdings, President Chief Executive Officer, and chair of the Board. Please go ahead Sir.

Speaker Change: Thank you operator, and welcome everyone to Organogenesis Holdings' first quarter fiscal year 2024 earnings conference call.

Gary S. Gillheeney: Joining on the call today by Dave Francisco, our Chief Financial Officer.

Gary S. Gillheeney: Let me start with a brief agenda of what we will cover during our prepared remarks, I will begin with an overview of our first quarter revenue results and an update on our key operating and strategic developments in recent months.

Gary S. Gillheeney: I will share some closing thoughts before we open the call for your questions.

Gary S. Gillheeney: Beginning with a review of our revenue results for Q1. Our sales results came in above the high end of the guidance range outlined on our fourth quarter call, reflecting a continuation of the positive momentum in business trends in early 2024 that we discussed on our call at the end of February. Our commercial team continues to see progress in their broad-based efforts to re-engage with our customers and bring our products back into the healing algorithms and formularies.

Dave: Beginning with a review of our revenue results for Q1 I'll.

Gary S. Gillheeney: Our commercial team continues to see progress and their broad based efforts to reengage with our customers to bring our product back to the healing algorithms and formularies.

Gary S. Gillheeney: We believe our first quarter results support our confidence that we focused our commercial team on the right strategy to navigate this challenging operating environment.

Gary S. Gillheeney: Turning to an update on our progress on our renewable program.

Gary S. Gillheeney: Our ongoing Phase III clinical trial evaluating the use of RENEW for the management of symptoms associated with knee osteoarthritis has continued to progress favorably in recent months. Last week, we announced top-line results from our first phase 3 clinical trial to evaluate the safety and efficacy of RENEW for the management of symptoms associated with knee osteoarthritis. The top line data was positive, and the primary endpoint was achieved with a p-value of 0.0177. The study demonstrated a statistically significant reduction in knee-away pain at six months as assessed by the Western Ontario McMaster University Arthritis Index pain scale compared to the subjects treated with saline control.

Gary S. Gillheeney: Blind data was positive and the primary endpoint was achieved with a P value of 0.0 $1 77.

Gary S. Gillheeney: The study demonstrated a statistically significant reduction in knee OA pain at six months as assessed by the Western Ontario, Mcmaster University arthritis index pain scale compared to the subjects treated with saline control.

Gary S. Gillheeney: In addition to improving Neo-A pain symptoms, Renu maintained patient function compared to saline control with a p-value of less than 0.0001. Renu also showed a favorable safety profile which is consistent with our prior studies. If approved, we believe introducing RENEW to a large and growing pain management market represents a transformational opportunity for organogenesis. Furthermore, introducing RENEW as an innovative pain management solution for the millions of patients suffering from Neo-A represents a significant new addressable market opportunity for organogenesis.

Gary S. Gillheeney: In addition to improving knee OA pain symptoms renew maintain patient function compared to salient control with a P value of less than 0.0001.

Gary S. Gillheeney: Renewed showed a favorable safety profile, which is consistent with our prior studies.

Gary S. Gillheeney: If approved we believe introducing renew to a large and growing pain management market represents a transformational opportunity for Ganoe Genesis if.

Gary S. Gillheeney: Specifically by 2027% an estimated $34 4 million Americans are expected to be affected by knee OA.

Gary S. Gillheeney: While there is no known treatment that completely cures knee OA. It is possible to treat disease symptoms with the goal of avoiding or delaying costly and invasive knee replacement surgery.

Gary S. Gillheeney: We believe RENEW, if approved, will address an unmet clinical need for all patients suffering from moderate to severe symptomatic knee osteoarthritis, and we are particularly excited about the unique opportunity for RENEW to serve the most severe knee OA patients who have limited non-surgical options, representing an estimated 5 million Americans. If successful, Renu would be the only FDA-approved biologic intraarticular injection to improve pain symptoms, even in the most severe cases of

Gary S. Gillheeney: We believe renewable if approved will address an unmet clinical need for all patients suffering from moderate to severe symptomatic knee osteoarthritis and we are particularly excited about the unique opportunity for renew to serve the most severe knee OA patients who have limited non surgical options representing an estimated five.

Gary S. Gillheeney: 5 million Americans.

Gary S. Gillheeney: If successful renew would be the only FDA approved biologic intra articular injection to improve pain symptoms even in the most severe cases of knee OA.

Gary S. Gillheeney: By way of reminder, 30% of the enrolled patients in the first Phase 3 trial were in the most severe Neo A patient population, also known as KL4. Based on the positive results of this clinical trial, along with our accumulated safety and efficacy data from our published 200-patient RCT and Renew's RMAT designation for NeoA, we intend to request a meeting with the FDA to discuss the clinical data requirements for a biologic license application dossier.

Gary S. Gillheeney: A reminder, 30% of the enrolled patients in the first phase III trial, where of the most severe knee OA patient population also known as <unk>.

Gary S. Gillheeney: Team is targeting completion of data analysis by the end of May and we look forward to sharing further information. Shortly thereafter army renewal performance in this important phase III perspective, double blinded multicenter saline controlled parallel group clinical trial of 515 patients.

Gary S. Gillheeney: We're also pleased with the notable progress we are seeing in our second phase III trial.

Speaker Change: Before turning the call over to Dave I wanted to share a few thoughts on recent developments in the area of Medicare reimbursement and coverage.

Gary S. Gillheeney: On April 25th a collaborative proposed LCD was published by seven Medicare administrative contractors. The proposed LCD addresses skin substitute graphs selia cellular <unk> tissue based products for the treatment of diabetic foot ulcers and venous leg ulcers in the Medicare population.

Gary S. Gillheeney: The proposed LCD addresses skin substitute grafts, cellular, and or tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers in the Medicare population. As outlined by CMS, the LCD was issued to make sure that Medicare coverage and people with Medicare have access to skin substitute products that are supported by evidence and that show they are reasonable and necessary for the treatment of diabetic foot and venous leg ulcers in the Medicare population, and that coverage aligns with professional guidelines for appropriately managing these wounds.

Gary S. Gillheeney: As outlined by CMS. The LCD was issue to make sure that Medicare covers and people with Medicare have access to skin substitute products that are supported by evidenced in that show they are reasonable and necessary for the treatment of diabetic foot and venous leg ulcers in the Medicare population and that coverage aligns with professional guidelines.

Gary S. Gillheeney: For appropriately managing these wounds.

Gary S. Gillheeney: The proposed LCD also calls for limiting the number of applications to four per case, as well as including allowances for additional treatment applications in cases where medically necessary. We applaud CMS and NMACS for continuing to prioritize coverage with demonstrated clinical efficacy for skin substitute products. We have been pushing for reform for many years and believe this proposed LCD represents a substantial step forward towards cleaning up the market. Importantly, we are confident that Organogenesis will be well positioned to gain market share now and in the future.

Gary S. Gillheeney: <unk> to gain market share now and in the future.

Gary S. Gillheeney: The proposed LCD includes 15 covered skin substitute products, which the MACs believe have the requisite published, peer-reviewed clinical evidence to support reimbursement. Importantly, the proposed LCD also includes a list of approximately 200 skin substitutes that are currently sold in the market today that have been designated as non-cover. Two of our commercialized brands are included on the proposed LCD covered list, Apligraf and Affinity, the latter of which is the only living amniotic offering on the covered list.

Gary S. Gillheeney: The proposed LCD includes 15 covered skin substitute products, which the Max belief have the requisite published peer reviewed clinical evidence to support reimbursement.

Gary S. Gillheeney: Importantly, the proposed LCD also includes a list of approximately 200 skin substitutes that are currently sold in the market today that have been designated as non covered.

Gary S. Gillheeney: Two of our commercialized brands are included on the proposed LCD covered list Apolo graph and affinity the latter of which is the only living amniotic offering on the covered list we.

Gary S. Gillheeney: We have four commercialized brands, Puriply, New Shield, Novacor, and Cygnus, that were designated as non-covered as part of the proposed LCD. We have a strategy to leverage existing strong clinical and real-world data, including RCTs, and have already initiated new RCTs to secure additional clinical evidence. We expect to have compelling cases to present to the MAX to secure coverage for additional products on the covered list later this year and into next year.

Gary S. Gillheeney: We have four commercialized brands pure apply new shield <unk> and Cigna that were designated as non covered as part of the proposed LCD.

Gary S. Gillheeney: We have a strategy to leverage existing strong clinical and real world data, including <unk> and have already initiated new RCT is to secure additional clinical evidence.

Gary S. Gillheeney: We expect to have compelling cases to present to the Max this year.

Gary S. Gillheeney: Secure coverage for additional products on the covered list later this year and into next year.

Gary S. Gillheeney: We strongly believe these material changes from CMS and the MACs in reimbursement for skin substance will be positive for the long-term health of the wound care market. While there will be a period of transition and disruption if these sweeping changes are implemented, we believe that Organogenesis' strong brand equity, established commercial infrastructure, and a plan to establish additional clinical validation to secure coverage of key commercialized products, which taken together represent a substantial competitive advantage for us, have us well positioned to maximize the enormous opportunity to serve more patients with our highly innovative and highly efficacious products. With that, I'll turn the call over to Dave.

Dave: While there will be a period of transition and disruption if the sweeping changes are implemented we believe that organogenesis strong brand equity established commercial infrastructure and our plan to establish additional clinical validation to secure coverage of key commercialized products, which taken together represent a substantial competitive advantage for us.

Dave: That has us well positioned to maximize the enormous opportunity to serve more patients with our highly innovative and highly efficacious products.

Dave: With that I'll turn the call over to date.

Dave: Thanks, Larry I'll begin with a review of our first quarter financial results.

David C. Francisco: Yes, otherwise specified all growth rates referenced during my prepared remarks are on a year over year basis.

David C. Francisco: Net revenue for the first quarter was $110 million up 2%.

David C. Francisco: As Gary mentioned these results were well ahead of expectations, we provided on our fourth quarter call, which called for a total first quarter revenue in the range of $98 million to $104 million as we experienced strong momentum building at the end of February that carried into March.

David C. Francisco: We provided on our fourth quarter call, which called for a total first quarter revenue in the range of $98 million to $104 million, as we experienced strong momentum building at the end of February that carried into March. Our Advanced Wound Care Net Revenue for the first quarter was $103.9 million, up 3%, and Net Revenue for Surgical and Sports Medicine Products for the first quarter was $6.1 million, down 9%. Gross profit for the first quarter was $81.3 million, or 73.9% of net revenue, compared to 75.3% last quarter. Gross margin was impacted year-over-year primarily due to shifts in product mix compared to the prior year period.

David C. Francisco: Operating expenses for the first quarter were $85.1 million compared to $85 million last year, an increase of $0.1 million, or less than 1%. The year-over-year change in operating expenses in the first quarter was driven by a 1.5 million, or 2%, decrease in selling general administrative expenses, offset by a 1.6 million, or 14%, increase in research and development costs compared to the prior year period. Operating loss for the first quarter was $3.9 million, compared to an operating loss of $4 million last year, a decrease of $0.1 million.

David C. Francisco: Gross profit for the first quarter was $81 3 million or <unk> 73, 9% of net revenue compared to 75, 3% last year.

David C. Francisco: The gross margin was impacted year over year, primarily due to shifts in product mix compared to the prior year period.

David C. Francisco: Operating expenses for the first quarter was $85 1 million compared to $85 million last year, an increase of <unk> 1 million or less than 1%.

David C. Francisco: Operating loss for the first quarter was $3 9 million compared to an operating loss of $4 million last year, a decrease of <unk> 1 million.

David C. Francisco: Net loss for the first quarter was $2 1 million.

David C. Francisco: <unk> to net loss of $3 million last year, a decrease of <unk> 9 million.

David C. Francisco: Adjusted net loss for the first quarter was $1 4 million compared to <unk> $7 million last year, an increase in adjusted net loss of <unk> 8 million.

David C. Francisco: Adjusted EBITDA for the first quarter was $2.6 million, or 2.3% of net revenue, compared to $3.8 million, or 3.5% of net revenue last quarter. We have provided a full reconciliation of our adjusted net income and adjusted EBITDA results in our earnings. Turning to the balance sheet, as of March 31, 2024, the company had $89.3 million in cash and cash equivalents and restricted cash and $64.9 million in debt. That compared to $104.3 million in cash, cash equivalents, and restricted cash and $66.2 million in debt obligations as of December 31, 2023.

David C. Francisco: Adjusted EBITDA for the first quarter was $2 6 million or two 3% of net revenue compared to $3 8 million or three 5% of net revenue last year we.

David C. Francisco: We have provided a full reconciliation of our adjusted net income and adjusted EBITDA results in our earnings release.

David C. Francisco: Turning to the balance sheet as of March 31, 2024, the company had $89 3 million in cash and cash equivalents and restricted cash and $64 9 million of debt obligations that compared to $104 $3 million in cash cash equivalents and restricted cash and $66 2 million in debt obligations as of December 31, 2020.

David C. Francisco: We also have up to 125 million of available borrowings on a revolving credit facility as of March 31st, 2024. Turning to a review of our 2024 financial guidance, despite the strong momentum that we are experiencing in the business, we are reaffirming our prior guidance that we referenced in our press release this afternoon to account for the potential near-term disruption in the market.

David C. Francisco: Three.

David C. Francisco: We also have up to $125 million of available borrowings on our revolving credit facility as of March 31 2024.

Q1 2024 Organogenesis Holdings Inc Earnings Call

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