Q4 2024 AVITA Medical Inc Earnings Call

In a listen only mode. After the speaker's presentation, there will be a question and answer session to ask a question. During the session you will need to press star one on your telephone you will then hear an automated message advising your hand is raised to withdraw your question. Please press star one again, please be advised that today's.

Jessica Ekberg: The conference is being recorded I would now like to hand, the conference over to your speaker today, Jessica Ekberg director of Investor Relations. Please go ahead.

Jessica Ekberg: Thank you operator, welcome cause either medical fourth quarter and full year.

Jessica Ekberg: 24 earnings call joining me on today's call are Jim Corbett, Chief Executive Officer, and David O'toole, Chief Financial Officer, Thank our news release and presentation are available.

Jessica Ekberg: On our website www dot Davita medical Dot com under the Investor Relations section.

Jessica Ekberg: Before we begin I'd like to remind you that this call includes forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.

Statements are neither promises nor guarantees and involve known and unknown risks and uncertainties that could cause actual results to differ materially from any expectations expressed or implied.

Will be a question and answer session to ask a question. During the session you will need to press star one on your telephone you will then hear an automated message at fighting your hand is raised to withdraw your question. Please press star. One again, please be advised that today's conference is being recorded I would now like to hand the conference.

Jessica Ekberg: Forward looking statements.

Jessica Ekberg: Please review our most recent filings with the SEC for a comprehensive description of the risk factors.

Jessica Ekberg: Forward looking statements provided during this call are based on management's expectations as of today I will now turn the call over to Jim for his comments.

Speaker Change: Over to your speaker today, Jessica Ekberg director of Investor Relations. Please go ahead.

Jessica Ekberg: Thank you operator, welcome cause either medical fourth quarter and full year 2024 earnings call. Joining me on today's call are Jim Corbett.

Jim Corbett: Thank you Jessica.

Speaker Change: Good afternoon to those in the U S and good morning to our Australia investors.

Speaker Change: Thank you for joining us today as we review a year of remarkable progress and complete transformation.

David O'Toole: As I Could've officer, and David O'toole, Chief Financial Officer.

Our earnings release and presentation are available on our website www dot Viva medical Dot com under the Investor Relations section.

Speaker Change: Over the past year, we evolved from a single product company into a multi product leader and therapeutics acute wound care.

This initiative began in 2023.

David O'Toole: While we begin I'd like to remind you that this call includes forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.

Speaker Change: Launch, our strategic growth plan and expanded our core business to treat trauma and surgical wounds under the full thickness skin defects indication.

David O'Toole: These statements are neither promises nor guarantees and involve known and unknown risks and uncertainties that could cause actual results to differ materially from any expectations expressed or implied by the forward looking statements.

Speaker Change: To support these efforts we began building.

Speaker Change: Scalable infrastructure.

Speaker Change: At this stage for our first portfolio expansion.

Speaker Change: In January 2024, we announced Permian.

David O'Toole: Please review our most recent filings with the SEC for a comprehensive description of the risk factors.

Speaker Change: First addition to a multi product portfolio.

Speaker Change: By April 2024, we have launched in marketing in a pivotal milestone in our transformation.

David O'Toole: Any forward looking statements provided during this call are based on management's expectations as of today.

Speaker Change: Mining our portfolio with our mission.

David O'Toole: I'll now turn the call over to Jim for his comments.

Speaker Change: This submission shown on slide three.

Jim Corbett: Thank you Jessica and good afternoon to those in the U S and good morning to our Australia investors.

Speaker Change: It is a cornerstone of who we are and where we're headed.

Speaker Change: Let me explain is significant and how it is shaping our future success.

Speaker Change: Thank you for joining us today as we review a year of remarkable progress and complete transformation.

Speaker Change: Our mission is to position our beta medical is a leading therapeutic acute wound care company.

Over the past year, we evolved from a single product company to a multi product leader and therapeutics acute wound care.

Speaker Change: Living transformative solutions or technologies are designed to optimize wound healing.

Speaker Change: This initiative began in 2023 three launch our strategic growth plan and expanded our core business to treat trauma and surgical wounds under the full thickness skin defects indication.

Speaker Change: Secondly, accelerating the time to patient recovery.

Speaker Change: The words in this statement or meaningful let's break down what this means.

Speaker Change: Therapeutic means that our solutions are designed to actively heal and cure patients not just be palliative forms of care.

Speaker Change: To support these efforts we began building scalable infrastructure.

Speaker Change: And at this stage for our first portfolio expansion.

Speaker Change: Acute defines the nature of our focus we treat patients with event driven injuries burns traumatic or surgical wounds not chronic wounds, such as diabetic foot ulcers venous leg ulcers or pressure sores simply put our patients are victims of severe unexpected accidents.

Speaker Change: In January 2024, we announced permanent nerve.

Speaker Change: The first edition to a multi product portfolio.

Speaker Change: By April 2024, we have launched it marking a pivotal milestone in our transformation aligning our portfolio with our mission.

Speaker Change: This submission shown on slide three.

Speaker Change: Events are car crashes industrial fires or traumatic burns.

Speaker Change: This is a cornerstone of who we are and where we're headed.

Speaker Change: Common denominator does not their age.

Speaker Change: Can you explain is significance and how it is shaping our future success.

Speaker Change: Not their gender nor is it their ethnicity, but rather the shared nature of their injuries. These injuries could be the result of a solo road incident.

Speaker Change: Our mission is to position our beta medical as a leading therapeutic acute wound care company delivering transformative solutions or technologies are designed to optimize wound healing effectively accelerating the time to patient recovery.

Speaker Change: <unk> sustained from an industrial fire or worse.

Speaker Change: Multiple injuries from a tragic event like the recent terror attack in New Orleans.

Speaker Change: Right, they're diverse scenarios these patients all have injuries.

Speaker Change: The words in this statement or meaningful let's break down what this means.

Speaker Change: Two traumatic events, our mission to help patients heal faster not only reduces overall health care costs.

Speaker Change: Therapeutic means that our solutions are designed to actively heal and cure patients.

Speaker Change: More importantly helps patients return home to their loved ones more quickly.

Speaker Change: Not just be palliative forms of care.

Speaker Change: Acute defines the nature of our focus.

Speaker Change: Underscoring the power of our technologies and a driving force behind our expanded product portfolio.

Speaker Change: Patients with event driven injuries.

Speaker Change: <unk> come out of core surgical wounds, not chronic wounds, such as diabetic foot ulcers venous leg ulcers or pressure sores simply put our patients are victims of severe unexpected accidents or events.

Speaker Change: Please turn to slide four to see the related markets that we serve as I explained how our product portfolio aligns with our mission.

Speaker Change: Let's start with our core product resell and review, how it optimizes patient healing and accelerates patient recovery.

Speaker Change: Crashes industrial fires post-traumatic burns.

Speaker Change: The common denominator is not their age it's not their gender north is it their ethnicity, but rather the shared nature of their injuries. These injuries could be the result of a solo road incident.

Speaker Change: First and foremost what makes resale special is that it is skin sparing.

Speaker Change: Allowing physicians to achieve closure using significantly less healthy donor skin.

Speaker Change: Also known as autologous skin.

Speaker Change: Burns sustained from an industrial fire or worse.

Speaker Change: Compared to traditional grafting techniques, we sell expands the autologous sample 80 to one additionally, substantial clinical evidence demonstrates that patients treated with resell fuel faster experienced less scarring and leave the hospital sooner.

Speaker Change: Multiple injuries from a tragic event like the recent terrorist attack in New Orleans, despite their diverse scenarios. These patients all have injuries due to traumatic events, our mission to help patients heal faster not only reduces overall health care costs, but more importantly, the pace.

Speaker Change: We sell go our next generation system combines the proven outcomes of resell with enhanced features that simplify and streamed streamlined its use in both burn and trauma centers.

Speaker Change: <unk> return home to their loved ones more quickly.

Speaker Change: This underscores the power of our technologies and a driving force behind our expanded product portfolio.

Speaker Change: <unk> is going very well, we've converted nearly all of our burn accounts and over 70% of our trauma center accounts for approximately 83% of our total unit volume.

Speaker Change: Please turn to slide four to see the related markets that we serve as I explained how our product portfolio aligns with our mission.

Speaker Change: Let's start with our core product resell and review, how it optimizes patient feeling and accelerating patient recovery.

Speaker Change: As a reminder, each of our standard resale go processing kits to treat up to 1920 square centimeters.

Speaker Change: First and foremost what makes resale special is that it is skin sparing.

Speaker Change: Which is roughly 10% of total body surface area.

Speaker Change: Allowing physicians to achieve closure using significantly less healthy donor skin.

Speaker Change: However, most traumatic wounds are under 480 square centimeters or about two 5% total body surface area.

Speaker Change: Also known as autologous skin.

Speaker Change: Compared to traditional grafting techniques, we sell expanse. The autologous sample 82, one additionally, substantial clinical evidence demonstrates that patients treated with resell yield faster experienced less scarring and leave the hospital sooner.

Speaker Change: This size difference created somewhat of a cognitive dissonance for the clinicians using a standard resale kit to treat a small wound.

Speaker Change: Like using a sledge hammer driving a small mill.

Speaker Change: To address this we read as we dealt with designed resale go many.

Speaker Change: We sell go our next generation system combines the proven outcomes of resell with enhanced features that simplifying streamed streamlined.

Speaker Change: The wounds under 480 square centimeters.

A critical gap in our trauma care offering.

Speaker Change: As anticipated we received approval for resale go many on December 23rd we are rolling out we saw go many to burn and trauma centers that currently treat a significant volume of smaller loans during Q1.

Speaker Change: Hughes and both burn and trauma centers with.

Speaker Change: The conversion to retail co is going very well, we've converted nearly all of our current accounts and over 70% of our trauma center accounts for approximately 83% of our total unit volume.

Speaker Change: Incidentally recycle many uses the same resale go processing device.

Speaker Change: As a reminder, each of our standard resale go processing kits to treat up to 1920 square centimeters, which is roughly 10% of total body surface area.

Speaker Change: Standard we sell go processing kit.

Speaker Change: This innovation is the foundation of our portfolio unlocking possibilities and therapeutic acute wound care with complementary solutions like Coke helix and Permian.

Speaker Change: However, most traumatic wounds are under 480 square centimeters or about two 5% total body surface area.

Speaker Change: Permian Derm.

Speaker Change: Temporary biosynthetic dressing further strengthens our portfolio by supporting wound healing before and after grafting.

Speaker Change: This size difference created somewhat of a cognitive dissonance for the clinicians using a standard resale kit to treat a small wound.

Speaker Change: Plays a role in helping clinicians field.

Speaker Change: Like using a sledge hammer driving a small mill too.

Speaker Change: Youll patients faster get patients home sooner and reduce hospital stays.

Speaker Change: To address this we read this week with designed resale go many.

Speaker Change: By lowering overall cost of care want to take a moment to remind you about the unique qualities of permitting.

Speaker Change: For wounds under 480 square centimeters.

Speaker Change: Playing a critical gap in our trauma care offering.

Speaker Change: First it is of course facilitated facilitating airflow two the wound.

Speaker Change: As anticipated we received approval for resale go many on December 23rd.

Speaker Change: Promote healing, while enabling exit date granted.

Speaker Change: We're rolling out we saw go with many to burn and trauma centers that currently treat a significant volume of smaller loans during Q1.

Speaker Change: Next is prosody is flexible.

Speaker Change: So, let's the clinicians adjust moisture levels, ensuring optimal hieland conditions for each patient's unique wound needs.

Speaker Change: Incidentally, we saw go many uses the same resale go processing device as a standard we saw go processes yet.

Speaker Change: Finally, it's transparent cover allows clinicians to monitor the skin.

Speaker Change: This innovation is the foundation of our portfolio unlocking possibilities and therapeutic acute wound care with complementary solutions like Coke helix and Permian.

Speaker Change: To monitor the skin graft fueling progress without disturbing it Rob.

Speaker Change: Rather than lifting or removing the dressy.

Speaker Change: Dressing, which can potentially disrupt the graft.

Speaker Change: <unk> have a clear view of the progress, making it uniquely effective.

Speaker Change: Permian Derm.

Speaker Change: Temporary biosynthetic dressing further strengthens our portfolio by supporting wound healing before and after grafting.

Speaker Change: Taking our wound healing approach step further our newly FDA cleared dermal matrix scope helix represents a breakthrough in addressing the critical need for accelerated graft readiness.

Speaker Change: Plays a role in helping clinicians feel.

Speaker Change: Youll patients faster.

Speaker Change: <unk> home sooner and reduce hospital stays and therefore by lowering overall cost of care want to take a moment to remind you about the unique qualities of Permian.

Speaker Change: Helix is a collagen derived dermal matrix.

Speaker Change: That we co developed with regenerative biosciences.

Speaker Change: First it is of course facilitated facilitating airflow two the wound to promote healing, while enabling exit date granted.

Speaker Change: Our goal was clear create a material that integrates into the wound bed and absorbs histologically, eliminating the need for removal before skin graft application and reducing the number of days graft readiness.

Speaker Change: Next is processes flexible, which lets the clinicians adjusted moisture levels, ensuring optimal human conditions for each patient's unique wound needs.

Speaker Change: In a validated foreseen model our preclinical work demonstrated.

Speaker Change: Co helix is used as a dermal matrix on a large wound.

Speaker Change: It's transparent cover allows clinicians to monitor the skin.

Speaker Change: It is ready for grafting in just seven days.

Speaker Change: To monitor the skin graft fueling progress without disturbing it.

Speaker Change: Compared to 12 to 21 days or alternative withdrawn matrices in the studies.

Speaker Change: Rather than lifting or removing the dressing which can potentially disrupt the graft.

This faster readiness translates directly to shorter hospital stays reduced cost and better patient outcomes.

Speaker Change: <unk> have a clear view of the progress, making it uniquely effective.

Speaker Change: And full thickness wounds co helix provides a <unk> structure that supports tissue re growth in the formation of new blood vessels eventually absorbed into the wound.

Speaker Change: Taking our wound healing approach step further our newly FDA cleared dermal matrix cookie legs.

Speaker Change: Ah represents a breakthrough in addressing the critical need for accelerated graft readiness.

Speaker Change: Illustrate the significant benefits of faster healing.

Speaker Change: Helix is a collagen derived dermal matrix.

Speaker Change: To understand the complexities and challenges associated with treating both thickness wounds.

Speaker Change: That we co developed with regenerative biosciences.

Our goal was clear create a material that integrates into the wound bed and absorbs histologically, eliminating the need for removal before skin graft application and reducing the number of days Kraft readiness.

Speaker Change: By definition, a full thickness skin injury penetrates all layers of the skin.

Speaker Change: Causing significant soft tissue loss and damage to the connective tissue structural integrity.

Speaker Change: Unlike a superficial knee abrasion for your own cells, repopulate quickly and often heal overnight full thickness wounds lack the necessary healthy cells to rebuild the missing connective tissue.

Speaker Change: In a validated foreseen model or <unk>.

Preclinical work demonstrating.

Speaker Change: Co helix is used as a dermal matrix on a large wound.

Speaker Change: It is ready for grafting in just seven days compared to 12 to 21 days or alternative withdrawn matrices in the studies.

Speaker Change: <unk> the wound open and at risk of severe infection and scarring.

Speaker Change: <unk> timely surgery and delayed timing surgical invention intervention.

Speaker Change: Example.

Speaker Change: This faster readiness translates directly to shorter hospital stays reduced cost and better patient outcomes.

Speaker Change: The standard of care is a two stage procedure.

Speaker Change: Let me describe it for you.

Speaker Change: It would have cleaned the wound bed and immediately perform a split thickness skin graft to close the wound.

Speaker Change: Full thickness wounds co helix provides a <unk> structure that supports tissue re growth in the formation of new blood vessels and eventually absorbed into the wound.

Speaker Change: <unk> may not take due to insufficient connective tissue without.

Speaker Change: Cloud first preparing the wound bed using a dermal matrix there could be a loss of functionality.

Speaker Change: Bill straight the significant benefits of faster healing.

Speaker Change: Additionally, an unsightly outcome, resulting from the deep tissue loss and likely heavy scarring.

Speaker Change: Wanted to understand the complexities and challenges associated with treating both thickness wounds.

Speaker Change: This is why full fitness.

Speaker Change: By definition, a full thickness skin injury penetrates all layers of the skin.

Speaker Change: Injuries, requiring structured two stage surgical approach to reconstruct the lost or damaged tissue.

Causing significant soft tissue loss and damage to the connective tissue structural integrity.

Speaker Change: Cases of severe tissue loss, such as a shark bite or.

Speaker Change: <unk> bacterial infection treatment may also involve excision of damaged tissue.

Speaker Change: Unlike a superficial knee abrasion for your own cells, repopulate quickly and often heal overnight.

Speaker Change: And the use of co helix to build a terminal base, followed by split thickness skin graft closure.

Speaker Change: Thickness wounds lack the necessary healthy cells to rebuild the missing connective tissue.

Speaker Change: And possibly an application of permanent derm to protect healing environment.

Speaker Change: Leaves the wound open and at risk of severe infection and scarring.

Speaker Change: It is important for us to develop human clinical data to support the launch of <unk>.

Speaker Change: Late timely surgery and delayed timely surgical invention intervention.

Speaker Change: Oh helix.

Speaker Change: For example.

Speaker Change: To accomplish this we have initiated a post market clinical study known ESCO helix one.

Speaker Change: The standard of care is a two stage procedure.

Speaker Change: Let me describe it for you.

Speaker Change: If you were to clean the wound bed and immediately perform a split thickness skin graft to close the wound.

Speaker Change: Which is currently pending IRB approval at multiple sites across the U S.

Speaker Change: <unk> may not take due to insufficient connective tissue.

Speaker Change: This study uses and objective performance criteria study design known as O P C.

Speaker Change: First preparing the wound bed using a dermal matrix there could be a loss of functionality.

Speaker Change: Benchmark co helix performance against published data from alternative dermal matrices.

Speaker Change: Additionally, an unsightly outcome, resulting from the deep tissue loss and likely heavy scarring.

Speaker Change: We are measuring key outcomes over a 26 week period, including days to graft readiness phase to closure and days to go home.

Speaker Change: Why full thickness injuries, requiring structured two stage surgical approach to reconstruct the lost or damaged tissue.

Speaker Change: Anticipate that this study will demonstrate accelerated seven day graft readiness and shorter overall time to wound closure compared to alternative dermal matrices further reinforcing the value of co helix.

Speaker Change: Okay.

Speaker Change: In the cases of severe tissue loss, such as sharp buy or.

Speaker Change: <unk> bacterial infection treatment may also involve excision of damaged tissue.

Speaker Change: And the use of <unk> to build a terminal base, followed by split thickness skin graft closure.

Speaker Change: Early patients have already been completed ahead of the formal enrollment.

Speaker Change: And possibly an application of permanent term to protect healing environment.

Speaker Change: <unk> one.

Speaker Change: In fact, our first case has already shown promising results consistent with our preclinical findings.

Speaker Change: It is important for us to develop human clinical data to support the launch of coil.

Speaker Change: Let's turn to slide number five look at the highlights of this case.

Speaker Change: Oh helix.

Speaker Change: To accomplish this we have initiated a post market clinical study known as co helix one.

In mid January.

67 year old woman sustained a third degree burn while cooking over her stove as shown in image a.

Speaker Change: Which is currently pending IRB approval at multiple sites across the U S.

Speaker Change: This study uses and objective performance criteria study design bonus O P C bench.

Speaker Change: She was treated at the Ohio State Wexner Medical Center, where she received an application of Coke helix as seen in image B.

Speaker Change: Benchmark co helix performance against published data from alternative dermal matrices.

Speaker Change: By day seven as shown an image see her wound was ready for grafting.

Speaker Change: We are measuring key outcomes over a 26 week period, including days to graft readiness phase two closure days to go home.

Speaker Change: With our preclinical findings.

Speaker Change: Within a week and a half she was discharged from the hospital. According to one of her clinicians pets, you've been treated with an alternative dermal matrix for hospital stay would likely have extended to a month.

Speaker Change: Anticipate that this study will demonstrate accelerated seven day graft readiness and shorter overall time to wound closure compared to alternative dermal matrices further reinforcing the value of <unk>.

Speaker Change: This case highlights why as you can see on slide six the medical community has already started to recognize coke helix as a game changer in the treatment of acute wounds.

Speaker Change: Early patients have already been completed ahead of the formal enrollment.

Speaker Change: <unk> one.

Speaker Change: In fact, our first case has already shown promising results consistent with our preclinical findings.

Speaker Change: According to our treating physician not only does co helix reduce the amount of time, a patient spends in the hospital, but he believes that it will allow physicians to treat more patients because of how easy it was to use in the operating room.

Speaker Change: Turn to slide number five look at the highlights of this case.

Speaker Change: In mid January <unk>.

Speaker Change: 67 year old woman sustained a third degree burn while cooking over her stove has shown an image a.

Speaker Change: Quite honestly this outcome is a turning point for a veto medical and a breakthrough and acute wound care setting a new standard for treating and healing severe injuries, while lowering the cost of care and shortening the time.

Speaker Change: She was treated at the Ohio State Wexner Medical Center, where she received an application of Coke helix as seen in image B.

Speaker Change: For patients to return home.

Speaker Change: For me, Adam <unk> fit strategically within our portfolio as illustrated on slide seven.

Speaker Change: By day, seven as shown an image seed.

Speaker Change: <unk> was ready for grafting.

Speaker Change: By playing an integral roles in the two stage standard of care for full thickness.

Speaker Change: With our preclinical findings with it.

Speaker Change: A week and a half she was discharged from the hospital.

Speaker Change: <unk>.

Speaker Change: By playing integral roles in the two stage standard of care for full thickness wounds consider a patient.

Speaker Change: Turning to one of our clinicians and she'd been treated with an alternative thermal metrics or hospital stay would likely have extended for a month.

Speaker Change: So the burn cover 10% of their total body surface area.

Speaker Change: This case highlights why as you can see on slide six the medical community has already started to recognize coke helix as a game changer in the treatment of acute wounds.

Speaker Change: First the <unk>.

Speaker Change: Procedure begins with a surgical surgical excision of the burn.

Speaker Change: Next Permian <unk> could be applied to temporize, the wound bed, allowing the wound to improve for a short period of time.

Speaker Change: According to our treating physician not only does co helix reduce the amount of time patient spends in the hospital, but he believes that it will allow physicians to treat more patients because of how easy it was to use in the operating room.

Speaker Change: Clinicians have determined the wound bed is free from necrotic tissue and infection. So helix is applied to prepare the wound bed for grafting.

Speaker Change: Quite honestly this outcome is a turning point for our BD medical and a breakthrough and acute wound care setting.

Speaker Change: Approximately seven days later, which is four to 14 days faster than alternative dermal matrices wound graft is ready, meaning there is sufficient tissue regrowth to proceed to the second stage.

Speaker Change: Setting a new standard for treating and healing severe injuries, while lowering the cost of care and shortening the time.

Speaker Change: Patients to return home.

Speaker Change: The second stage begins with a split thickness messed autograft combined with resales brown skin cells placed over the newly generated tissue.

Speaker Change: Permian Durham, and co helix fit strategically within our portfolio as illustrated on slide seven.

Speaker Change: By playing an integral roles in the two stage standard of care for full thickness.

Speaker Change: As a reminder.

Speaker Change: <unk> supports definitive closure use significantly less hopefully skin compared to traditional auto grafting procedures remember that resell expands the autologous sample 80 to one.

Speaker Change: <unk>.

Speaker Change: By playing integral roles in two stage standard of care for full thickness wounds consider a patient.

Speaker Change: The layer of permanent term is then applied over both the graft and the newly applied brown skin cells and separately to the resale donor site.

Speaker Change: The burn cover 10% of their total body surface area.

First the procedure begins with the surgery surgical excision of the burn.

Speaker Change: To aid in the healing process of both wounds.

Speaker Change: Next Permian <unk> could be applied to temporize, the wound bed, allowing the wound to improve for a short period of time.

Speaker Change: <unk> is considered continuously assessed to determine when the patient is ready to leave the hospital.

After clinicians have determined the wound bed is free from the chronic tissue.

Speaker Change: This integrated approach improves clinical outcomes while significantly.

Speaker Change: And infection.

Speaker Change: Helix is applied to prepare the wound bed for grafting.

Speaker Change: Expanding our freedom medicals market opportunity.

Speaker Change: Let's look at the total available market potential per patient.

Speaker Change: Approximately seven days later, which is four to 14 days faster than alternative dermal matrices wound grafts as ready, meaning there is sufficient tissue re growth to proceed to the second stage.

Speaker Change: For a 10% to 20% total body surface area of wound.

Speaker Change: The average selling price for resell is $6500 to $13000.

Speaker Change: The second stage begins with a split thickness meshed autograft combined with resale brown skin cells placed over the newly generated tissue.

Speaker Change: Permian <unk> at $2000 to $4000 is addressing.

Speaker Change: <unk> has applied to the same wound.

Speaker Change: As a reminder, we sell supports definitive closure use significantly less hopefully skin compared to traditional auto grafting procedures remember that resell expands the autologous sample 80 to one <unk>.

Speaker Change: Increases the potential average selling price between 20000 to $40000.

Speaker Change: In the aggregate and all three products are used together the potential average average selling price ranges between 28550.

Speaker Change: A layer of permanent Germany is then applied over both the graft and the newly applied spray on skin cells and separately to the resale donor site.

Speaker Change: <unk> $57000.

Speaker Change: All the while providing substantial clinical and economic benefits by accelerating the time for the patient to return home.

Speaker Change: And the healing process of both wounds.

Speaker Change: This wound is consistent continuously assessed to determine when the patient is ready to leave the hospital.

Speaker Change: One last point.

Speaker Change: <unk> can also be used independently or resell as demonstrated in the Western Medical Center case discussed earlier, resulting in an additional increase of the total addressable market for Vida medical.

Speaker Change: This integrated approach improves clinical outcomes while significantly.

Speaker Change: Spanning a beta medicals market opportunity.

Speaker Change: Look at the total available market potential per patient.

Speaker Change: On April one we will initiate a full commercial launch of co helix for large war wounds using a consignment model with RFID tracking simplify hospital adoption and inventory management.

Speaker Change: We're a 10% to 20% total body surface area of wound.

Speaker Change: Average selling price for resale is $6500 to $13000.

Speaker Change: Our sales reps will use the RFID reader track inventory for the hospital, our internal accounting and the FDA.

Speaker Change: Permian <unk> at $2000.

Speaker Change: $4000 is addressing.

Speaker Change: We plan to price SKU helix below current market leaders further positioning it as a value driven solution.

Speaker Change: When co helix is applied to the same one.

Speaker Change: And it increases the potential average selling price between 20000 to $40000.

Speaker Change: Competitive pricing, coupled with a consignment model and a reduced time to graft are key benefits that we believe will help us progress through the value analysis committee process faster.

Speaker Change: In the aggregate and all three products are used together the potential average average selling price ranges between 28500 <unk>.

With co helix, we add nearly $1 billion to our total addressable market or Tam just within the 120 plus burn centers on top of the approximate $500 million Tam for resell in the $100 million Tam for Permian turn in these.

Speaker Change: $57000.

Speaker Change: All the while providing substantial clinical and economic benefits by accelerating the time for the patient to return home.

Speaker Change: One last 0.0 helix can also be used independently or resell as demonstrated in the Western Medical Center case discussed earlier, resulting in an additional increase of the total addressable market for <unk> medical.

Speaker Change: Same burn centers and trauma centers targeting full thickness wounds.

Speaker Change: Helix adds.

Speaker Change: On April one we will initiate a full commercial launch of co helix for large war wounds using a consignment model with RFID tracking simplify hospital adoption and inventory management or.

Speaker Change: $135 billion in Tam.

Speaker Change: Durham contributes $135 million in Tam and resale provides a potential of one 5 billion and 10 in the aggregate.

Speaker Change: Our sales reps will use the RFID reader track inventory for the hospital, our internal accounting and the FDA.

Speaker Change: <unk> medical and now has a combined $3 $5 billion Tam opportunity in the U S alone.

Speaker Change: We plan to price SKU helix below current market leaders further positioning it as a value driven solution.

Speaker Change: Take a moment and look backwards.

Speaker Change: Two years ago, our total Tam for reset was $500 million.

Speaker Change: Competitive pricing, coupled with a consignment model and our route reduced time to graft are key benefits that we believe will help us progress through the value analysis committee process faster.

Speaker Change: Totally in burn centers.

Speaker Change: <unk> 18 months ago, when we received FDA approval for the full thickness indication, which dramatically expanded our tam by allowing us to enter the trauma center market.

Speaker Change: With co helix, we add nearly $1 billion to our total addressable market or Tam just within the 120 plus burn centers on top of the approximate $500 million Tam for resell in the $100 million Tam for permanent turn in these.

Speaker Change: In that time, we've gone from <unk>.

Speaker Change: A $500 million.

Speaker Change: Tim Burns to a $3 $5 billion Tam Burns and trauma centers.

Speaker Change: Looking ahead.

Speaker Change: Our strategy is clear number one expand resale go adoption.

Speaker Change: Same burn centers and trauma centers targeting full thickness wounds co helix adds one.

Speaker Change: Number two rollout we shall go minute during the first quarter focused on trauma centers. This will expand our trauma center market by approximately 270000, both thickness acute wounds annually to be clear, we will not be targeting chronic wounds are chronic wound centers.

Speaker Change: $135 billion in Tam.

Speaker Change: Derm contributes $135 million in Tam and resale provides a potential of one 5 billion in Tampa in the aggregate.

Speaker Change: Three launched co helix commercially.

Speaker Change: Medical now has a combined $3 $5 billion Tam opportunity in the U S alone.

Speaker Change: Number four continue to rollout perimeter.

Speaker Change: And finally number five we expect the notified body in the European Union.

Speaker Change: Take a moment and look backwards too.

Speaker Change: To grant the CE Mark for me. So go by the middle of the year opening up markets in Europe and Australia.

Speaker Change: Two years ago, our total Tam for reset was $500 million.

Speaker Change: Totally in burn centers.

Speaker Change: 18 months ago, when we received FDA approval for the full thickness indication, which dramatically expanded our tam by allowing us to enter the trauma center market.

Speaker Change: We remain committed to generating free cash flow in the second half of the year and achieving GAAP profitability during Q4 of 2025.

Speaker Change: In summary, 2024 was a transformational year.

In that time, we've gone from <unk>.

Speaker Change: A $500 million.

Speaker Change: Expanded product portfolio, which now includes resell yourself go we sell go many Permian Derm and co helix has taken us from a $500 million Tam with single product focused solely on burn centers with three $5 billion Tam and therapeutic acute wound care.

Tim Burns: Tim Burns to a $3 $5 billion Tam Burns and trauma centers.

Speaker Change: Looking ahead our.

Speaker Change: Our strategy is clear number one expand resale go adoption.

Speaker Change: Number two rollout we sell go minute during the first quarter focused on trauma centers. This will expand our trauma center market by approximately 270000 bulk thickness acute wounds annually to be clear, we will not be targeting chronic wounds are chronic wound centers.

Speaker Change: Across both burns and trauma centers on.

Want to thank our team customers and shareholders for their unwavering support as we continue to revolutionize the standard of care and therapeutic acute wound treatment.

Speaker Change: With that I'll turn the call over to David for a closer look at our financial results and guidance.

Speaker Change: Number three launched co helix commercially.

Speaker Change: <unk> continued to rollout perimeter.

Speaker Change: David.

Speaker Change: And finally number five we expect the notified body in the European Union.

Speaker Change: Thank you Jim for the <unk>.

Speaker Change: Three months ended December 31, 2024, our commercial revenue was $18 4 million.

Speaker Change: Two grand the CE Mark for me. So go by the middle of the year opening up markets in Europe and Australia.

Speaker Change: Representing a 30% increase compared to the same period in 2023.

Speaker Change: Remain committed to generating free cash flow in the second half of the year and achieving GAAP profitability during Q4 of 2025 and.

Speaker Change: This growth was driven primarily by the continued deployment and adoption of <unk> and our existing burn centers as well as new accounts and trauma centers.

In summary, 2024 was a transformational year.

Speaker Change: As we look forward to 2025, we expect resale go many ankle helix.

Speaker Change: Expanded product portfolio, which now includes resell yourself go we sell go many Permian term co helix has taken us from a $500 million Tam the single product focused solely on burn centers with <unk>.

Speaker Change: Tribute substantially to our revenue growth following their launches in February.

Speaker Change: April respectively.

Speaker Change: Permian <unk> revenue also gaining momentum throughout the year.

Speaker Change: Three $5 billion Tam therapeutic acute wound care across both burns and trauma centers onto.

Speaker Change: As expected our gross profit margin for the fourth quarter improved to 87, 6%.

Speaker Change: I want to thank our team.

Speaker Change: <unk> and shareholders for their unwavering support as we continue to revolutionize.

Speaker Change: Covering from the temporary decline last quarter and slightly increasing from 87, 3%.

Standard of care and therapeutic acute wound treatment with that I'll turn the call over to David for a closer look at our financial results and guidance.

Speaker Change: In the same period of 2023.

Speaker Change: As I indicated during our third quarter conference call Q3, operating expenses were elevated in that quarter due to onetime non reoccurring expenses.

Speaker Change: David.

David O'Toole: Thank you Jim.

David O'Toole: For the three months ended December 31, 2024, our commercial revenue was $18 4 million representing.

Speaker Change: In line with this previous statement, our Q4 operating expenses totaled $26 1 million or.

David O'Toole: Representing a 30% increase compared to the same period in 2023.

Speaker Change: $4 1 million decrease from the Q3 total of $30 2 million.

David O'Toole: This growth was driven primarily by the continued deployment and adoption of <unk> and our existing burn centers as well as new accounts and trauma centers.

Speaker Change: We have no plans to increase our head count or other operating expenses in 2025.

As we look forward to 2025.

Speaker Change: As such Q4 total operating expenses should be a consistent baseline for each quarter in 2025.

David O'Toole: We expect resale go many co helix contribute substantially to our revenue growth.

Speaker Change: Also note that the total operating expenses of $26 1 million in the fourth quarter include noncash expenses of approximately $2 8 million of stock based compensation expense.

David O'Toole: Owing their launches in February and April respectively.

David O'Toole: The Permian <unk> revenue also gaining momentum throughout the year.

David O'Toole: As expected our gross profit margin for the fourth quarter improved to 87, 6%.

Speaker Change: And approximately <unk> 4 million of depreciation and amortization.

David O'Toole: Covering from the temporary decline last quarter and slightly increasing from 87, 3% in the same period of 2023.

Speaker Change: Q4, 2024 operating expenses increased by $1 4 million.

Speaker Change: Compared to the same period in 2023.

David O'Toole: As I indicated during our third quarter conference call Q3, operating expenses were elevated in that quarter due to onetime non reoccurring expenses.

Speaker Change: This increase was primarily due to $3 9 million rise in <unk>.

Speaker Change: Sales and marketing expenses.

Speaker Change: <unk> from employee related costs within the expanded commercial sales organization.

David O'Toole: In line with this previous statement, our Q4 operating expenses totaled $26 1 million or.

Speaker Change: G&A expenses decreased by 0.6 million due to lower salaries and benefits as well as reduced professional fees.

David O'Toole: $4 $1 million decrease.

Q3, total up $30 2 million.

David O'Toole: We have no plans to increase our head count or other operating expenses in 2025.

Speaker Change: Similarly, R&D expenses declined by $1 9 million, reflecting lower outside professional fees due to the completion of the <unk> <unk> study.

David O'Toole: As such.

David O'Toole: Q4, total operating expenses should be a consistent baseline for each quarter in 2025.

Speaker Change: Other income expense shifted from $6 3 million and income in the same period in the prior year to an expense of <unk> 3 million in the current quarter.

David O'Toole: Also note that the total operating expenses of $26 1 million in the fourth quarter include noncash expenses of approximately $2 8 million of stock based compensation expense.

Speaker Change: The $6 $6 million decrease primarily resulted from a onetime noncash gain.

Speaker Change: Of $9 4 million from the wind down of our foreign subsidiaries offset by the change in fair value of the warrant liability.

David O'Toole: And approximately 0.4 million depreciation and amortization.

Q4, 2024 operating expenses increased by $1 4 million.

Speaker Change: For the fourth quarter. Other income expense consisted of a noncash charge of <unk> 7 million related to the change in fair value of the warrant liability offset by <unk> 4 million in investment income.

David O'Toole: Paired to the same period in 2023.

David O'Toole: This increase was primarily due to $3 9 million rise in <unk>.

David O'Toole: Sales and marketing expenses.

Speaker Change: Briefly I'd like to address the guidance announcement made on January 7th.

David O'Toole: Going from employee related costs within the expanded commercial sales organization.

Speaker Change: We have gained a better understanding of the year and purchasing pattern among our key customers.

David O'Toole: G&A expenses decreased by 0.6 million due to lower salaries and benefits as well as reduced professional fees.

Speaker Change: At the end of Q4, several top accounts strategically chose not to finalize pending purchase orders due to yearend cash preservation strategies.

David O'Toole: Similarly, R&D expenses declined by $1 9 million, reflecting lower outside professional fees due to the completion of the <unk> tone study.

Speaker Change: Leading to an approximately $3 million to $4 million revenue shortfall.

Speaker Change: Importantly, these deferred purchases were due to timing decisions.

David O'Toole: Other income expense shifted from $6 3 million and income in the same period in the prior year.

Speaker Change: A lack of demand for our commercial operational issues on our part.

David O'Toole: <unk> expense of <unk> 3 million in the current quarter.

Speaker Change: During January we experienced normal purchasing activities, which should result in renewed strong first quarter revenue growth.

David O'Toole: The $6 $6 million decrease primarily resulted from a onetime noncash gain of.

David O'Toole: $9 4 million from the wind down of our foreign subsidiaries offset by the change in fair value of the warrant liability.

Speaker Change: Moving onto the full year results.

Speaker Change: The full year ended December 31, 2024, our commercial revenue increased 29% to <unk>.

David O'Toole: For the fourth quarter. Other income expense consisted of a noncash charge of <unk> 7 million related to the change in fair value of the warrant liability.

Speaker Change: $64 million compared to $49 8 million in 2023.

David O'Toole: Outset by zero point $4 million in investment income.

It was disappointing to have the revenue Miss in the fourth quarter.

Speaker Change: Briefly I'd like to address the guidance announcement made on January 7th.

Speaker Change: But as you can see from this slide we do not want to lose sight of the fact that we have had significant year over year revenue growth for the last five years.

Speaker Change: We have gained a better understanding of the year and purchasing pattern among our key customers.

Speaker Change: At the end of Q4, several top accounts strategically chose not to finalize pending purchase orders due to yearend cash preservation strategies.

Speaker Change: The 29% growth in 2024, it was driven by the resell go transition.

Speaker Change: <unk> penetration within existing accounts.

Speaker Change: New account growth targeting trauma centers.

Speaker Change: Leading to an approximately $3 million to $4 million revenue shortfall.

Speaker Change: The gross margin for the full year was 85, 8% meeting the higher end of our previously given guidance of 85% to 86%.

Speaker Change: Importantly, these deferred purchases were due to timing decision not a lack of demand for commercial operational issues on our part.

Speaker Change: During January we experienced normal purchasing activities, which should result in renewed strong first quarter revenue growth.

Speaker Change: And up a 130 basis points from 84, 5% in 2023.

Speaker Change: Total operating expenses were $111 8 million compared to $86 4 million in 2023.

Speaker Change: Moving onto the full year results for the full year ended December 31, 2024, our commercial revenue increased 29% to.

Speaker Change: The increase is primarily attributable to $20 9 million and higher sales and marketing expenses, reflecting employee related costs from our commercial teams expansion.

Speaker Change: $64 million.

Compared to $49 8 million in 2023.

Speaker Change: It was disappointing to have the revenue Miss in the fourth quarter.

Speaker Change: G&A expenses rose by $4 9 million due to increased head count along with higher salaries and benefits and stock based compensation.

Speaker Change: But as you can see from the slide we do not want to lose sight of the fact that we have had.

Speaker Change: Inefficient year over year revenue growth for the last five years.

Speaker Change: R&D costs declined by <unk> 5 million, primarily due to reduced professional fees, partially offset by higher employee related compensation costs within our medical science liaison team.

Speaker Change: The 29% growth in 2024 was driven by the resell go transition deeper penetration within existing accounts.

Speaker Change: And new account growth targeting trauma centers.

Speaker Change: Other income expense for the year decreased by $8 3 million moving from $8 5 million and income in the prior year to income of <unk> 2 million in 2024.

Speaker Change: The gross margin for the full year was 85, 8% meeting the higher end of our previously given guidance of 85% to 86%.

This change primarily resulted from a onetime noncash gain of $9 4 million in 2023 from the wind down of certain of our foreign subsidiaries.

Speaker Change: Up 130 basis points from 84, 5% in 2023.

Speaker Change: Total operating expenses were $111 8 million compared to $86 4 million in 2023.

Speaker Change: Offset by a change in the fair value of the warrant liability.

Speaker Change: Interest expense increased by $4 $2 million year over year.

Speaker Change: The increase is primarily attributable to $20 9 million and higher sales and marketing expenses, reflecting employee related costs from our commercial teams expansion.

Speaker Change: <unk> to the long term debt of $40 million under the <unk> credit agreement.

Speaker Change: Net loss for the fourth quarter was $11 6 million or a loss of 44 per basic and diluted share compared to a net loss of $7 1 million or a loss of 28 per basic and diluted share in the same period in 2023.

Speaker Change: G&A expenses rose by $4 9 million due to increased head count along with higher salaries and benefits.

Speaker Change: <unk> based compensation.

Speaker Change: R&D costs declined by zero point $5 million, primarily due to reduced professional fees, partially offset by higher employee related compensation costs within our medical science liaison team.

Speaker Change: Net loss for the full year 2024 was $61 8 million or a loss of $2 39 per share compared to a net loss of $35 4 million or a loss of $1 40 per share in the prior year.

Speaker Change: Other income expense for the year decreased by $8 3 million moving from $8 5 million and income in the prior year to income of <unk> 2 million in 2024.

As of December 31, we had $35 9 million in cash and marketable securities.

Speaker Change: As reported last quarter, we utilized $9 7 million in cash during Q3.

Speaker Change: This change primarily resulted from a onetime noncash gain of $9 4 million in 2023 from the wind down of certain of our foreign subsidiaries.

Speaker Change: We continue this downward trend further reducing our use of cash to $8 5 million in the fourth quarter.

Speaker Change: Offset by a change in the fair value of the warrant liability.

Speaker Change: This reduction was achieved despite an increase in accounts.

Speaker Change: Interest expense increased by $4 $2 million year over year attributable to the long term debt of $40 million under the <unk> credit agreement.

Speaker Change: Receivable, which rose by $4 1 million to a total of $11 8 million as of December 31, 2024, compared to $7 7 million as of December 31, 2023.

Speaker Change: Net loss for the fourth quarter was $11 6 million or a loss of 44 per basic and diluted share compared to a net loss of $7 1 million or a loss of 28 per basic and diluted share in the same period in 2023.

Speaker Change: Note that our days sales outstanding or DSO did not increase.

As we move towards generating free cash flow in the second half of 2025, we anticipate that our use of cash will continue to decline over the next three quarters.

Speaker Change: Net loss for the full year 2024 was $61 8 million or a loss of $2 39 per share.

Speaker Change: In connection with our debt facility with Orben, Ed we executed an amendment today to lower the trailing 12 month revenue Covenant four quarters, ending March 31, 2025 through March 31 2026.

Speaker Change: <unk> to a net loss of $35 4 million or a loss of $1 40 per share in the prior year.

As of December 31, we had $35 9 million in cash and marketable securities.

Speaker Change: The 12 month trailing covenant of $115 million four quarters, ending after March 31, 2026 remains unchanged.

Speaker Change: As reported last quarter, we utilized $9 7 million in cash during Q3.

Speaker Change: We continue this downward trend further reducing our use of cash to $8 5 million in the fourth quarter.

Speaker Change: Looking ahead for the full year 2025, we expect commercial revenue to be in the range of $100 million to $106 million representing growth of 55% to 65% compared to 2024.

This reduction was achieved despite an increase in that.

Speaker Change: Counts receivable, which rose by $4 1 million to a total of $11 8 million as of December 31, 2024, compared to $7 7 million as of December 31, 2023.

Speaker Change: Additionally, we expect to generate free cash flow in the second half of this year and achieved GAAP profitability during Q4 of 2025.

Speaker Change: Note that our days sales outstanding or DSO did not increase.

Speaker Change: As previously stated we do not foresee any further expansion of our commercial organization over the next 18 to 24 months.

Speaker Change: As we move towards generating free cash flow in the second half of 2025, we anticipate that our use of cash will continue to decline over the next three quarters.

Speaker Change: This revenue guidance and financial projections are consistent with our announcement made on January seven.

Speaker Change: In connection with our debt facility with Oregon that we executed an amendment today.

Speaker Change: We remain confident in the success of resell go the April 1st full commercial launch of <unk>.

Speaker Change: Lower the trailing 12 month revenue Covenant four quarters, ending March 31, 2025 through March 31 2026.

Speaker Change: And the rollout of resale go many combined.

Speaker Change: Combined with the growing adoption of perimeter.

Speaker Change: These strategic efforts.

Speaker Change: The 12 month trailing covenant of $115 million per quarters, ending after March 31, 2026 remains unchanged.

Speaker Change: Position us to deliver strong results this year and drive significant shareholder value.

Speaker Change: With that I will turn the call back to the operator for your questions.

Looking ahead for the full year 2025, we expect commercial revenue to be in the range of $100 million to $106 million.

Speaker Change: Thank you as a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please standby, while we compile the Q&A roster.

Speaker Change: Representing growth of 55% to 65% compared to 2024.

Additionally, we expect to generate free cash flow in the second half of this year and achieved GAAP profitability during Q4 of 2025.

Speaker Change: Okay.

Speaker Change: And our first question comes from Matthew O'brien with Piper Sandler Your line is now open.

Speaker Change: As previously stated we do not foresee any further expansion of our commercial organization over the next 18 to 24 months.

Speaker Change: Hey, this is Phil on for Matt Thanks for taking our questions.

Speaker Change: <unk> like I guess, just on the cadence of the guidance.

This revenue guidance and financial projections are consistent with our announcement made on January seven.

Speaker Change: Now would you expect similar sequential growth each quarter or might it be a little bit more back half weighted given the contribution from <unk>.

Speaker Change: We remain confident in the success of resell go.

Speaker Change: Oh helix and maybe some timing of facts.

Speaker Change: The April 1st full commercial launch of <unk> and.

Speaker Change: And the rollout of resell go many combined with the growing adoption of perimeter.

Speaker Change: Yeah, well now we have you know.

Speaker Change: A little bit more complex.

Speaker Change: These strategic efforts, which should position us to deliver strong results this year and drive significant shareholder value.

Speaker Change: Multi product Rollouts will will create some you know.

Speaker Change: Some complexity in answering your question, So let me try and do.

Speaker Change: It simply.

Speaker Change: With that I will turn the call back to the operator for your questions.

Speaker Change: Consecutively from Q4, you should expect will be up notably in Q1.

Speaker Change: Thank you as a reminder to ask a question. Please press star one one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please standby, while we compile the Q&A roster.

By that time, we'll be in full launch.

Speaker Change: We shall go many and Permian Derm is now.

Speaker Change: Additionally, gaining a lot of momentum. So Q2 should then also be up sequentially.

Speaker Change: Okay.

And our first question comes from Matthew O'brien with Piper Sandler Your line is open.

Speaker Change: And yes, you are right that co helix has such a big revenue impact in.

Speaker Change: Hey, this is Phil on for Matt Thanks for taking our questions.

Speaker Change: In the back half it could have a very significant effect.

Speaker Change: <unk> like I guess, just on the cadence of the guidance.

Speaker Change: She is having a consecutive quarter cadence increasing over prior quarter.

Now would you expect similar sequential growth each quarter or might it be a little bit more back half weighted given the contribution from <unk>.

Speaker Change: It's so to speak we have plenty of gunpowder here and a lot to execute but plenty too.

Speaker Change: Oh helix and maybe some timing.

Speaker Change: Keep our revenue line driving.

Speaker Change: Max.

Speaker Change: I would expect that cadence to.

Speaker Change: Yeah, well now we have.

Speaker Change: B rather strong during the year.

Speaker Change: A little bit more complex.

Speaker Change: That's helpful and I guess, just sticking with guidance and trying to dive down a little deeper as for what's assumed in the growth of the three product categories I think in your prepared remarks.

Speaker Change: Multi product Rollouts will create some you know some.

Speaker Change: Complexity in your answering your question So let me try and do it simply.

Speaker Change: Consecutively from Q4, you should expect will be up.

Speaker Change: Our guidance assumes somewhat significant contribution from co helix I was hoping if you could provide a little bit more color on on what that might entail.

Speaker Change: Notably in Q1.

Speaker Change: By that time, we'll be in full launch.

Speaker Change: As far as.

Speaker Change: Michelle go many.

Speaker Change: Market share gains pretty quickly in the second half of 'twenty five maybe attachment rates to koby electron current result procedures.

Speaker Change: And Permian germ is now.

Speaker Change: Additionally, gaining a lot of momentum so Q2 should then.

Speaker Change: Also be up sequentially.

Speaker Change: Sort of thing just to get us a little bit more comfortable with that second half.

Speaker Change: And yes, you are right that <unk> is such a big revenue impact.

Speaker Change: Yeah.

Speaker Change: We're not going to breakout I think by product at this point today, but I'll give you a way to think about it.

Speaker Change: In the back half it could have a very significant effect.

Speaker Change: She is having a consecutive quarter cadence increasing over prior quarter.

Speaker Change: When I gave you the breakout of what the Tam is per case.

Speaker Change: We do if you recall the.

Speaker Change: So to speak we have plenty of gunpowder here and a lot to execute but plenty too.

Speaker Change: Resale contribution the perimeter and contribution potential co healer contribution.

Speaker Change: Keep our revenue line driving.

Speaker Change: And if you just looked at Burns for example.

Speaker Change: I would expect that cadence to.

Speaker Change: We treat about.

Speaker Change: B rather strong during the year.

Speaker Change: In burn cases.

Speaker Change: That's helpful and I guess, just sticking with guidance and trying to dive down a little deeper as for what's assumed in the growth of the three product categories. I think in your prepared remarks, the guidance assumed somewhat significant contribution from <unk> I was hoping if you could provide a little bit more color on on what that might.

Speaker Change: In the last quarter or two right at about that rate it's growing.

Speaker Change: Those averaged in excess of.

Speaker Change: 10% total body surface area.

Speaker Change: You try to figure out how it was kind of an equation. We don't know the answer to which is how quickly we get through back but as soon as you do that.

Speaker Change: Entail.

Speaker Change: As far as market.

Speaker Change: Market share gains pretty quickly in the second half of 'twenty five maybe attachment rates to co helix on current result procedures that sort of thing just to get us a little bit more comfortable with that second half.

Speaker Change: Revenue upside is considerable.

Speaker Change: We'll get some experienced about that we've taken are.

Speaker Change: A very careful approach with a limited market release here in Q1, where we're doing cases.

Speaker Change: Yes.

Speaker Change: We're not going to breakout I think by product at this point today, but I'll give you a way to think about it.

Speaker Change: We're what we're doing is gathering clinical data because it's post approval. Then we are in the process of enrolling co helix, one which by virtue of the very significant difference, we're proving right seven days to graft versus in some cases 20.

Speaker Change: When I gave you the breakout of what the Tam is per case.

Speaker Change: We do if you recall the <unk>.

Speaker Change: Resale contribution the perimeter contribution potential co healer contribution.

Speaker Change: You don't need a big number of patients to prove.

Tim Burns: And if you just looked at Burns for example.

Speaker Change: Statistically.

Speaker Change: In fact, it's approximately 40 patients to achieve full enrollment so that will give us a lot of.

Speaker Change: We treat about.

Speaker Change: A thousand burn cases.

Speaker Change: And the last quarter or two right at about that rate it's growing.

Speaker Change: Our support in the first by the end of the first half.

Speaker Change: And those averaged in excess of.

Speaker Change: Thank you might think about that.

10% total body surface area.

Speaker Change: Thanks, so much.

Speaker Change: Thank you.

Speaker Change: If you try to figure out how it was kind of an equation. We don't know the answer to which is how quickly we get through back but as soon as you do the revenue upside is considerable.

Speaker Change: Our next question comes from Ross Osborne of Cantor Fitzgerald. Your line is open.

Speaker Change: Hey, guys. This is Matthew park on for Ross today, Thanks for taking the questions I.

Speaker Change: We'll get some experienced about that we've taken.

Speaker Change: I guess, starting with too many.

Speaker Change: A very careful approach with a limited market release here in Q1, where we're doing cases that where we're what we're doing is gathering clinical data because it's post approval. Then we are in the process of enrolling co helix, one which by virtue of the very significant.

Speaker Change: Hey, How's it going as you continue to roll out many.

Speaker Change: Are there any trends or in adoption or feedback that stand out.

Speaker Change: It kind of gives you confidence once you go into this full commercial launch.

Speaker Change: Well actually what's what's good about many.

Speaker Change: It's used in the same our PD the same processing device, it's actually.

Speaker Change: Difference, we're proving right seven days to graft versus in some cases 20.

Speaker Change: Cassette design is this is exactly the same and from a manufacturing point of view the three.

You don't need a big number of patients to prove.

Speaker Change: At statistically.

Speaker Change: Three wells that you put scan and buffer an enzyme in are just smaller.

Speaker Change: In fact, it's approximately 40 patients to achieve full enrollment.

Speaker Change: So it's very good.

Speaker Change: We will give us a lot of.

Speaker Change: <unk> to us and this concept, where a doctor would feel like Wow I'm using a 10%.

Speaker Change: Our support in the first by the end of the first half.

Speaker Change: Thank you might think about that.

Speaker Change: Total body surface area treatment to treat.

Speaker Change: Thanks, so much.

Speaker Change: Less than two 5% total body surface area.

Speaker Change: Thank you.

Speaker Change: Problem that seems wasteful, that's how they felt.

Speaker Change: Our next question comes from Ross <unk> of Cantor Fitzgerald. Your line is open.

Speaker Change: When we did the market research on it so actually.

Speaker Change: A vast majority of those 270000 surgical and trauma wounds are under that 480 square centimeters at two 5%. So we're quite optimistic it's been just about just a month. So it's a little bit early for trends, but we of course don't have.

Speaker Change: Hey, guys. This is Matthew parked on for Ross today, Thanks for taking the question I.

Speaker Change: I guess, starting with too many.

Hi, How's it going as you continue to roll out many.

Speaker Change: Are there any trends are and adoption or feedback that stand out.

Speaker Change: It kind of gives you confidence once you go into this full commercial launch.

Speaker Change: Well actually what's.

Speaker Change: They've already got the resale processing device, so it's a rather easy trend.

Speaker Change: What's good about many is it's used in the same our PD the same processing device it's actually.

Speaker Change: Additional choice for them, so we're quite optimistic about it.

Speaker Change: <unk> design is this is exactly the same from a manufacturing point of view the.

Speaker Change: Got it that makes sense and then just one more from me do you mind reminding US again, what drove the high gross margin in the quarter and I guess, how we should think about the general cadence of gross margin in 2025.

Speaker Change: The three wells that you put scan and buffer an enzyme in are just smaller.

Speaker Change: So it is very <unk>.

David O'Toole: Yes. This is David thanks, Thanks for the question as.

Speaker Change: G to use and this concept, where a doctor would feel like Wow I'm using a 10%.

David O'Toole: As far as the gross margin for the quarter was over 87%.

Speaker Change: Total body surface area treatment to treat.

David O'Toole:

Less than two 5% total body surface area.

David O'Toole: We believe.

David O'Toole: Our gross margin for resell products will stay in that range, 85% to 87%.

Speaker Change: Problem that seems wasteful, that's how they felt.

Speaker Change: When we did the market research on it so actually the vast majority of those 270000 surgical and trauma wounds are under that 480 square centimeters at two 5%. So we're quite optimistic it's been just about just a month. So it's a little bit early for.

David O'Toole: Overall gross margin is going to go down because of the distribution of arrangements, we have norco helix and Permian, which we share.

David O'Toole: Gross margin on that basically 50, 50, so as those products become more.

Speaker Change: <unk> trends, but we of course don't have.

David O'Toole: Significant in our portfolio and our revenue mix. Our gross margin overall is going to go down, but as I've said and as you probably know that that profit margin all drops to the bottom line because there is no additional cost due to generate that revenue.

Speaker Change: They've.

Speaker Change: Got the resale processing device, so it's a rash.

Speaker Change: Other easy Tramp.

Speaker Change: Final choice for them.

Speaker Change: We're quite optimistic about it.

Speaker Change: Got it that makes sense and then just one more from me do you mind reminding US again, what drove the high gross margin in the quarter and I guess, how we should think about the general cadence of gross margin in 2025.

David O'Toole: Our overall gross margin made.

David O'Toole: A small decrease.

David O'Toole: But we're still going to be in a better position from an operating profit margin basic basis.

Speaker Change: Yeah. This is David Thanks for the question.

Speaker Change: As far as the gross margin for the quarter was over 87%.

David O'Toole: Got it that makes sense and thanks for taking my questions guys.

David O'Toole: Thank you.

Speaker Change: We believe.

Speaker Change: Our gross margin for resell products will stay in that range, 85% to 87%.

Speaker Change: Our next question comes from Ryan Zimmerman of BTG. Your line is open.

Speaker Change: Good afternoon can you hear me okay.

Speaker Change: Overall gross margin is going to go down because of the distribution of arrangements we have.

Speaker Change: Well, Ryan How're you doing.

Speaker Change: Good good thanks for taking my question.

Speaker Change: Questions from me guys.

Speaker Change: So that's first.

Speaker Change: Co helix and Permian, which we share.

Speaker Change: Jim I appreciate youre, not breaking out guidance by product how much international sales is contemplated in the guidance.

Speaker Change: Gross margin on that basically 50, 50, so as those products become more.

Speaker Change: And when do you expect potentially clearance in Europe.

Speaker Change: Significant in our portfolio and our revenue mix. Our gross margin overall is going to go down, but as I've said and as you probably know.

Speaker Change: Yeah, It's a great question, it's modest Ryan.

Speaker Change: And the reason it's modest as we just we've been through.

Speaker Change: That profit margin all drops to the bottom line because there is no additional cost to generate that revenue.

Speaker Change: The substantive review with the notified body.

Speaker Change: And as a as a fact.

E R M.

Speaker Change: Our overall gross margin.

Speaker Change: We see exactly they had committed to us approval in October.

Speaker Change: A small decrease.

Speaker Change: But we're still going to be in a better position from an operating profit margin basic.

Speaker Change: We're now in.

Speaker Change: February.

Speaker Change: And we don't have it yet so we don't have a we don't have any technical challenges, but we have an unpredictable process. So.

Speaker Change: Yeah.

Speaker Change: Got it that makes sense and thanks for taking my questions guys.

Thank you.

Speaker Change: That's that's representative of our mid year expectation yet there is no more.

Speaker Change: Our next question comes from Ryan Zimmerman of <unk>. Your line is open.

Speaker Change: Submission materials to be reviewed or submitted.

Speaker Change: Good afternoon can you hear me okay.

Speaker Change: At this time.

Speaker Change: Well, Ryan How're you doing.

Speaker Change: So it is modest.

Speaker Change: Good good thanks for taking the question.

Speaker Change: Okay.

Speaker Change: And then the inventory that was in the channel in the fourth quarter Jim.

Speaker Change: Two questions from me guys.

Speaker Change: So first.

Speaker Change: A couple of questions on that so one how much of that was re sell how much of that was <unk>.

Speaker Change: Jim I appreciate youre, not breaking out guidance by product how much international sales is contemplated in the guidance.

Speaker Change: Mia Derm and was all of that work down in the fourth quarter, because David to your comments that you expect the sales to pick up in the first quarter.

Speaker Change: And when you expect potentially clearance in Europe.

Speaker Change: Yeah, that's a great question, it's modest Ryan.

Speaker Change: Is there I guess I'm, just wondering why there isn't inventory to be worked down.

Speaker Change: And the reason it's modest as we just we've been through.

Speaker Change: In the first quarter necessarily from what was in the channel kind of late in December.

Speaker Change: The substantive review with the notified body.

Speaker Change: And you know as a as a fact.

Speaker Change: Yeah. So.

Speaker Change: A couple of comments the majority of inventory for us resale permanent terms still a small part of our inventory.

Speaker Change: They are.

Speaker Change: We see exactly they had committed to us approval in October.

Speaker Change: We're now in.

Speaker Change: And Oh excuse me our sales fundamentally we have inventory on the balance sheet.

Speaker Change: February.

Speaker Change: And we don't have it yet so we don't have a we don't have any technical challenges, but we have an unpredictable process. So.

Speaker Change: And <unk>.

Speaker Change: It's different in the permanent derm is the really rather large increase in evaluation, so where we're getting the traction that took us a little while to.

Speaker Change: That's that's representative of our mid year expectation yet there is no more submission materials to be reviewed or submitted.

Speaker Change: Basically developed a clinical support materials that are necessary because it was not on the market really before even though it had been.

Speaker Change: At this time.

Speaker Change: Test Mark tests launched I guess by Milliken before.

Speaker Change: It is modest.

Speaker Change: And then the inventory that was in the channel in the fourth quarter Jim.

Speaker Change: With respect to your question.

Speaker Change: Keep in mind all of our customers have inventory on the shelf because of the nature of our business right.

Speaker Change: A couple of questions on that so one how much of that was re sell how much of that was hernia derm and was all of that work down in the fourth quarter because David to your comments that you expect the sales will pick up in the first quarter.

Speaker Change: Where therapeutic for acute wound business right. So.

Speaker Change: When the patient shows up they have to have it.

Speaker Change: No.

Speaker Change: We are not having any signs that would suggest that there is inventory to work off to make.

Is there I guess I'm, just wondering why there isn't inventory to be worked down in.

Speaker Change: Revenue are successful in Q1.

Speaker Change: In the first quarter necessarily from what was in the channel kind of late in December.

Speaker Change: So I don't think thats going to be.

Speaker Change: That is not showing as a challenge to us at the moment.

Speaker Change: Yes.

Speaker Change: A couple of comments the majority of inventory for us retail I mean, the Permian still a small part of our inventory.

Speaker Change: Okay.

Speaker Change: Last one for me just sneak one in.

Speaker Change: That's helpful. Jim.

David O'Toole: And the last one from me David There is a little lease revenue.

Speaker Change: And Oh excuse me our sales on the mentally we have inventory on the balance sheet.

Speaker Change: This quarter and so I'm just wondering if you expect that to be a bigger trend in the placement of systems over time.

Speaker Change: What's different in permanent derm is the really a rather large increase in evaluation, so where we're getting the traction that took us a little while to.

David O'Toole: As you think about your guidance the one Oh sorry.

David O'Toole: Yeah. So the lease revenue is just a portion of the overall resell sale of the RP case in RPT, our RP case.

Speaker Change: Basically developed a clinical support materials that are necessary because it was not on the market really before even though it had been.

Speaker Change: Test Mark tests launched I guess by Milligan before.

With respect to your question.

David O'Toole: We as you may remember pre.

Speaker Change: Keep in mind all of our customers.

David O'Toole: Provided our hospitals and facilities with the RPT the processing unit no.

Speaker Change: Inventory on the shelf because of the nature of our business right.

David O'Toole: No cost.

Speaker Change: Sure.

Speaker Change: Our therapeutic for acute wound business right. So.

David O'Toole: And.

David O'Toole: Or accounting purposes, and this is only for accounting.

Speaker Change: When the patient shows up they have to happen.

David O'Toole: We have to allocate a portion of the revenue from the sale of the RP case, the actual disposable kits.

Speaker Change: So we.

Speaker Change: We are not having any signs that would suggest that theres inventory to work off to make.

David O'Toole: Queen revenue and lease revenue.

Speaker Change: Revenue are successful in Q1.

David O'Toole: And Thats what that is it really isn't lease revenue, it's an accounting treatment that is required.

Speaker Change: So I don't think that's going to be.

Speaker Change: That's not showing as a challenge to us at the moment.

David O'Toole: Okay.

Speaker Change: Okay.

David O'Toole: That's very clear yes.

Speaker Change: Last one for me just want to sneak one in.

David O'Toole: It can be very helpful to it really it's almost worth thinking about it as the amortization methodology for the cost of the RPT.

Jim Corbett: That's helpful. Jim.

Speaker Change: And the last one from me David There is a little lease revenue.

Speaker Change: This quarter and so I'm just wondering if you expect that to be a bigger trend in the placement of systems over time.

David O'Toole: So that's what I was trying to understand because.

David O'Toole: I just was wondering if essentially the mark.

David O'Toole: Model.

Speaker Change: You know as you're thinking about your guidance the one oh sorry.

David O'Toole: Is changing in terms of how you're placing systems necessary.

Speaker Change: Yeah. So the lease revenue is just a portion of the overall resell sale of the RP case in RPT RP case.

David O'Toole: Just trying to understand yes, yes, okay. So yes, we're not we're not.

Speaker Change: Thank you.

David O'Toole: Thank you.

Speaker Change: Okay.

Speaker Change: Our next question comes from Brooks O'neil of Lake Street Capital markets. Your line is open.

Speaker Change: We as you may remember.

Speaker Change: Provided our hospitals and facilities with the RPT the processing unit.

Speaker Change: Thank you and good evening.

Speaker Change: No cost.

Speaker Change: So I have not had a chance to read the 8-K related to the REIT.

And.

Speaker Change: For accounting purposes, and this is only for accounting.

Speaker Change: We have to allocate a portion of the revenue from the sale of the RP case, the actual disposable kits.

Speaker Change: Negotiated credit agreement, but in the <unk>.

Speaker Change: Prior one.

Speaker Change: Some question about the.

Speaker Change: Quarterly covenant.

Speaker Change: Tween revenue and lease revenue.

Speaker Change: And then I considered it a giant deal.

Speaker Change: And that's what that is it really isn't lease revenue, it's an accounting treatment that is required.

Speaker Change: You have to begin repaying that debt, but can you just give us a sense for how much of a question you've gotten in for example, Q1 Q2 and Q3.

Speaker Change: Okay.

Speaker Change: That's very clear yeah.

Speaker Change: It can be very helpful to it really it's almost worth thinking about it as the amortization methodology for that.

Speaker Change: As you look toward the end of this year.

Speaker Change: Yes Brooks thanks, Thanks for the question.

Speaker Change: Cost of the RPT.

Speaker Change: No.

Speaker Change: What I was trying to understand because.

Speaker Change: All of the details are in the 8-K, but I'll give you the details for.

Speaker Change: I just was wondering if essentially the model.

Speaker Change: For these first two quarters.

Speaker Change: It is changing in terms of how you're placing systems necessary. That's what I was trying to understand yes, yes. Okay. So yeah, we're not we're not.

Speaker Change: Sure.

Speaker Change: The revenue is on a trailing 12 month.

Speaker Change: And for the first quarter.

Speaker Change: Thank you.

Speaker Change: <unk> now $73 million.

Speaker Change: Thank you.

Speaker Change: Down from $75 million for the last 12 months.

Speaker Change: Yeah.

Speaker Change: Our next question comes from Brooks O'neil of Lake Street Capital markets. Your line is open.

Speaker Change: For Q2.

Speaker Change: Yes.

Speaker Change: It is now it's now $78 million.

Speaker Change: Thank you and good evening.

Speaker Change: Right.

Speaker Change: So I have not had a chance to read the 8-K related to the <unk>.

Speaker Change: Down from $90 million.

Speaker Change: Alright.

Speaker Change: All of them.

Speaker Change: There was a significant decrease doesn't give any indication that that's what we think our revenue is going to be it. Just gives you said a little bit of cushion. So that we don't have to repay the debt.

Speaker Change: Renegotiated credit agreement, but in the <unk>.

Speaker Change: Prior ones.

Speaker Change: Some question about the.

Speaker Change: Quarterly.

Speaker Change: Covenant.

Speaker Change: And then I considered it a giant deal.

Speaker Change: Right.

Speaker Change: They have to begin repaying that debt, but can you just give us a sense for how much of a question you've gotten in for example, Q1 Q2 and Q3.

Speaker Change: And I am.

Speaker Change: Guessing, but again haven't read it.

Speaker Change: The terms are substantially the same or is it.

Speaker Change: Been a big change.

Speaker Change: Change in terms of.

Speaker Change: As you look toward the end of this year.

Speaker Change: What happens if you happened to break the covenants under the new agreement.

Speaker Change: Yes Brooks thanks, Thanks for the question.

Speaker Change: The terms remain the same.

Speaker Change: All of the details are in the 8-K, but I'll give you the details.

Speaker Change: Okay great.

Speaker Change: And then the second thing I was curious about.

Speaker Change: For these first two quarters.

Speaker Change: It's my sense that with co helix you got the initial approval based.

Speaker Change: Sure.

Speaker Change: The revenue is on a trailing 12 months.

Speaker Change: And for the first quarter.

Speaker Change: Not so much on.

Speaker Change: It is now $73 million.

Speaker Change: Human.

Speaker Change: Clinical evidence but.

Speaker Change: Down from $75 million over the last 12 months.

Speaker Change: Animal work.

Speaker Change: And I'm curious you mentioned Jim mentioned the.

Speaker Change: For Q2.

Speaker Change: What sounded like tremendous success at Ohio.

Speaker Change: It is now it's now $78 million.

Speaker Change: Ohio State, but.

Speaker Change: Can you just give us some color on weather.

Right.

Speaker Change: Down from $90 million.

Speaker Change: You are beginning to amass sufficient clinical evidence with humans to support the notion that co helix can be a material contributor to your revenues.

Speaker Change: Alright.

Speaker Change: There was a significant decrease doesn't give any indication that that's what we think our revenue is going to be it. Just gives you said a little bit of cushion. So that we don't have to repay the debt.

Speaker Change: In the back part of 2025.

Brooks O'neil: Yeah Brooks.

Speaker Change: Right.

Brooks O'neil: So we got we received.

Speaker Change: And I'm.

Brooks O'neil: Approval for that dermal matrix.

Speaker Change: Guessing, but again I haven't read it.

Speaker Change: The terms are substantially the same or has there been a big.

Brooks O'neil: <unk> with the market in terms of.

Brooks O'neil: How you get what the FDA requirements are they are pretty clear.

Change in terms of the what.

Speaker Change: What happens if you happen to break.

Brooks O'neil: Now the work we did in the.

Speaker Change: Covenants under the new agreement.

Brooks O'neil: <unk> validated <unk> model.

Speaker Change:

Speaker Change: Terms remain the same.

Brooks O'neil: Quite a scientific project than we did at 18 times. So we've looked at a lot of different materials and we were looking for.

Speaker Change: Okay great.

And then the second thing I was curious about.

Speaker Change: It's my sense that with co helix you got the initial approval based.

Brooks O'neil: Very precise qualities of histological absorption yet providing the.

Speaker Change: Not so much on.

Brooks O'neil: The matrix.

Speaker Change: Human.

Brooks O'neil: Structure or in growth.

Speaker Change: Clinical evidence but.

Speaker Change: Animal work.

Brooks O'neil: Blood vessels.

Speaker Change: And I'm curious you mentioned Jim mentioned the.

Brooks O'neil: And yet have it go away. So they don't have to remove it all those kinds of factors and it has a lot to do with how you sterilize it and how you process the denatured collagen.

Speaker Change: What sounded like tremendous success at I think Ohio state, but.

Speaker Change: Can you just give us some color on weather.

Speaker Change: You are beginning to amass sufficient clinical evidence with humans to support the notion that co helix can be a material contributor to your revenues.

Brooks O'neil: When we when we applied our preclinical data, we've probably showed it to at least 50 positions at this point.

Brooks O'neil: We haven't met one yet who didn't want to try it.

Speaker Change: In the back part of 2025.

Brooks O'neil: So that's oh.

Brooks: Yes Brooks.

Brooks O'neil: Kind of a piece of information right.

Brooks: So we've got we received approval for that thermal metrics consistent with the market in terms of.

Brooks O'neil: We've done a number of cases because of course, it's approved that are not in the study.

Brooks O'neil: And so far all of them.

Brooks O'neil: I've remarked, how well it handles.

Brooks: How you get what the FDA requirements are there are pretty clear.

Brooks O'neil: Intra procedure and it is producing the clinical outcome in the short run we are not all of them have reached the seven days because we only have done this recently.

Brooks: Now the work we did in the.

Brooks: Post the validated foreseen model.

Brooks: It's quite a scientific project than we did at 18 times. So we've looked at a lot of different materials and we were looking for.

Brooks O'neil: No ready to graft, but none have taken longer.

Brooks: Precise qualities of histological absorption yes.

Brooks O'neil: And at this point.

Brooks O'neil: So we really feel good about and those are on humans.

Brooks: It's providing the matrix or <unk>.

Brooks O'neil: So we plan on having 20 sites to enroll those 40 patients.

Brooks: Structure.

Brooks: In growth of blood vessels.

Brooks: And yet have it go away. So they don't have to remove it all of those kinds of factors and it has a lot to do as how you sterilize it and how you process the de natured collagen.

Brooks O'neil: So we expect that we'll be able to do a couple of things that are.

Brooks O'neil: That are by design and.

Brooks O'neil: And let me share them with you so on one hand.

Brooks O'neil: It's a study with an IRB is under controlled follow up on.

Brooks: So when we when we applied our preclinical data, we've probably showed it to at least 50 positions at this point.

Brooks O'neil: On another it's a post market study.

Brooks O'neil: So in the agreement.

Brooks O'neil: During the course of the study.

Brooks: Haven't met one who.

Brooks: We didn't want to try it.

Brooks O'neil: Imagine that a site has five patients enrolled.

Brooks: So that's oh.

Brooks: Kind of a piece of information right.

Brooks O'neil: That physician can share that data with us or on the podium or in an abstract.

Brooks: We've done a number of cases because of course, it's approved that are not in the study.

Brooks: And so far all of them.

Brooks O'neil: During the period of the study so we don't have to wait until the study fully enrolled.

Brooks: I've remarked, how well it handles.

Brooks: Intra procedure.

Brooks O'neil: And.

Brooks O'neil: And becomes published in its aggregate sometime late in the year, rather we will be able to use that data as it's developed and that was very intentional as part of the study design.

Brooks: And it is producing the clinical outcome in the short run we are not all of them have reached the seven days because we only have done this recently.

Brooks: How ready to graft, but none have taken longer.

Brooks O'neil: No.

Brooks O'neil: Can any of that.

Brooks: And at this point.

Speaker Change: I think we're going to have the data by April one that supports a strong launch at that time.

Brooks: Yeah.

Brooks: We really feel good about it.

Brooks: Yes.

[noise] [noise].

Brooks O'neil: Great. Thank you.

Speaker Change: I'll just.

Speaker Change: Finished by saying I'm amazed at how much you guys have accomplished congratulations and keep it up.

Speaker Change: Thanks Brooks. Thank you Sir thank you.

Speaker Change: Our next question comes from Joshua Jennings of TV Cowen. Your line is now open.

Brooks: Yeah.

Brooks: Okay.

Brooks: Okay.

Joshua Jennings: Hi, good afternoon, thanks for taking the questions.

Brooks: Yeah.

Brooks: Okay.

Brooks: Okay.

Speaker Change: Okay Cool Brooks comments on congratulations on all the progress just.

Brooks: Yes.

Brooks: Okay.

Joshua Jennings: Follow up on Bruce's question as well just on adoption.

Speaker Change: Physician can share that data with us or on the podium or in an abstract.

Joshua Jennings: Adoption pace of co helix and <unk>, what are you going to be running a cost effectiveness study with Dan.

Speaker Change: During the period of the study so we don't have to wait.

Joshua Jennings: And I think cause for.

Speaker Change: Until the study fully enrolled.

Joshua Jennings: Recently, Brian was a big driver of adoption utilization.

Speaker Change: And.

Speaker Change: And becomes published in its aggregate sometime late in the year, rather we will be able to use that data as it's developed and that was very intentional as part of the study design.

Joshua Jennings: Exciting the first case at Ohio State that the patients discharged in 10 days.

Joshua Jennings: Expectations for her severity for would've been closer to 30.

Joshua Jennings: I mean, how big of a driver do you guys anticipate that length of stay reduction in cost of that seems to be overtime calculation adoption utilization.

Speaker Change: So.

Speaker Change: In any event.

Speaker Change: I think we're going to have the data by April one that supports a strong launch at that time.

Joshua Jennings: Josh we think it can be a very large deal and it very well fits.

Speaker Change: Great.

Speaker Change: I'll just.

Joshua Jennings: With the resell theme as you know those.

Speaker Change: <unk> finished by saying I'm amazed at how much you guys have accomplished congratulations and keep it up.

Joshua Jennings: A lot of data out there that demonstrates that patients treated with <unk> cel exit the hospital, 30% sooner and so helix fits that theme and what when we work to get cost justification for resell that is a very important matter for hospitals. These days and it should be.

Brooks: Thanks Brooks.

Speaker Change: Thank you.

Speaker Change: Our next question comes from Joshua Jennings of TV Cowen Your line is open.

Speaker Change: Hi, good afternoon, thanks for taking the questions.

Joshua Jennings: And so very important matter for the treating physicians and the patients they treat.

Speaker Change: Okay Cool Brooks comments on congratulations on the progress just want a follow.

Speaker Change: Follow up on Bruce's question as well just on.

Joshua Jennings: So this seven days, we think is going to be very determinant and giving us.

Speaker Change: Adoption pace of co helix.

Speaker Change: <unk> as you'll be running a cost effectiveness study within.

Joshua Jennings: Some leverage in terms of adoption and by the way the study cant.

Speaker Change: And I think cost effectiveness for resale and Brian was a big driver of adoption utilization.

Joshua Jennings: And place inclusion with.

Joshua Jennings: Co helix alone are co helix with resale so won't be it will have both enrolled so.

Speaker Change: Exciting the first case at Ohio State that the patients discharged in 10 days.

Joshua Jennings: Really looking at standard of care.

Speaker Change: Expectations for her severity for would've been closer to 30.

Joshua Jennings: Great and then just speaking of the coal helix 140 patients enrolled in and just the vac process I mean.

Speaker Change: I mean, how big of a driver do you guys anticipate that length of stay reduction in cost of decades to be overtime for coke helix adoption utilization.

Joshua Jennings: Is that enough.

Joshua Jennings: I'm, assuming your expectation is that that includes one will be enough for most banks to get over the hump and give a positive decision.

Speaker Change: Josh we think it can be a very large deal and it very well fits.

Speaker Change: With the resell theme as you know there is.

Joshua Jennings: Do you see that playing out thanks for taking the questions.

A lot of data out there that demonstrates that patients treated with <unk> cel exit the hospital, 30% sooner and co helix fits that theme and when we work to get cost justification for resell that is a very important matter for hospitals. These days and it should be.

Speaker Change: Josh I think in the near term what will be.

Joshua Jennings: <unk> will be the following.

They will want to see the preclinical data in the vac because it's.

Joshua Jennings: It's published in.

Joshua Jennings: And published.

Speaker Change: Acacia now to want to see the case studies that we have done in real time.

Speaker Change: Third they will want to have us be at a price point that save some money.

Speaker Change: And so very important matter for the treating physicians and the patients they treat.

Speaker Change: For they will want to not have to buy the inventory and they will appreciate the <unk>.

Speaker Change: So this seven days, we think is going to be very determinant and giving us.

Consignment RFID system that we're going to market with.

Speaker Change: I think all of those will contribute to a faster back time.

Speaker Change: Some leverage in terms of adoption and by the way the study contemplates inclusion with.

Jim Corbett: Excellent Thanks, Jim.

Speaker Change: Co helix alone or co helix with resale so it won't be it will have both enrolled so it's real.

Speaker Change: Thanks. Thank you that concludes our question and answer session. At this time I would like to turn it back to Jim Corbett for closing remarks.

Speaker Change: Looking at standard of care.

Speaker Change: Great and then just sticking with the KOL helix won 40 patients enrolled in and just the vac process.

Jim Corbett: Thank you operator, and thanks to all of you for calling in and listening. We're really excited about the transformation of our company of EDA medical into a therapeutic acute wound care company.

Speaker Change: Is that enough.

Speaker Change: I'm, assuming your expectation is that that includes one will be enough for most banks.

Speaker Change: Next to get over the hump and give a positive decision or how do you see that playing out thanks for taking the questions.

Jim Corbett: We have a lot of excitement for the year ahead, and I'm looking forward to sharing with you. Thank you.

Jim Corbett: This concludes today's conference call. Thank you for participating and you may now disconnect.

Speaker Change: Josh I think in the near term what will be important will be the following.

Speaker Change: They will want to see the preclinical data in Nevada, because it's.

Speaker Change: It's published in <unk>.

Speaker Change: Published.

Location now they want to see the case studies that we have done in real time.

Speaker Change: Third they will want to have us be at a price point that save some money.

Speaker Change: For they will want to not have to buy the inventory and they will appreciate the.

Speaker Change: Consignment RFID system that we're going to market with I think all of those will contribute to a faster back time.

Speaker Change: Excellent Thanks James.

Speaker Change: Thanks. Thank you that concludes our question and answer session. At this time I would like to turn it back to Jim Corbett for closing remarks.

Jim Corbett: Thank you operator, and thanks to all of you for calling in and listing.

Speaker Change: Really excited about the transformation of our company of EDA medical into a therapeutic acute wound care company we.

Speaker Change: We have a lot of excitement for the year ahead, and I'm looking forward to sharing with you. Thank you.

Speaker Change: This concludes today's conference call. Thank you for participating and you may now disconnect.

Speaker Change: Okay.

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Speaker Change: Good day and thank you for standing by welcome to the Davita Medical fourth quarter 2024 earnings Conference call. At this time all participants are in a listen only mode. After the speaker's presentation. There will be a question and answer session to ask a question. During the session you will need to crush SAR one one on.

Your telephone.

Speaker Change: Then youre an automated message advising your hand is raised to withdraw your question. Please press star. One again, please be advised that today's conference is being recorded I would now like to hand, the conference over to your speaker today, Jessica Clark Director of Investor Relations. Please go ahead.

Speaker Change: Thank you operator, welcome Kathy the medical fourth quarter and full year 2000.

Speaker Change: For our earnings call joining me on today's call are Jim Corbett.

Speaker Change: Executive Officer, and David O'toole, Chief Financial Officer, Inc. Earnings release, and presentation are available on our website www Dot Davita medical Dot com under the Investor Relations section.

Speaker Change: Before we begin I would like to remind you that this concludes forward looking statements within the meaning of the private Securities Litigation Reform Act of 1095.

Speaker Change: These statements are neither promises nor guarantee and involve known and unknown risks and uncertainties that could cause actual results to differ materially from any expectations expressed or implied by the forward looking statements.

Speaker Change: Please review our most recent filings with the SEC for a comprehensive description of the risk factors.

Speaker Change: Any forward looking statements provided during this call are based on management's expectations.

Today, I will now turn the call over to Jim for his comments.

Jim Corbett: Thank you Jessica and good afternoon to those in the U S and good morning to our Australia investors.

Speaker Change: Thank you for joining us today as we review a year of remarkable progress and complete transformation.

Speaker Change: Over the past year, we evolved from a single product company to a multi product leader and therapeutics acute wound care.

Speaker Change: This initiative began in 2023 as we launch our strategic growth plan and expanded our core business to treat trauma and surgical loans under the full thickness skin defects indication.

Speaker Change: To support these efforts we began building.

Speaker Change: Scalable infrastructure setting the stage for our first portfolio expansion.

Speaker Change: In January 2024, we announced Permian era, the first edition to our multi product portfolio.

Speaker Change: By April 2024, we have launched it marking a pivotal milestone in our transformation.

Speaker Change: Aligning our portfolio with our mission.

Speaker Change: This submission shown on slide three.

Speaker Change: Cornerstone of who we are and where we're headed let me explain is significance and how it is shaping our future success.

Speaker Change: Our mission is to position a beta medical is a leading therapeutic acute wound care company.

Speaker Change: Delivering transformative solutions or technologies are designed to optimize wound healing.

Speaker Change: Effectively accelerating the time to patient recovery.

Speaker Change: Words in this statement or meaningful let's break down what this means.

Speaker Change: Therapeutic means that our solutions are designed to actively heal and cure patients.

Speaker Change: Not just be palliative forms of care.

Speaker Change: Acute defines the nature of our focus we treat patients with event driven injuries.

Speaker Change: <unk> dramatic or surgical wounds, not chronic wounds, such as diabetic foot ulcers venous leg ulcers or pressure sores simply put our patients are victims of severe unexpected accidents or events at car crashes industrial fires post-traumatic burns.

Speaker Change: Common denominator does not their age is not their gender nor is it their ethnicity, but rather the shared nature of their injuries. These <unk> could be the result of a solo road incident.

Burns sustained from an industrial fire or worse.

Speaker Change: Multiple injuries from a tragic event like the recent terror attack in New Orleans.

Speaker Change: Spite their diverse scenarios. These patients all have injuries due to traumatic events in our mission to help patients heal faster.

Speaker Change: Reduces overall health care costs, but more importantly helps patients return home to their loved ones more quickly.

Underscores the power of our technologies and a driving force behind our expanded product portfolio.

Speaker Change: Please turn to slide four to see the related markets that we serve as I explained how our product portfolio aligns with our mission.

Speaker Change: Let's start with our core product resell and review, how it optimizes patient healing and accelerates patient recovery.

Speaker Change: First and foremost what makes resale special is that it is skin's barrier.

Speaker Change: Allowing physicians to achieve closure using significantly less healthy donor skin.

Speaker Change: Also known as autologous skin.

Compared to traditional grafting techniques, we sell expands the autologous sample 80 to one additionally, substantial clinical evidence demonstrates that patients treated with resell yield faster experienced less scarring and leave the hospital sooner.

Speaker Change: We sell go our next generation system combines the proven outcomes of resell.

Enhanced features that simplify upstream streamlined its use in both burn and trauma centers.

Speaker Change: Conversion to resale co is going very well, we have converted nearly all of our burn accounts and over 70% of our trauma center accounts for approximately 83% of our total unit volume.

Speaker Change: As a reminder, each of our standard resell co processing kits to treat up to 1920 square centimeters.

Speaker Change: Which is roughly 10% of total body surface area.

Speaker Change: Oliver most traumatic wounds are under 480 square centimeters or about two 5% total body surface area.

Speaker Change: This size difference created somewhat of a cognitive dissonance for the clinicians using a standard resale kit to treat a small wound.

Speaker Change: Like using a sledge hammer driving a small mill to.

Speaker Change: To address this we read this we designed resale go many.

Speaker Change: For wounds under 480 square centimeters.

Speaker Change: A critical gap in our trauma care offering.

Speaker Change: As anticipated we received approval for resale go many on December 23rd.

Speaker Change: We are rolling out we saw go with many to burn and trauma centers that currently treat a significant volume of smaller loans during Q1 <unk>.

Speaker Change: Incidentally, we saw go many uses the same resale go processing device.

Speaker Change: Standard we saw go processing.

Speaker Change: This.

Speaker Change: <unk> is a foundation of our portfolio unlocking possibilities and therapeutic acute wound care with complementary solutions like co helix and Permian.

Permian Derm.

Speaker Change: Temporary biosynthetic dressing further strengthens our portfolio by supporting wound healing before and after grafting.

Speaker Change: Plays a role in helping clinicians field.

Speaker Change: Youll patients faster get patients home sooner and reduce hospital stays there by lowering overall cost of care want to take a moment to remind you about the unique qualities of Permian.

Speaker Change: First it is of course facilitated facilitating airflow two the one <unk>.

Speaker Change: Promote healing, while enabling exited eight granted.

Speaker Change: Next is prosodies flexible, which lets the clinicians adjusted moisture levels, ensuring optimal hieland conditions for each patient's unique wound needs.

Speaker Change: Finally, it's transparent cover allowance commissions to monitor the skin.

Speaker Change: Monitor skin grafts fueling progress without disturbing it.

Speaker Change: Rather than lifting are removing interrupt our dressing which can potentially disrupt the graft.

Speaker Change: <unk> have a clear view of the progress, making it uniquely effective.

Speaker Change: Taking our wound healing approach step further our newly FDA cleared dermal matrix Skokie lakes represents a breakthrough in addressing the critical need for accelerated graft readiness.

Speaker Change: Helix is a collagen derived dermal matrix.

Speaker Change: We co developed with regenerative biosciences are.

Speaker Change: Our goal was clear.

Speaker Change: A material integrates into the wound bed and absorbs histologically, eliminating the need for removal before skin graft application and reducing the number of days scrapped readiness.

Speaker Change: And a validated foreseen model our preclinical work demonstrated.

Speaker Change: Co helix is used as a dermal matrix on a large wound.

Speaker Change: It is ready for grafting in just seven days.

Speaker Change: Compared to 12 to 21 days, where alternative withdrawn matrices in the studies.

Speaker Change: This faster readiness translates directly to shorter hospital stays reduced cost and better patient outcomes.

Speaker Change: Full thickness wounds co helix provides a <unk> structure that supports tissue regrowth in the formation of new blood vessels essentially absorbed into the world.

Speaker Change: Illustrate the significant benefits of faster healing.

Speaker Change: To understand the complexities and challenges associated with treating both thickness wounds I.

Speaker Change: A definition.

Speaker Change: Full thickness skin injury penetrates all layers of the skin.

Speaker Change: Causing significant soft tissue loss and damage to the connective tissue structural integrity.

Speaker Change: Unlike a superficial knee abrasion for your own cells, repopulate quickly and often heal overnight.

Speaker Change: This wounds lack the necessary healthy cells to rebuild the missing connective tissue.

Speaker Change: As the wound open and at risk of severe infection and scarring.

Speaker Change: Timely surgery and delayed timing surge of convention intervention.

Speaker Change: Example.

The standard of care is a two stage procedure.

Let me describe it for you.

Speaker Change: Over to cleaning the wound bed and immediately perform a split thickness skin graft to close the wound.

Speaker Change: <unk> may not take due to insufficient connective tissue without.

Speaker Change: Cloud first preparing the wound bed using a dermal matrix there could be a loss of functionality.

Speaker Change: Additionally, an unsightly outcome, resulting from the deep tissue loss and likely heavy scarring.

Speaker Change: This is why full fitness.

Speaker Change: Injuries, requiring structured two stage surgical approach to reconstruct the lost or damaged tissue.

Speaker Change: Cases of severe tissue loss, such as sharp buy or necrotizing bacterial infection treatment may also involve excision of damaged tissue.

Then the use of co helix to build a durable base followed by split thickness skin graft closure.

And possibly an allocation of Permian derm to protect healing environment.

Speaker Change: It is important for us to develop human clinical data to support the launch of <unk>.

Speaker Change: Oh helix.

Speaker Change: To accomplish this we have initiated a post market clinical study known as <unk> one.

Speaker Change: She is currently pending IRB approval at multiple sites across the U S.

Speaker Change: This study uses and objective performance criteria study design known as O P C.

Speaker Change: Benchmark co helix performance against published data from alternative dermal matrices.

We are measuring key outcomes over a 26 week period, including days to graft readiness phase to closure and days to go home.

Speaker Change: We anticipate that this study will demonstrate accelerated seven day graft readiness and shorter overall time to wound closure compared to alternative dermal matrices further reinforcing the value of <unk>.

Speaker Change: Early patients have already been completed ahead of the formal enrollment <unk> one.

Speaker Change: In fact, our first case has already shown promising results consistent with our preclinical findings.

Speaker Change: Turn to slide number five we look at the highlights of this case.

Speaker Change: In mid January is.

Speaker Change: A 67 year old woman sustained a third degree burn while cooking over her stove has shown an image.

She was treated at the Ohio State Wexner Medical Center, where she received an application of Coke helix as seen in image B.

Speaker Change: By day, seven as shown an image C for wound was ready for grafting.

Speaker Change: System with our preclinical findings.

Speaker Change: Within a week and a half she was discharged from the hospital. According to one of her conditions had she been treated with an alternative dermal matrix or hospital stay would likely have extended to a month.

Speaker Change: This case highlights why as you can see on slide six.

Speaker Change: The medical community has already started to recognize coke helix.

Speaker Change: The game changer in the treatment of acute wounds.

Speaker Change: According to our treating physician not only does co helix reduce the amount of time the patient spends in the hospital, but he believes that it will allow physicians to treat more patients because of how easy it was to use in the operating room.

Speaker Change: Quite honestly this outcome is a turning point for our beauty medical breakthrough and acute wound care.

Speaker Change: Adding a new standard for treating and healing severe injuries, while lowering the cost of care and shortening the time for.

Speaker Change: For patients to return home.

Speaker Change: Permian Durham, and Cohill fit strategically within our portfolio as illustrated on slide seven.

Speaker Change: By playing an integral roles in the two states standard of care for full thickness.

<unk>.

Speaker Change: By playing integral roles in two stage standard of care for full thickness wounds.

Speaker Change: <unk> patient.

Speaker Change: The Byrne covering 10% of their total body surface area.

Speaker Change: First the procedure begins with the surgery surgical excision of the burn.

Speaker Change: Next Permian derm could be applied to temporize, the wound bed, allowing the wound to improve for a short period of time.

Speaker Change: After clinicians have determined the wound bed is free from the chronic tissue and infection or helix is applied to prepare the wound bed for grafting.

Speaker Change: Approximately seven days later, which is four to 14 days faster than alternative dermal matrices wound grabbed his ready, meaning there is sufficient tissue regrowth to proceed to the second stage.

Speaker Change: The second stage begins with a split thickness meshed autograft combined with resales brown skin cells placed over the newly generated tissue.

Speaker Change: As a reminder, we sell support definitive closure use significantly less hopefully skin compared to traditional autograft procedures remember that resell expanse. The autologous sample 18 to one <unk>.

Speaker Change: A layer of permanent term is then applied over both the graft and the newly applied spray on skin cells and separately to the resell donor site.

Speaker Change: Wade in all healing process of both loans.

Speaker Change: This wound is considered continuously assessed to determine when the patient is ready to leave the hospital.

Speaker Change: This integrated approach improves clinical outcomes while significantly.

Speaker Change: Spanning a beta medicals market opportunity.

Speaker Change: Look at the total available market potential per patient.

Speaker Change: For a 10% to 20% total body surface area of wound.

Speaker Change: Average selling price for resell is $6500 to $13000.

Permian Byrne: Permian Byrne at $2000 to $4000 is addressing.

Speaker Change: When cohorts is applied to the same one.

Speaker Change: Increases the potential average selling price between 20000 to $40000.

Speaker Change: In the aggregate and all three products are used together the potential average average selling price ranges between 28500.

Speaker Change: $57000, all the while providing substantial clinical and economic benefits by accelerating the time for the patient to return home.

Speaker Change: One last point.

Speaker Change: Helix can also be used independently of resell as demonstrated in the Western Medical Center case discussed earlier, resulting in an additional increase of the total addressable market for Vida medical.

Speaker Change: On April one we will initiate a full commercial launch of co helix for large warrant wounds using a consignment model with RFID tracking simplify hospital adoption and inventory management.

Speaker Change: Our sales reps will use the RFID reader track inventory for the hospital, our internal accounting and the FDA.

Speaker Change: We plan to price SKU helix below current market leaders further positioning it as a value driven solutions.

Speaker Change: Competitive pricing, coupled with a consignment model and a reduced time to graft are key benefits that we believe will help us progress through the value analysis committee process faster.

Speaker Change: With co helix, we add nearly $1 billion to our total addressable market or Tam.

Speaker Change: Within the 120, plus burn centers on top of the approximate $500 million Tam for resell in the $100 million Tam.

Speaker Change: <unk> in the same burn centers and trauma centers targeting full thickness wounds.

Speaker Change: Helix at $135 billion in Tam Premier Derm contributes $135 million and Tam and resale provides.

Speaker Change: A potential of one 5 billion in Tampa.

Speaker Change: Aggregate Vida medical now has a combined $3 $5 billion Tam opportunity in the U S alone.

A moment and look backwards.

Speaker Change: Two years ago, our total Tam for reset was $500 million.

Speaker Change: Totally in burn centers.

Speaker Change: Just 18 months ago, we received FDA approval for the full thickness indication, which dramatically expanded our tam by allowing us to enter the trauma center market.

Speaker Change: In that time, we've gone from a $500 million.

Tim Burns: Pam Burns to a $3 $5 billion, Tam and burns and trauma centers.

Speaker Change: <unk> ahead.

Speaker Change: Strategy is clear.

Number one expand resale go adoption.

Speaker Change: Number two rollout we shall go minute during the first quarter focused on trauma centers. This will expand our trauma center market by approximately 270000 bulk thickness acute wounds annually to be clear, we will not be targeting chronic wounds are chronic wound centers.

Speaker Change: Three logical helix commercially.

Speaker Change: Number four continue to rollout permit or.

Speaker Change: And finally number five we expect the notified body in the European Union.

Speaker Change: To grant the CE Mark for me. So go by the middle of the year opening up markets in Europe and Australia.

We remain committed to generating free cash flow in the second half of the year and achieving GAAP profitability during Q4 of 2025.

Speaker Change: Summary, 2024 was a transformational year.

Speaker Change: Branded product portfolio, which now includes resell Michelle go we saw go many Permian term co helix has taken us from a $500 million Tam with single product focused solely on burn centers with $3 $5 billion Tam.

Speaker Change: Therapeutic acute wound care across both burns and trauma centers onto.

Speaker Change: I want to thank our team customers and shareholders for their unwavering support as we continue to revolutionize.

Speaker Change: Standard of care and therapeutic acute wound treatment.

David O'Toole: With that I will turn the call over to David for a closer look at our financial results and guidance.

Speaker Change: David.

David O'Toole: Thank you Jim.

David O'Toole: For the three months ended December 31, 2024, our commercial revenue was $18 4 million.

David O'Toole: Representing a 30% increase compared to the same period in 2023.

David O'Toole: This growth was driven primarily by the continued deployment and adoption of resale go.

David O'Toole: Our existing burn centers as well as new accounts and trauma centers.

David O'Toole: As we look forward to 2025, we expect resale go many co helix to contribute substantially to our revenue growth.

David O'Toole: Owing their launches in February and April respectively.

David O'Toole: The Permian <unk> revenue also gaining momentum throughout the year.

David O'Toole: As expected our gross profit margin for the fourth quarter improved to 87, 6%.

David O'Toole: Covering from the temporary decline last quarter and slightly increasing from 87, 3% in the same period of 2023.

David O'Toole: As I indicated during our third quarter conference call Q3, operating expenses were elevated in that quarter due to onetime non reoccurring expenses.

David O'Toole: In line with his previous statement, our Q4 operating expenses totaled $26 1 million or.

David O'Toole: $4 $1 million decrease.

David O'Toole: From the Q3 total up $30 2 million.

David O'Toole: We have no plans to increase our head count or other operating expenses in 2025.

David O'Toole: As such Q.

David O'Toole: For total operating expenses should be a consistent baseline for each quarter in 2025.

David O'Toole: Also note that the total operating expenses of $26 1 million in the fourth quarter include noncash expenses of approximately $2 8 million of stock based compensation expense.

David O'Toole: And approximately 0.4 million depreciation and amortization.

David O'Toole: Q4, 2024 operating expenses increased by $1 4 million.

David O'Toole: Paired to the same period in 2023.

David O'Toole: This increase was primarily due to $3 9 million rise in sales and marketing expenses stemming from employee related costs within the expanded commercial sales organization.

David O'Toole: G&A expenses decreased by 0.6 million due to lower salaries and benefits as well as reduced professional fees.

David O'Toole: Similarly, R&D expenses declined by $1 9 million, reflecting lower outside professional fees due to the completion of the <unk> study.

David O'Toole: Other income expense shifted from $6 3 million and income in the same period in the prior year to an expense of <unk> 3 million in the current quarter.

David O'Toole: The $6 $6 million decrease primarily resulted from a onetime noncash gain.

Of $9 4 million from the wind down of our foreign subsidiaries offset by the change in fair value of the warrant liability.

David O'Toole: For the fourth quarter. Other income expense consisted of a noncash charge of <unk> 7 million related to the change in fair value of the warrant liability offset by zero point $4 million in investment income.

David O'Toole: Briefly I'd like to address the guidance announcement made on January 7th.

David O'Toole: We have gained a better understanding of the year and purchasing pattern among our key customers.

David O'Toole: At the end of Q4, several top accounts strategically chose not to finalize pending purchase orders due to yearend cash preservation strategies.

David O'Toole: Leading to an approximately $3 million to $4 million revenue shortfall.

David O'Toole: Importantly, these deferred purchases were due to timing decisions.

David O'Toole: To lack of demand for commercial operational issues on our part.

David O'Toole: During January we experienced normal purchasing activities, which should result in renewed strong first quarter revenue growth.

David O'Toole: Moving on to the full year results for the full year ended December 31 2024.

David O'Toole: Our commercial revenue increased 29% to <unk>.

David O'Toole: $64 million compared to $49 8 million in 2023.

David O'Toole: It was.

David O'Toole: Appointing to have the revenue Miss in the fourth quarter.

David O'Toole: But as you can see from the slide.

David O'Toole: Do not want to lose sight of the fact that we have had significant year over year revenue growth for the last five years.

David O'Toole: The 29% growth in 2024 was driven by the resale go transition.

David O'Toole: Super penetration within existing accounts and.

David O'Toole: And new account growth targeting trauma centers.

David O'Toole: The gross margin for the full year was 85, 8% meeting the higher end of our previously given guidance of 85% to 286%.

David O'Toole: And up 130 basis points from 84, 5% in 2023.

David O'Toole: Total operating expenses were $111 8 million compared to $86 4 million in 2023.

David O'Toole: The increase is primarily attributable to $20 9 million and higher sales and marketing expenses, reflecting employee related costs from our commercial teams expansion.

David O'Toole: G&A expenses rose by $4 9 million.

David O'Toole: Two increased head count along with higher salaries and benefits and stock based compensation.

David O'Toole: R&D costs declined by zero point $5 million, primarily due to reduced professional fees, partially offset by higher employee related compensation costs within our medical science liaison team.

David O'Toole: Other income expense for the year decreased by $8 3 million moving from $8 5 million and income in the prior year to income of <unk> 2 million in 2024.

David O'Toole: This change primarily resulted from a onetime noncash gain of $9 4 million in 2023 from the wind down of certain of our foreign subsidiaries.

David O'Toole: Offset by a change in the fair value of the warrant liability.

David O'Toole: Interest expense increased by $4 $2 million year over year.

David O'Toole: <unk> to the long term debt of $40 million under the <unk> credit agreement.

David O'Toole: Net loss for the fourth quarter was $11 6 million or a loss of 44 per basic and diluted share compared to a net loss of $7 1 million or a loss of 28 per basic and diluted share in the same period in 2023.

David O'Toole: Net loss for the full year 2024 was $61 8 million or a loss of $2 39 per share compared to a net loss of $35 4 million or <unk>.

Loss of $1 40 per share in the prior year.

David O'Toole: As of December 31, we had $35 9 million in cash and marketable securities.

David O'Toole: As reported last quarter, we utilized $9 7 million in cash during Q3.

David O'Toole: We continue this downward trend further reducing our use of cash to $8 5 million in the fourth quarter.

David O'Toole: This reduction was achieved despite an increase in that.

David O'Toole: <unk> receivable, which rose by $4 1 million to a total of $11 8 million as of December 31, 2024, compared to $7 7 million as of December 31, 2023.

David O'Toole: Note that our days sales outstanding or DSO did not increase.

David O'Toole: As we move towards generating free cash flow in the second half of 2025, we anticipate that our use of cash will continue to decline over the next three quarters.

David O'Toole: In connection with our debt facility with urban Ed We executed an amendment today to lower the trailing 12 month revenue covenant.

David O'Toole: <unk> ending March 31, 2025 through March 31, 2026.

David O'Toole: The 12 month trailing covenant of one <unk>.

David O'Toole: Entered 15 million poor quarters, ending after March 31, 2026 remains unchanged.

David O'Toole: Looking ahead for the full year 2025, we expect commercial revenue to be in the range of $100 million to $106 million representing growth of 55% to 65% compared to 2024.

Additionally, we expect to generate free cash flow in the second half of this year and achieved GAAP profitability during Q4 of 2025.

David O'Toole: As previously stated we do not foresee any further expansion of our commercial organization over the next 18 to 24 months.

David O'Toole: This revenue guidance and financial projections are consistent with our announcement made on January seven.

David O'Toole: We remain confident in the success of resell go.

David O'Toole: April 1st full commercial launch with <unk>.

David O'Toole: And the rollout of resale go many combined with a growing adoption of perimeter.

David O'Toole: These strategic efforts, which should position us to deliver strong results this year and drive significant shareholder value.

David O'Toole: With that I will turn the call back to the operator for your questions.

Speaker Change: Thank you as a reminder to ask a question. Please press star one on your telephone and wait for your name to be announced to withdraw. Your question. Please press star one again, please standby, while we compile the Q&A roster.

Speaker Change: And our first question comes from Matthew O'brien with Piper Sandler Your line is open.

Speaker Change: Hey, this is Phil on for Matt Thanks for taking our questions.

Speaker Change: For starters I guess, just on the cadence of the guidance.

Speaker Change: Now would you expect similar sequential growth each quarter or might it be a little bit more back half weighted given the contribution from <unk>.

Speaker Change: Co helix and maybe some timing.

Speaker Change: Max.

Speaker Change: Well now we have.

Speaker Change: A little bit more complex.

Speaker Change: Multi product Rollouts will will create some.

Speaker Change: Some complexity in your answering your question. So let me try and do it simply.

Speaker Change: Consecutively from Q4, you should expect will be up notably in Q1.

Speaker Change: By that time, we'll be in full launch.

Speaker Change: Michelle go mini and.

Speaker Change: And Permian Derm is now.

Speaker Change: <unk>, gaining a lot of momentum so Q2 should then.

Speaker Change: Also be up sequentially.

Speaker Change: Yes, you are right that Coke helix has such a big revenue impact.

Speaker Change: In the back half it could have a very significant effect.

Speaker Change: <unk> is having a consecutive quarter cadence increasing over prior quarter.

Speaker Change: It's so to speak we have plenty of gunpowder here and a lot to execute but plenty too.

Speaker Change: Keep our revenue line driving.

Speaker Change: I would expect that cadence to.

Speaker Change: P rather strong during the year.

Speaker Change: That's helpful and I guess, just sticking with guidance and trying to dive down a little deeper as for what's assumed in the growth of the three product categories I think in your prepared remarks.

Speaker Change: The guidance assumes somewhat.