Q2 2025 Anika Therapeutics Inc Earnings Call
Operator: Investor Relations. Please proceed.
Thank you.
Good morning, and thank you for joining us for <unk> second quarter 2025 conference call and webcast.
Matt Hall: Thank you. Good morning, thank you for joining us for Anika's Q2 2025 conference call and webcast. I'm Matt Hall, Anika's Director of Corporate Development and Investor Relations. Our earnings press release was issued earlier this morning and is available on our Investor Relations website located at www.anika.com, as are the supplementary PowerPoint slides that will be used for the discussion today. With me on the call are Dr. Cheryl Blanchard, President and Chief Executive Officer, and Steve Griffin, Executive Vice President, Chief Financial Officer, and Chief Operating Officer, who will present our Q2 2025 financial results and business highlights. Please take a moment and open the slide presentation and refer to slide number 2. Before we begin, please understand that certain statements made during the call today constitute forward-looking statements as defined in the Securities Exchange Act of 1934.
Matt Hall, <unk> director of corporate development Investor Relations. Our earnings press release was issued earlier. This morning and is available on our Investor Relations website located at Www Dot Anika dot com as are the supplementary Powerpoint slides that will be used for discussion today.
With me on the call are Dr. Cheryl Blanchard, President and Chief Executive Officer, and Steve driven Executive Vice President Chief Financial Officer, and Chief Operating Officer, who will present, our second quarter 2025 financial results and business highlights.
Please take a moment and open the slide presentation and refer to slide number two.
Before we begin please understand that certain statements made during the call today constitute forward looking statements as defined in the Securities Exchange Act of $19 34.
These statements are based on our current beliefs and expectations and are subject to certain risks and uncertainties.
Matt Hall: These statements are based on our current beliefs and expectations and are subject to certain risks and uncertainties. The company's actual results could differ materially from any anticipated future results, performance, or achievements. We make no obligation to update these statements should future financial data or events occur that differ from the forward-looking statements presented today. Please also see our most recent SEC filings for more information about risk factors that could affect our performance. In addition, during the call, we may refer to several adjusted or non-GAAP financial measures, which may include adjusted EBITDA, adjusted net income from continuing operations, and adjusted earnings per share from continuing operations, which are used in addition to results presented in accordance with GAAP financial measures.
The company's actual results could differ materially from any anticipated future results performance or achievements.
We make no obligation to update these statements should future financial data or events occur that differ from the forward looking statements presented today.
Please also see our most recent SEC filings for more information about risk factors that could affect our performance.
In addition, during the call we may refer to several adjusted or non-GAAP financial measures, which may include adjusted EBITDA adjusted net income from continuing operations and adjusted earnings per share from continuing operations, which are used in addition to results presented in accordance with GAAP financial measures.
We believe that non-GAAP measures provide an additional way of viewing aspects of our operations and performance, but when considered with GAAP financial measures and a reconciliation of GAAP measures. They provide an even more complete understanding of our business.
Matt Hall: We believe that non-GAAP measures provide an additional way of viewing aspects of our operations and performance, but when considered with GAAP financial measures and the reconciliation of GAAP measures, they provide an even more complete understanding of our business. A reconciliation of these adjusted non-GAAP financial results, the most comparable GAAP measurements, are available at the end of the presentation slide deck and our Q2 2025 press release. Now I'd like to turn the call over to our President and CEO, Dr. Cheryl Blanchard. Cheryl?
A reconciliation of these adjusted non-GAAP financial results. The most comparable GAAP measurements are available at the end of the presentation slide deck and our second quarter 2025 press release.
And now I'd like to turn the call over to our President and CEO, Dr. Cheryl Blanchard.
<unk>.
Thanks, Matt Good morning, everyone and thank you for joining us today to discuss <unk> second quarter 2025 results.
Cheryl Blanchard: Thanks, Matt. Good morning, everyone, and thank you for joining us today to discuss Anika's Q2 2025 results. Please turn to slide 3. This has been a meaningful quarter for Anika, including a significant clinical update on Hyalofast. I'll begin today's remarks with that important development, but before I dive in, I want to note that our quarterly performance was in line with expectations, and we remain on track to deliver our full year 2025 guidance. I'll return to our financial results after walking through the Hyalofast clinical update. Earlier today, we shared an important announcement on the top-line results from our US pivotal Phase III Hyalofast clinical trial.
Please turn to slide three.
This has been a meaningful quarter for anika, including a significant clinical update on how fast I will begin today's remarks with that important development, but before I dive in I want to note that our quarterly performance was in line with expectations and we remain on track to deliver our full year 2025 guidance.
I'll return to our financial results after walking through the Halifax clinical update.
Sure.
Earlier today, we shared an important announcement on the topline results from our U S pivotal phase III <unk> clinical trial.
This study, which enrolled its first patient in 2015 is a randomized controlled trial comparing Halifax in combination with autologous bone marrow aspirate concentrate also called <unk>.
Operator: This study, which enrolled its first patient in 2015, is a randomized controlled trial comparing Hyalofast in combination with autologous bone marrow aspirate concentrate, also called BMAC, to an active comparator as the control arm, a surgical technique called microfracture, in the treatment of articular cartilage defects. Superiority between the groups was to be determined with 2 prespecified coprimary endpoints, percent change from baseline to 2 years in both KOOS pain and IKDC function. While Hyalofast demonstrated consistent improvements in treated patients across all measures of pain and function relative to microfracture, we're disappointed the study missed on achieving statistical significance on its prespecified coprimary endpoints under the original statistical framework.
To an active comparator as the control arm of surgical technique called Microfracture in the treatment of articulate cartilage defects.
Superiority between the groups was to be determined with two pre specified co primary endpoints.
<unk> change from baseline to two years in both koos pain and <unk> function.
<unk> demonstrated consistent improvements in treated patients across all measures of pain and function relative to Microfracture. We're disappointed the study missed on achieving statistical significance on its pre specified co primary endpoints under the original statistical framework.
Given the consistently demonstrated improvements over microfracture in this trial and the efficacy of <unk> demonstrated in numerous independent studies outside the U S. We believe these results reflect limitations in the study context, rather than the performance of Halifax itself.
Operator: Given the consistently demonstrated improvements over microfracture in this trial and the efficacy of Hyalofast demonstrated in numerous independent studies outside the U.S., we believe these results reflect limitations in the study context rather than the performance of Hyalofast itself. Importantly, we remain highly encouraged by the totality of evidence supporting the product, which I will discuss. As a reminder, Hyalofast has successfully treated more than 35,000 patients in over 35 countries since its launch in 2009 outside the U.S. Let me take a moment to dive into more detail on the study results. The trial required randomization to microfracture, which was considered the standard of care when the study was initiated. Microfracture served as the active comparator.
Importantly, we remain highly encouraged by the totality of evidence supporting the product, which I will discuss.
As a reminder, Halifax has successfully treated more than 35000 patients and over 35 countries since its launch in 2009 outside the U S.
Let me take a moment to dive into more detail on the study results.
The trial required randomization to Microfracture, which was considered the standard of care when the study was initiated.
Microfracture served as the active comparator, however over the 10 years of trial enrollment its broad use by surgeons declined significantly and it is no longer regarded as the standard of care for cartilage lesions in most countries, including the U S.
Operator: However, over the 10 years of trial enrollment, its broad use by surgeons declined significantly, and it is no longer regarded as the standard of care for cartilage lesions in most countries, including the US. The study was likely impacted by both a higher subject dropout rate in the microfracture arm and missed visits during COVID, both resulting in missing data. This missing data resulted in a reduced available sample size and complicated the statistical analysis. In accordance with FDA guidelines, Anika statistically imputed missing data, which did not treat withdrawals from the microfracture arm as treatment failures. To be clear, Hyalofast demonstrated improvements over microfracture, but the study did not achieve statistical significance in the coprimary endpoints.
The study was likely impacted by both a higher subject dropout rate in the Microfracture arm and missed visits during COVID-19, both resulting in missing data.
Missing data resulted in a reduced evaluable sample size and complicated the statistical analysis.
In accordance with FDA guidelines, Anika statistically imputed missing data, which did not treat withdrawals from the microfracture arm as treatment failures.
To be clear Halifax demonstrated improvements over microfracture, but the study did not achieve statistical significance in the co primary endpoints.
Importantly, we did achieve statistical significance on several key secondary endpoints and other measures, including cruise sports and recreation function Koos quality of life and total koos all of which have served as the basis for FDA approval of the other cartilage repair products available in the U S.
Operator: Importantly, we did achieve statistical significance on several key secondary endpoints and other measures, including KOOS sports and recreation function, KOOS quality of life, and total KOOS, all of which have served as the basis for FDA approval of the other cartilage repair products available in the US. In addition, because Anika has sold Hyalofast outside the US for over 15 years, we have a significant amount of clinical data from a number of independent international clinical studies, including a paper published last year with positive 15-year outcomes. We believe the totality of the data, including hitting significance on endpoints used for prior FDA approvals, statistically significant responder analyses, and multiple independent international studies, strongly supports the clinical value of Hyalofast as a single-stage, off-the-shelf cartilage repair solution. This is especially compelling when compared to the current US standard of care that requires two separate surgical procedures.
In addition, because anika has sold how fast outside the U S. For over 15 years, we have a significant amount of clinical data from a number of independent international clinical studies, including a paper published last year with positive 15 year outcomes.
We believe the totality of the data, including hitting significance on endpoints used for prior FDA approvals.
Statistically significant responder analyses and multiple independent International studies strongly supports the clinical value of pilot fast as a single stage off the shelf cartilage repair solution.
This is especially compelling when compared to the current U S standard of care that requires two separate surgical procedures.
Based on these results we plan to submit the third and final PMA module on our original schedule in the second half of this year. After data analysis has been completed.
Operator: Based on these results, we plan to submit the 3rd and final PMA module on our original schedule in H2 of this year after data analysis has been completed. Once the data analysis is complete, we will provide further disclosure of the data. The submission will include post-hoc analyses and additional endpoints that achieved statistical significance in this study that have previously been accepted by the FDA and other approvals, in addition to the robust international data. We remain confident in the strength of our data and look forward to working closely with the agency as they review our application through the Breakthrough Devices Program. In anticipation of upcoming discussions with the FDA, we are extending our commercial timeline to 2027 to ensure adequate time for a thorough review and dialogue around the full data package.
Once the data analysis is complete we will provide further disclosure of the data.
This submission will include post hoc analyses and additional endpoints that achieved statistical significance. In this study that had previously been accepted by the FDA and other approvals. In addition to the robust international data.
We remain confident in the strength of our data and look forward to working closely with the agency as they review our application through the breakthrough devices program.
In anticipation of upcoming discussions with the FDA, we are extending our commercial timeline to 2027 to ensure adequate time for a thorough review and dialogue around the full data package.
<unk> continues to represent a significant opportunity for anika to expand our leadership in regenerative solutions and deliver meaningful innovation to patients suffering from cartilage lesions.
Operator: Hyalofast continues to represent a significant opportunity for Anika to expand our leadership in regenerative solutions and deliver meaningful innovation to patients suffering from cartilage lesions. Turning to Cingal, I'm pleased to announce that we made meaningful progress during the quarter advancing the final steps toward NDA filing and remaining on track to initiate the bioequivalent study by year-end. As a reminder, this bioequivalent study and the toxicity studies initiated earlier this year address the final requirements before submission. We plan to provide an update on the Cingal program timing after we start the bioequivalent study. Next, I'd like to provide an update on Integrity. I'm pleased to share that Integrity has already exceeded its full year 2024 performance and is currently on track to more than double in 2025, ahead of original expectations, and Integrity led the 41% growth in regenerative solutions revenue this quarter.
Turning to Cingal I am pleased to announce that we made meaningful progress during the quarter advancing the final steps toward NDA filing and.
And remaining on track to initiate the bioequivalence study by year end.
As a reminder, this bioequivalence study and the toxicity studies initiated earlier this year address the final requirements before submission with.
We plan to provide an update on cingal on the Cingal program timing after we start the bioequivalence study.
Next I'd like to provide an update on integrity I am pleased to share that integrity has already exceeded its full year 2020 for performance and is currently on track to more than double in 2025 ahead of original expectations and integrity led the 41% growth in regenerative solutions revenue this quarter.
<unk>.
This exceptional growth reflects our early positive clinical data strong market momentum and increasing adoption across a broader base of surgeons.
Operator: This exceptional growth reflects our early positive clinical data, strong market momentum, and increasing adoption across a broader base of surgeons. What's particularly encouraging is that surgeons are not only using Integrity more frequently but also expanding its application across a wider range of tendon repair procedures. While the shoulder remains the primary driver of the U.S. augmentation market, we see meaningful traction in other anatomies, including the hip, knee, and ankle, which together represent over $40 million in addressable market opportunity. In other news around Integrity momentum, during the quarter, we received 510(k) clearance for 2 new Integrity shapes and sizes that are planned to launch in a limited release by year-end. These 2 new SKUs are designed to support repairs in both insertional and midsubstance Achilles tendons, patellar tendon, quadriceps tendon, and gluteus medius tendon, to name a few.
It's particularly encouraging is that surgeons are not only using integrity more frequently but also expanding its application across a wider range of tendon repair procedures.
While the shoulder remains the primary driver of the U S augmentation market, we see meaningful traction in other anatomies, including the hip knee and ankle, which together represent over $40 million in addressable market opportunity.
In other news around integrity momentum during the quarter. We received five 10-K clearance for two new integrity shapes and sizes that are planned to launch in a limited release by yearend.
These two new Skus are designed to support repairs in both insertion and mid substance Achilles tendon patellar tendon quadriceps tendon and gluteus media has tended to name a few.
The revenue contributions of these new shapes and sizes will be modest in the second half of this year as we continue to ramp up production and training activities.
Operator: The revenue contributions of these new shapes and sizes will be modest in H2 of this year as we continue to ramp up production and training activities. We expect them to positively impact future commercial sales for this critical product. This expansion further strengthens our ability to penetrate this addressable market and reinforces Integrity's position as a versatile and scalable regenerative platform. Let me now walk you through the high-level financial results for the quarter. I am pleased to report that we delivered financial results in line with expectations as we overcame difficult manufacturing yield challenges at the start of the quarter. I'm proud of the work that our teams have done to overcome these challenges despite the financial impact that it had in the quarter. Revenue in the quarter was down 8%.
However, we expect them to positively impact future commercial sales for this critical product.
This expansion further strengthens our ability to penetrate this addressable market and reinforces integrity position as a versatile and scalable regenerative platform.
Let me now walk you through the high level financial results for the quarter I am pleased to report that we delivered financial results in line with expectations as we overcame difficult manufacturing yield challenges at the start of the quarter.
I am proud of the work that our teams have done to overcome these challenges despite the financial impact that it had in the quarter.
Revenue in the quarter was down 8%. However, we continued to demonstrate strength in our commercial channel led by our regenerative solutions offerings, which were up 41% or.
Operator: However, we continue to demonstrate strength in our commercial channel led by our regenerative solutions offerings, which were up 41%. Our OEM channel, although lower year-over-year, was in line with our expectations as J&J works to stabilize this important, profitable channel for our business. In light of the near-term revenue pressure, we have taken proactive steps to reset our operating expense profile, driving a 17% reduction in total operating expenses year-over-year. Adjusted EBITDA was roughly flat for the quarter, while we continue to invest in our most promising commercial opportunities. Lastly, I will mention that we have successfully completed the material transition services activities with respect to the divestitures of both Parcus and Arthrosurface and are now fully focused on our strategy leveraging our proprietary hyaluronic acid technologies.
Our OEM channel, although lower year over year was in line with our expectations as J&J works to stabilize this important profitable channel for our business.
In light of the near term revenue pressure, we have taken proactive steps to reset our operating expense profile driving a 17% reduction in total operating expenses year over year.
Adjusted EBITDA was roughly flat for the quarter, while we continue to invest in our most promising commercial opportunities.
Lastly, I will mention that we have successfully completed the materials transition services activities with respect to the divestitures of both parkas and Arthur surface.
And are now fully focused on our strategy leveraging our proprietary hela ironic acid technologies.
With that I'll now turn the call over to Steve for a detailed review of our financial results.
Operator: With that, I'll now turn the call over to Steve for a detailed review of our financial results.
Thank you Cheryl.
Before we dive into the financial results I want to begin with an update on the production challenges we encountered earlier this quarter.
Steve Griffin: Thank you, Cheryl. Before we dive into the financial results, I want to begin with an update on the production challenges we encountered earlier this quarter. Since April, our teams have successfully resolved the lower production yields and restored output to historic levels. While we experienced reduced shipments in April and May, I want to emphasize that this did not result in any delayed deliveries to patients. Toward the end of the quarter, we were modestly behind on certain international OA pain shipments, which impacted commercial revenue slightly. We expect to fully recover and deliver product for these purchase orders in Q3. I'm proud of the cross-functional collaboration that enabled us to resolve this issue within the quarter, and we've implemented new procedures to help ensure that this type of disruption does not recur. With that, I'll now provide financial updates on the quarter.
Since April our teams have successfully resolved the lower production yields and restored output to historic levels.
While we experienced reduced shipments in April and May I want to emphasize that this did not result in any delayed deliveries to patients.
Towards the end of the quarter, we were modestly behind on certain international OA pain shipments, which impacted commercial revenue slightly.
However, we expect to fully recover and deliver product for these purchase orders in the third quarter.
I'm proud of the cross functional collaboration that enabled us to resolve this issue within the quarter and we've implemented new procedures to help ensure that this disrupt type of disruption does not recur.
With that I will now provide financial updates on the quarter.
Please refer to slide four of the presentation.
In the second quarter Anika generated $28 2 million in total revenue, an 8% decline compared to the same period in 2024.
Matt Hall: Please refer to slide 4 of the presentation. In Q2, Anika generated $28.2 million in total revenue, an 8% decline compared to the same period in 2024. Revenue in our commercial channel, which includes our globally distributed, highly differentiated products, was flat year over year at $11.9 million. Within this channel, regenerative solutions delivered standout performance, growing 41% year over year driven by continued momentum in the Integrity implant system. Importantly, Integrity has now achieved sequential growth for 5 consecutive quarters, and as of June, we've already exceeded full year 2024 revenue for the product, on track to more than double in 2025. This underscores the strength of the platform and the growing demand we are seeing in the market.
Revenue in our commercial channel, which includes our globally distributed highly differentiated products was flat year over year at $11 9 million. However.
However, within this channel regenerative solutions delivered standout performance growing 41% year over year, driven by continued momentum in the integrity implant system.
Importantly, integrity has now achieved sequential growth for five consecutive quarters and as of June we've already exceeded full year 2020 for revenue for the product on track to more than double in 2025.
This underscores the strength of the platform and the growing demand we are seeing in the market.
Offsetting this growth was a 10% decline in international OA pain sales, primarily due to approximately $900000 and unfilled orders stemming from previously mentioned lower yields as well as a difficult year over year comparison due to the timing of shipments in Q2 2024.
Matt Hall: Offsetting this growth was a 10% decline in international OA pain sales, primarily due to approximately $900,000 in unfilled orders stemming from previously mentioned lower yields, as well as a difficult year-over-year comparison due to the timing of shipments in Q2 2024. Absent the lower yields, we would have expected international OA pain to be flat and the commercial channel to be up approximately 8%. With yields now fully restored, our teams are working diligently to fulfill backlogged distributor orders and expect to recover these orders in Q3. Revenue in the OEM channel, which includes our domestic OA pain and non-orthopedic products sold under long-term agreements, declined 13% in Q2 to $16.3 million. This performance was in line with our expectations, reflecting continued pressure on demand and pricing for Orthovisc, as well as lower pricing for Monovisc, offset partially by higher end-user volume.
Absent the lower yields we would've expected international OA pain to be flat in the commercial channel to be up approximately 8%.
With yields now fully restored our teams are working diligently to fulfill backlog distributor orders and expect to recover these orders in the third quarter.
Revenue in the OEM channel, which includes our domestic OA pain and non orthopedic products sold under long term agreements declined 13% in the second quarter to $16 $3 million.
This performance was in line with our expectations, reflecting continued pressure on demand and pricing for ortho risk as well as lower pricing for monovisc offset partially by higher end user volume.
Monovisc pricing was stronger this quarter due to the timing of contractually obligated payor rebates from J&J, which as with others. In this market can vary significantly from quarter to quarter.
Matt Hall: Monovisc pricing was stronger this quarter due to the timing of contractually obligated payer rebates from J&J, which, as with others in this market, can vary significantly from quarter to quarter. We anticipate a pricing decline in Q3 followed by a modest rebound in Q4, with no change to our full-year pricing outlook. While we do not directly control this channel, we remain actively engaged with our partner to drive for greater price stability and market expansion. Despite ongoing headwinds, Monovisc and Orthovisc continue to lead the US market and remain profitable contributors to our business. The remainder of our OEM business, our non-orthopedic sales, grew in the quarter due to the timing of customer orders. Q2 gross margin was 51%, down 16 percentage points from the same period last year.
We anticipate the pricing decline in Q3, followed by a modest rebound in the fourth quarter with no change to our full year pricing outlook.
While we do not directly control. This channel we remain actively engaged with our partner to drive for greater price stability and market expansion.
Despite ongoing headwinds Monovisc and <unk> continue to lead the U S market and remain profitable contributors to our business.
The remainder of our OEM business, our non orthopedic sales grew in the quarter due to the timing of customer orders.
Second quarter gross margin was 51% down 16 percentage points from the same period last year.
The primary driver was a one time $3 million charge related to the lower yields of Monovisc and Cingal in April and May.
Matt Hall: The primary driver was a one-time, $3 million charge related to the lower yields of Monovisc and Cingal in April and May. This charge, largely non-cash, represents the full extent of the lower yields and falls within the previously communicated range for the full-year impact. Excluding this one-time item, gross margin would have been above 60% for the quarter. In addition, gross margins were impacted by a $3 million year-over-year decline in Monovisc and Orthovisc sales to J&J, primarily driven by lower pricing that impacts both transfer units and royalties and directly reduces gross profit. With the lower yields now resolved, we expect gross margins to improve in the H2 of the year to the 58% to 59% range as we communicated on our first quarter call.
This charge largely noncash represents the full extent of the lower yields and falls within the previously communicated range for the full year impact.
Excluding this one time item gross margin would have been above 60% for the quarter.
In addition, gross margins were impacted by a $3 million year over year decline in Monovisc and <unk> sales to J&J, primarily driven by lower pricing that impacts both transfer units and royalties and directly reduces gross profit.
With the lower yields now resolved, we expect gross margins to improve in the second half of the year. So the 58% to 59% range as we communicated on our first quarter call.
That said the combination of reduced high margin J&J revenue in the first half manufacturing challenges and will result in a lower overall gross margin for 2025.
Matt Hall: That said, the combination of reduced high-margin J&J revenue and the H1 manufacturing challenges will result in a lower overall gross margin for 2025. These dynamics were anticipated and are already reflected in our full-year guidance. Turning to operating expenses, total Q2 OpEx was $18.5 million, down $3.8 million or 17% compared to the same period last year. Selling, general, and administrative expenses declined 22%, while research and development expenses were down 6%. The $3 million reduction in SG&A was primarily driven by a one-time, non-recurring $1.6 million expense in 2024 and $1.4 million in headcount-related cost-savings actions. As we've pivoted the strategic focus of the company, we continue to streamline and optimize our organizational structure to align with our future direction. These actions reflect our commitment to disciplined cost management and to mitigating the impact of revenue pressures while continuing to invest in areas that support long-term growth.
These dynamics were anticipated and are already reflected in our full year guidance.
Turning to operating expenses.
Total second quarter, Opex was $18 5 million down $3 8 million or 17% compared to the same period last year.
Selling general and administrative expenses declined 22%, while research and development expenses were down 6%.
The $3 million reduction in SG&A was primarily driven by a onetime nonrecurring $1 6 million expense in 2024, and $1 $4 million in head count related cost savings actions.
As we've pivoted the strategic focus of the company, we continue to streamline and optimize our organizational structure to align with our future direction.
These actions reflect our commitment to disciplined cost management and to mitigating the impact of revenue pressures, while continuing to invest in areas that support long term growth.
Adjusted EBITDA from continuing operations was negative $200000 in the second quarter, a decline of $4 $9 million compared to the same period in 2024.
Matt Hall: Adjusted EBITDA from continuing operations was -$200,000 in Q2, a decline of $4.9 million compared to the same period in 2024. The decrease was primarily driven by the one-time scrap costs for our recent manufacturing challenges, in addition to lower high-margin revenue from J&J, partially offset by the meaningful reductions in operating expenses. Without the one-time scrap costs, the company would have generated positive EBITDA in Q2. Now turning to cash and liquidity. In Q2, we used $200,000 in operating cash flow, an improvement compared to the $1.1 million of cash used in the same period last year. This was driven by stronger working capital management and disciplined cost controls in response to revenue pressures. We invested $1.4 million in capital expenditures during Q2, down $2 million year over year due to timing.
The decrease was primarily driven by the onetime scrap costs for our recent manufacturing challenges. In addition to lower high margin revenue from J&J.
Partially offset by the meaningful reductions in operating expenses.
Without the onetime scrap costs the company would have generated positive EBITDA in the quarter.
Now turning to cash and liquidity.
In the second quarter, we used $200000 in operating cash flow an improvement compared to the $1 $1 million of cash used in the same period last year.
This was driven by stronger working capital management and disciplined cost controls and response to revenue pressures.
We invested $1 4 million in capital expenditures during the quarter down $2 million year over year due to timing.
These investments are focused on expanding capacity at our Massachusetts manufacturing facility to support anticipated volume growth across Monovisc, cingal integrity and tile a fast.
Matt Hall: These investments are focused on expanding capacity at our Massachusetts manufacturing facility to support anticipated volume growth across Monovisc, Cingal, Integrity, and Hyalofast. This will position us well to meet future demand and scale efficiently. We ended Q2 with $53 million in cash and no debt. On slide 5, I'll review our full-year financial outlook for 2025. We are maintaining our 2025 full-year guidance. For the full year, we continue to expect our commercial channel to generate between $47 and $49.5 million in revenue, representing 12% to 18% growth in 2025. Our OEM channel remains on track to deliver between $62 and $65 million, a range of 16% to 20% decline versus 2024. At the midpoint of down 18%, this range is reflective of higher volumes but lower pricing for J&J.
This will position us well to meet future demand and scale efficiently.
We ended the second quarter was $53 million in cash and no debt.
Now on slide five I'll review, our full year financial outlook for 2025.
We are maintaining our 2025 full year guidance.
For the full year, we continue to expect our commercial channel to generate between 47 and $49 $5 million in revenue, representing 12% to 18% growth in 2025.
Our OEM channel remains on track to deliver between $60 million to $65 million a range of 16% to 20% decline versus 2024.
At the midpoint of down 18%. This range is reflective of higher volumes, but lower pricing for J&J.
As a reminder, J&J has full control of sales marketing and pricing activities for these products in the United States and Anika receives transfer unit revenue and royalties based on J&J is end user pricing.
Matt Hall: As a reminder, J&J has full control of sales, marketing, and pricing activities for these products in the United States, and Anika receives transfer unit revenue and royalties based on J&J's end-user pricing. Now turning to profitability. We are maintaining our 2025 adjusted EBITDA guidance range of -3% to +3%. As a reminder, this range is reflective of three primary impacts, all of which we shared at the end of the Q1. First, the impacts from lower manufacturing yields and scrap from Monovisc and Cingal experienced in the H1 of 2025. Second, lower pricing from J&J for Monovisc and Orthovisc. Lastly, the 2025 costs associated with the Cingal bioequivalence study required for our NDA filing. As a result of the Hyalofast clinical trial outcomes, we are revising our long-term revenue guidance for the commercial channel to reflect a possible extension of the FDA review process.
Now turning to profitability, we are maintaining our 2025 adjusted EBITDA guidance range of negative 3% to positive 3%.
As a reminder, this range is reflective of three primary impacts all of which we shared at the end of the first quarter.
The impacts from lower manufacturing yields and scrap for Monovisc and Cingal experienced in the first half of 2025.
Second lower pricing from J&J for Monovisc and <unk>.
And lastly, the 2025 costs associated with the Cingal Bioequivalence study required for our NDA filing.
As a result of the high Holdfast clinical trial outcomes, we are revising our long term revenue guidance for the commercial channel to reflect a possible extension of the FDA review process.
While we still plan to file the PMA in the second half of 2025, we are now modeling for a 12 month delay in launch timing.
Matt Hall: While we still plan to file the PMA in H2 2025, we are now modeling for a 12-month delay in launch timing. As a result, we are updating our commercial channel growth outlook to 10% to 20% in both 2026 and 2027 compared to our prior range of 20% to 30% growth. We currently anticipate a $3 million revenue contribution from Hyalofast in 2027, with full market release in 2028. These revised projections reflect growth from our already approved products, particularly Integrity, and continued strength in our international OA pain portfolio, both of which have demonstrated strong momentum. Despite this adjustment, our liquidity remains strong, with no need to raise capital, and we remain confident in our ability to execute on our long-term strategy. With that, I will now turn the call back over to Cheryl.
As a result, we are updating our commercial channel growth outlook to 10% to 20% in both 2026 and 2027 compared to our prior range of 20% to 30% growth.
We currently anticipate a $3 million revenue contribution from Hale of fast in 2027 with full market release in 2028.
These revised projections reflect growth from our already approved products, particularly integrity and continued strength in our international OA pain portfolio, both of which have demonstrated strong momentum.
Despite this adjustment our liquidity remains strong with no need to raise capital and we remain confident in our ability to execute on our long term strategy.
With that I will now turn the call back over to Sheryl. Thanks.
Thanks, Steve.
In closing we remain confident in the key value drivers of our business.
Cheryl Blanchard: Thanks, Stephen. In closing, we remain confident in the key value drivers of our business. Integrity continues to outperform expectations, and we anticipate double-digit organic growth in our commercial channel consistent with our 2025 guidance. We have a clear path forward to complete the Cingal NDA submission, and while the Hyalofast trial did not meet its primary endpoints, we believe the totality of the data supports a viable path to FDA approval. I want to sincerely thank the entire Anika team for their continued dedication to delivering innovative solutions that improve the lives of patients around the world. With that, we'll open up the line for questions. Operator, please proceed.
Integrity continues to outperform expectations, and we anticipate double digit organic growth in our commercial channel consistent with our 2025 guidance.
We have a clear path forward to complete the Cingal NDA submission and while the how fast trial did not meet its primary endpoint. We believe the totality of the data supports a viable path to FDA approval.
I want to sincerely. Thank the entire anika team for their continued dedication to delivering innovative solutions that improve the lives of patients around the world.
And with that we'll open up the line for questions. Operator. Please proceed.
Thank you Lee.
Ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press the star followed by the number one on your Touchtone phone you will hear a prompt that youre Honda has been a race schedule issued a decline from the polling process. Please press the star followed by the number two if you are using a speaker phone. Please.
Operator 2: Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. Should you have a question, please press the star followed by the number 1 on your touchstone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number 2. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Anderson Schoch with B. Riley Securities. Please go ahead.
The handset before pressing any quiche one moment. Please for your first question.
Your first question comes from Anderson shock with B Riley's Securities. Please go ahead.
Hey, good morning, and thank you for taking our questions and congrats on the strong quarter. So your gross margin guidance of 50% to 59% implies gross margins returning to about 62% to 63% in the back half of the year I guess, what will drive the sequential improvement.
Anderson Schoch: Hey, good morning. Thank you for taking our questions and congrats on the strong quarter. Your gross margin guidance of 58% to 59% implies gross margins returning to about 62% to 63% in H2. I guess what will drive this sequential improvement?
Yes, I appreciate the question Anderson I appreciate the opportunity to clarify my commentary is specifically, 50% to 59% in the second half of the year for the overall margin to be slightly below that on the aggregate for the full year given the first half dynamics.
Steve Griffin: Yeah, I appreciate the question, Anderson. I appreciate the opportunity to clarify. My commentary is specifically 58% to 59% in the H2 of the year, for the overall margin to be slightly below that on the aggregate for the full year given the H1 dynamics. I think what gives us that confidence is the fact that a lot of the charges that stem from the beginning of this quarter are very much so one-time in nature. When I look at the performance of the business, excluding that, the business performed well in the quarter. I think one thing that we are very aware of is the fact that the gross margins for the Q2, excluding that one-time impact, are above 60%, and the H2 will be slightly below that.
And I think what gives us that confidence is the fact that a lot of the charges that stemmed from the beginning of this quarter are very much so onetime in nature and when I look at the performance of the business excluding that the business performed well in the quarter I think one thing that we are very aware of is the fact that the gross margins for the second quarter, excluding that onetime impact are above 60.
In the second half will be slightly below that a lot of that is driven by the timing or excuse me the pricing dynamic for J&J on Monovisc north of us that we expect in the second half of the year.
Steve Griffin: A lot of that is driven by the pricing dynamic for J&J on Monovisc and Orthovisc that we expect in H2.
Okay got it and then do you have any progress to report on additional OEM partnerships to diversify your OEM revenue away from J&J.
Anderson Schoch: Okay, got it. Do you have any progress to report on additional OEM partnerships to diversify your OEM revenue away from J&J?
Yeah in terms of.
Additional.
Cheryl Blanchard: Yeah, in terms of kind of additional opportunities in the OEM channel, I don't have anything to report today. That is a topic that we continue to assess, and we have talked about the fact that Cingal will most likely fit into that OEM channel. As we make continued progress, really making meaningful progress here this year in getting closer to an NDA filing, that's certainly a topic that will become probably more visible as we move into the future.
Opportunities in the OEM channel I don't have anything to report today that is a topic that we continue to assess and we have talked about the fact that sink.
Cingal will most likely fit into that OEM channel and as we make continued progress.
Really making meaningful progress here this year in getting closer to an NDA filing that's certainly a topic that will be.
Become probably more visible as we move into the future.
Okay got it and then I guess integrity has demonstrated some really impressive growth in shoulder at how should we think about the expanded market opportunity with the new configurations for foot and ankle and Tulsa knee and hip.
Anderson Schoch: Okay, got it. I guess Integrity has demonstrated some really impressive growth in shoulder. How should we think about the expanded market opportunity with the new configurations for foot and ankle and also knee and hip?
Yeah. Thanks for the question, what we've seen with integrity is even with the current sizes that we sell that the surgeons are so excited about the benefits and features that integrity provides them, especially on kind of the enhanced regenerative capacity and the strength at time zero, even even when it's wet.
Cheryl Blanchard: Thanks for the question. What we've seen with Integrity is even with the current sizes that we sell, that the surgeons are so excited about the benefits and features that Integrity provides them, especially on kind of the enhanced regenerative capacity and the strength at time zero, even when it's wet, that in a lot of those other applications that I talked about today where there's a real need for additional strength and suture retention strength, they've started using existing Integrity in those applications, but it wasn't really fit to purpose from a size and aspect ratio perspective. They're excited to start using these new shapes and sizes in those other applications.
That in a lot of those other applications that I talked about today, where there's a real need for additional strength in suture retention strength. They started using existing integrity in those application, but it wasn't it really fit to purpose from a size and aspect ratio perspective, so they're excited.
To start using these new shapes and sizes in those other applications. So I think while we've already been serving that additional kind of $40 million addressable market opportunity. We think these new shapes and sizes that are are more purposeful and designed specifically for those anatomic locations will.
Cheryl Blanchard: I think while we've already been serving that additional kind of $40 million addressable market opportunity, we think these new shapes and sizes that are more purpose-fit and designed specifically for those anatomic locations will give us an increased opportunity going forward. As I mentioned, kind of having a more material impact on our commercial revenue into next year. This year is really around a limited release and getting our feet under us from a manufacturing and training and education and marketing perspective. We're excited to get those products out there this year, and we have a group of surgeons that are ready to go.
Give us an increased opportunity going forward and as I mentioned kind of having a more material impact on our commercial revenue into next year. This year is really around a limited release and.
Getting our feet under us from a manufacturing and training and education and marketing perspective. So we're excited to get those products out there. This year and we have a group of surgeons that are ready to go.
Okay got it. Thank you and then I guess on highlights that given the MS primary endpoints I guess, what gives you the confidence that the FDA could approve based on secondary endpoints in the international data.
Anderson Schoch: Okay, got it. Thank you. I guess on Hyalofast, given the missed primary endpoints, I guess what gives you the confidence that the FDA could approve based on secondary endpoints and the international data?
Yeah. It's a great question. So this product falls under the breakthrough device designation and FBA.
Cheryl Blanchard: Yeah, it's a great question. This product falls under the Breakthrough Device designation, and FDA has encouraged us to file all of our data. The study was really primarily impacted by missing data from the complexities of randomizing to that microfracture arm and the change in medical practice that occurred over the time of the trial, and frankly, missed data that occurred during COVID, which the FDA actually put guidance out around because a number of trials were impacted by that dynamic over that time period. FDA has encouraged us to submit our full data package, including the secondary endpoints that we did hit statistical significance on. Those secondary endpoints are what got used for other products that are currently approved in the United States.
<unk> has encouraged us to file all of our data.
The study was really primarily impacted by missing data from the complexities of randomized to that Microfracture arm and the change in medical practice that occurred over the time of the trial and frankly Miss data that occurred during COVID-19, which the FDA actually put guidance out around because the number of trials were.
<unk> by that dynamic over that time period.
So FDA has encouraged us to submit our full data package, including the secondary endpoints that we did hit statistical significance on.
Those secondary endpoints are what got used for other products that are currently approved in the United States.
And we have a very complete data package and robust data package of independent studies that were performed from our over 15 years of clinical experience outside the United States.
Cheryl Blanchard: We have a very complete data package and robust data package of independent studies that were performed from our over 15 years of clinical experience outside the United States.
Okay got it. Thank you. Thank you for taking our questions.
Absolutely. Thank you.
Anderson Schoch: Okay, got it. Thank you for taking our questions.
Cheryl Blanchard: Absolutely. Thank you.
Thank you.
Our next question comes from Jim Sidoti with Sidoti <unk> Company. Please go ahead.
Operator 2: Thank you. The next question comes from James Sidoti with Sidoti & Company. Please go ahead.
Hi, good morning.
Thanks for taking the questions.
James Sidoti: Hi, good morning. Thanks for taking the questions. With regard to gross margin, how should we think about gross margin going forward as the commercial channel becomes a bigger piece of the revenue part?
Good morning.
With regard to gross margin.
How should we think about gross margin going forward.
Okay.
Please.
The revenue part.
Yes.
Haven't given long term guidance as to where to expect gross margins into the future, but I would say the we have noted that the commercial channel is at a lower gross margin at its current state because of the fact that it includes our international products being sold and those are generally at a lower price point.
Steve Griffin: Yeah, we haven't given long-term guidance as to where to expect gross margins into the future, but I would say we have noted that the commercial channel is at a lower gross margin at its current state because of the fact that it includes our international products being sold, and those are generally at a lower price point. I would say, Jim, in the future, I would expect it to be in and around the range that I've shared for H2. There's sort of two things that are affecting it. One is the growth in the commercial channel, which could be an element that would depress that gross margin over time. Also, the growth in our newest products tend to be at a higher margin, so we'd expect to see that hopefully offset where we'd expect to see the declines from the international growth.
I would say Jim so in the future I would expect it to be in and around the range that I've shared for the second half and then theres sort of two things that are affecting it one is the growth in the commercial channel, which could be an element that would depress that gross margin over time, but also the growth in our newest products are tend to be at a higher margin. So we'd expect to see that hopefully offset.
We would expect to see the declines from international growth. So overall in and around the range for the second half of this year.
Steve Griffin: Overall, in and around the range for H2 2024.
Okay, but it sounds like as integrity.
James Sidoti: Okay, it sounds like as Integrity and hopefully Hyalofast get into the market, that those would be accretive to gross margin.
Hopefully <unk> get into the market.
Those would be.
<unk> to gross margin.
That is correct.
Okay, and with regards to Cingal U.
Steve Griffin: That is correct.
James Sidoti: Okay. With regards to Cingal, Cheryl, you talked about the distribution a little bit. Could you sign a distribution deal prior to release of the product, or are you going to wait for FDA approval to announce something?
So you talked about the distribution a little bit.
Could could you signed a distribution deal prior to release.
The product or are you going to wait for FDA approval.
Announce something.
Yeah, I'll tell you on that topic my focus is in driving.
Cheryl Blanchard: I'll tell you, on that topic, my focus is in driving as much shareholder value as I can with that incredible product that has very exciting clinical data and a real opportunity in the US market as a next-generation osteoarthritis pain product. The decision around timing for that is really going to be driven around the best way to drive value. The good news is that we are making real progress with the FDA. We've got processes ongoing to overcome the final two filing issues and look forward once we begin that bioequivalence study to giving a full update on the timeline of that program.
As much shareholder value as I can with that incredible product that has.
Very exciting clinical data and a real opportunity in the U S market as the next generation osteoarthritis pain product. So the decision around timing for that is really going to be driven around the best way to drive value. The good news is that we are making real progress with the <unk>.
FTA, we've got processes ongoing to overcome the final two filing issues and look forward. Once we begin that bio equivalent study to giving.
A full update on the timeline of that program.
Alright, alright, and the last.
For me cash.
James Sidoti: All right. All right. The last one for me, cash. You don't give specific guidance on cash flow, but can we assume you're probably at in terms of cash on hand, that this is probably a low point for you, that at this point, you should start seeing cash on hand start to increase going forward?
We don't give specific guidance on cash flow, but can we assume youre probably at.
In terms of cash on hand that this is probably a low point for you that at this point you should start seeing cash on hand start to increase going forward.
We haven't given specifics on our cash balance forecast I think what we have given some guidance around is that we expect to see improvements in operating cash flow I think we've demonstrated that.
Steve Griffin: We haven't given specifics on a cash balance forecast. I think what we have given some guidance around is that we expect to see improvements in operating cash flow. I think we've demonstrated some pretty good controls here as we've come through the disposition of two businesses. Jim, the only thing that would cause us to have a lower cash balance would be associated with CapEx investments. Obviously, we've been making some strategic investments into our Massachusetts facility here, and that would likely cause us to have a little bit of a lower cash balance into the future. We expect to hopefully offset some of that with some of the growth in operating cash flow.
Some pretty good controls here as we've come through the disposition of two businesses, Jim the only thing that would cause us to have a lower cash balance would be associated with capex investments. So obviously, we've been making some strategic investments into our Massachusetts facility here and that would likely caused us to have a little bit of a lower cash balance into the future.
We expect to hopefully offset some of that with some of the growth in operating cash flow.
So with regard to capacity do you think by the end of the year Youll have sufficient capacity to meet demand for integrity Cingal, how fast over the next several years.
James Sidoti: With regard to capacity, do you think by the end of the year, you'll have sufficient capacity to meet demand for Integrity, Cingal, Hyalofast over the next several years?
I think it is going to be continued investment that we're making into our facility. So it's something we'll be doing over a period of time I think the level of Capex that we forecasted for this year I think is appropriate for us to be able to meet the ramp for next year, but we'll be continuing to upgrade equipment, especially in preparation for cingal as volumes for both Monovisc and Cingal and <unk>.
Steve Griffin: I think it's going to be a continued investment that we're making into our facility. It's something we'll be doing over a period of time. I think the level of CapEx that we forecasted for this year, I think, is appropriate for us to be able to meet the ramp for next year. We'll be continuing to upgrade equipment, especially in preparation for Cingal as volumes for both Monovisc and Cingal continue to grow and our cross-linked products are a little bit more complicated to make and require more investment.
To grow and our cross selling products are a little bit more complicated to make and require more investment.
Okay alright, thank you.
First thank you thanks, Jim.
James Sidoti: Okay. All right. Thank you.
Thank you.
Steve Griffin: Of course. Thank you.
Matt Hall: Thanks, Jim. Thank you. The next question comes from Michael Petusky with Barrington Research. Please go ahead.
Next question comes from Michael <unk> with Barrington Research. Please go ahead.
Hey, good morning.
So I guess Sheryl.
Michael Petusky: Good morning. I guess, Cheryl, is there any more detail you can give around sort of the reduced sample size, higher dropout? I think there was maybe 200 patients initially targeted in the Hyalofast trial. I'm just curious. I mean, how many patients did you actually have full data on?
Are there any more detail you can give around sort of the.
Reduced sample size higher dropout.
I think there was maybe 200 patients initially targeted in the <unk> trial I'm, just curious I mean, how much how many patients did you actually have full data on.
Yeah. Thanks for the question Mike.
I will tell you that yes, so first of all Youre right.
Cheryl Blanchard: Yeah, thanks for the question, Mike. I will tell you that yes, first of all, you're right. The study design had us enroll 200 patients. The dropout occurred differentially in the microfracture arm because of the fact that microfracture, really, the clinical practice changed. Patients dropped out both before surgery, before they even got the microfracture surgery, and during the course of the trial, not coming back for appointments sort of as they progressed through the trial. It happened in both cases. In terms of the number of patients we have full data on, we have not reported out the details of our full dataset yet because our analysis continues. I mentioned in my prepared comments that as soon as we get the full data analysis completed, that we will provide additional disclosure on that. More to come on kind of the full dataset.
The study design had us enroll 200 patients and the dropout occurred differentially in the Microfracture arm because of the fact that microfracture really the clinical practice changed.
<unk> dropped out both before surgery like before they even got the Microfracture surgery and <unk>.
During the course of the trial like.
Not coming back for appointments sort of as they progress through the trial. So it happened in both cases.
In terms of the number of patients we have full data on <unk>.
We have not reported out the details of our full data set yet because our analysis continues and I mentioned in my prepared comments that as soon as we get the full data analysis completed that we will provide additional disclosure on that so more to come on kind of the full dataset. We also though did.
Have missing data as I mentioned, because this trial was run smack through the middle of Covid.
Cheryl Blanchard: We also, though, did have missing data, as I mentioned, because this trial was run smack through the middle of COVID. FDA recognized that a lot of clinical trials were impacted by patients not being able to return for follow-up visits. They actually put out guidance that is helpful to us on how to treat that. While the study was primarily impacted, really, in our miss on statistical significance, I would highlight, though, that Hyalofast consistently demonstrated improvements over microfracture in both pain and function. It's really a miss on statistical significance. Those are the topics that we'll continue to have ongoing dialogue with FDA.
Recognize that a lot of clinical trials were impacted by patients not being able to return for follow up visits and they actually put out guidance that is helpful to us on how to treat that so while the study was primarily impacted really in our.
Miss on statistical significance I would highlight though that house has consistently demonstrated improvements over microfracture in both pain and function, it's really a miss on statistical significance.
And those those are the topics that we will continue to have ongoing dialogue with FDA, but FDA has communicated to us to submit the full data package, including all of the analyses, including the additional endpoints that were used for prior approvals and including all of our fulsome dataset.
Cheryl Blanchard: FDA has communicated to us to submit the full data package, including all of the analyses, including the additional endpoints that were used for prior approvals, and including all of our fulsome dataset that we have from our number of independent studies performed outside the US from the over 15 years of clinical experience internationally.
We have from our number of independent studies performed outside the U S from the over 15 years of clinical experience internationally.
Sure I'm, just curious because I don't know the answer to this.
Michael Petusky: Cheryl, I'm just curious because I don't know the answer to this. Is it typical for the FDA to sort of say in a case where you've sort of missed the primary endpoints, we really encourage you to submit the full data package, I mean, is that just sort of template language that, Hey, submit what you have, and we'll take a look, or is there actually something to be encouraged about in terms of what they've said to you regarding that matter?
Is it is it typical for the FDA to sort of say in the case, where you have sort of missed the primary endpoints, but we really encourage you to submit the full data package I mean is that just sort of.
Sort of template language. He submit what you have and we'll take a look or is there actually something to be encouraged about in terms of what they have said to you regarding that matter.
Yeah, I will just communicate to you that they've they have.
Cheryl Blanchard: Yeah, I will just communicate to you that they have communicated to us to submit the full data package. They obviously understand that we have missing data. Again, we're not completely done with our data analysis, which is why we haven't put the actual data out until that's completed and QC'ed, which we will do at the point in time that that's done. FDA did communicate to us that they wanted us to submit the full data package, including all of those elements that I described. To keep in mind, this is a breakthrough device.
Communicated to us to submit the full data package. They they obviously understand that we have missing data.
And again, we're not completely done with our data analysis, which is why we haven't put the actual data out until thats completed in Q seed, which we will do at the point in time that is that that's done but FDA did communicate to us that they wanted us to submit the full data package, including all of those elements that I describe.
<unk>.
And to keep in mind. This is a breakthrough device.
Great.
Okay.
So moving on Steve I was just curious in terms of the I think it was something like an incremental $14 million investment that you guys are making in the regenerative portfolio is that still holding or if you guys maybe shifted bad at all given given the highway fascinated or just generally.
Michael Petusky: Right. Okay. Moving on, Steve, I was curious. In terms of the I think it was something like an incremental $14 million investment that you guys are making in the regenerative portfolio. Is that still holding, or have you guys maybe shifted that at all given the Hyalofast news or just generally your desire to sort of maybe manage this business a little tighter? I'm just curious.
Your desire to sort of maybe manage this business a little tighter I'm just curious.
It's a good question. The short answer is it is still on track as a $14 million investment into the business. The news around highway fast as with.
Steve Griffin: It's a good question. The short answer is it is still on track as a $14 million investment into the business. The news around Hyalofast is we just got unblinded, so this is very new for us. I would say that in terms of better cost discipline and thinking about where we can make strategic investments that are going to pay off for our long-term business, we are constantly doing that, and that is something that we will consistently do. I'm not going to share anything necessarily here, but I would say that we consistently look at where we're making investments to try and make sure that we're delivering the most optimal outcome for shareholders.
We just got on blinded. So this is very new for us, but I would say that in terms of <unk>.
Better cost discipline, and thinking about where we can make strategic investments, they're going to pay off for our long term business. We are constantly doing that and that is something that we will consistently do I'm not going to share anything necessarily here, but I would say that we consistently look at where we're making investments to try and make sure that we're delivering the most optimal outcome for shareholders.
Let me just follow up is it possible that 14, and even even going forward internal investment you're pointing to make 26 as a possible maybe that that number's curbed at some point in the.
Michael Petusky: Let me just follow up. Is it possible that $14 and even going forward, internal investment you plan to make in 2026, is it possible maybe that number is curbed at some point in the H2 of this year?
Second half of this year.
Yes.
Possible.
Maybe we will share more in the future when we get to that point, but.
Steve Griffin: Yeah, it's possible. I mean, maybe we'll share more in the future when we get to that point, but it's possible.
As possible.
Okay Alright, great.
Last question I guess, Sheryl probably bouncing back to you in terms of integrity. Occasionally you guys have and I may have I may have missed this forgive me if I missed this but.
Michael Petusky: Okay. All right. Great. Just last question, I guess, Cheryl, probably bouncing back to you. In terms of Integrity, occasionally, you guys have and I may have missed this. Forgive me if I missed this, but you occasionally have shared either sort of surge and adoption commentary or even surgery numbers. I'm just curious if you have anything to share on that. Forgive me if you mentioned that, and I just missed it. Thanks.
You occasionally have shared either sort of surge in adoption commentary or or even even surgery numbers I'm. Just curious if you have anything to share on that and forgive me. If you mentioned that and I just missed it.
Yeah, I didn't give an update on surgery numbers, because we were really more focused now on what we are driving from a topline perspective, and the fact that we're.
Cheryl Blanchard: Yeah, I didn't give an update on surgery numbers because we were really more focused now on what we're driving from a top-line perspective and the fact that we're on track to really double that business this year. I'm sure as we go forward, we'll continue to provide those updates, but I think you can just kind of extrapolate that based on the fact that we're really overachieving. We're ahead of expectations, and we're projecting to do a doubling of that business this year.
On track to really double that business. This year I'm sure as we go forward, we will continue to provide those updates but I.
I think you can just kind of extrapolate that based on the fact that we're really over achieving were ahead of expectations.
And we're projecting to do a doubling of that business this year.
Alright, thank you so much youre.
Youre welcome. Thank you Mike.
Michael Petusky: All right. Thank you so much.
Cheryl Blanchard: You're welcome. Thank you, Mike.
Thank you.
Okay.
There are no further questions at this time.
Operator 2: Thank you. There are no further questions at this time. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.
Ladies and gentlemen, this concludes today's conference call. Thank you for your participation you may now disconnect.