Q4 2025 Pacira BioSciences Inc Earnings Call
Speaker #1: Good day and thank you for standing by Welcome to the Q4 2025 Pacira BioSciences, Inc. Earnings Conference Call . At this time , all participants are in a listen only mode After the speakers presentation , there will be a question and answer session To ask a question during the session , you will need to press star one one on your telephone .
Operator: Good day, and thank you for standing by. Welcome to the Q4 2025 Pacira BioSciences 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 press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Susan Mesco, Head of Investor Relations. Please go ahead.
[Analyst] (Jefferies): Good day, and thank you for standing by. Welcome to the Q4 2025 Pacira BioSciences 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 press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Susan Mesco, Head of Investor Relations. Please go ahead.
Speaker #1: You will then hear an automated message advising your hand is raised To withdraw your question , please press Star one . One again .
Speaker #1: Please be advised that today's conference is being recorded . I would now like to hand the conference over to your speaker today , Susan Mesco , Head of Investor Relations .
Speaker #1: Please go ahead
Speaker #2: Thank you . Good afternoon everyone . Welcome to today's conference call to discuss our fourth quarter and full year 2020 financial results Joining me are Frank Li , Chief Executive officer Chief commercial officer .
Susan Mesco: Thank you. Good afternoon, everyone. Welcome to today's Conference Call to discuss our Q4 and full year 2025 financial results. Joining me are Frank Li, Chief Executive Officer, Brendan Tian, Chief Commercial Officer, and Sean Cross, Chief Financial Officer. Before we begin, let me remind you that this call will include forward-looking statements subject to the safe harbor provisions of federal securities laws. Such statements represent our judgment as of today and may involve risks and uncertainties. This may cause our actual results, performance, or achievements to differ materially. For information concerning risk factors that could affect the company, please refer to our filings with the SEC or the Pacira website. Lastly, as a reminder, we will be discussing non-GAAP financial measures on today's call. A description of these metrics, along with our reconciliation to GAAP, can be found in the news release issued earlier this afternoon.
Susan Mesco: Thank you. Good afternoon, everyone. Welcome to today's Conference Call to discuss our Q4 and full year 2025 financial results. Joining me are Frank Li, Chief Executive Officer, Brendan Tian, Chief Commercial Officer, and Sean Cross, Chief Financial Officer. Before we begin, let me remind you that this call will include forward-looking statements subject to the safe harbor provisions of federal securities laws. Such statements represent our judgment as of today and may involve risks and uncertainties. This may cause our actual results, performance, or achievements to differ materially. For information concerning risk factors that could affect the company, please refer to our filings with the SEC or the Pacira website. Lastly, as a reminder, we will be discussing non-GAAP financial measures on today's call. A description of these metrics, along with our reconciliation to GAAP, can be found in the news release issued earlier this afternoon.
Speaker #2: And Shawn Cross chief financial officer Before we begin , let me remind you that this call will include forward looking statements subject to the safe harbor provisions of federal securities laws .
Speaker #2: Such statements represent our judgment as of today and may involve risks and uncertainties This may cause our actual results , performance or achievements to differ materially .
Speaker #2: For information concerning risk factors that could affect the company , please refer to our filings with the SEC or the website Lastly , as a reminder , we will be discussing non-GAAP financial measures on today's call .
Speaker #2: A description of these metrics, along with our reconciliation to GAAP, can be found in the news release issued earlier this afternoon.
Speaker #2: With that , I will now turn the call over to Frank . Leigh
Susan Mesco: With that, I will now turn the call over to Frank Li.
Susan Mesco: With that, I will now turn the call over to Frank Li.
Speaker #3: Thank you . Susan , and good afternoon , everyone . Joining today's call . I'm pleased to share Becerra's fourth quarter and full year 2020 results .
Frank D. Lee: Thank you, Susan. Good afternoon, everyone joining today's call. I'm pleased to share Pacira's Q4 and full year 2025 results and to reflect on what was truly a transformative year for our company. At Pacira, our mission remains unwavering to deliver innovative, non-opioid pain management therapies that transform lives. Everything we do starts with the patient. We're guided by the science, supported by our people, and grounded in a commitment to improve recovery while reducing exposure to opioids. When I look back at where we stood a year ago, the contrast is striking. Entering 2025, Pacira faced uncertainty with questions around EXPAREL's long-term exclusivity, inconsistent margins, and limited pipeline visibility. Today, we're a very different company. We have a clear strategic direction, reinvigorated top-line growth, a solidified exclusivity runway, and a significantly expanded patent protection.
Frank Lee: Thank you, Susan. Good afternoon, everyone joining today's call. I'm pleased to share Pacira's Q4 and full year 2025 results and to reflect on what was truly a transformative year for our company. At Pacira, our mission remains unwavering to deliver innovative, non-opioid pain management therapies that transform lives. Everything we do starts with the patient. We're guided by the science, supported by our people, and grounded in a commitment to improve recovery while reducing exposure to opioids. When I look back at where we stood a year ago, the contrast is striking. Entering 2025, Pacira faced uncertainty with questions around EXPAREL's long-term exclusivity, inconsistent margins, and limited pipeline visibility. Today, we're a very different company. We have a clear strategic direction, reinvigorated top-line growth, a solidified exclusivity runway, and a significantly expanded patent protection.
Speaker #3: And to reflect on what was truly a transformative year for our company Our mission remains unwavering to deliver innovative Non-opioid pain management therapies that transform lives Everything we do starts with the patient .
Speaker #3: We're guided by the science , supported by our people and grounded in a commitment to improve recovery . While reducing exposure to opioids When I look back at where we stood a year ago , the contrast is striking Entering 2025 , the Sierra faced uncertainty with questions around long term exclusivity , inconsistent margins and limited pipeline visibility Today , we're a very different company .
Speaker #3: We have a clear strategic direction , reinvigorated top line growth , a solidified exclusivity runway and a significantly expanded patent protection . In addition , we're advancing a promising pipeline that is now entering a data rich phase Most importantly , we're a company once again growing with momentum .
Frank D. Lee: In addition, we're advancing a promising pipeline that is now entering a data-rich phase. Most importantly, we're a company once again growing with momentum. Our exceptionally dedicated team has helped more than 2.5 million patients. Last year, we achieved $726 million in revenue and delivered the highest gross margins in our history. This progress is a direct result of our Five by '30 strategy, which we introduced last year to guide our next chapter of growth. Today, one year later, I'm proud of where we stand. In our aim to help 3 million patients annually by 2030, we're already at 2.5 million and climbing. Volume trends in 2025 show we're moving towards our goal of double-digit top-line growth. We are clearly on track for 5 percentage point improvement in margins over 2024 through enhanced manufacturing efficiencies.
Frank Lee: In addition, we're advancing a promising pipeline that is now entering a data-rich phase. Most importantly, we're a company once again growing with momentum. Our exceptionally dedicated team has helped more than 2.5 million patients. Last year, we achieved $726 million in revenue and delivered the highest gross margins in our history. This progress is a direct result of our Five by '30 strategy, which we introduced last year to guide our next chapter of growth. Today, one year later, I'm proud of where we stand. In our aim to help 3 million patients annually by 2030, we're already at 2.5 million and climbing. Volume trends in 2025 show we're moving towards our goal of double-digit top-line growth. We are clearly on track for 5 percentage point improvement in margins over 2024 through enhanced manufacturing efficiencies.
Speaker #3: Our exceptionally dedicated team has helped more than 2.5 million patients last year . We achieved $726 million in revenue and delivered the highest gross margins in our history This progress is a direct result of our five by 30 strategy , which we introduced last year to guide our next chapter of growth Today , one year later , I'm proud of where we stand in our aim to help 3 million patients annually by 2030 .
Speaker #3: We're already at 2.5 million and climbing. Volume trends in 2025 showed we're moving towards our goal of double-digit top line growth. We are clearly on track for a five percentage point improvement in margins over 2024 through enhanced manufacturing efficiencies. We're advancing our goal of five new pipeline programs.
Frank D. Lee: We're advancing our goal of five new pipeline programs. This is demonstrated by our progress with PCRX-201, PCRX-2002, and three HCAd-based preclinical programs.... Finally, we're targeting five strategic partnerships. J&J MedTech and LG Chem highlight the caliber of partners joining us on this journey. We look forward to adding more. In short, the next chapter of Pacira's growth is no longer conceptual, it is coming into clear focus. Our flagship product, EXPAREL, delivered solid performance. We're now seeing early durable signs of volume-based growth we achieved in the second half of 2025. As Brendan will highlight later in the call, much of this is driven by a combination of expanding NOPAIN education and awareness, increasing commercial payer adoption, streamlining product acquisition via GPO contracting, and growing demand across all sites of care.
Frank Lee: We're advancing our goal of five new pipeline programs. This is demonstrated by our progress with PCRX-201, PCRX-2002, and three HCAd-based preclinical programs.... Finally, we're targeting five strategic partnerships. J&J MedTech and LG Chem highlight the caliber of partners joining us on this journey. We look forward to adding more. In short, the next chapter of Pacira's growth is no longer conceptual, it is coming into clear focus. Our flagship product, EXPAREL, delivered solid performance. We're now seeing early durable signs of volume-based growth we achieved in the second half of 2025. As Brendan will highlight later in the call, much of this is driven by a combination of expanding NOPAIN education and awareness, increasing commercial payer adoption, streamlining product acquisition via GPO contracting, and growing demand across all sites of care.
Speaker #3: This is demonstrated by our progress with 200 won . Two zero , zero two and three Hcab based preclinical programs Finally , we're targeting five strategic partnerships JJ , MedTech and LG chem highlight the caliber of partners joining us on this journey , and we look forward to adding more .
Speaker #3: In short , the next chapter of growth is no longer conceptual . It is coming into clear focus Our flagship product , Exparel , delivered solid performance .
Speaker #3: We're now seeing early , signs of volume based growth we achieved in the second half of 2025 as brand will highlight later in the call .
Speaker #3: Much of this is driven by a combination of expanding , no pain , education and awareness , increasing commercial payer adoption , streamlining product acquisition via GPO , contracting , and growing demand across all sites of care Last year , we exceeded our goal and ended the year with 102 million lives with CMS or commercial coverage outside of the surgical bundle .
Frank D. Lee: Last year, we exceeded our goal and ended the year with 102 million lives with CMS or commercial coverage outside of the surgical bundle. This achievement demonstrate that payers recognize the value of expanding access to EXPAREL. It also establishes a foundation for shifting both decision-making and utilization patterns. On the IP front, we secured a volume-limited settlement with Fresenius, giving EXPAREL runway visibility through 2039. Complementing this, we strengthened our IP estate to 21 patents across two families. This is a dramatic evolution from the single patent we had when the first Paragraph IV was filed. All of this positions EXPAREL for sustained, steady growth, consistent with the role it plays in the evolution of opioid-sparing postsurgical care. This quarter, we announced a significant partnership with LG Chem, a leading healthcare company with deep surgical and orthopedic experience.
Frank Lee: Last year, we exceeded our goal and ended the year with 102 million lives with CMS or commercial coverage outside of the surgical bundle. This achievement demonstrate that payers recognize the value of expanding access to EXPAREL. It also establishes a foundation for shifting both decision-making and utilization patterns. On the IP front, we secured a volume-limited settlement with Fresenius, giving EXPAREL runway visibility through 2039. Complementing this, we strengthened our IP estate to 21 patents across two families. This is a dramatic evolution from the single patent we had when the first Paragraph IV was filed. All of this positions EXPAREL for sustained, steady growth, consistent with the role it plays in the evolution of opioid-sparing postsurgical care. This quarter, we announced a significant partnership with LG Chem, a leading healthcare company with deep surgical and orthopedic experience.
Speaker #3: This achievement demonstrates that payers recognize the value of expanding access to Exparel. It also establishes a foundation for shifting both decision making and utilization patterns.
Speaker #3: On the IT front , we secured a volume limited settlement with Brazil , giving Exparel runway visibility through 2039 . Complementing this , we strengthened our IP estate to 21 patents across two families .
Speaker #3: This is a dramatic evolution from the single patent we had when the first paragraph four was filed. All of this positions Exparel for sustained, steady growth consistent with the role it plays in the evolution of opioid-sparing, post-surgical care.
Speaker #3: This quarter , we announced significant partnership with LG chem , a leading healthcare company with deep surgical and orthopedic experience . They will commercialize Exparel in select Asia-Pacific countries , beginning with South Korea and Thailand , with regulatory filings anticipated .
Frank D. Lee: They will commercialize EXPAREL in select Asia-Pacific countries, beginning with South Korea and Thailand, with regulatory filings anticipated this year. This agreement delivers an upfront payment, transfer pricing, and tiered royalties, while opening access to new markets with a proven partner. We are forecasting revenues from this agreement to begin in 2027, and to extend through the life of our patents in the 2040s. Similarly, we expect our partnership with J&J MedTech to gain traction this year. Their sales force is now fully trained and triples our reach for ZILRETTA in the US. Now turning to our pipeline. The coming year will be pivotal as we enter a data-rich period with key clinical milestones that include an interim analysis for the first half of the year that will inform next steps for our study of ZILRETTA in shoulder OA.
Frank Lee: They will commercialize EXPAREL in select Asia-Pacific countries, beginning with South Korea and Thailand, with regulatory filings anticipated this year. This agreement delivers an upfront payment, transfer pricing, and tiered royalties, while opening access to new markets with a proven partner. We are forecasting revenues from this agreement to begin in 2027, and to extend through the life of our patents in the 2040s. Similarly, we expect our partnership with J&J MedTech to gain traction this year. Their sales force is now fully trained and triples our reach for ZILRETTA in the US. Now turning to our pipeline. The coming year will be pivotal as we enter a data-rich period with key clinical milestones that include an interim analysis for the first half of the year that will inform next steps for our study of ZILRETTA in shoulder OA.
Speaker #3: This year, this agreement delivers an upfront payment, transfer pricing, and tiered royalties, while opening access to new markets with a proven partner. We are forecasting revenues from this agreement to begin in 2027 and to extend through the life of our patents in the 2040s.
Speaker #3: Similarly, we expect our partnership with JJ MedTech to gain traction this year. Their sales force is now fully trained and triples our reach for Zilretta in the US. Now turning to our pipeline.
Speaker #3: The coming year will be a pivotal as we enter a data rich period with key clinical milestones that include an interim analysis for the first half of the year that will inform next steps for our study of zilretta in shoulder away top line results from IVR study for the treatment of spasticity are expected before the end of the year , following a mid-year interim analysis This is an important opportunity given the significant lack of innovation and patient satisfaction in this debilitating condition .
Frank D. Lee: Top-line results from our iovera° study for the treatment of spasticity are expected before the end of the year, following a mid-year interim analysis. This is an important opportunity, given the significant lack of innovation and patient satisfaction in this debilitating condition. 52-week data from Part A of our phase 2 ASCEND study of PCRX-201 remain on track for the end of the year. I'd like to highlight PCRX-201, the lead program from our proprietary HCAd platform, as it deserves special emphasis. 201 has the potential to revolutionize the OA treatment landscape and be at the forefront of local gene therapy for the masses. It is locally administered, non-integrating, and mechanistically de-risked IL-1 blockade therapy. Our two-part phase 2 ASCEND study is assessing safety and tolerability of PCRX-201. Like most phase 2 studies, ASCEND is not powered for efficacy.
Frank Lee: Top-line results from our iovera° study for the treatment of spasticity are expected before the end of the year, following a mid-year interim analysis. This is an important opportunity, given the significant lack of innovation and patient satisfaction in this debilitating condition. 52-week data from Part A of our phase 2 ASCEND study of PCRX-201 remain on track for the end of the year. I'd like to highlight PCRX-201, the lead program from our proprietary HCAd platform, as it deserves special emphasis. 201 has the potential to revolutionize the OA treatment landscape and be at the forefront of local gene therapy for the masses. It is locally administered, non-integrating, and mechanistically de-risked IL-1 blockade therapy. Our two-part phase 2 ASCEND study is assessing safety and tolerability of PCRX-201. Like most phase 2 studies, ASCEND is not powered for efficacy.
Speaker #3: In 52 week data from part A of our phase two study , a PCR 201 remain on track for the end of the year .
Speaker #3: I'd like to highlight 201, the lead program from our proprietary platform, as it deserves special emphasis. 201 has the potential to revolutionize the treatment landscape and be at the forefront of local gene therapy for the masses.
Speaker #3: It is locally administered , non-integrating and mechanistically de-risked . IL one blockade therapy Our two part phase two Ascend study is assessing safety and tolerability of 201 .
Speaker #3: Like most phase two studies , ascend is not powered for efficacy . The primary objective is safety , but we'll be looking for efficacy trends as measured by key secondary endpoints Later this year , we will report topline data from part A of the study , which randomized 49 patients .
Frank D. Lee: The primary objective is safety, we'll be looking for efficacy trends as measured by key secondary endpoints. Later this year, we'll report top-line data from Part A of the study, which randomized 49 patients. This is an important study that will yield more valuable insights than a typical Phase 2 study, since it includes an active steroid comparator. In parallel, we're rapidly establishing a commercially viable manufacturing process to enable Part B enrollment to start around mid-year. Part B will enroll approximately 90 patients. We're also planning a Phase 2 study of PCRX-2002 for patients undergoing bunionectomy surgery that we expect to begin later this year. This is our longer-acting, easy-to-administer ropivacaine-based polymer gel. We believe 2002 is highly complementary to EXPAREL, particularly in procedures where nerve blocks are not ideal. These programs exemplify our portfolio strategy, which is balancing innovative, de-risked assets across acute and musculoskeletal health settings.
Frank Lee: The primary objective is safety, we'll be looking for efficacy trends as measured by key secondary endpoints. Later this year, we'll report top-line data from Part A of the study, which randomized 49 patients. This is an important study that will yield more valuable insights than a typical Phase 2 study, since it includes an active steroid comparator. In parallel, we're rapidly establishing a commercially viable manufacturing process to enable Part B enrollment to start around mid-year. Part B will enroll approximately 90 patients. We're also planning a Phase 2 study of PCRX-2002 for patients undergoing bunionectomy surgery that we expect to begin later this year. This is our longer-acting, easy-to-administer ropivacaine-based polymer gel. We believe 2002 is highly complementary to EXPAREL, particularly in procedures where nerve blocks are not ideal. These programs exemplify our portfolio strategy, which is balancing innovative, de-risked assets across acute and musculoskeletal health settings.
Speaker #3: This is an important study that will yield more valuable insights than a typical Phase 2 study, since it includes an active steroid comparator in parallel, and will rapidly establish a commercially viable manufacturing process to enable Part B enrollment to start around mid-year.
Speaker #3: Part B will enroll approximately 90 patients We're also planning a phase two study of PCR 2002 for patients undergoing bunionectomy surgery that we expect to begin later this year .
Speaker #3: This is our longer acting easy to administer Ropivacaine based polymer gel We believe 2002 is highly complementary to Exparel , particularly in procedures where nerve blocks are not ideal These programs exemplify our portfolio strategy , which is balancing innovative de-risked assets across acute and musculoskeletal health settings As John will highlight later in the call , we remain disciplined stewards of capital , investing in growth and innovation .
Frank D. Lee: As Shawn will highlight later in the call, we remain disciplined stewards of capital, investing in growth and innovation. In parallel, we returned capital to shareholders with $150 million of stock repurchases, reducing the outstanding shares to 41 million. In summary, what a difference a year makes! Across every dimension core to our business: strategic, clinical, commercial, financial, and operational, Pacira is stronger today than it has ever been. We have reinvigorated EXPAREL growth in the US, established a foundation for ex-US revenue to begin next year, robust IP supporting a long-term EXPAREL runway, commercial partners of exceptional quality, and a pipeline poised to deliver meaningful data. Collectively, all grounded in a clear strategic plan with our Five by '30 initiatives.
Frank Lee: As Shawn will highlight later in the call, we remain disciplined stewards of capital, investing in growth and innovation. In parallel, we returned capital to shareholders with $150 million of stock repurchases, reducing the outstanding shares to 41 million. In summary, what a difference a year makes! Across every dimension core to our business: strategic, clinical, commercial, financial, and operational, Pacira is stronger today than it has ever been. We have reinvigorated EXPAREL growth in the US, established a foundation for ex-US revenue to begin next year, robust IP supporting a long-term EXPAREL runway, commercial partners of exceptional quality, and a pipeline poised to deliver meaningful data. Collectively, all grounded in a clear strategic plan with our Five by '30 initiatives.
Speaker #3: In parallel , we return capital to shareholders with $150 million of stock repurchases , reducing the outstanding shares to 41 million . In summary , what a difference a year makes .
Speaker #3: Across every dimension , core to our business , strategic , clinical , commercial , financial and operational is stronger today than it has ever been We have reinvigorated growth in the US , established a foundation for ex-US revenue to begin next year .
Speaker #3: Robust IP supporting a long term runway , commercial partners have exceptional quality and a pipeline poised to deliver meaningful data Collectively , all grounded in a clear strategic plan with our five by 30 initiatives With that , I'd like to turn the call over to Brent to share more details on our fourth quarter .
Shawn Cross: ... With that, I'd like to turn the call over to Brent to share more details on our Q4 commercial performance. Brent?
Shawn Cross: ... With that, I'd like to turn the call over to Brent to share more details on our Q4 commercial performance. Brent?
Speaker #3: Commercial performance . Brent Thank you , Frank , and good afternoon to all . Joining us today I'm very pleased to review the increased commercial momentum achieved in 2025 , which reflects both disciplined execution and a clear strategic vision .
Brendan Teehan: Thank you, Frank. Good afternoon to all joining us today. I'm very pleased to review the increased commercial momentum achieved in 2025, which reflects both disciplined execution, and a clear strategic vision. I'll focus today on our flagship product, EXPAREL. Expanding patient and provider access to our best-in-class long-acting analgesic was our top priority in 2025. As you know, Pacira has been the driving force behind a multiyear initiative to get the NOPAIN legislation across the finish line. This underscores our leadership in the space and our patient-focused mission. We're now just past the 1-year markup for the rollout of NOPAIN, and the progress it has yielded is exceeding our expectations. In a recent survey of nearly 750 physicians, and pharmacy leaders, 82% view NOPAIN as important for advancing non-opioid stewardship.
Brendan Teehan: Thank you, Frank. Good afternoon to all joining us today. I'm very pleased to review the increased commercial momentum achieved in 2025, which reflects both disciplined execution, and a clear strategic vision. I'll focus today on our flagship product, EXPAREL. Expanding patient and provider access to our best-in-class long-acting analgesic was our top priority in 2025. As you know, Pacira has been the driving force behind a multiyear initiative to get the NOPAIN legislation across the finish line. This underscores our leadership in the space and our patient-focused mission. We're now just past the 1-year markup for the rollout of NOPAIN, and the progress it has yielded is exceeding our expectations. In a recent survey of nearly 750 physicians, and pharmacy leaders, 82% view NOPAIN as important for advancing non-opioid stewardship.
Speaker #3: I'll focus today on our flagship product , Exparel expanding patient and provider access to our best in class long acting analgesic was our top priority in 2025 .
Speaker #3: As you know , Syria has been the driving force behind a multiyear initiative to get the no pain legislation across the finish line .
Speaker #3: This underscores our leadership in the space and our patient focused mission . We're now just past the one year mark for the rollout of No Pain and the progress that has yielded is exceeding our expectations .
Speaker #3: In a recent survey of nearly 750 physicians and pharmacy leaders , 82% view no pain as important for advancing Non-opioid stewardship 92% believe no pain is already contributing to reduced opioid prescribing , and nearly half report changes taking place across protocols , formularies and prescribing patterns This research aligns directly with the original intent of no pain , which was to reduce unnecessary opioid exposure around surgery by providing appropriate reimbursement for proven alternatives We continue to validate these findings with claims , data and the early signals are quite encouraging .
Brendan Teehan: 92% believe NOPAIN is already contributing to reduced opioid prescribing, and nearly half report changes taking place across protocols, formularies, and prescribing patterns. This research aligns directly with the original intent of NOPAIN, which was to reduce unnecessary opioid exposure around surgery by providing appropriate reimbursement for proven alternatives. We continue to validate these findings with claims data, and the early signals are quite encouraging. The momentum is real. NOPAIN provided the initial catalyst to begin knocking down the financial barriers that have historically prevented best practice pain management. For decades, bundled reimbursement incentivized the use of cheaper generic approaches that often incorporate opioids. Increasingly, this is no longer the case. With NOPAIN, we secured separate reimbursement at ASP plus 6% for Medicare patients in outpatient settings. This was a great starting point.
Brendan Teehan: 92% believe NOPAIN is already contributing to reduced opioid prescribing, and nearly half report changes taking place across protocols, formularies, and prescribing patterns. This research aligns directly with the original intent of NOPAIN, which was to reduce unnecessary opioid exposure around surgery by providing appropriate reimbursement for proven alternatives. We continue to validate these findings with claims data, and the early signals are quite encouraging. The momentum is real. NOPAIN provided the initial catalyst to begin knocking down the financial barriers that have historically prevented best practice pain management. For decades, bundled reimbursement incentivized the use of cheaper generic approaches that often incorporate opioids. Increasingly, this is no longer the case. With NOPAIN, we secured separate reimbursement at ASP plus 6% for Medicare patients in outpatient settings. This was a great starting point.
Speaker #3: The momentum is real . No pain , provided the initial catalyst to begin knocking down the financial barriers that have historically prevented best practice .
Speaker #3: Pain management for decades Bundled reimbursement incentivized the use of cheaper generic approaches that often incorporate opioids Increasingly , this is no longer the case with no pain , we secured separate reimbursement at ASP plus 6% for Medicare patients in outpatient settings .
Speaker #3: This was a great starting point fitting commercial plans to follow suit with access reimbursement has helped accelerate change in the market Here , we've exceeded our internal goal and ended 2025 with 102 million lives with Exparel coverage outside the surgical bundle .
Brendan Teehan: Getting commercial plans to follow suit with access-creating reimbursement has helped accelerate change in the market. Here, we've exceeded our internal goal and ended 2025 with 102 million lives with EXPAREL coverage outside the surgical bundle. This represents a notable shift in policy for some of the largest payers, including Aetna, Cigna, TRICARE, and Humana, among others. We will continue to expand our commercial coverage in 2026 to further broaden access in the months ahead. Our access efforts are strategic, focusing on key markets with high procedural volumes. We have significantly expanded payer coverage in our top five states, which account for roughly 40% of EXPAREL volumes. This directly translates into growth in our Q4 volumes, collectively up more than 7% in these markets over 2024. On top of these important reimbursement wins, our strategic pricing programs are delivering results.
Brendan Teehan: Getting commercial plans to follow suit with access-creating reimbursement has helped accelerate change in the market. Here, we've exceeded our internal goal and ended 2025 with 102 million lives with EXPAREL coverage outside the surgical bundle. This represents a notable shift in policy for some of the largest payers, including Aetna, Cigna, TRICARE, and Humana, among others. We will continue to expand our commercial coverage in 2026 to further broaden access in the months ahead. Our access efforts are strategic, focusing on key markets with high procedural volumes. We have significantly expanded payer coverage in our top five states, which account for roughly 40% of EXPAREL volumes. This directly translates into growth in our Q4 volumes, collectively up more than 7% in these markets over 2024. On top of these important reimbursement wins, our strategic pricing programs are delivering results.
Speaker #3: This represents a notable shift in policy for some of the largest payers , including Aetna , Cigna , Tricare and Humana , among others .
Speaker #3: We will continue to expand our commercial coverage in 2026 to further broaden access in the months ahead Our access efforts are strategic , focusing on key markets with high procedural volumes .
Speaker #3: We have significantly expanded payer coverage in our top five states , which account for roughly 40% of Exparel volumes This directly translates into growth in our fourth quarter volumes , collectively up more than 7% in these markets over 2024 .
Speaker #3: On top of these important reimbursement wins , our strategic pricing programs are delivering results through these growth focused pricing programs . Healthcare systems can afford the opportunity to be at the forefront of opioid sparing pain management .
Brendan Teehan: Through these growth-focused pricing programs, healthcare systems can afford the opportunity to be at the forefront of opioid-sparing pain management. Our contracted business drove high single-digit volume growth in the second half of 2025, double the volume growth we saw in the first half of the year. To further expand market access, we are generating real-world data to further highlight the EXPAREL value proposition to payers. We have several health economics and outcome studies on track for presentation at upcoming congresses, including the Academy of Managed Care Pharmacy, the Orthopaedic Research Society, and the American Society of Regional Anesthesia and Pain Medicine. Our initiatives include the comprehensive real-world IGOR registry, which now has more than 3,200 OA patients enrolled and is providing valuable information for EXPAREL, ZILRETTA, iovera°, as well as other products. These data will help guide best practice for osteoarthritis patients along their treatment journey.
Brendan Teehan: Through these growth-focused pricing programs, healthcare systems can afford the opportunity to be at the forefront of opioid-sparing pain management. Our contracted business drove high single-digit volume growth in the second half of 2025, double the volume growth we saw in the first half of the year. To further expand market access, we are generating real-world data to further highlight the EXPAREL value proposition to payers. We have several health economics and outcome studies on track for presentation at upcoming congresses, including the Academy of Managed Care Pharmacy, the Orthopaedic Research Society, and the American Society of Regional Anesthesia and Pain Medicine. Our initiatives include the comprehensive real-world IGOR registry, which now has more than 3,200 OA patients enrolled and is providing valuable information for EXPAREL, ZILRETTA, iovera°, as well as other products. These data will help guide best practice for osteoarthritis patients along their treatment journey.
Speaker #3: Our contracted business drove high single digit volume growth in the second half of 2025 , double the volume growth we saw in the first half of the year To further expand market access , we are generating real world data to further highlight the value proposition to payers .
Speaker #3: We have several health economics and outcomes studies on track for presentation at upcoming congresses , including the Academy of Managed Care , Pharmacy , the Orthopaedic Research Society , and the American Society of Regional Anesthesia and Pain Medicine Our initiatives include the comprehensive Real World Igor Registry , which now has more than 3200 patients enrolled and is providing valuable information for Exparel , Zilretta as well as other products These data will help guide best practice for osteoarthritis patients along their treatment journey .
Speaker #3: In summary , we are encouraged by the progress made establishing a strong foundation in 2025 . As a result , Exparel is well positioned to drive steady top line growth in 2026 and beyond .
Brendan Teehan: In summary, we are encouraged by the progress made establishing a strong foundation in 2025. As a result, EXPAREL is well positioned to drive steady top-line growth in 2026 and beyond. With that, I'll turn the call over to Shawn for his review of the financials.
Brendan Teehan: In summary, we are encouraged by the progress made establishing a strong foundation in 2025. As a result, EXPAREL is well positioned to drive steady top-line growth in 2026 and beyond. With that, I'll turn the call over to Shawn for his review of the financials.
Speaker #3: With that , I'll turn the call over to Sean for his review of the financials Thank you Brandon . I'll start with an update on sales and margin trends .
Shawn Cross: Thank you, Brent. I'll start with an update on sales and margin trends. Q4 EXPAREL sales increased to $155.8 million, versus $147.7 million in 2024. Volume growth of approximately 7% was partially offset by a shift in bio mix and discounting from our third GPO going live, with each having a roughly equal impact. As we move forward in 2026, we expect the delta between volume and revenue growth in the first half of the year to be similar to the second half of 2025, and then narrow after we anniversary our third GPO agreement mid-year. Q4 ZILRETTA sales were $33 million, essentially flat versus 2024. For iovera°, Q4 sales grew to $7 million versus $6.5 million in 2024. Turning to gross margins.
Shawn Cross: Thank you, Brent. I'll start with an update on sales and margin trends. Q4 EXPAREL sales increased to $155.8 million, versus $147.7 million in 2024. Volume growth of approximately 7% was partially offset by a shift in bio mix and discounting from our third GPO going live, with each having a roughly equal impact. As we move forward in 2026, we expect the delta between volume and revenue growth in the first half of the year to be similar to the second half of 2025, and then narrow after we anniversary our third GPO agreement mid-year. Q4 ZILRETTA sales were $33 million, essentially flat versus 2024. For iovera°, Q4 sales grew to $7 million versus $6.5 million in 2024. Turning to gross margins.
Speaker #3: Fourth quarter sales increased to 155.8 million versus 147.7 million in 2024 . Volume growth of approximately 7% was partially offset by a shift in vial mix and discounting from our third GPO going live , with each having roughly equal impact As we move forward in 2026 , we expect the delta between volume and revenue growth in the first half of the year to be similar to the second half of 2025 , and the narrow after we anniversary , our third GPO agreement mid-year Fourth quarter Zorita .
Speaker #3: Sales were 33 million , essentially flat versus 2024 for aloe . Fourth quarter sales grew to 7 million versus 6.5 million in 2024 .
Speaker #3: Turning to gross margins on a consolidated basis , our fourth quarter non-GAAP gross margin improved to 80% versus 79% last year , 2025 gross margins benefited from better than expected yields from both of our enhanced , larger scale 200 liter facilities These higher production volumes resulted in lower per unit costs .
Shawn Cross: On a consolidated basis, our Q4 non-GAAP gross margin improved to 80% versus 79% last year. 2025 gross margins benefited from better-than-expected yields from both of our enhanced, larger-scale, 200-liter EXPAREL facilities. These higher production volumes resulted in lower per-unit costs. This performance benefited cost of goods sold, but also placed us ahead of our 6-month inventory target. As a result, we have adjusted production volumes accordingly and anticipate exiting this year at our targeted inventory and steady state production. Going forward, through our continuous improvement initiatives, we expect a steady increase in annual gross margins over time. This places us on track for achieving our Five by '30 objective for a 5 percentage point improvement by 2030 over the 76% non-GAAP gross margins reported in 2024.
Shawn Cross: On a consolidated basis, our Q4 non-GAAP gross margin improved to 80% versus 79% last year. 2025 gross margins benefited from better-than-expected yields from both of our enhanced, larger-scale, 200-liter EXPAREL facilities. These higher production volumes resulted in lower per-unit costs. This performance benefited cost of goods sold, but also placed us ahead of our 6-month inventory target. As a result, we have adjusted production volumes accordingly and anticipate exiting this year at our targeted inventory and steady state production. Going forward, through our continuous improvement initiatives, we expect a steady increase in annual gross margins over time. This places us on track for achieving our Five by '30 objective for a 5 percentage point improvement by 2030 over the 76% non-GAAP gross margins reported in 2024.
Speaker #3: This performance benefited cost of goods sold , but also placed us ahead of our six month inventory target As a result , we have adjusted production volumes accordingly and anticipate exiting this year at our targeted inventory and steady state production Going forward through our continuous improvement initiatives .
Speaker #3: We expect a steady increase in annual gross margins over time. This places us on track for achieving our 'Five by 30' objective for a five percentage point improvement by 2030.
Speaker #3: Over the 76% non-GAAP gross margins reported in 2024. For non-GAAP R&D expense, the fourth quarter increased to $34.4 million from $22.0 million reported last year.
Shawn Cross: For non-GAAP R&D expense, the Q4 increased to $34.4 million from $22.0 million reported last year. This increase relates to the $5 million upfront payment to AmacaThera for the in-licensing of PCRX-2002, our advancing phase II development program for PCRX-201, as well as expenses associated with the ZILRETTA and iovera registrational studies. Non-GAAP SG&A expense came in at $91.9 million for Q4, which is up from $70.6 million in Q4 of 2024. Q4 SG&A was impacted by unanticipated costs associated with business development, due diligence, and litigation. As for the balance sheet, we exited Q4 in a position of strength, with $238 million cash and investments.
Shawn Cross: For non-GAAP R&D expense, the Q4 increased to $34.4 million from $22.0 million reported last year. This increase relates to the $5 million upfront payment to AmacaThera for the in-licensing of PCRX-2002, our advancing phase II development program for PCRX-201, as well as expenses associated with the ZILRETTA and iovera registrational studies. Non-GAAP SG&A expense came in at $91.9 million for Q4, which is up from $70.6 million in Q4 of 2024. Q4 SG&A was impacted by unanticipated costs associated with business development, due diligence, and litigation. As for the balance sheet, we exited Q4 in a position of strength, with $238 million cash and investments.
Speaker #3: This increase relates to the 5 million upfront payment to Amika Thera for the in-licensing of PCR , 2002 . Our advanced phase two development program for PCR 201 , as well as expenses associated with the Zilretta and I o Registrational studies non-GAAP G&A expenses came in at 91.9 million for the fourth quarter , which is up from 70.6 million in the fourth quarter of 2020 .
Speaker #3: For fourth quarter , SGA was impacted by unanticipated costs associated with business development , due diligence and litigation . As for the balance sheet , we exited the fourth quarter in a position of strength with 238 million cash and investments with a business that is producing significant operating cash flow .
Shawn Cross: With a business that is producing significant operating cash flow, we believe we are well equipped to advance our Five by '30 strategy and create shareholder value. With respect to capital deployment, we will continue to maintain a disciplined and strategic approach, focusing on 3 key areas. First, driving top-line growth by leveraging our existing commercial infrastructure. Second, advancing an innovative pipeline and becoming the leader in musculoskeletal pain and adjacencies. We are prioritizing accretive end market assets to leverage our established commercial footprint and de-risked clinical stage programs. Third, opportunistically returning capital to shareholders. During Q4, we executed an additional $50 million in share repurchases. As a result, we retired approximately 2 million shares common stock and reduced outstanding shares to approximately 41 million as of year-end.
Shawn Cross: With a business that is producing significant operating cash flow, we believe we are well equipped to advance our Five by '30 strategy and create shareholder value. With respect to capital deployment, we will continue to maintain a disciplined and strategic approach, focusing on 3 key areas. First, driving top-line growth by leveraging our existing commercial infrastructure. Second, advancing an innovative pipeline and becoming the leader in musculoskeletal pain and adjacencies. We are prioritizing accretive end market assets to leverage our established commercial footprint and de-risked clinical stage programs. Third, opportunistically returning capital to shareholders. During Q4, we executed an additional $50 million in share repurchases. As a result, we retired approximately 2 million shares common stock and reduced outstanding shares to approximately 41 million as of year-end.
Speaker #3: We believe we are well equipped to advance our five by 30 strategy and create value with respect to capital deployment . We will continue to maintain a disciplined and strategic approach , focusing on three key areas .
Speaker #3: First , driving top line growth by leveraging our existing commercial infrastructure . Second , advancing an innovative pipeline and becoming the leader in musculoskeletal pain and adjacencies .
Speaker #3: We are prioritizing accretive in-market assets to leverage our established commercial footprint and de-risked clinical stage programs . And third , opportunistically returning capital to shareholders During the fourth quarter , we executed an additional $50 million in share repurchases .
Speaker #3: As a result , we retired approximately 2 million shares . Common stock , and reduced outstanding shares to approximately 41 million as of year end .
Speaker #3: To remind you , as of December 31st , we $150 million remaining on our share buyback authorization , which runs through the end of this year .
Shawn Cross: To remind you, as of December 31st, we have $150 million remaining on our share buyback authorization, which runs through the end of this year. We will continue to be opportunistic with stock repurchases, given what we believe is a significant disconnect in our market valuation. Going forward, we will continue to be highly strategic, balancing favorable operating margins while advancing our Five by '30 strategy. That brings us to our full-year financial guidance for 2026 as follows: Total revenue of $745 to $770 million. For EXPAREL, sales of $600 to $620 million. As Bryn mentioned, we believe the brand is well positioned for a steady cadence of growth in 2026 and beyond. With respect to quarterly trends, we expect 2026 to largely follow historical patterns.
Shawn Cross: To remind you, as of December 31st, we have $150 million remaining on our share buyback authorization, which runs through the end of this year. We will continue to be opportunistic with stock repurchases, given what we believe is a significant disconnect in our market valuation. Going forward, we will continue to be highly strategic, balancing favorable operating margins while advancing our Five by '30 strategy. That brings us to our full-year financial guidance for 2026 as follows: Total revenue of $745 to $770 million. For EXPAREL, sales of $600 to $620 million. As Bryn mentioned, we believe the brand is well positioned for a steady cadence of growth in 2026 and beyond. With respect to quarterly trends, we expect 2026 to largely follow historical patterns.
Speaker #3: We will continue to be opportunistic with stock repurchases Given what we believe is a significant disconnect in our market valuation Going forward , we will continue to be highly strategic , balancing favorable operating margins while advancing our five by 30 strategy .
Speaker #3: That brings us to our full-year financial guidance for 2026, as follows: total revenue of $745 to $770 million for Exparel.
Speaker #3: Sales of 600 to 620 million . As Brent mentioned , we believe the brand is well positioned for a steady cadence of growth in 2026 and beyond with respect to quarterly trends , we expect 2026 to largely follow historical patterns in terms of percentage contribution to full year sales , dollars .
Shawn Cross: In terms of percentage contribution to full-year EXPAREL sales dollars, we expect Q1 to be approximately 1 percentage point lower than the previous few years due to the impact of the January and February storms. For the remainder of the year, we expect Q2 and Q3 to be evenly balanced, and Q4 to remain in line with prior years' trends as the highest contributor to the full-year sales dollars. Lastly, as a reminder, while Q4 is typically EXPAREL's strongest in terms of dollars, it is not always the highest in terms of year-over-year growth %. For ZILRETTA and iovera°, we are currently assuming 2026 will be in line with 2025. As we gain more visibility into our J&J partnership and other ZILRETTA and iovera° initiatives taking hold, we will update accordingly.
Shawn Cross: In terms of percentage contribution to full-year EXPAREL sales dollars, we expect Q1 to be approximately 1 percentage point lower than the previous few years due to the impact of the January and February storms. For the remainder of the year, we expect Q2 and Q3 to be evenly balanced, and Q4 to remain in line with prior years' trends as the highest contributor to the full-year sales dollars. Lastly, as a reminder, while Q4 is typically EXPAREL's strongest in terms of dollars, it is not always the highest in terms of year-over-year growth %. For ZILRETTA and iovera°, we are currently assuming 2026 will be in line with 2025. As we gain more visibility into our J&J partnership and other ZILRETTA and iovera° initiatives taking hold, we will update accordingly.
Speaker #3: We expect the first quarter to be approximately one percentage point lower than the previous few years , due to the impact of the January and February storms For the remainder of the year , we expect the second and third quarters to be evenly balanced .
Speaker #3: The fourth quarter to remain in line with prior year's trends as the highest contributor to the full year sales dollars Lastly , as a reminder , while the fourth quarter is typically strongest in terms of dollars , it is not always the highest in terms of year over year growth percentage Brazil Rita and Aloe Vera .
Speaker #3: We are currently assuming 2026 will be in line with 2025, as we gain more visibility into our J&J partnership and other Zilretta and VERAS initiatives.
Speaker #3: Taking hold . We will update accordingly . The final component of our 2026 revenue guidance relates to $7 million in revenues expected from our licensing agreement for the veterinary market non-GAAP gross margins of 77 to 79% , with respect to quarterly cadence , we expect the first three quarters margins to benefit from sales of lower cost inventory For the fourth quarter , we expect margins to be below our full year range due to the sale of higher cost inventory , as well as shutdown related costs and other expenses non-GAAP R&D expense of 105 to 115 million at the midpoint .
Shawn Cross: The final component of our 2026 revenue guidance relates to $7 million in revenues expected from our EXPAREL licensing agreement for the veterinary market. Non-GAAP gross margins of 77% to 79%. With respect to quarterly cadence, we expect the Q1, Q2, Q3 margins to benefit from sales of lower-cost inventory. For the Q4, we expect margins to be below our full-year range due to the sale of higher-cost inventory, as well as shutdown-related costs and other expenses. Non-GAAP R&D expense of $105 to $115 million. At the midpoint, this represents a 5% increase over 2025 and aligns with our Five by '30 strategy to transition into an innovative biopharmaceutical company. Non-GAAP SG&A expense of $320 to $340 million.
Shawn Cross: The final component of our 2026 revenue guidance relates to $7 million in revenues expected from our EXPAREL licensing agreement for the veterinary market. Non-GAAP gross margins of 77% to 79%. With respect to quarterly cadence, we expect the Q1, Q2, Q3 margins to benefit from sales of lower-cost inventory. For the Q4, we expect margins to be below our full-year range due to the sale of higher-cost inventory, as well as shutdown-related costs and other expenses. Non-GAAP R&D expense of $105 to $115 million. At the midpoint, this represents a 5% increase over 2025 and aligns with our Five by '30 strategy to transition into an innovative biopharmaceutical company. Non-GAAP SG&A expense of $320 to $340 million.
Speaker #3: This represents a 5% increase over 2025 and aligns with our five by 30 strategy to transition into an innovative biopharmaceutical company . non-GAAP G&A expenses of 320 to 340 million at the midpoint , this is a slight increase over 2025 , as we are now leveraging our existing commercial infrastructure , which is well equipped to support growth stock based compensation of 54 to 62 million .
Shawn Cross: At the midpoint, this is a slight increase over 2025, since we are now leveraging our existing commercial infrastructure, which is well equipped to support growth. Stock-based compensation of $54 to $62 million. Lastly, for those modeling adjusted EBITDA, we expect our 2026 depreciation expense to be approximately $30 million. With that, I'll turn the call back to Frank.
Shawn Cross: At the midpoint, this is a slight increase over 2025, since we are now leveraging our existing commercial infrastructure, which is well equipped to support growth. Stock-based compensation of $54 to $62 million. Lastly, for those modeling adjusted EBITDA, we expect our 2026 depreciation expense to be approximately $30 million. With that, I'll turn the call back to Frank.
Speaker #3: And lastly , for those modeling adjusted EBITDA , we expect our 2026 depreciation expense to be approximately 30 million . With that , I'll turn the call back to Frank .
Speaker #3: Thank you . Sean . I'm incredibly proud of our team and energized by the opportunities ahead . While we made great progress in 2025 , I'm even more excited about 2026 .
Frank D. Lee: Thank you, Sean. I'm incredibly proud of our team and energized by the opportunities ahead. While we made great progress in 2025, I'm even more excited about 2026. As I've said before, this is a year of Pacira, a year in which we bring bold ideas, high energy, and commitment to transforming what's possible in non-opioid pain management. With that, we're ready to open up the call for questions. Operator?
Frank Lee: Thank you, Sean. I'm incredibly proud of our team and energized by the opportunities ahead. While we made great progress in 2025, I'm even more excited about 2026. As I've said before, this is a year of Pacira, a year in which we bring bold ideas, high energy, and commitment to transforming what's possible in non-opioid pain management. With that, we're ready to open up the call for questions. Operator?
Speaker #3: As I've said before , this is a year of Sierra , a year in which we bring bold ideas , high energy and commitment to transforming what's possible in Non-opioid pain management .
Speaker #3: With that , we're ready to open up the call for questions . Operator .
Speaker #1: As a reminder to ask a question , please press star one one on your telephone and wait for your name to be announced .
Operator: 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 one again. Please stand by while we compile the Q&A roster. Our first question comes from Dennis Ding with Jefferies. Your line is open.
Operator: 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 one again. Please stand by while we compile the Q&A roster. Our first question comes from Dennis Ding with Jefferies. Your line is open.
Speaker #1: To withdraw your question , please press star one . One again , please stand by while we compile the Q&A roster Our first question comes from Dennis Ding with Jefferies .
Speaker #1: Your line is open
Speaker #4: Hi , this is Andrea on for Dennis . Thanks for taking our questions . I had a quick one around the readout in terms of trends in efficacy that you're talking about .
[Analyst] (Jefferies): Hi, this is Sandia on for Dennis. Thanks for taking our questions. I had a quick one around the OA readout. In terms of trends and efficacy that you're talking about, what exactly do you think constitutes a clinically meaningful signal there, provided that we are not expecting a stat sig? Thank you.
[Analyst] (Jefferies): Hi, this is Sandia on for Dennis. Thanks for taking our questions. I had a quick one around the OA readout. In terms of trends and efficacy that you're talking about, what exactly do you think constitutes a clinically meaningful signal there, provided that we are not expecting a stat sig? Thank you.
Speaker #4: What exactly do you think constitute a clinically meaningful signal ? There , provided that we are not expecting a stat sig ? Thank you
Speaker #3: Thanks for the question , Cindy . With regard to , I believe you mentioned PCR 201 part A trial that will read out at the end of the year and just to remind folks , we enrolled 49 patients in that trial and we expect to report the results near year end .
Frank D. Lee: Thanks for the question, Sandy. With regard to, I believe you mentioned PCRX-201 part A trial, that will read out at the end of the year. Just to remind folks, we enrolled 49 patients in that trial, and we expect to report the results near year-end. With that said, you know, I'm gonna turn it over to Jonathan Slonin, our Chief Medical Officer, to take you through the endpoints that we're actually gonna be reporting out on, then I'll provide some additional context. Jonathan?
Frank Lee: Thanks for the question, Sandy. With regard to, I believe you mentioned PCRX-201 part A trial, that will read out at the end of the year. Just to remind folks, we enrolled 49 patients in that trial, and we expect to report the results near year-end. With that said, you know, I'm gonna turn it over to Jonathan Slonin, our Chief Medical Officer, to take you through the endpoints that we're actually gonna be reporting out on, then I'll provide some additional context. Jonathan?
Speaker #3: And so with that said , I'm going to turn it over to Jonathan Slonin , our chief medical officer , to take you through the endpoints that we're actually going to be reporting out on .
Speaker #3: And then I'll provide some additional context . So , Jonathan
Speaker #5: Thank you, Frank. So, like most phase two studies, ASCEND is not powered for efficacy. So the primary focus of this study is safety.
Jonathan Slonin: Thank you, Frank. Like most phase II studies, ASCEND is not powered for efficacy. The primary focus of this study is safety, but we are actually also looking at important efficacy trends measured by key secondary endpoints. We're going to take a look at endpoints related to pain, stiffness, and function. Examples are NRS pain scores. We're going to look at WOMAC for pain and stiffness, and functional indicators using KOOS and ADLs. We will be looking at that data. Remember, it's a two-part study. The first part, of 45 patients that you referred to, are already enrolled, and we will have top-line data at the end of the year around safety and trends for our endpoints.
Jonathan Slonin: Thank you, Frank. Like most phase II studies, ASCEND is not powered for efficacy. The primary focus of this study is safety, but we are actually also looking at important efficacy trends measured by key secondary endpoints. We're going to take a look at endpoints related to pain, stiffness, and function. Examples are NRS pain scores. We're going to look at WOMAC for pain and stiffness, and functional indicators using KOOS and ADLs. We will be looking at that data. Remember, it's a two-part study. The first part, of 45 patients that you referred to, are already enrolled, and we will have top-line data at the end of the year around safety and trends for our endpoints.
Speaker #5: But we are actually also looking at important efficacy trends measured by key secondary endpoints. And so we're going to take a look at endpoints related to pain, stiffness, and function. Examples are noise pain scores.
Speaker #5: We're going to look at womac for pain and stiffness and functional indicators using Koos and ADLs . So we we'll be looking at that data .
Speaker #5: Remember it's a two part study . The first part of 45 patients that you referred to are already enrolled . And we will have top line data at the end of the year .
Speaker #5: Around safety and trends for our endpoints .
Speaker #3: And so let me just add on to that . Thank you , Jonathan , that just to remind folks , this one has an active comparator .
Frank D. Lee: Let me just add on to that. Thank you, Jonathan. That, just to remind folks, this one has an active comparator. We do have a short-acting steroid on board, and certainly, we have some context in terms of how short-acting steroids respond in various studies, in addition to having some data from our IGOR registry that we talked about earlier. We'll be able to look at some of those trends. Again, I wanna reiterate what Jonathan said. This is primarily a safety study. It's not powered for efficacy, but we intend to look at the endpoints that Jonathan just articulated.
Frank Lee: Let me just add on to that. Thank you, Jonathan. That, just to remind folks, this one has an active comparator. We do have a short-acting steroid on board, and certainly, we have some context in terms of how short-acting steroids respond in various studies, in addition to having some data from our IGOR registry that we talked about earlier. We'll be able to look at some of those trends. Again, I wanna reiterate what Jonathan said. This is primarily a safety study. It's not powered for efficacy, but we intend to look at the endpoints that Jonathan just articulated.
Speaker #3: So we do have a short-acting steroid on board. And certainly, we have some context in terms of how short-acting steroids respond in various studies.
Speaker #3: In addition to having some data from our registry that we talked about earlier . So we'll be able to look at some of those trends .
Speaker #3: But again , I want to reiterate what Jonathan said . This is primarily a safety study . It's not powered for efficacy , but we intend to look at the endpoints at Jonathan , just articulated
Speaker #4: Got it . And just a quick follow up . Do you expect a certain do you have an internal bar of the numerical separation on some of these endpoints .
[Analyst] (Jefferies): Got it. Just a quick follow-up. Do you have an internal bar of the numerical separation on some of these endpoints, or is it just really looking for separation?
[Analyst] (Jefferies): Got it. Just a quick follow-up. Do you have an internal bar of the numerical separation on some of these endpoints, or is it just really looking for separation?
Speaker #4: Or is it just really looking for separation
Speaker #3: Yeah , thanks for that . I think again , I think this is just primarily more for safety and trends And so we have at least some I would say context from our phase one study that I believe you're familiar with .
Frank D. Lee: Yeah.
Frank Lee: Yeah.
Jonathan Slonin: So-
Jonathan Slonin: So-
Frank D. Lee: Thanks for that. I think, again, I think this is just primarily more for safety and trends. We have at least some, I would say, context from our phase 1 study that, I believe you're familiar with, and we have some context from our IGOR registry and other studies that have reported out on short-acting steroids. Again, the trial is not powered for efficacy, but we can put the data in sort of that context.
Frank Lee: Thanks for that. I think, again, I think this is just primarily more for safety and trends. We have at least some, I would say, context from our phase 1 study that, I believe you're familiar with, and we have some context from our IGOR registry and other studies that have reported out on short-acting steroids. Again, the trial is not powered for efficacy, but we can put the data in sort of that context.
Speaker #3: And we have some context from our Igor registry and other studies that are reported out on short acting steroids . So again , the trial is not powered for efficacy , but we can put the data in sort of that context
Speaker #4: Okay . Got it . Thank you
[Analyst] (Jefferies): Okay, got it. Thank you.
[Analyst] (Jefferies): Okay, got it. Thank you.
Frank D. Lee: Yeah.
Frank Lee: Yeah.
Speaker #1: Thank you . Our next question comes from Douglas Tsao with H.C. Wainwright . Your line is open
Operator: Thank you. Our next question comes from Douglas Tsao with HC Wainwright. Your line is open.
Operator: Thank you. Our next question comes from Douglas Tsao with HC Wainwright. Your line is open.
Speaker #6: Hi . Good afternoon . Thanks for taking the questions . Just first , just curious if we can hear some perspective . You know , in terms of the guidance in particular on Exparel , you know , what are the factors that could lead you to sort of come in at the higher end of the range as well as maybe some of the potential factors that could sort of bring you to the lower end of the range .
Douglas Tsao: Hi, good afternoon. Thanks for taking the questions. Just first, just curious if we can hear some perspective, you know, in terms of the guidance, in particular on EXPAREL. You know, what are the factors that could lead you to sort of come in at the higher end of the range, as well as maybe some of the potential sort of factors that could sort of bring you to the lower end of the range? I have a follow-up on the PCRX-201 study. Thank you.
Douglas Tsao: Hi, good afternoon. Thanks for taking the questions. Just first, just curious if we can hear some perspective, you know, in terms of the guidance, in particular on EXPAREL. You know, what are the factors that could lead you to sort of come in at the higher end of the range, as well as maybe some of the potential sort of factors that could sort of bring you to the lower end of the range? I have a follow-up on the PCRX-201 study. Thank you.
Speaker #6: And then I have a follow up on on the 201 study . Thank you
Speaker #3: Sure . Let me provide a little bit of highlights here and turn it over to Brent First off , I'm really proud of what the team is able to accomplish this past year .
Frank D. Lee: Sure. Let me provide a little bit of highlights here and then turn it over to Brent. First off, I'm really proud of what the team's able to accomplish this past year and really standing up a commercial medical market access powerhouse. You can see how that's paid off for us in terms of the growth that we demonstrated in volume in the second half of the year versus first half, as well as the number of lives now that we have covered outside of the bundle. I'm encouraged by where we are. I expect a steady cadence of growth going forward. Let me turn it to Brent for some additional commentary.
Frank Lee: Sure. Let me provide a little bit of highlights here and then turn it over to Brent. First off, I'm really proud of what the team's able to accomplish this past year and really standing up a commercial medical market access powerhouse. You can see how that's paid off for us in terms of the growth that we demonstrated in volume in the second half of the year versus first half, as well as the number of lives now that we have covered outside of the bundle. I'm encouraged by where we are. I expect a steady cadence of growth going forward. Let me turn it to Brent for some additional commentary.
Speaker #3: And really standing up a commercial medical market access powerhouse . And you can see how that's paid off for us in terms of the growth that we demonstrated in volume in the second half of the year versus first half , as well as the number of lives .
Speaker #3: Now that we have covered outside of the bundle . And so I'm encouraged by where we are . I expect a steady cadence of growth going forward .
Speaker #3: And so let me turn it to Brent for some additional commentary . Yeah , thanks for the question . And well aligned with the response .
Jonathan Slonin: Yeah. Thanks for the question and well-aligned with the response. I think we're performing very well. We have positioned ourselves for that steady growth. This is a great starting point in terms of guidance. I think it also provides us with a little bit of opportunity for upside or downside developments from a market perspective. I think Shawn made some comments about, you know, first quarter and some interesting storm dynamics, which always have some implications to a product that is driven by procedures taking place, particularly elective procedures. Other than that, I think our investments are showing promise and are paying off. I think our leading indicators reinforce that confidence.
Brendan Teehan: Yeah. Thanks for the question and well-aligned with the response. I think we're performing very well. We have positioned ourselves for that steady growth. This is a great starting point in terms of guidance. I think it also provides us with a little bit of opportunity for upside or downside developments from a market perspective. I think Shawn made some comments about, you know, first quarter and some interesting storm dynamics, which always have some implications to a product that is driven by procedures taking place, particularly elective procedures. Other than that, I think our investments are showing promise and are paying off. I think our leading indicators reinforce that confidence.
Speaker #3: I think we're performing very well. We have positioned ourselves for that steady growth, and this is a great starting point in terms of guidance.
Speaker #3: I think it also provides us with a little bit of opportunity for upside or downside developments . From a market perspective . I think Sean made some comments about first quarter and some interesting storm dynamics , which always have some implications to a product that is driven by procedural for by procedures taking place , particularly elective procedures .
Speaker #3: But other than that , I think our investments are showing promise and are paying off . And I think our leading indicators reinforce that confidence Doug , a second question .
Frank D. Lee: Doug, you have a second question?
Frank Lee: Doug, you have a second question?
Speaker #6: Yeah . And then just on sure , one , we'll obviously get that initial data and it's not , as you said , sort of powered for , for for for efficacy .
Douglas Tsao: Yeah, just on PCRX-201, you know, we'll obviously get that initial data, and, you know, it's not, as you said, sort of powered for efficacy. I'm just curious, is there anything that you could learn just in combination with the phase I data that looks so compelling, and obviously, the duration looks so promising as well, that could sort of lead you to sort of maybe accelerate the program in any way, you know, into sort of a registrational phase? Thank you.
Douglas Tsao: Yeah, just on PCRX-201, you know, we'll obviously get that initial data, and, you know, it's not, as you said, sort of powered for efficacy. I'm just curious, is there anything that you could learn just in combination with the phase I data that looks so compelling, and obviously, the duration looks so promising as well, that could sort of lead you to sort of maybe accelerate the program in any way, you know, into sort of a registrational phase? Thank you.
Speaker #6: I'm just curious , is there anything that you could learn just in combination with the phase one data that looks so compelling ? And obviously the duration looks so promising as well , that could sort of lead you to sort of maybe accelerate the program in any way .
Speaker #6: You know , into sort of a registrational phase . Thank you .
Speaker #3: Yeah , thanks for that . So let me step back here a little bit for context . You know , certainly this platform is a very exciting platform .
Frank D. Lee: Yeah, thanks for that. let me step back here a little bit for context. you know, certainly this platform is a very exciting platform, the HCAd platform. As we all know, this is a locally administered gene therapy. This could be the first gene therapy for the masses, as we talk about, as opposed to gene therapy that's systemic for rare disease. We're excited about this program. We're encouraged by the phase I results. From a phase II perspective, what we're excited about is, as Jonathan mentioned, we had planned for 45 patients, but we actually enrolled 49, and we did that ahead of schedule. that's a good sign.
Frank Lee: Yeah, thanks for that. let me step back here a little bit for context. you know, certainly this platform is a very exciting platform, the HCAd platform. As we all know, this is a locally administered gene therapy. This could be the first gene therapy for the masses, as we talk about, as opposed to gene therapy that's systemic for rare disease. We're excited about this program. We're encouraged by the phase I results. From a phase II perspective, what we're excited about is, as Jonathan mentioned, we had planned for 45 patients, but we actually enrolled 49, and we did that ahead of schedule. that's a good sign.
Speaker #3: Platform. And, as we all know, this is a locally administered gene therapy. So, this could be the first gene therapy for the masses.
Speaker #3: As we talk about as opposed to gene therapy , the systemic for rare disease So we're excited about this program . We're encouraged by the phase one results from a phase two perspective .
Speaker #3: What we're excited about is , as Jonathan mentioned , we have planned for 45 patients , but we actually enrolled 49 . And we did that ahead of schedule .
Speaker #3: And so that's a good sign. And as we think about, as we progress through the course of the year, as I mentioned, we'll report these data towards the end of the year.
Frank D. Lee: As we think about as we progress through the course of the year, as I mentioned, we'll report these data towards the end of the year. I wanna come back to safety is our primary objective with looking at trends, given what we know about how short-acting steroids respond from various data sets, including our IGOR data set, and certainly we have our longer-acting ZILRETTA as context as well. Again, as context, difficult to compare cross studies, but the phase I study, as you mentioned, was compelling, with 72 patients that we've now followed up with at 3 years. Given all of that, we'll take all that into stock, and report out at the end of the year.
Frank Lee: As we think about as we progress through the course of the year, as I mentioned, we'll report these data towards the end of the year. I wanna come back to safety is our primary objective with looking at trends, given what we know about how short-acting steroids respond from various data sets, including our IGOR data set, and certainly we have our longer-acting ZILRETTA as context as well. Again, as context, difficult to compare cross studies, but the phase I study, as you mentioned, was compelling, with 72 patients that we've now followed up with at 3 years. Given all of that, we'll take all that into stock, and report out at the end of the year.
Speaker #3: And I want to come back to safety . Is our primary objective , with looking at trends , given what we know about how short acting steroids respond from various data sets , including our Igor data set .
Speaker #3: And certainly we have our longer acting zoreeda as context as well . And again , as context . Difficult to compare across studies , but the phase one study , as you mentioned , was compelling with 72 patients that we've now followed up with at three years .
Speaker #3: And so given all of that , we'll take all that into stock and report out at the end of the year . And just to remind that phase two , part B is scheduled to start enrolling mid this year with commercially viable product .
Frank D. Lee: Just to remind that Phase 2 Part B is scheduled to start enrolling mid this year with commercially viable product. This is important, and our target is to enroll about 90 patients there. Those data, along with the Part A data, will certainly inform how we proceed in terms of a accelerated fashion, base case fashion, et cetera, for the remainder of the development program. What I'm encouraged about is, as you know, we have RMAT designation, which provides us the opportunity to regularly communicate with the FDA. I would say so far, the discussions have been constructive.
Frank Lee: Just to remind that Phase 2 Part B is scheduled to start enrolling mid this year with commercially viable product. This is important, and our target is to enroll about 90 patients there. Those data, along with the Part A data, will certainly inform how we proceed in terms of a accelerated fashion, base case fashion, et cetera, for the remainder of the development program. What I'm encouraged about is, as you know, we have RMAT designation, which provides us the opportunity to regularly communicate with the FDA. I would say so far, the discussions have been constructive.
Speaker #3: And so this is important . And our target is to enroll about 90 patients . There . And that those data along with the part a data will certainly inform how we proceed in terms of a accelerated fashion base case .
Speaker #3: Fashion etc. for the remainder of the program . So what I'm encouraged about is , as you know , we have our mat designation , which provides us the opportunity to regularly communicate with the FDA .
Speaker #3: And I would say so far , the discussions have been constructed
Speaker #6: Great . Thank you so much
Douglas Tsao: Great. Thank you so much.
Douglas Tsao: Great. Thank you so much.
Speaker #1: Thank you . Our next question comes from Les Salusky with Truist Securities . Your line is open
Operator: Thank you. Our next question comes from Les Sulewski with Truist Securities. Your line is open.
Operator: Thank you. Our next question comes from Les Sulewski with Truist Securities. Your line is open.
Les Sulewski: Good evening. Thank you for taking my questions. Frank, perhaps when taking in the Five by '30 plan into consideration, could you help us bridge the double-digit revenue growth target versus the just introduced mid-single digit growth for 2026? Specifically for EXPAREL, would you frame the 6% growth for this year as conservative, or does it reflect specific headwinds you're already seeing in Q4 or Q1? I have a follow-up.
Speaker #6: Good evening . Thank you for taking my questions . Frank . Perhaps when taking in the five by 30 plan into consideration , could you help us bridge the double digit revenue growth target versus the just introduced mid-single digit growth for 2026 ?
Les Sulewski: Good evening. Thank you for taking my questions. Frank, perhaps when taking in the Five by '30 plan into consideration, could you help us bridge the double-digit revenue growth target versus the just introduced mid-single digit growth for 2026? Specifically for EXPAREL, would you frame the 6% growth for this year as conservative, or does it reflect specific headwinds you're already seeing in Q4 or Q1? I have a follow-up.
Speaker #6: And then specifically for would you frame the 6% growth for this year as conservative or does it reflect specific headwinds you're already seeing in four Q or one Q ?
Speaker #6: And I have a follow up
Speaker #3: Sure . And as let me address the second question first , as Brett mentioned , we're confident about what we've done here in 2025 as a good indicator of what we're going to do in 2026 .
Frank D. Lee: Sure. Let me address the second question first. As Brent mentioned, we're confident about what we've done here in 2025 as a good indicator of what we're gonna do in 2026. you know what? It's a good starting point, it's, I think, a good place to start, given what we believe is a relatively soft market in terms of elective procedures. It gives us an opportunity and room for any upside or downside as the year progresses in the elective procedure market. I wanna really reiterate that. Secondly, as we think about now, Five by '30, as I articulated earlier on, we're making very good progress towards Five by '30.
Frank Lee: Sure. Let me address the second question first. As Brent mentioned, we're confident about what we've done here in 2025 as a good indicator of what we're gonna do in 2026. you know what? It's a good starting point, it's, I think, a good place to start, given what we believe is a relatively soft market in terms of elective procedures. It gives us an opportunity and room for any upside or downside as the year progresses in the elective procedure market. I wanna really reiterate that. Secondly, as we think about now, Five by '30, as I articulated earlier on, we're making very good progress towards Five by '30.
Speaker #3: And , you know what ? It's a good starting point . And it's I think , a good place to start given what we believe is a relatively soft market in terms of elective procedures .
Speaker #3: So it gives us an opportunity and room for any upside or downside as the year progresses . In the elective procedure market . So I want to really reiterate that .
Speaker #3: Secondly , as we think about now five , by 30 , as I articulated earlier on , we're making very good progress towards five by 30 .
Speaker #3: And I would think about what we've done in second half of last year . We've committed to this year . And as we move forward , as we move forward , I would expect that we'll continue to drive broader access in terms of , you know , covered lives outside the bundle .
Frank D. Lee: I would think about what we've done in the second half of last year, what we've committed to this year. As we move forward, I would expect that we will continue to drive broader access in terms of, you know, covered lives outside the bundle. I would expect that we would extend our reach for both EXPAREL and ZILRETTA further through partnerships, as we talked about. In addition, starting in 2027, we will have contribution from ex-US sales of EXPAREL. As I articulated, we signed with a very strong partner in Asia Pacific, LG Chem, we intend to sign additional partnerships outside of the US where it makes sense, and those contributions will also help with top-line growth.
Frank Lee: I would think about what we've done in the second half of last year, what we've committed to this year. As we move forward, I would expect that we will continue to drive broader access in terms of, you know, covered lives outside the bundle. I would expect that we would extend our reach for both EXPAREL and ZILRETTA further through partnerships, as we talked about. In addition, starting in 2027, we will have contribution from ex-US sales of EXPAREL. As I articulated, we signed with a very strong partner in Asia Pacific, LG Chem, we intend to sign additional partnerships outside of the US where it makes sense, and those contributions will also help with top-line growth.
Speaker #3: I would expect that we would extend our reach for both X and Zilretta further through partnerships . As we talked about and in addition , starting in 2027 , we will have contribution from ex-US sales of Exparel .
Speaker #3: And so as I articulated , we signed with the very strong partner in Asia Pacific , LG chem . And we intend to sign additional partnerships outside of the US where it makes sense .
Speaker #3: And those contributions will also help with top line growth . So I would say I would summarize it that way in terms of not only the core growth , but through partnerships , both here in the US as well as Ex-u.s.
Frank D. Lee: I would say, I would summarize it that way in terms of not only the core growth, but through partnerships, both here in the US as well as ex-US, which allows us to extend our reach in a very efficient way.
Frank Lee: I would say, I would summarize it that way in terms of not only the core growth, but through partnerships, both here in the US as well as ex-US, which allows us to extend our reach in a very efficient way.
Speaker #3: , which allows us to extend our reach in a very efficient way.
Les Sulewski: Thank you. As a follow-up, you reached 100 million lives now, and, you know, noted implementation and of reimbursement takes some time, but it does appear that sentiment around EXPAREL is high on the positive side. From, you know, from the feedback you're getting, is the barrier more on the adoption, the clinical adoption, rather than reimbursement that you're seeing? Thank you.
Les Sulewski: Thank you. As a follow-up, you reached 100 million lives now, and, you know, noted implementation and of reimbursement takes some time, but it does appear that sentiment around EXPAREL is high on the positive side. From, you know, from the feedback you're getting, is the barrier more on the adoption, the clinical adoption, rather than reimbursement that you're seeing? Thank you.
Speaker #6: Thank you . As a follow up , you reached 100 million lives now . And you know , noted implementation of reimbursement takes some time , but it does appear that sentiment around Exparel is high .
Speaker #6: On the positive side . So from , you know , from the feedback you're getting is the barrier more on the adoption , the clinical adoption rather than reimbursement that you're seeing .
Speaker #6: Thank you
Speaker #3: So let me provide a little bit of context and I'll turn it over to Brent here . I have to tell you I'm really proud of the team in terms of what we've been able to do .
Frank D. Lee: Let me provide a little bit of context, and I'll turn it over to Brent here. I have to say, I'm really proud of the team in terms of what we've been able to do. We reported 102 million lives covered outside of the bundle. This is an important distinction now, covered outside of the bundle, because it's a much higher number if you just say covered. This is outside the bundle. What we're seeing is really encouraging signs that this momentum will continue, and that our customers are able to code and get reimbursed in ways that make a lot of sense for the patient and to the institution. Brent, let me turn it over to you.
Frank Lee: Let me provide a little bit of context, and I'll turn it over to Brent here. I have to say, I'm really proud of the team in terms of what we've been able to do. We reported 102 million lives covered outside of the bundle. This is an important distinction now, covered outside of the bundle, because it's a much higher number if you just say covered. This is outside the bundle. What we're seeing is really encouraging signs that this momentum will continue, and that our customers are able to code and get reimbursed in ways that make a lot of sense for the patient and to the institution. Brent, let me turn it over to you.
Speaker #3: We reported 102 million lives covered outside of the bundle. This is an important distinction. Now, covered outside of the bundle, because it's a much higher number.
Speaker #3: If you just say covered . So this is outside the bundle . And what we're seeing is really encouraging signs that this momentum will continue .
Speaker #3: And that our customers are able to code and get reimbursed in ways that make a lot of sense for the patient and to the institution .
Speaker #3: So , Brent , let me turn it over to you for sure . Thanks . Very good question . Very proud that we've gotten by the end of the fourth quarter to 102 million lives .
Brendan Teehan: For sure. Thanks, and a very good question. Very proud that we've gotten, by the end of Q4, to 102 million lives. That number has already climbed to about 110 million within the first month of 2026, and we have no intention of stopping in looking to get as many lives covered outside the surgical bundle as possible. I'd also note that the accumulation of those covered lives has taken time. NOPAIN was an excellent start. If you watch our cadence throughout 2025, was really the addition of those commercial lives that started to gain attention of more of those economic stakeholders, especially in the second half of the year, and something we intend to capitalize on in 2026.
Brendan Teehan: For sure. Thanks, and a very good question. Very proud that we've gotten, by the end of Q4, to 102 million lives. That number has already climbed to about 110 million within the first month of 2026, and we have no intention of stopping in looking to get as many lives covered outside the surgical bundle as possible. I'd also note that the accumulation of those covered lives has taken time. NOPAIN was an excellent start. If you watch our cadence throughout 2025, was really the addition of those commercial lives that started to gain attention of more of those economic stakeholders, especially in the second half of the year, and something we intend to capitalize on in 2026.
Speaker #3: That number has already climbed to about 110 million within the first month of 2026. And we have no intention of stopping and are looking to get as many lives covered outside the surgical bundle as possible.
Speaker #3: also note that the accumulation of those covered lives has taken time . No pain was an excellent start . If you watch our cadence throughout 2025 , it was really the addition of those commercial lives that started to gain attention of more of those economic stakeholders , especially in the second half of the year , and something we intend to capitalize on in 2026 .
Speaker #3: So I would say it's a function of time . On the one hand . And then getting the attention of economic stakeholders , particularly thinking about the difference in cost recovery for exparel outside the surgical bundle , which will be a key priority moving forward .
Brendan Teehan: I would say it's a function of time on the one hand, and then getting the attention of economic stakeholders, particularly thinking about the difference in cost recovery for EXPAREL outside the surgical bundle, which will be a key priority moving forward.
Brendan Teehan: I would say it's a function of time on the one hand, and then getting the attention of economic stakeholders, particularly thinking about the difference in cost recovery for EXPAREL outside the surgical bundle, which will be a key priority moving forward.
Speaker #3: Yeah . Thank you . Brenna . And I'll just add on top of that , you know , I think historically and this is the spirit of the no pain act is my sense is that folks , there was not a lot of debate about which products are good for the patient , but the financial barriers were real , both in terms of product acquisition as well as remittance reimbursement .
Frank D. Lee: Yeah. Thank you, Brent. I'll just add on top of that, you know, I think historically, and this is the spirit of the NOPAIN Act, is my sense is that folks, there was not a lot of debate about which products are good for the patient, but the financial barriers were real, both in terms of product acquisition as well as remittance, reimbursement. On the product acquisition side, as we've mentioned, we've now signed GPO contracts. The last of them will lap mid this year, that provides performance-driven incentives there to acquire the product.
Frank Lee: Yeah. Thank you, Brent. I'll just add on top of that, you know, I think historically, and this is the spirit of the NOPAIN Act, is my sense is that folks, there was not a lot of debate about which products are good for the patient, but the financial barriers were real, both in terms of product acquisition as well as remittance, reimbursement. On the product acquisition side, as we've mentioned, we've now signed GPO contracts. The last of them will lap mid this year, that provides performance-driven incentives there to acquire the product.
Speaker #3: So on the product acquisition side , as we mentioned , we've now signed GPO contracts . The last of them will lap mid this year .
Speaker #3: So that provides performance driven incentives there to acquire the product . And then on the remittance side , reimbursement . We're really pleased to see that .
Frank D. Lee: Then on the remittance side, reimbursement, we're really pleased to see that, you know, of course, Medicare provides ASP plus 6% in terms of reimbursement, but if we take a look at what the commercial setting provides, it's often much higher than that. Clinicians are able to choose the right product, and now it makes financial sense for their institutions as well.
Frank Lee: Then on the remittance side, reimbursement, we're really pleased to see that, you know, of course, Medicare provides ASP plus 6% in terms of reimbursement, but if we take a look at what the commercial setting provides, it's often much higher than that. Clinicians are able to choose the right product, and now it makes financial sense for their institutions as well.
Speaker #3: Of course , Medicare provides ASP plus 6% in terms of reimbursement . But if we take a look at what the commercial setting provides , it's often much higher than that .
Speaker #3: So clinicians are able to choose the right product, and now it makes financial sense for their institutions as well.
Speaker #1: Thank you. Our next question comes from Serge Belanger with Needham & Company. Your line is open.
Operator: Thank you. Our next question comes from Serge Belanger with Needham & Company. Your line is open.
Operator: Thank you. Our next question comes from Serge Belanger with Needham & Company. Your line is open.
Speaker #7: Hi . This is John on for Serge today . Thanks for taking our question . Just one for us today . I wanted to touch on Zilretta and the J&J MedTech partnership .
[Analyst] (Needham & Company): Hi, this is John on for Serge today. Thanks for taking our question. Just one for us today. I wanted to touch on ZILRETTA and the J&J MedTech partnership. You know, just curious what you think, you know, if any, headwinds were that led to the relatively flat performance in 2025 and what you may be looking for in 2026 that could provide some confidence in establishing a growth profile, now that the J&J team is fully active?
[Analyst] (Needham Company): Hi, this is John on for Serge today. Thanks for taking our question. Just one for us today. I wanted to touch on ZILRETTA and the J&J MedTech partnership. You know, just curious what you think, you know, if any, headwinds were that led to the relatively flat performance in 2025 and what you may be looking for in 2026 that could provide some confidence in establishing a growth profile, now that the J&J team is fully active?
Speaker #7: Just curious what you think , if any headwinds were that led to the relatively flat performance in 25 and what you may be looking for in 26 that could provide confidence in establishing a growth profile now that the J&J team is fully active .
Speaker #3: Yeah , thanks for the question , John . Let me provide a little bit of context and then turn it over to to Brent about what we expect going forward .
Frank D. Lee: Yeah, thanks for the question, John. Let me provide a little bit of context and then turn it over to Brent about what we expect going forward. As you'll know, back in 2025, as part of our prioritization and really building a commercial medical market access powerhouse, we said we're gonna prioritize EXPAREL. That's what we did, and we focused on EXPAREL, and we restructured the sales forces accordingly, to stand up a separate sales force for ZILRETTA and a separate sales force for iovera°. That caused some disruption, and that was impacting sales. That's some of the context behind that. Certainly, for Johnson & Johnson now, we spent last year training the team and getting them up to speed.
Frank Lee: Yeah, thanks for the question, John. Let me provide a little bit of context and then turn it over to Brent about what we expect going forward. As you'll know, back in 2025, as part of our prioritization and really building a commercial medical market access powerhouse, we said we're gonna prioritize EXPAREL. That's what we did, and we focused on EXPAREL, and we restructured the sales forces accordingly, to stand up a separate sales force for ZILRETTA and a separate sales force for iovera°. That caused some disruption, and that was impacting sales. That's some of the context behind that. Certainly, for Johnson & Johnson now, we spent last year training the team and getting them up to speed.
Speaker #3: As you know , back in 2025 , as part of our prioritization and really building a commercial medical market , access powerhouse , we said we're going to prioritize exparel .
Speaker #3: So that's what we did . And we focused on expert role , and we restructured the sales forces accordingly to stand up a separate sales force for Zorita and a separate sales force for Ivra , so that caused some disruption .
Speaker #3: And that was impacting sales. So that's some of the context behind that. And certainly for Johnson & Johnson. Now, we spent last year training the team and getting them up to speed.
Speaker #3: And so let me turn it over to Brent to talk about sort of how we think about 2026 . Yeah . Thank you Frank .
Frank D. Lee: Let me turn it over to Brent to talk about sort of, you know, how we think about 2026.
Frank Lee: Let me turn it over to Brent to talk about sort of, you know, how we think about 2026.
Brendan Teehan: Yeah. Thank you, Frank, and great question. I would describe the latter half of 2025 as a time where both of our organizations were kind of forming our plans on the local level for the teams. Please remember that while they expand our footprint, J&J has as many as five or six counterparts that would cross paths with Pacira. Just making sure that we were well coordinated in our messaging was important. We now have, entering 2026, clear growth objectives for our partner for the year. They've added that to their incentive compensation plan, which is super critical. We also have appropriate target selection, where J&J will take the primary lead on the accounts where they have existing relationships.
Brendan Teehan: Yeah. Thank you, Frank, and great question. I would describe the latter half of 2025 as a time where both of our organizations were kind of forming our plans on the local level for the teams. Please remember that while they expand our footprint, J&J has as many as five or six counterparts that would cross paths with Pacira. Just making sure that we were well coordinated in our messaging was important. We now have, entering 2026, clear growth objectives for our partner for the year. They've added that to their incentive compensation plan, which is super critical. We also have appropriate target selection, where J&J will take the primary lead on the accounts where they have existing relationships.
Speaker #3: And great question . I would describe the latter half of 2025 as a time where both of our organizations were kind of forming our our plans on the local level for the teams .
Speaker #3: And please remember that while they expand our footprint , they also have a JJ has as many as 5 or 6 counterparts that would would cross paths with with Pacira .
Speaker #3: So just making sure that we were , well coordinated in our messaging was important . We now have entering 2026 clear growth objectives for our partner for the year , and they've added that to their incentive compensation plan , which is super critical .
Speaker #3: We also have appropriate target selection where J&J will take the primary lead on the accounts , where they have where they have existing relationships , and they now have , for the first time ever .
Brendan Teehan: They now have, for the first time ever, and at, I think, a very important time in their company's life cycle, a clinically strong complement to the viscosupplements in ZILRETTA, and a solution where they often have not had one. That, coupled with what ZILRETTA offers in terms of consistent reimbursement versus what has been super, relatively variable, I would say, on the viscosupplement side-
Brendan Teehan: They now have, for the first time ever, and at, I think, a very important time in their company's life cycle, a clinically strong complement to the viscosupplements in ZILRETTA, and a solution where they often have not had one. That, coupled with what ZILRETTA offers in terms of consistent reimbursement versus what has been super, relatively variable, I would say, on the viscosupplement side-
Speaker #3: And I think a very important time in in their company's life cycle , a clinically strong compliment to the visco supplements in Zilretta and a solution where they often have not had one .
Speaker #3: That coupled with what Zilretta offers in terms of consistent reimbursement versus what has been super relatively variable , I would say on the viscosupplement side , that provides a very strong complementary asset that we are optimistic in in 2026 .
Frank D. Lee: ... provides a very strong, complementary asset that we are, you know, optimistic in 2026. Once we gain a little traction, we'll start to show the fruits of that partnership.
Frank Lee: ... provides a very strong, complementary asset that we are, you know, optimistic in 2026. Once we gain a little traction, we'll start to show the fruits of that partnership.
Speaker #3: Once we gain a little traction , we'll start to to show the fruits of that , that partnership
Speaker #1: Thank you . Our next question comes from Hardik Parekh with J.P. Morgan . Your line is open .
Operator: Thank you. Our next question comes from Hardik Parikh with J.P. Morgan. Your line is open.
Operator: Thank you. Our next question comes from Hardik Parikh with J.P. Morgan. Your line is open.
Speaker #8: Hey guys . Thank you for time today . I was just wondering , I know in for Q you guys said you had some unexpected business development cost .
Hardik Parikh: Hey, guys. Thank you for the time today. I was just wondering, I know in Q4 you guys said you had some unexpected business development costs. You know, as you guys try to grow and diversify the business, can we think of that as maybe happening more often in terms of having some of these kind of one-off business development types of deals? Just want to see how active you guys think you will be going forward. Thank you.
Hardik Parikh: Hey, guys. Thank you for the time today. I was just wondering, I know in Q4 you guys said you had some unexpected business development costs. You know, as you guys try to grow and diversify the business, can we think of that as maybe happening more often in terms of having some of these kind of one-off business development types of deals? Just want to see how active you guys think you will be going forward. Thank you.
Speaker #8: And as you guys try to grow and diversify the business , can we can we think of that as maybe happening more often and kind of having some of these kind of one off business development type types of deals ?
Speaker #8: Just wanted to see how active you guys think you will be going forward . Thank you .
Speaker #3: Yeah . Thanks for the question . Heartache and as Sean articulated , those were due to not only business development , but for some litigation as well .
Frank D. Lee: Yes, thanks for the question, Hardik, as Shawn articulated, those were due to not only business development, but for some litigation as well. Just to step back a little bit, as Shawn mentioned, you know, our priority is to really think about how we maximize overall shareholder value. Part of that is how do we invest in the business for our core? As you can see from the guidance, that's largely done as we think about, you know, what we do for commercial medical market access, and that's going to be relatively flat, as Shawn mentioned.
Frank Lee: Yes, thanks for the question, Hardik, as Shawn articulated, those were due to not only business development, but for some litigation as well. Just to step back a little bit, as Shawn mentioned, you know, our priority is to really think about how we maximize overall shareholder value. Part of that is how do we invest in the business for our core? As you can see from the guidance, that's largely done as we think about, you know, what we do for commercial medical market access, and that's going to be relatively flat, as Shawn mentioned.
Speaker #3: And so, just to step back a little bit, as Shawn mentioned, you know, our priority is to really think about how we maximize overall shareholder value.
Speaker #3: And part of that is how do we invest in the business for our core . And as you can see from the guidance , that's largely done as we think about , you know , what we do for commercial medical market access .
Speaker #3: And that's going to be relatively flat . As Sean mentioned . And now slowly , we're investing in R&D . And at some point it makes sense to think about , as Sean mentioned , accretive deals that could be products that could be dropped into the bag today .
Frank D. Lee: Now slowly, we're investing in R&D. At some point, it makes sense to think about, as Shawn mentioned, accretive deals that could be products that could be dropped into the bag today, that would be accretive, that we could provide synergies, and that would make a lot of sense. I think that's an important priority for us, and do that in a very disciplined way, as well as to think about what are those de-risked clinical assets that are in later stages of development that we have expertise and we could carry further. That's how we think about it, because it's important to think about how we replenish our portfolio and to drive sales. What I'm really pleased about is, if you think about our pipeline now versus just a year ago, it's quite changed.
Frank Lee: Now slowly, we're investing in R&D. At some point, it makes sense to think about, as Shawn mentioned, accretive deals that could be products that could be dropped into the bag today, that would be accretive, that we could provide synergies, and that would make a lot of sense. I think that's an important priority for us, and do that in a very disciplined way, as well as to think about what are those de-risked clinical assets that are in later stages of development that we have expertise and we could carry further. That's how we think about it, because it's important to think about how we replenish our portfolio and to drive sales. What I'm really pleased about is, if you think about our pipeline now versus just a year ago, it's quite changed.
Speaker #3: That would be accretive , that we could provide synergies , and that would make a lot of sense . So I think that's an important priority for us .
Speaker #3: And do that in a very disciplined way . As well as to think about what are those de-risked clinical assets that are in later stages of development that we have expertise , and we could carry further .
Speaker #3: So that's how we think about it , because it's important to think about how we replenish our portfolio and to not and to drive sales .
Speaker #3: And what I'm really pleased about is if you think about our pipeline now versus just a year ago , it's quite changed . So now , as we think about that 2030 and beyond horizon , we have the following we have ex-US sales of our products .
Frank D. Lee: Now as we think about that 2030 and beyond horizon, we have the following: We have ex-US sales of our products. We have the AmacaThera 143, now called PCRX-2002, in that timeframe. We also have PCRX-201, you know, in that, around 2030 type of timeframe. As we look at how we continue to build our business, we'll drive against that 5x30 objective of putting more things in the pipeline, but also ensuring that we grow double digits.
Frank Lee: Now as we think about that 2030 and beyond horizon, we have the following: We have ex-US sales of our products. We have the AmacaThera 143, now called PCRX-2002, in that timeframe. We also have PCRX-201, you know, in that, around 2030 type of timeframe. As we look at how we continue to build our business, we'll drive against that 5x30 objective of putting more things in the pipeline, but also ensuring that we grow double digits.
Speaker #3: We have the Amika Thera one for three now called PCR , 2002 . In that time frame we also have PCR 201 . You know , in that round 2030 type of time frame .
Speaker #3: And so as we look at how we continue to build our business , will drive against that five by 30 . Objective of putting more things in the pipeline , but also ensuring that we grow double digits
Hardik Parikh: Thank you.
Hardik Parikh: Thank you.
Speaker #8: Thank you
Speaker #1: Thank you. I'm showing no further questions at this time. I'd now like to turn it back to Susan Mesco for closing remarks.
Operator: Thank you. I'm showing no further questions at this time. I would now like to turn it back to Susan Mesco for closing remarks.
Operator: Thank you. I'm showing no further questions at this time. I would now like to turn it back to Susan Mesco for closing remarks.
Speaker #2: Thank you Danny , and thanks to all in the call for your questions and time today . We're excited about the opportunities ahead and remain focused on executing our five by 30 growth strategy with discipline and purpose .
Susan Mesco: Thank you, Danny, and thanks to all on the call for your questions and time today. We're excited about the opportunities ahead and remain focused on executing our five by thirty growth strategy with discipline and purpose. As we move through 2026, we are confident in our ability to build on our momentum and position Pacira for long-term success. Thank you again for your continued support, and be well.
Susan Mesco: Thank you, Danny, and thanks to all on the call for your questions and time today. We're excited about the opportunities ahead and remain focused on executing our five by thirty growth strategy with discipline and purpose. As we move through 2026, we are confident in our ability to build on our momentum and position Pacira for long-term success. Thank you again for your continued support, and be well.
Speaker #2: As we move through 2026, we are confident in our ability to build on our momentum and position for long-term success. Thank you again for your continued support, and be well.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.