2/26/2026

speaker
Operator
Conference Operator

2024-2025 PACER 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 Mesko, Head of Investor Relations. Please go ahead.

speaker
Susan Mesko
Head of Investor Relations

Thank you. Good afternoon, everyone. Welcome to today's conference call to discuss our fourth quarter and full year 2025 financial results. Joining me are Frank Lee, Chief Executive Officer, Brendan Thien, 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 PCIRA 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. With that, I will now turn the call over to Frank Ley.

speaker
Frank Lee
Chief Executive Officer

Thank you, Susan, and good afternoon, everyone, joining today's call. I'm pleased to share Becerra's fourth quarter and full year 2025 results and to reflect on what was truly a transformative year. for our company. At Pacera, 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, Pacera faced uncertainty with questions around XBRL'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. 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 5 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 five percentage point improvement in margins over 2024 through enhanced manufacturing efficiencies. We're advancing our goal of five new pipeline programs. This is demonstrated by our progress with PCRX201 PCRx2002, and three HCaB-based pre-clinical 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. In short, the next chapter of this year's growth is no longer conceptual. It is coming into clear focus. Our flagship product, Expiril, delivered solid performance. We're now seeing early durable signs of volume-based growth we achieved in the second half of 2025. As Bren will highlight later in the call, much of this is driven by a combination of expanding no-paying 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. This achievement demonstrates that payers recognize the value of expanding access to Expiril. 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 Expiril 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 four was filed. All of this positions XBRL for sustained, steady growth, consistent with the role it plays in the evolution of opioid sparing post-surgical care. This quarter, we announced significant partnership with LG Chem, a leading healthcare company with deep surgical and orthopedic experience. They will commercialize XBRL 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, JJ MedTech, to gain traction this year. Their sales force is now fully trained and triples our reach for Soretta in the U.S. 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 and shoulder OA. Top line results from 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. And 52-week data from Part A of our Phase II ASCEND study of PCRX201 remain on track for the end of the year. I'd like to highlight PCRX201, the lead program from our proprietary HCaP 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 II ASCEND study is assessing safety and tolerability of PCRX201. Like most Phase II 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'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 II study since it includes an active steroid comparator. In parallel, we're rapidly establishing a commercial 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 II study of PCRF2002 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 Expiril, particularly in procedures where nerve blocks are not ideal. These programs exemplify our portfolio strategy, which is balancing innovative de-risk assets across acute and musculoskeletal health settings. As Sean will highlight later in the call, we remain disciplined stewards of capital investing in growth and innovation. In parallel, we return capital 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. Visera is stronger today than it has ever been. We have reinvigorated Expo growth in the US establish a foundation for revenue to begin next year. Robust supporting a long term expo runway. Commercial partners of exceptional quality and a pipeline boys to deliver meaningful data. Collectively all grounded in a clear strategic plan with our 5 by 30 initiatives. With that, I'd like to turn the call over to Bren to share more details on our fourth quarter commercial performance. Bren. 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. I'll focus today on our flagship product, XFRL. 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 no pain legislation across the finish line. This underscores our leadership in the space and our patient-focused mission. We're now just past the one-year markup for the rollout of no pain, and the progress it has yielded is exceeding our expectations. 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. The momentum is real. No pain 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 no pain, we secured separate reimbursement at ASP plus 6% for Medicare patients in outpatient settings. This was a great starting point. 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 XBRL 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 X4L volumes. This directly translates into growth in our fourth quarter 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. 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 external value proposition to payers. We have several health economics and outcomes studies on track for presentation at upcoming congresses, including the Academy of Managed Care Pharmacy, the Orthopedic 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 Expirel, Xilretta, Iovera, as well as other products. These data will help guide best practice for osteoarthritis patients along their treatment journey. In summary, we are encouraged by the progress made establishing a strong foundation in 2025 as a result as well positioned to drive steady top line growth in 2026 and beyond with that. I'll turn the call over to Sean for his review of the financials.

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