Pacira BioSciences, Inc.

Good day, and thank you for standing by. Welcome to the Pacera Biosciences third quarter 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 that 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 first speaker today, Susan Mesko. Please go ahead.

Thank you. Good afternoon, everyone. Welcome to today's conference call to discuss our third quarter 2025 financial results. Joining me are Frank Lee, Chief Executive Officer, Brendan Thien, Chief Commercial Officer, and Sean Cross, Chief Financial Officer. Jonathan Slonin, our Chief Medical Officer, is also here for our question and answer session. 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. These are available from the SEC or the PACERO 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 Lee.

Thank you, Susan, and good afternoon to everyone joining today's call. We're pleased to report another successful quarter of strong execution across our corporate clinical and commercial initiatives. We're seeing top line growth accelerate with year-over-year revenues increasing by 6%, driven by a strong quarter for Exporil and Ivera. We continue to make important progress advancing our 5x30 path to growth and value creation. To remind you, this plan supports two broad strategic initiatives. First, growing our best-in-class commercial-based business, and second, advancing an innovative pipeline of potentially transformative assets such as PCRX 201. Notable third quarter highlights include increasing export demand with year-over-year volumes up approximately 9%. This is the highest quarterly growth we've seen in over three years and underscores the value of our commercial investments. Improving manufacturing efficiencies. and favorable gross margin supporting our second increase in full-year guidance. Significant cash flows and a strong balance sheet enabling investments in new growth initiatives. Meaningfully expanding our clinical pipeline with the in-licensing of AMT143. This complementary long-acting non-opioid directly aligns with our 5 by 30 strategy and has the potential to provide longer pain relief versus currently available local analgesics. Disciplined and strategic capital deployment, including share repurchases of another $50 million. And finally, solidifying our exclusivity runway with the listing of our 21st expiry patent. This now appears in the FDA's orange book and additional patents are forthcoming. I'll begin with a high-level overview of our commercial portfolio, where we're seeing improving trends for each of our products. For our flagship product, Expiril, momentum is on the rise as a result of strong execution, expanding market access, awareness, and utilization. On the market access front, we continue to make important strides, improving patient access to opioid-sparing pain therapies. To that end, our GPO partnerships, and performance-based contracting are delivering and growing our XBRL user base. We continue to secure key wins with additional national and regional commercial payers now providing separate XBRL reimbursement. We remain ahead of plan and expect to surpass our full-year goal of 100 million covered lives across commercial and government payers. emotionally responsive product are underway, we're confident the foundation is in place for a return to growth. Our colleagues at Johnson & Johnson MedTech are now trained and active in the field. This partnership is a great example of 5 by 30 in action. We have tripled our commercial footprint, which we believe will provide a meaningful incremental growth. Lastly, IAVERA. at a strong third quarter as a result of this dedicated sales force and other commercial investments. On the manufacturing front, the team continues to make important progress with third quarter gross margins, supporting another increase in guidance. Switching gears to the pipeline, here we're focused on becoming the therapeutic area leader in musculoskeletal pain and adjacencies. These are large markets with high-invent need. Clinical initiatives center around advancing an innovative pipeline along with life cycle management for our commercial base. For new product development, we're prioritizing complementary mid to late stage de-risked opportunities spanning the patient journey. PCRX201 is a great example that's advancing in a phase two study for osteoarthritis of the knee. Interest in the study has been high, and we recently concluded enrollment for part A ahead of plan, placing us on track for 12-month data next year. The data continue to underscore PCRS 201's potential to revolutionize OA treatment landscape and be at the forefront of local gene therapy for the masses. Last month, we presented three-year follow-up data from the phase one study at the American College of Rheumatology Convergence. These data demonstrated sustained efficacy. with improvements in pain, stiffness, and function for over three years. Importantly, efficacy was observed across all structural severity subgroups, including the most severe. Investigators also highlighted that pre-existing neutralizing antibodies did not affect PCR-201's efficacy or safety at all three doses. Natural immune responses are a major obstacle for gene therapies, and these preliminary data indicate the potential for redosing. We also expanded our pipeline with the recent in-licensing of EMT143, a novel, long-acting formulation of ropivacaine. This asset sits squarely in our wheelhouse, given our deep expertise in long-acting, locally administered pain therapeutics. This franchise-enhancing asset is highly complementary to Expirel and will allow us to serve a broader range of patients and healthcare professionals. Its innovative hydrogel technology is a proprietary combination of two polymers. It's easy to administer, requiring only installation into the surgical site with minimal reliance on specialized technique. The hydrogel rapidly forms a slow-release FIFO as it warms to body temperature. In a phase one study, AMT143 demonstrated sustained analgesic release through 14 days. This supports its potential for several days of pain control, which would be the longest duration among currently available local analgesics. These data, along with ropivacaine's validated mechanism of action, provide an attractive development risk and differentiated product profile. We expect to initiate a Phase II program next year, which places on track for commercialization to begin within our 5 by 30 timeframe. Given its strong commercial synergies, we expect it to be meaningfully accretive to cash flows and earnings. With respect to our HCaB-based preclinical portfolio, we've prioritized three programs, all with disease-modifying potential in painful conditions of high MFD. PCRX1003 for degenerative disc disease, addressing a major cause of chronic back pain with few currently available effective therapies. PCRX1002 for dry eye disease, a widespread condition where current treatments offer only temporary relief. And PCRX1001 for canine osteoarthritis, which has strong out-licensing potential for large market lacking durable solutions. Switching gears to lifecycle management, here we're highlighting the value of our products with real-world data. Last month, we presented three health economics and outcome studies at the AMCP Nexus. The use of Expiril was associated with reduced opioid use, lower costs, and improved recovery outcomes. Our comprehensive real-world IGRA registry now has more than 3,000 OA patients enrolled As you know, OA is a unique condition that patients live with for decades and receive a myriad of pain treatments as their disease progresses. IGOR is positioned to provide in-depth insights into the patient journey. We're capturing clinical and economic data as well as patient reported outcomes for all three of our products. Its potential for meaningful evidence is better than any known OA registry of its kind. And to round out the pipeline discussion are two registrational studies for Zoleta in the shoulder OA and Iovera in spasticity are progressing. We expect to have interim data readouts from both studies next year. The last item I'll touch upon are the recent paragraph four notifications. And as you know, generic attempts are common for successful products like Expiril. A great deal has changed since the first genetic filer. where we had one patent at the time. Our current Experil patent estate is stronger than it's ever been, and the team continues to innovate to further solidify our runway. Bottom line, any antifiler has a very high series of hurdles they will need to overcome to be commercially successful. We intend to vigorously protect our intellectual property and have an expertise focused on advancing our legal strategy. As for the rest of us, we're sharply focused on driving growth and remain confident ExpoRule will be a key growth driver of our success for the foreseeable future. With that, I'd like to turn the call over to Bren to share more details on our commercial performance and the third friend.