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Pacira BioSciences, Inc.
8/5/2025
Good day, and thank you for standing by. Welcome to the Becerra Biosciences Q2 2025 earnings conference call. At this time, all participants are in 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 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 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, Head of Investor Relations. Please go ahead.
Thank you. Good afternoon, everyone. Welcome to today's conference call to discuss our second quarter 2025 financial results. Joining me are Frank Lee, Chief Executive Officer, Brendan Tehan, Chief Commercial Officer, and Sean Cross, Chief Financial Officer. Tony Molloy, Chief Legal and Compliance Officer, is also here for today's question and answer session. Before we begin, let me remind you that this call will include forward-looking statements subject to the State 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 FCC. These are available from the FCC or the Patera 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, everyone. I'm pleased to report that the first half of 2025 was marked by solid execution across our corporate, clinical, and commercial initiatives. The stage is set for accelerating top-line growth in the second half of the year, and importantly, we delivered several key milestones to advance our 5 by 30 path to growth and value creation. To remind you, this plan supports two broad strategic imperatives, first, growing our strong commercial-based business, and second, advancing an innovative pipeline of potentially transformative assets such as PCRX201. Notable second quarter accomplishments include the following, improving export performance with 6% year-over-year volume growth, the highest in eight quarters, strong commercial progress, allowing us to reiterate and narrow our range for revenue guidance, Favorable gross margins supporting an increase in guidance. Enhanced capital structure and liquidity with a new $300 million revolver and significant reduction of debt. And finally, disciplined and strategic capital allocation with the repurchase of $50 million of common stock. Brent and Sean will share more specifics on the quarter shortly. I'll begin with a high-level overview of our commercial portfolio, where our three vesting class products continue to generate significant cash flow. Our flagship product, Xperil, the first half of 2025, was marked by solid execution across three priorities, market access, awareness, and utilization. We now have a strong base to build on, and we're seeing encouraging momentum across key leading indicators for Xperil. On the market access front, we continue to advocate for expanded patient access to opioid-sparing pain therapies. To that end, we're pleased to see a new policy outlined by CMS and its preliminary rule for 2026. CMS is proposing to completely phase out its inpatient-only list over the next three years, starting with the removal of hundreds of procedures in 2026. In parallel, many of these procedures will be added to its list of procedures covered in ambulatory surgical centers. We believe this will enhance the expert on market opportunity in the outpatient settings. On the IP front, our legal team secured a favorable reexamination of our 495 patent from the US Patent and Trademark Office. Importantly, during this process, we amended the patent's claims to add volume limitations and to address other issues noted in the New Jersey Court's opinion last year. The 495 patent will be reissued shortly, and we believe it will be the strongest in our heuristic acid family of patents. In parallel, the team continues to innovate and expand our heuristic acid and IVRA patent families with two new patents. Both claim expo composition are listed in the FDA's Orange Book, with exclusivity into the 2040s. Shifting gears to strategic partnerships, a key component of 5 by 30 with an objective of 5 partnerships by 2030. We recently executed a potentially transformative collaboration with Johnson & Johnson MedTech for Zoleta. We believe this will significantly expand our reach and patient access for Zoleta. The proven long-lasting benefits of Zaretta and its distinct mechanism of action make it an ideal addition to the J&J MedTech's existing portfolio of OA pain solutions. Because there's no one-size-fits-all for treating patients suffering from OA pain, a personalized approach is essential with a highly complementary non-opioid option. The J&J MedTech team, we better support multiple treatment paths and improve the patient journey. For Pacera, this collaboration essentially doubles our sales calls for Zolretta, which is a promotion-responsive product. It gives us access to a well-established team and an extensive customer base. These relationships span a variety of physician specialists beyond orthopedics, such as sports medicine, osteopathy, pain management, and rheumatology. We believe this will meaningfully accelerate the Zulretta growth trajectory in an efficient manner. As for growth margins, enhanced manufacturing efficiencies have allowed us to increase our full-year guidance. This is a result of a multi-year investment in our 200-liter facilities in Swindon and San Diego. These suites provide ample capacity to meet demand with more favorable cost structure and manufacturing yields. Turning now to our pipeline, where we're focused on becoming the therapeutic area leader in musculoskeletal pain and adjacencies. These are large markets with high unmet patient needs. Our two registrational studies for Zolretta in the shoulder OA and Iovera in spasticity are progressing according to plan. To further solidify our leadership in opioid sparing innovation, we're advancing Innovations in Genicular Outcomes Registry, or IGOR. PICERA designed this comprehensive, prospective, observational, real-world study in the interest of science, not as a health authority obligation. 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, and we're capturing clinical and economic data as well as patient-reported outcomes. Its potential for meaningful insights is better than any known OA registry of its kind. With over 2,500 patients enrolled to date and growing, IGOR is now bearing fruit Recent and upcoming publications are further reinforcing the value of our products. In addition, we believe the insights gained from IGOR will support much-needed innovation and new product development for treating away pain. PCRX201 is a great example of innovation that we believe has the potential to revolutionize the treatment landscape. Clinical data continue to underscore the promise and disease-modifying potential of PCRX201 and the HCaTS platform. In June, we presented three-year follow-up data at the European Alliance of Associations for Rheumatology Congress. Very few OA studies reached such a milestone for study duration. Results showed that a single intra-articular injection of PCRX201 was well-tolerated with sustained efficacy through three years. In addition, we're making great progress in rolling our phase two ASCEND study Part A on track to conclude by year end. Beyond PCARCS 201, we have a promising portfolio of other HCaD platform-based assets that may have disease-modifying potential in other musculoskeletal diseases and adjacencies. We look forward to sharing more as the year progresses. In summary, this quarter is marked by solid execution across corporate, political, and commercial initiatives. as well as delivery of key milestones that advance our 5 by 30 strategy. With that, I'd like to turn the call over to Brent to share more details on our commercial performance on the second quarter.
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