Pacira BioSciences is a specialty pharmaceutical company focused on developing and delivering innovative non-opioid pain management solutions to improve patient outcomes.
Frank, how would you assess your first year at Pacira BioSciences?
I am incredibly pleased to be here at Pacira BioSciences, a company that is a leader in non-opioid pain management therapies. Over the past several months, we have focused on solidifying our mission, principles, and values, which are critical for driving the organization forward. Our mission is clear: to innovate and deliver non-opioid pain management therapies that transform patients' lives—a phrase I do not use lightly, as it reflects a significant step forward in improving outcomes for those we serve.
Additionally, we have clarified our therapeutic strategy, prioritizing musculoskeletal diseases, pain, and market access capabilities. We are modernizing how we deliver our products to healthcare professionals and patients, ensuring we are meeting their needs effectively. Feedback from employees and investors has been overwhelmingly positive, with strong engagement and alignment on our growth strategy to establish Pacira as a commercial medical and market access powerhouse.
Why is addressing the opioid crisis so critical, and how did Pacira position itself as a leader in this effort?
The opioid crisis is a significant issue, and Pacira has been at the forefront of addressing it. After a brief retirement, I decided to come to work at Pacira because I am inspired by the company’s mission and its recognition that surgical procedures often serve as gateways to opioid addiction. Years ago, standard practice encouraged the liberal use of opioids post-surgery, leading many patients to develop dependencies. Pacira saw this crisis unfolding and committed itself to finding solutions.
The company took action by advocating for changes at the congressional level, emphasizing the importance of reimbursing non-opioid therapies separately from bundled surgical payments. This advocacy led to the passing of the No Pain Act, effective January 1, 2025. This legislation allows separate reimbursement for non-opioid products like EXPAREL, removing financial barriers for physicians and incentivizing opioid-sparing treatments. Pacira’s leadership extended beyond its own products, advocating for the reimbursement of 11 therapies industry-wide, demonstrating its commitment to addressing this critical public health issue.
What alternatives does Pacira offer to opioids?
We currently market three key products. Our flagship product, EXPAREL, is a bupivacaine liposome injection that provides extended pain relief by blocking nerve signals for up to four days, significantly reducing opioid use post-surgery. To date, it has helped an estimated 15 million patients, a testament to its impact. Recently, we secured an important patent that further strengthens EXPAREL’s market position.
Our second product, ZILRETTA, is a long-acting steroid for osteoarthritis pain. Unlike traditional steroids that last about a month, ZILRETTA provides three months of pain relief. Patients have reported high satisfaction due to its prolonged efficacy. The third, iovera°, is a device that freezes nerves to block pain signals for three months. Beyond pain management, we are exploring its use in treating spasticity, with promising early results improving quality of life for patients with conditions like cerebral palsy and post-stroke complications.
In our pipeline, we are also advancing a gene therapy for osteoarthritis, which showed benefits lasting up to two years from a single local injection. This therapy, PCRX-201, recently received regenerative medicine advanced therapy (RMAT) designation from the FDA, highlighting its potential as a breakthrough for the 30 million U.S. osteoarthritis patients. We are optimistic that this could transform the standard of care, not only for knees but potentially for other affected areas like hands, delivering targeted, lasting relief with an excellent safety profile.
Is Pacira ready to meet the potential demand for its offerings starting next year, following the implementation of the No Pain Act?
Absolutely. We have been planning for this for some time. First, on the manufacturing side, we have scaled up significantly. We now have two manufacturing sites, both operating with 200-liter production capacities, which is a substantial upgrade from our previous smaller-scale operations. This year, we received 200-liter approval for our San Diego facility, ensuring we will have ample capacity to meet the demand for both EXPAREL and ZILRETTA.
Secondly, we have invested heavily in becoming a commercial, medical, and market access powerhouse to support education and awareness about the new reimbursement changes. While the No Pain Act creates opportunities, it is critical that physicians and institutions understand how to take advantage of it. We have enhanced our capabilities, increased staff, and actively engaged with our customers to communicate these changes. Our market research indicates growing awareness and willingness to act, so while it will take effort, I am optimistic about 2025.
Do you believe that opioids will be completely replaced by non-opioid solutions?
I think it is unlikely that opioids will be entirely replaced, at least in the near or mid-term. There are certain patients, such as those with cancer or sickle cell disease, for whom opioids remain the most effective option due to the severity of their pain. That said, I believe non-opioid approaches will significantly shift prescribing habits for most surgical and less severe pain cases.
Do you plan to expand beyond the U.S. market?
Yes, international markets are very important to us. The challenges we address with opioid-sparing solutions exist globally, albeit at varying levels of severity. To expand effectively, we plan to partner with companies that have the expertise and capabilities to navigate these markets. We are already in discussions with several potential partners to make this a reality.
How would you explain Pacira’s stock performance in recent months?
Stock performance can be influenced by multiple factors. For us, there are three main buckets. First, uncertainty—particularly related to litigation—has weighed on our stock. While we lost an initial patent case that is now on appeal, what I think is often overlooked by the investment community is that this is only the first infringement case. We have many patents protecting EXPAREL. Separate patient infringement lawsuits are underway and additional EXPAREL patents are forthcoming.
Second, sales growth trajectory is critical. While our sales have been relatively flat, we anticipate double-digit growth moving forward, thanks to opportunities from the No Pain Act, J-codes for reimbursement, and our commercial investments. Finally, pipeline innovation plays a big role. Investors look to future growth beyond the current portfolio, and we are confident our transformative pipeline, including PCRX-201, will drive significant value. Resolving uncertainty and showcasing growth will position us as an innovative biopharma leader.
Where do you hope to see Pacira one year from now?
Our strategy is to maintain and grow our leadership in musculoskeletal pain and adjacent areas. In a year, I hope to reflect on progress in several areas. First, we aim to strengthen our mission and culture further, ensuring our passion for delivering innovative, non-opioid therapies resonates across the organization. Employee engagement is strong now, and we are committed to improving it even more.
Second, we want to expand our therapeutic pipeline with more transformative products like PCRX-201. This will help to address unmet needs for patients with conditions like osteoarthritis. Lastly, by leveraging our commercial, medical, and market access capabilities, we aim to achieve accelerated double-digit sales growth. We are on track to meet these goals, and I look forward to sharing our progress next year.
