On July 14, 2022 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary revenues of $169.4 million for the second quarter of 2022, compared with $135.6 million for the second quarter of 2021 (Press release, Pacira Pharmaceuticals, JUL 14, 2022, View Source [SID1234616669]). The company’s revenues include net product sales of EXPAREL (bupivacaine liposome injectable suspension), ZILRETTA (triamcinolone acetonide extended-release injectable suspension), and the iovera° system. The company began recognizing sales of ZILRETTA in November 2021 after completing its acquisition of Flexion Therapeutics, Inc.
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"We continue to execute our growth strategy and are pleased to have posted record sales in the second quarter. In mid-June, EXPAREL sales trends strengthened despite ongoing pockets of persistent labor shortages and pandemic-related disruptions facing the elective surgery market. This was augmented by ZILRETTA sales, which underscore the successful integration of this synergistic product," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "EXPAREL has continued to outpace the recovery of the elective surgery market and we are seeing expanding utilization across all target markets and sites of care, with particularly robust growth within outpatient sites of care. We continue to drive education and awareness around the value of ZILRETTA and iovera° as both complementary and standalone non-opioid solutions for managing osteoarthritis pain and remain confident in the long-term growth opportunity for both products."
"On the clinical front, we remain on track with activities advancing according to plan. We have completed enrollment in the first of two studies evaluating EXPAREL as a lower extremity nerve block and we expect to complete enrollment in the second study in the coming weeks. We are also finalizing the design of our label expansion studies for ZILRETTA in shoulder osteoarthritis and type 2 diabetes. In addition, we are preparing to meet with the U.S. Food and Drug Administration (FDA) to discuss the design of our Phase 3 registration study for iovera° as a treatment for spasticity. With a complementary portfolio of innovative non-opioid options, we believe we are uniquely positioned to deliver robust near- and long-term growth," continued Mr. Stack.
Second Quarter and June 2022 Preliminary Revenue Highlights
EXPAREL net product sales were $137.0 million and $130.1 million for the second quarters of 2022 and 2021 and $47.3 million and $45.8 million for the months of June 2022 and 2021, respectively. EXPAREL average daily sales were 105 percent of the prior year for the second quarter and 103 percent of the prior year for the month of June, respectively. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. For the second quarter, EXPAREL selling days were 64 in both 2022 and 2021. For the month of June, EXPAREL selling days were 22 in 2022 and 2021. Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $1.0 million and $1.0 million in the second quarters of 2022 and 2021, respectively.
ZILRETTA net product sales were $27.4 million for the second quarter of 2022 and $9.8 million for the month of June 2022. ZILRETTA sales in the second quarter of 2021 occurred prior to the completion of the company’s acquisition of Flexion in November 2021.
iovera° net product sales were $3.2 million and $3.8 million for the second quarters of 2022 and 2021 and $1.1 million and $1.4 million for the months of June 2022 and 2021, respectively.
Second quarter 2022 royalty revenue was $0.8 million, compared with $0.6 million in 2021.
Since early 2020, the company’s revenues have been impacted by COVID-19 and pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives. While the degree of impact has diminished during the course of the pandemic due to the introduction of vaccines and the lessening of elective surgery restrictions, certain pandemic-related operational challenges persist. It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise.
The company is not providing 2022 revenue or gross margin guidance at this time given the continued uncertainty around labor shortages, COVID-19, and the pace of recovery for the elective surgery market. To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales for EXPAREL, ZILRETTA, and iovera° until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. Pacira completed its acquisition of Flexion Therapeutics on November 19, 2021, which added ZILRETTA (triamcinolone acetonide extended-release injectable suspension) to its commercial offering.
The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the second quarter or full year 2022.