On August 3, 2022 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported financial results for the second quarter of 2022 (Press release, Pacira Pharmaceuticals, AUG 3, 2022, View Source;991.htm [SID1234617386]).

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Second Quarter 2022 Financial Highlights

Total revenues of $169.4 million
Net product sales of $137.0 million for EXPAREL, $27.4 million for ZILRETTA, and $3.2 million for iovera°
Net income of $19.9 million, or $0.44 per share (basic) and $0.40 per share (diluted)
Adjusted EBITDA of $44.9 million
"We achieved record revenue for the second quarter, which was marked by strength across the entire portfolio amid ongoing market headwinds. We continue to invest in our training facilities and marketing programs to help facilitate growth throughout the balance of the year and beyond," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "The second quarter also marked our 21st consecutive quarter of positive adjusted EBITDA, which underscores our consistency and reliability as stewards for our stakeholders. We continue to execute our strategy, confident that the ongoing transition of surgeries to the outpatient setting and other market dynamics will support our growth as we work to create lasting value."

Recent Business Highlights

Completion of Patient Enrollment in Two Phase 3 Registration Studies of EXPAREL as a Lower Extremity Nerve Block. Today the company is announcing the completion of patient enrollment in its two Phase 3 studies of EXPAREL as a nerve block in lower extremity surgeries. The first study is evaluating EXPAREL as an adductor canal block for total knee arthroplasty and the second is evaluating EXPAREL as a popliteal sciatic nerve block for bunionectomy. The company believes positive results from these studies will form the basis for a Supplemental New Drug Application submission seeking label expansion to include lower extremity nerve blocks.
New EXPAREL Patent and Notice of Allowance. In June 2022, the U.S. Patent and Trademark Office (USPTO) issued Patent Number 11,357,727. This patent is a product by process patent, with an expiration date of January 22, 2041. This patent is now listed in the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalents Evaluations (Orange Book). In July, the company received a Notice of Allowance from the USPTO for a U.S. Patent Application claiming chemical composition of EXPAREL. After issuance, Pacira will submit this patent for listing in the Orange Book.
Second Quarter 2022 Financial Results

Total revenues were $169.4 million in the second quarter of 2022, versus the $135.6 million reported for the second quarter of 2021.
EXPAREL net product sales were $137.0 million in the second quarter of 2022, versus the $130.1 million reported for the second quarter of 2021.
ZILRETTA net product sales were $27.4 million in the second quarter of 2022. The company began recognizing ZILRETTA sales upon completing its acquisition of Flexion Therapeutics, Inc. in November 2021.
Second quarter 2022 iovera° net product sales were $3.2 million, versus the $3.8 million reported for the second quarter of 2021.
Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $1.0 million in the second quarter of 2022, versus the $1.0 million reported for the second quarter of 2021.
Second quarter 2022 royalty and collaborative licensing and milestone revenues were $0.8 million, versus the $0.7 million reported for the second quarter of 2021.
Total operating expenses were $138.2 million in the second quarter of 2022, versus the $100.7 million reported for the second quarter of 2021.
Research and development (R&D) expenses were $26.3 million in the second quarter of 2022, compared to $12.6 million in the second quarter of 2021. R&D expenses included $5.1 million and $4.6 million of product development and manufacturing capacity expansion costs in the second quarters of 2022 and 2021, respectively.
Selling, general and administrative (SG&A) expenses were $65.0 million in the second quarter of 2022, compared to $50.8 million in the second quarter of 2021.
GAAP net income was $19.9 million, or $0.44 per share (basic) and $0.40 per share (diluted), in the second quarter of 2022, compared to $19.1 million, or $0.43 per share (basic) and $0.42 per share (diluted), in the second quarter of 2021.
Non-GAAP net income was $24.0 million, or $0.53 per share (basic) and $0.51 per share (diluted), in the second quarter of 2022, compared to $35.3 million, or $0.80 per share (basic) and $0.77 per share (diluted), in the second quarter of 2021.
Adjusted EBITDA was $44.9 million in the second quarter of 2022, compared to $50.3 million in the second quarter of 2021.
Pacira ended the second quarter of 2022 with cash, cash equivalents and short-term available-for-sale investments ("cash") of $316.4 million. Cash provided by operations was $29.8 million in the second quarter of 2022, compared to $30.1 million in the second quarter of 2021.
Pacira had 45.5 million basic and 52.5 million diluted weighted average shares of common stock outstanding in the second quarter of 2022.
See "Non-GAAP Financial Information" below.

Financial Guidance

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. Given the continued uncertainty around labor shortages, COVID-19 and the pace of recovery for the elective surgery market, the company is currently not providing revenue or gross margin guidance. To provide greater transparency, Pacira 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. Pacira is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com

Today the company is reiterating its full-year 2022 operating expense guidance as follows:

Non-GAAP R&D expense of $75 million to $85 million; and
Non-GAAP SG&A expense of $220 million to $230 million.
The company is adjusting its full-year 2022 guidance for stock-based compensation to $47 million to $50 million.

See "Non-GAAP Financial Information" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Wednesday, August 3, 2022, at 8:30 a.m. ET. To participate in the conference call, dial 1-800-715-9871 and provide the passcode 9287305. International callers may dial 1-646-307-1963 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-800-770-2030 (domestic) or 1-609-800-9909 (international) using the passcode 9287305. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP net income per common share, non-GAAP weighted average common shares outstanding-diluted, non-GAAP cost of goods sold, non-GAAP research and development (R&D) expense, non-GAAP selling, general and administrative (SG&A) expense, and adjusted EBITDA (as defined below), because these non-GAAP financial measures exclude the impact of items that management believes affect comparability or underlying business trends.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, R&D expense and SG&A expense outlook for 2022 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of the Company’s financial statements by providing greater transparency into the operating performance of Pacira and its future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures.