On May 4, 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 first quarter of 2022 (Press release, Pacira Pharmaceuticals, MAY 4, 2022, View Source;991.htm [SID1234613538]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
First Quarter 2022 Financial Highlights
•Total revenues of $158.0 million
•Net product sales of $129.2 million for EXPAREL, $23.6 million for ZILRETTA, and $3.0 million for iovera°
•Net income of $6.8 million, or $0.15 per share (basic and diluted)
•Adjusted EBITDA of $53.8 million, or $1.20 per share (basic) and $1.16 per share (diluted)
"We were delighted to end the first quarter of 2022 with record high EXPAREL sales for the month of March, which underscores the significant progress we continue to make despite operational headwinds in the elective surgery market due to COVID and labor-related disruptions," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "The successful integration of the Flexion acquisition was evidenced by strong ZILRETTA sales in the first quarter, which we expect to be an important near- and long-term contributor to earnings."
"We look forward to completing our two Phase 3 studies of EXPAREL for lower extremity nerve block and to launching new high-potential registration programs evaluating EXPAREL as a stellate ganglion block for cardiac dysrhythmia. Additionally, as the market moves rapidly toward ultrasound-guided iovera° blocks delivered by pain management specialists, we plan to use our IGOR registry to publish real-world evidence to better support our commercial initiatives," continued Mr. Stack.
Recent Business Highlights
•Daryl Gaugler Appointed Chief Operating Officer. Today the company is announcing the appointment of Daryl Gaugler to the position of Chief Operating Officer effective May 4, 2022. Mr. Gaugler has served as the company’s Senior Vice President of Commercial Operations since June 2019. Mr. Gaugler is a seasoned life sciences executive with 30 years
of experience in commercial leadership that includes building and directing over 400 commercial teams and designing go-to-market strategies for more than 20 companies. Prior to Pacira, Mr. Gaugler spent over 20 years with the Quintiles Transnational organization (now IQVIA). In his most recent role at Quintiles, President of North America Commercial Solutions, Mr. Gaugler delivered significant revenue and profit growth while leading customer satisfaction and employee engagement within the organization.
•New EXPAREL Patents. In March and April 2022, the U.S. Patent and Trademark Office (U.S. PTO) issued Patent Numbers 11,278,494, 11,304,904 and 11,311,486. The ‘494 and ‘486 patents cover composition of EXPAREL while the ‘904 is a product by process patent, each having an expiration date of January 22, 2041. All three patents are now listed in the U.S. Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalents Evaluations (Orange-Book).
•Second Innovation and Training Facility. The company recently launched development plans for its second training facility in Houston, Texas. This 19,000 square-feet state-of-the-art facility will feature an adaptive lecture hall, broadcast studio, and lab space for cadaver and other interactive workshops. Together with the company’s Tampa facility, this second training center will play a core role in developing physician champions and community-based clinicians who want to stay on the forefront of opioid-sparing pain management. The company expects to open the Houston facility before the end of 2022 to host programs for EXPAREL, ZILRETTA and iovera°.
First Quarter 2022 Financial Results
•Total revenues were $158.0 million in the first quarter of 2022, versus the $119.0 million reported for the first quarter of 2021.
•EXPAREL net product sales were $129.2 million in the first quarter of 2022, versus the $114.7 million reported for the first quarter of 2021.
•ZILRETTA net product sales were $23.6 million in the first quarter of 2022. The company began recognizing ZILRETTA sales upon completing its acquisition of Flexion Therapeutics, Inc. in November 2021.
•First quarter 2022 iovera° net product sales were $3.0 million, versus the $3.3 million reported for the first quarter of 2021.
•Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $1.6 million in the first quarter of 2022, versus the $0.8 million reported for the first quarter of 2021.
•First quarter 2022 royalty and collaborative licensing and milestone revenues were $0.6 million, versus the $0.3 million reported for the first quarter of 2021.
•Total operating expenses were $140.6 million in the first quarter of 2022, versus the $99.6 million reported for the first quarter of 2021.
•Research and development (R&D) expenses were $21.6 million in the first quarter of 2022, compared to $15.9 million in the first quarter of 2021. R&D expenses included $5.0 million
and $4.7 million of product development and manufacturing capacity expansion costs in the first quarters of 2022 and 2021, respectively.
•Selling, general and administrative (SG&A) expenses were $64.3 million in the first quarter of 2022, compared to $48.5 million in the first quarter of 2021.
•GAAP net income was $6.8 million, or $0.15 per share (basic and diluted), in the first quarter of 2022, compared to $10.4 million, or $0.24 per share (basic) and $0.23 per share (diluted), in the first quarter of 2021.
•Non-GAAP net income was $29.9 million, or $0.67 per share (basic) and $0.64 per share (diluted), in the first quarter of 2022, compared to $24.5 million, or $0.56 per share (basic) and $0.53 per share (diluted), in the first quarter of 2021.
•Adjusted EBITDA was $53.8 million, or $1.20 per share (basic) and $1.16 per share (diluted) in the first quarter of 2022, compared to $36.2 million, or $0.83 per share (basic) and $0.79 per share (diluted) in the first quarter of 2021.
•Pacira ended the first quarter of 2022 with cash, cash equivalents and short-term available-for-sale investments ("cash") of $452.2 million. Cash provided by operations was $30.8 million in the first quarter of 2022, compared to $12.1 million in the first quarter of 2021.
•Pacira had 44.9 million basic and 46.4 million diluted weighted average shares of common stock outstanding in the first quarter of 2022.
See "Non-GAAP Financial Information" below.
Financial Guidance
The company’s product sales continue to be impacted by COVID-19, which has caused significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Given the continued uncertainty around 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 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. Pacira is currently not reporting preliminary monthly ZILRETTA net product sales as the required adjustments for certain product rebate programs are calculated after the end of the quarter.
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;
•Non-GAAP SG&A expense of $220 million to $230 million; and
•Stock-based compensation of $40 million to $45 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, May 4, 2022, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 4063578. International callers may dial 1-720-545-0035 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 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 4063578. 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 cost of goods sold, non-GAAP research and development (R&D) expense, non-GAAP selling, general and administrative (SG&A) expense, adjusted EBITDA (as defined below) and adjusted EBITDA per share, 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 our 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.