On March 1, 2017 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported financial results for 2016 and its outlook for 2017. The company is also announcing positive topline results for its Phase 4 study of EXPAREL in total knee arthroplasty, or TKA (Press release, Pacira Pharmaceuticals, MAR 1, 2017, View Source;p=RssLanding&cat=news&id=2250542 [SID1234517950]).
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"We made important progress in 2016 advancing our three-part EXPAREL growth strategy and setting the stage for continued success," said Dave Stack, chief executive officer and chairman of Pacira. "We have multiple, major milestones on track for 2017, including the positive topline results reported today from our Phase 4 study in TKA. Our collaboration with DePuy Synthes is off to a strong start and will allow us to maximize these important data and broaden the use of EXPAREL as an opioid-sparing solution for prolonged postsurgical pain relief."
Recent Highlights
Positive topline results for Phase 4 TKA study. Pacira reported that its Phase 4 study of EXPAREL in patients undergoing TKA has met its co-primary endpoints for postsurgical pain and opioid reduction. The study was a multicenter, randomized, double-blind, controlled, parallel group study comparing EXPAREL based local analgesia infiltration to standard bupivacaine based local analgesia infiltration each as part of a standard multimodal analgesic protocol. The co-primary efficacy endpoints were the area under the curve (AUC) of visual analog scale (VAS) pain intensity scores from 12 to 48 hours after surgery and total opioid consumption from zero to 48 hours after surgery. The EXPAREL group achieved a statistically significant reduction in AUC VAS scores compared to the group who did not receive EXPAREL (p=0.0381). In addition, patients who received EXPAREL consumed significantly fewer opioids than patients who did not receive EXPAREL during the 48 hours that followed surgery (p=0.0048). The company plans to report the statistical results for key secondary endpoints from this study in the coming weeks. Full results will be submitted for publication in a peer-reviewed medical journal.
Partnership with DePuy Synthes to maximize EXPAREL opportunity. In January 2017, the company announced a co-promotion agreement with DePuy Synthes to market and promote the use of EXPAREL for orthopedic procedures in the US market. The DePuy Synthes field representatives, specializing in joint reconstruction, spine, sports medicine and trauma, will expand the reach and frequency of EXPAREL education in hospital surgical suites and ambulatory surgery centers. DePuy Synthes will also include EXPAREL in the Orthopedic Episode of Care Approach, a comprehensive offering for health systems and surgeons. In addition to supporting DePuy Synthes, Pacira will focus on soft tissue surgeons in key specialties, as well as anesthesiologists. Pacira will continue to act as the overall EXPAREL account manager.
Additional EXPAREL patent to issue that will extend protection until December 2021. The company has received an issue notification from the United States Patent and Trademark Office (USPTO) regarding its patent application 11/678,615, which is entitled "Production of Multivesicular Liposomes." The USPTO projects that the application will issue with the patent number 9,585,838 on March 7, 2017. The patent includes a patent term adjustment and will expire on December 24, 2021. Once listed, this will be the company’s third patent listed in the Orange Book for EXPAREL.
Fourth Quarter 2016 Financial Results
EXPAREL net product sales were $71.4 million in the fourth quarter of 2016, a 6% increase over the $67.2 million reported for the fourth quarter of 2015.
Total revenues were $72.9 million in the fourth quarter of 2016, a 5% increase over the $69.3 million reported for the fourth quarter of 2015.
Total operating expenses were $75.4 million in the fourth quarter of 2016, compared to $70.1 million in the fourth quarter of 2015.
GAAP net loss was $4.0 million, or $0.11 per share (basic and diluted), in the fourth quarter of 2016, compared to a GAAP net loss of $2.5 million, or $0.07 per share (basic and diluted), in the fourth quarter of 2015.
Non-GAAP net income was $3.6 million, or $0.10 per share (basic) and $0.09 per share (diluted), in the fourth quarter of 2016, compared to non-GAAP net income of $8.3 million, or $0.22 per share (basic) and $0.20 per share (diluted), in the fourth quarter of 2015.
Pacira had 37.4 million basic weighted average shares of common stock outstanding in the fourth quarter of 2016.
For non-GAAP measures, Pacira had 39.7 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2016.
Full-Year 2016 Financial Results
EXPAREL net product sales were $265.8 million in 2016, an 11% increase over the $239.9 million in 2015.
Total revenues were $276.4 million in 2016, an 11% increase over the $249.0 million in 2015.
Total operating expenses were $308.4 million in 2016, compared to $239.5 million in 2015.
GAAP net loss was $37.9 million, or $1.02 per share (basic and diluted), in 2016, compared to GAAP net income of $1.9 million, or $0.05 per share (basic) and $0.04 (diluted), in 2015.
Non-GAAP net income was $25.2 million, or $0.68 per share (basic) and $0.62 per share (diluted), in 2016, compared to non-GAAP net income of $39.4 million, or $1.08 per share (basic) and $0.95 per share (diluted), in 2015.
Pacira ended 2016 with cash, cash equivalents and short-term investments ("cash") of $172.6 million.
Pacira had 37.2 million basic weighted average shares of common stock outstanding in 2016.
For non-GAAP measures, Pacira had 40.5 million diluted weighted average shares of common stock outstanding in 2016.
2017 Outlook
Pacira announces its full year 2017 financial guidance as follows. Pacira expects:
EXPAREL net product sales of $290 million to $310 million.
Non-GAAP gross margins of approximately 70%.
Non-GAAP research and development (R&D) expense of $50 million to $60 million.
Non-GAAP selling, general and administrative (SG&A) expense of $145 million to $155 million.
Stock-based compensation of $30 million to $35 million.
See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2017 Financial Guidance" below.