Pacira Pharmaceuticals Inc (NASDAQ:PCRX) provided updates on EXPAREL® (bupivacaine liposome injectable suspension) for postsurgical pain in the United States and announced consolidated financial results for the fourth quarter and full year ended December 31, 2015. In addition, the Company announced the results of the oral surgery study in third molar, or “wisdom teeth,” procedures, with a per-protocol (PP) analysis demonstrating statistical significance, and an intention-to-treat (ITT) analysis strongly trending towards significance in spite of the underpowered study size resulting from one of three clinical sites being eliminated for protocol violations.
“We finished 2015 with a solid performance in spite of the challenges we faced this past year,” said Dave Stack, chief executive officer and chairman of Pacira. “In 2016, we look forward to refocusing our efforts on developing and supporting the untapped market opportunities for EXPAREL and DepoFoam®, starting with the official oral surgery launch, advancement of robust clinical programs in nerve block and orthopedic procedures as well as patient and healthcare provider outreach.”
- FDA Resolution Enables Renewed Focus on Providing Alternatives to Opioids and Improving Patient Care: In December, Pacira announced that it had achieved an amicable resolution in its lawsuit against the U.S. Food and Drug Administration(FDA). The key features of the resolution include the formal rescission of the FDA’sSeptember 2014 Warning Letter, approval of a labeling supplement that reaffirms and clarifies the broad scope of the 2011 FDA approved indication for EXPAREL and acknowledgement that procedures involving infiltration in oral surgery or into the transversus abdominis plane (TAP block) are covered by the approved label.
- Oral Surgery Data to Support Official Launch: We anticipate a late third quarter 2016 launch for oral surgery, an on-label indication. The launch timing is targeted around the annual meeting of the American Association of Oral and Maxillofacial Surgeons (AAOMS) in September, our introduction into the marketplace of a 10 mL vial in a 4-pack configuration and positive findings from our study in third molar procedures.
In the third molar study, one of the three study sites was excluded from our analyses due to protocol violations, resulting in an underpowered study size. An extensive PP analysis of the study demonstrated statistical significance of the primary endpoint (P=0.0007), the area under the curve (AUC) of the NRS pain intensity scores through 48 hours. An ITT analysis indicated a strong trend (P=0.06) in favor of the primary endpoint, a trend that would have been statistically significant with proper study powering.
- Collaborative Educational Efforts Raise Awareness and Empower Patients on Pain Control Choices: In November 2015, Pacira, along with HealthyWomen, a leading health information resource for women, and Dr. Kristi Funk, renowned breast cancer surgeon and women’s health advocate, collaborated to launch the “Postsurgical Pain Control: Voice Your Choice” campaign to raise awareness of pain control choices and to encourage women to discuss treatment plans with their physician before surgery. The survey of more than 700 women in the United Stateswho had undergone surgery found that while over 90 percent of respondents were aware of the risk of addiction to opioids and would prefer not to use them to manage pain after their procedure, 80 percent still did.
Fourth Quarter 2015 Financial Results
- EXPAREL net product revenues were $67.2 million in the fourth quarter of 2015, compared to $59.0 million in the fourth quarter of 2014.
- Total revenues were $69.3 million in the fourth quarter of 2015, compared to $61.8 million in the fourth quarter of 2014.
- Total operating expenses were $70.1 million in the fourth quarter of 2015, compared to $53.9 million in the fourth quarter of 2014.
- GAAP net loss was ($2.5) million, or ($0.07) per share (basic and diluted), in the fourth quarter of 2015, compared to GAAP net income of $5.8 million, or $0.16 per share (basic) and $0.14 per share (diluted), in the fourth quarter of 2014.
- Non-GAAP net income was $8.3 million, or $0.22 per share (basic) and $0.20 per share (diluted), in the fourth quarter of 2015, compared to non-GAAP net income of$14.5 million, or $0.40 per share (basic) and $0.35 per share (diluted), in the fourth quarter of 2014.
- Pacira had 36.8 million basic and 40.9 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2015.
Full Year 2015 Financial Results
- EXPAREL revenues were $239.9 million, compared to $188.5 million in 2014.
- Total revenues were $249.0 million, compared to $197.7 million in 2014.
- Total operating expenses were $239.5 million, compared to $202.8 million in 2014.
- GAAP net income was $1.9 million, or $0.05 per share (basic) and $0.04 per share (diluted), compared to a GAAP net loss of ($13.7) million, or ($0.39) per share (basic and diluted), in 2014.
- Non-GAAP net income was $39.4 million, or $1.08 per share (basic) and $0.95 per share (diluted), compared to non-GAAP net income of $15.2 million, or $0.43 per share (basic) and $0.37 per share (diluted), in 2014.
- Pacira ended 2015 with cash and cash equivalents, short-term investments and long-term investments (“cash”) of $172.4 million.
- Pacira had approximately 36.5 million basic and 41.3 million diluted weighted average shares of common stock outstanding for the full 2015 fiscal year.
Pacira expects the following operating expenses for 2016:
- Non-GAAP research and development (R&D) expense of $60 million to $70 million.
- Non-GAAP selling, general and administrative (SG&A) expense of $125 million to $135 million.
- Stock-based compensation expense of $35 million to $40 million. (Original Source)
Shares of Pacira closed yesterday at $59.61. PCRX has a 1-year high of $121.95 and a 1-year low of $35.78. The stock’s 50-day moving average is $62.89 and its 200-day moving average is $59.00.
On the ratings front, Pacira has been the subject of a number of recent research reports. In a report issued on January 29, Merrill Lynch analyst Steve Byrne upgraded PCRX to Buy, with a price target of $75, which implies an upside of 25.8% from current levels. Separately, on January 27, Piper Jaffray’s David Amsellem reiterated a Buy rating on the stock and has a price target of $93.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Steve Byrne and David Amsellem have a total average return of -0.6% and -4.6% respectively. Byrne has a success rate of 42.3% and is ranked #2240 out of 3666 analysts, while Amsellem has a success rate of 39.0% and is ranked #3104.
The street is mostly Bullish on PCRX stock. Out of 7 analysts who cover the stock, 6 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $99.33, which represents a potential upside of 66.6% from where the stock is currently trading.
Pacira Pharmaceuticals Inc is a specialty pharmaceutical company. The Company is engaged in the development, commercialization and manufacture of proprietary pharmaceutical products for use in hospitals and ambulatory surgery centers.