Pacira Pharmaceuticals, Inc. Reports 2015 Financial Results
-- 2015 Total Net Revenues Up 26 Percent Over 2014 --
-- 2015 EXPAREL® Net Revenues Up 27 Percent Over 2014 --
-- Per-Protocol Analysis of Oral Surgery Data Demonstrates Statistical Significance; Supports Launch Activities in Late Third Quarter 2016 --
-- Conference Call Today at
“We finished 2015 with a solid performance in spite of the challenges we faced this past year,” said
Recent Developments
- 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 2011FDA 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 inthe United States who 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.
2016 Outlook
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 .
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,
A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 93538831. The replay of the call will be available for two weeks from the date of the live call.
The live, listen-only webcast of the conference call can also be accessed by visiting the “Investors & Media” section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for 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 (loss), because such measures exclude stock-based compensation expense, loss on early extinguishment of debt and amortization of debt discount. These measures supplement our financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future R&D and SG&A expenditure outlook for 2016 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 at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP net income (loss) measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See a reconciliation of non-GAAP net income (loss) to GAAP net income (loss) below.
About Pacira
About EXPAREL®
EXPAREL (bupivacaine liposome injectable suspension) is currently indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain score with up to a 45 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.
Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence greater-than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting.
Please see the full Prescribing Information for more details available at http://www.exparel.com/pdf/EXPAREL_Prescribing_Information.pdf.
Forward Looking Statements
Any statements in this press release about our future expectations, plans, outlook and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the related timing and success of
(Tables to Follow)
| Pacira Pharmaceuticals, Inc. | ||||||||
| Condensed Consolidated Balance Sheets | ||||||||
| (unaudited) | ||||||||
| (in thousands) | ||||||||
| December 31, | December 31, | |||||||
| 2015 | 2014 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents, restricted cash and short-term investments | $ | 158,965 | $ | 158,167 | ||||
| Accounts receivable, net | 25,855 | 22,366 | ||||||
| Inventories, net | 61,645 | 29,263 | ||||||
| Prepaid expenses and other current assets | 6,117 | 4,461 | ||||||
| Total current assets | 252,582 | 214,257 | ||||||
| Long-term investments | 13,462 | 24,431 | ||||||
| Fixed assets, net | 90,324 | 60,632 | ||||||
| Goodwill | 30,880 | 23,761 | ||||||
| Intangibles, net | 81 | 403 | ||||||
| Other assets | 2,294 | 2,588 | ||||||
| Total assets | $ | 389,623 | $ | 326,072 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 8,739 | $ | 6,758 | ||||
| Accrued expenses | 35,375 | 28,311 | ||||||
| Convertible senior notes (*) | 105,928 | 103,100 | ||||||
| Current portion of royalty interest obligation | - | 276 | ||||||
| Current portion of deferred revenue | 1,426 | 1,426 | ||||||
| Income taxes payable | 208 | 139 | ||||||
| Total current liabilities | 151,676 | 140,010 | ||||||
| Deferred revenue | 8,082 | 9,508 | ||||||
| Other liabilities | 11,473 | 5,409 | ||||||
| Total stockholders’ equity | 218,392 | 171,145 | ||||||
| Total liabilities and stockholders’ equity | $ | 389,623 | $ | 326,072 | ||||
| (*) The convertible senior notes are contractually due in 2019. However, because of certain conditions that were met during the three months ended December 31, 2015, the note holders can convert any time during the quarter ended March 31, 2016. | ||||||||
| Pacira Pharmaceuticals, Inc. | ||||||||||||||||
| Consolidated Statements of Operations | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| (in thousands, except per share amounts) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| Revenues: | ||||||||||||||||
| EXPAREL | $ | 67,194 | $ | 58,993 | $ | 239,851 | $ | 188,528 | ||||||||
| DepoCyt(e) | 995 | 1,837 | 4,636 | 4,998 | ||||||||||||
| Total net product sales | 68,189 | 60,830 | 244,487 | 193,526 | ||||||||||||
| Collaborative licensing and milestone revenue | 357 | 356 | 1,426 | 1,287 | ||||||||||||
| Royalty revenue | 774 | 607 | 3,084 | 2,855 | ||||||||||||
| Total revenues | 69,320 | 61,793 | 248,997 | 197,668 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of goods sold | 19,427 | 18,968 | 71,837 | 77,440 | ||||||||||||
| Research and development | 13,153 | 3,886 | 28,662 | 18,731 | ||||||||||||
| Selling, general and administrative | 37,553 | 31,019 | 139,043 | 106,662 | ||||||||||||
| Total operating expenses | 70,133 | 53,873 | 239,542 | 202,833 | ||||||||||||
| Income (loss) from operations | (813 | ) | 7,920 | 9,455 | (5,165 | ) | ||||||||||
| Other (expense) income: | ||||||||||||||||
| Interest income | 175 | 145 | 678 | 382 | ||||||||||||
| Interest expense | (1,884 | ) | (2,055 | ) | (7,725 | ) | (8,278 | ) | ||||||||
| Loss on early extinguishment of debt | (1 | ) | - | (52 | ) | - | ||||||||||
| Royalty interest obligation | - | 6 | (71 | ) | (323 | ) | ||||||||||
| Other, net | (83 | ) | (41 | ) | (165 | ) | (159 | ) | ||||||||
| Total other expense, net | (1,793 | ) | (1,945 | ) | (7,335 | ) | (8,378 | ) | ||||||||
| Income (loss) before income taxes | (2,606 | ) | 5,975 | 2,120 | (13,543 | ) | ||||||||||
| Income tax (expense) benefit | 108 | (173 | ) | (264 | ) | (173 | ) | |||||||||
| Net income (loss) | $ | (2,498 | ) | $ | 5,802 | $ | 1,856 | $ | (13,716 | ) | ||||||
| Net income (loss) per share: | ||||||||||||||||
| Basic net income (loss) per common share | $ | (0.07 | ) | $ | 0.16 | $ | 0.05 | $ | (0.39 | ) | ||||||
| Diluted net income (loss) per common share | $ | (0.07 | ) | $ | 0.14 | $ | 0.04 | $ | (0.39 | ) | ||||||
| Weighted average common shares outstanding: | ||||||||||||||||
| Basic | 36,783 | 36,079 | 36,540 | 35,299 | ||||||||||||
| Diluted | 36,783 | 41,571 | 41,301 | 35,299 | ||||||||||||
| Pacira Pharmaceuticals, Inc. | ||||||||||||||||
| Reconciliation of GAAP to Non-GAAP Financial Information | ||||||||||||||||
| (unaudited) | ||||||||||||||||
| (in thousands, except per share amounts) | ||||||||||||||||
| Three Months Ended | Year Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| GAAP net income (loss) | $ | (2,498 | ) | $ | 5,802 | $ | 1,856 | $ | (13,716 | ) | ||||||
| Non-GAAP adjustments: | ||||||||||||||||
| Stock-based compensation expense | 9,728 | 7,623 | 33,368 | 24,822 | ||||||||||||
| Loss on early extinguishment of debt | 1 | - | 52 | - | ||||||||||||
| Non-cash debt discount amortization | 1,022 | 1,035 | 4,102 | 4,139 | ||||||||||||
| Total Non-GAAP adjustments | 10,751 | 8,658 | 37,522 | 28,961 | ||||||||||||
| Non-GAAP net income | $ | 8,253 | $ | 14,460 | $ | 39,378 | $ | 15,245 | ||||||||
| GAAP basic net income (loss) per common share | $ | (0.07 | ) | $ | 0.16 | $ | 0.05 | $ | (0.39 | ) | ||||||
| GAAP diluted net income (loss) per common share | $ | (0.07 | ) | $ | 0.14 | $ | 0.04 | $ | (0.39 | ) | ||||||
| Non-GAAP basic net income per common share | $ | 0.22 | $ | 0.40 | $ | 1.08 | $ | 0.43 | ||||||||
| Non-GAAP diluted net income per common share | $ | 0.20 | $ | 0.35 | $ | 0.95 | $ | 0.37 | ||||||||
| Weighted average common shares outstanding - basic | 36,783 | 36,079 | 36,540 | 35,299 | ||||||||||||
| Weighted average common shares outstanding - diluted | 40,937 | 41,571 | 41,301 | 40,676 | ||||||||||||
| Cost of goods sold reconciliation: | ||||||||||||||||
| GAAP cost of goods sold | $ | 19,427 | $ | 18,968 | $ | 71,837 | $ | 77,440 | ||||||||
| Stock-based compensation expense | (1,633 | ) | (1,260 | ) | (6,012 | ) | (3,582 | ) | ||||||||
| Non-GAAP cost of goods sold | $ | 17,794 | $ | 17,708 | $ | 65,825 | $ | 73,858 | ||||||||
| Research and development reconciliation: | ||||||||||||||||
| GAAP research and development | $ | 13,153 | $ | 3,886 | $ | 28,662 | $ | 18,731 | ||||||||
| Stock-based compensation expense | (1,994 | ) | (953 | ) | (5,134 | ) | (6,490 | ) | ||||||||
| Non-GAAP research and development | $ | 11,159 | $ | 2,933 | $ | 23,528 | $ | 12,241 | ||||||||
| Selling, general and administrative reconciliation: | ||||||||||||||||
| GAAP selling, general and administrative | $ | 37,553 | $ | 31,019 | $ | 139,043 | $ | 106,662 | ||||||||
| Stock-based compensation expense | (6,101 | ) | (5,410 | ) | (22,222 | ) | (14,750 | ) | ||||||||
| Non-GAAP selling, general and administrative | $ | 31,452 | $ | 25,609 | $ | 116,821 | $ | 91,912 | ||||||||
Company Contact:Pacira Pharmaceuticals, Inc. Jessica Cho , (973) 254-3574 Jessica.Cho@pacira.com Media Contact: Coyne Public RelationsErin Drelick , (973) 588-2162 edrelick@coynepr.com