PARSIPPANY, N.J., March 31, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX), an emerging specialty pharmaceutical company, today announced financial results for the fourth quarter and full-year ended December 31, 2010, provided an update on the execution of its pre-commercial and launch strategies for EXPAREL™ and established 2011 financial guidance.
"Since our initial public offering in February, we have continued to make significant progress in educating healthcare professionals and other decision makers on the advantages of EXPAREL, including multiple recent data presentations at medical meetings and the formation of several clinical advisory boards led by key opinion leaders," said David Stack, president and chief executive officer of Pacira Pharmaceuticals, Inc. "We have received encouraging feedback from these health care providers regarding the need for a safe, long-acting, easy to use analgesic to manage postsurgical pain. As we continue to advance our pre-launch strategy, we are planning to conduct a number of health outcomes studies focused on the potential for EXPAREL to control pain with reduced reliance on opioid (morphine) analgesics. The health outcomes program is designed in collaboration with our acute health care customers in order to define postsurgical patient and procedure needs where reduced opioid (morphine) consumption provides the opportunity for enhanced patient care and hospital economics."
At December 31, 2010 there were approximately 575,000 shares of common stock outstanding. As of March 31, 2011, reflecting the issuance of shares of common stock in the IPO, and the conversion of outstanding preferred stock and promissory notes, approximately 17.2 million shares of common stock were outstanding.
Full Year 2011 Financial GuidancePacira currently expects to achieve the following financial results for the full-year ending December 31, 2011:
If granted a broad postsurgical pain label by the FDA, Pacira would be positioned to address a U.S. market opportunity of approximately 25 million infiltration and elastomeric bag procedures per year. Based upon the current PDUFA date and potential FDA approval timeline, Pacira plans to commercialize EXPAREL in the U.S. in the fourth quarter of 2011. Beyond infiltration, the company expects to develop EXPAREL for use in nerve block and epidural administration procedures, which collectively represent an additional 14 million annual opportunities per year. Pacira believes there are multiple product opportunities for EXPAREL in the future as well as significant potential for its DepoFoam® technology platform, which supports an additional pipeline of development assets and partnering opportunities.
Upcoming ActivitiesPacira expects to present at the following investor conferences:
Pacira expects to have a presence at the following medical meetings:
Today's Conference Call and Webcast ReminderThe Pacira management team will host a conference call discussing the company's fourth quarter financial results, recent developments and 2011 financial guidance today at 9:00 a.m. (ET). The call can be accessed by dialing 1-866-831-6270 (domestic) or 1-617-213-8858 (international) five minutes prior to the start of the call and providing the passcode 94842804. A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international), providing the passcode 43508327. 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 be accessed by visiting the investors section of the Pacira's website at www.pacira.com. A replay of the webcast will be archived on the company's website for two weeks following the call.
About PaciraPacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the development, manufacture, and commercialization of novel pharmaceutical products, based on its proprietary DepoFoam drug delivery technology, for use in hospitals and ambulatory surgery centers. In December 2010, Pacira announced that its New Drug Application (NDA) for EXPAREL, the company's most advanced investigational product candidate, had been accepted for filing by the U.S. Food and Drug Administration (FDA). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of July 28, 2011 for the review of the EXPAREL NDA. EXPAREL is a bupivacaine-based product and has completed extensive Phase 3 clinical development for postoperative analgesia by infiltration. EXPAREL consists of bupivacaine encapsulated in DepoFoam, which is designed to address the limitations of widely used medications by enhancing their dosing and/or administration profile. Additional information about Pacira is available at www.pacira.com.
About EXPAREL™EXPAREL is Pacira's proprietary drug candidate consisting of bupivacaine encapsulated in DepoFoam®, both of which are currently used separately in FDA-approved products. Bupivacaine is a well-characterized anesthetic/analgesic that has an established safety profile with more than 20 years of use in the United States. Several Phase 2 and Phase 3 clinical trials have been completed for EXPAREL and demonstrate statistically significant reduction of pain in soft tissue and orthopedic surgery in different surgical models. Clinical data from phase 3 trial 316 demonstrates that EXPAREL provides analgesia for up to 72 hours post-surgery, the primary endpoint for the trial. The package insert for bupivacaine indicates it provides anesthesia for up to 7 hours. The safety of EXPAREL was evaluated in 10 randomized, double-blind, local administration into the surgical wound clinical studies involving 823 patients; the most common adverse events following EXPAREL administration were nausea, constipation, and vomiting.
Safe HarborThis press release contains forward-looking statements of Pacira Pharmaceuticals that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," "contemplate," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the company's plans to develop and commercialize EXPAREL; the Company's plans to continue to manufacture and provide support services for its commercial partners who have licensed DepoCyt(e) and DepoDur; the timing of, and the Company's ability to obtain, regulatory approval of EXPAREL; the timing of the Company's anticipated commercial launch of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the Company's ability to serve those markets; the Company's plans to expand the indications of EXPAREL to include nerve block and epidural administration; ands our commercialization and marketing capabilities Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements; and those risks discussed in "Risk Factors" and elsewhere in Pacira Pharmaceuticals' final prospectus dated February 2, 2011 and in its other filings with the Securities and Exchange Commission. The forward-looking statements in this press release represent Pacira Pharmaceutical's views as of the date of this press release. The Company anticipates that subsequent events and development will cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it has no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing Pacira Pharmaceutical's views as of any date subsequent to the date of this press release. Pacira Pharmaceuticals, Inc.Consolidated Statement of Operations(in thousands, except shares and per share data)Three Months Ended Dec 31,Twelve Months Ended Dec 31,2010200920102009 Revenues: Supply revenue
1,0121,1383,7054,044 Collaborative licensing and development revenue
6661,0953,2174,638 Total revenues
2,1914,28414,56215,006 Operating expenses: Cost of revenues
2,1083,47812,27612,301 Research and development
3,6747,51618,62826,233 Selling, general and administrative
2,0891,1006,0305,020 Total operating expenses
7,87112,09436,93443,554 Loss from operations
(5,680)(7,810)(22,372)(28,548) Other income
5014150367 Loss on early extinguishment of debt
(184)(184)- Interest: Interest income
343114677 Interest expense
(1,382)(733)(3,959)(1,723) Royalty interest obligation
118(473)(930)(1,880) Net loss
(27,149)$ (31,707) Basic and diluted net loss per common share
(47.29)$ (55.32) Weighted average common shares outstanding - basic and diluted
573,989573,870574,072573,118 Proforma loss per common share - Basic and diluted (unaudited) $
(1.58) Shares used in computing proforma loss per common share - Basic and diluted (unaudited) (1) 17,232,917(1)
Pro forma includes the impact of the conversion of all of our outstanding shares of Series A convertible preferred stock and our secured and unsecured notes (including the notes issued upon the first closing of the December 2010 Convertible Notes) and accrued interest thereon into common stock and proceeds from initial public offering, completed in February 2011, net of underwriters’ discounts and commissions and estimated offering expenses. Pacira Pharmaceuticals, Inc.Condensed Consolidated Balance Sheets(in thousands)at December 31,20102010 Pro forma (1)2009 Cash and cash equivalents
4,568$ 7,077 Other current assets
4,9224,9225,472 Fixed assets, net
23,95023,95019,560 Intangibles and other assets, net
11,55710,15011,845 Total assets
43,954 Current liabilities
,322$14,417 Related party debt, including accrued interest
49,795-22,173 Long term debt
21,86921,869- Deferred revenue and other long term liabilities
26,95926,95930,313 Stockholders' equity
(48,383)38,440(22,949) Total liabilities and stockholders' equity
Pro forma includes the impact of the conversion of all of our outstanding shares of Series A convertible preferred stock and our secured and unsecured notes (including the notes issued upon the first closing of the December 2010 Convertible Notes) and accrued interest thereon into common stock and proceeds from initial public offering, completed in February 2011, net of underwriters’ discounts and commissions and estimated offering expenses. Contacts:Company Contact:
Pacira Pharmaceuticals, Inc.
James S. Scibetta, 973-254-3560
Pure Communications Inc.
Jennifer Beugelmans, 646-596-7473
|SOURCE Pacira Pharmaceuticals, Inc.|
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