PARSIPPANY, N.J., Oct. 31, 2011 /PRNewswire/ -- Pacira Pharmaceuticals, Inc. (Nasdaq: PCRX), an emerging specialty pharmaceutical company, today announced financial results for the third quarter ended September 30, 2011 and provided an update on the U.S. Food and Drug Administration's (FDA) approval of EXPAREL™ (bupivacaine liposome injectable suspension) and the commercial strategy to support the product launch.
"With the broad postsurgical pain management label granted by the FDA, we are well positioned to execute our commercial strategy for EXPAREL," said Dave Stack, president and chief executive officer of Pacira Pharmaceuticals, Inc. "Over the past several months, our entire organization has diligently focused on completing the pre-commercial activities necessary to prepare EXPAREL for launch. During this time, we have strengthened our relationships with clinicians and hospitals, presented data demonstrating the efficacy, safety and utility of EXPAREL and completed retrospective health outcomes studies highlighting the economic benefits of reducing opioid use in postsurgical pain management regimens. With these accomplishments as a platform, we believe we are on track for a successful hospital launch of EXPAREL in January 2012, focused on abdominal soft tissue surgeries typically performed by colorectal surgeons, general surgeons and OB/GYNs."
EXPAREL Commercial StrategyThe company has previously announced its intention to launch EXPAREL into the broad hospital market in early 2012. By the time of launch, Pacira expects to have achieved the following:
"Based upon our January launch timeline, we are moving forward with our strategy to build out a sales team that we believe can cover more than 81 percent of the hospital soft tissue surgery market," continued Mr. Stack. "This team will also be focused on assisting our commercial team with accelerating the formulary process at key hospitals and gaining momentum within the plastic surgery market, where there are lower formulary approval requirements. Additionally, we expect to maintain a high level of activity with new peer-reviewed data publications and presentations at key medical meetings, which we believe will help further support an accelerated formulary approval strategy. We are excited about the interest and support for EXPAREL to date, and with our recent FDA approval we believe we are in a strong position to bring a new, much-needed postsurgical pain management therapeutic to the market."
Full Year 2011 Financial Guidance
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 third quarter financial results, recent developments and 2011 financial guidance today at 9 a.m. (ET). The call can be accessed by dialing 1-866-831-6272 (domestic) or 1-617-213-8859 (international) five minutes prior to the start of the call and providing the passcode 24414196. 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 74599996. 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 EXPAREL™EXPAREL is an innovative product that combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. It represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting in the same fashion as current local anesthetics, which provide a relatively short duration of efficacy. By utilizing the DepoFoam platform, EXPAREL delivers bupivacaine for an extended period of time, providing analgesia with reduced opioid requirements for up to 72 hours. Additional information is available at www.EXPAREL.com.
Important Safety InformationThe safety of EXPAREL has been evaluated in 21 clinical trials, which include over 1300 subjects in the safety database. EXPAREL administered locally into the surgical site was evaluated in 10 randomized, double-blind, clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 mg to 532 mg of EXPAREL. EXPAREL is contraindicated in obstetrical paracervical block anesthesia. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. In these studies, the most common adverse reactions (incidence >10%) following EXPAREL administration were nausea, constipation, and vomiting.
Please see the full Prescribing Information for more details available at www.EXPAREL.com About PaciraPacira Pharmaceuticals, Inc. (Nasdaq: PCRX) is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company's current emphasis is the development of non-opioid products for postsurgical pain control, and its lead product, EXPAREL (bupivacaine liposome injectable suspension), was approved for administration into the surgical site to produce postsurgical analgesia by the U.S. Food and Drug Administration in October 2011. EXPAREL and two other commercially available products utilize the Pacira proprietary product delivery technology DepoFoam®, a unique platform that encapsulates drugs without altering their molecular structure and then releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.
Forward Looking StatementsAny statements in this press release about our future expectations, plans and prospects, including statements about EXPAREL's potential, and other statements containing the words "believes," "anticipates," "plans," "expects," 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: our plans to develop and commercialize EXPAREL; the success and timing of our commercial launch 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 commercialization and marketing capabilities; and other factors discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2010, and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
Pacira Pharmaceuticals, Inc.
James S. Scibetta, 973-254-3560
Pure Communications Inc.
Jennifer Beugelmans, 646-596-7473Pacira Pharmaceuticals, Inc.Consolidated Statement of Operations(unaudited)(in thousands, except share and per share amounts)Three Months
Ended September 30, Nine Months
Ended September 30, 2011201020112010 Revenues: Supply revenue
9221,0232,7432,693 Collaborative licensing and development revenue
1,3527653,8452,551 Total revenues
3,9564,53211,45612,371 Operating expenses: Cost of revenues
3,3573,57310,13810,168 Research and development
4,3445,71612,23714,954 Selling, general and administrative
4,9881,69413,4653,948 Total operating expenses
12,68910,98335,84029,070 Loss from operations
(8,733)(6,451)(24,384)(16,699) Other (expense) income: Interest income
4639111112 Interest expense
(910)(1,077)(4,068)(2,577) Royalty interest obligation
116(444)235(1,048) Other, net
(27)3361107 Total other expense, net
(775)(1,449)(3,661)(3,406) Net loss
(20,105) Basic and diluted net loss per common share
(35.02) Weighted average common shares outstanding - basic and diluted
17,230,826573,52114,826,054574,112Pacira Pharmaceuticals, Inc.Condensed Consolidated Balance Sheets(unaudited)(in thousands) September 30, December 31, 2011 2010 Assets Cash and cash equivalents and short-term investments
26,133 Restricted cash
1,6871,314 Other current assets
4,6453,608 Fixed assets, net
25,82523,950 Intangibles and other assets, net
8,38411,557 Total assets
,562 Liabilities and stockholders' equity (deficit) Current liabilities
,322 Related party debt, including accrued interest
-49,795 Long-term debt and royalty interest obligation
22,44524,865 Other long-term liabilities
23,46023,963 Stockholders' equity (deficit)
13,875(48,383) Total liabilities and stockholders' equity
|SOURCE Pacira Pharmaceuticals, Inc.|
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