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Pacira Pharmaceuticals, Inc. Reports 2011 Financial Results
Company On Track for Commercial Launch of EXPAREL® in April
"Last year was an important year for Pacira with our successful initial
public offering and the approval of EXPAREL by the
EXPAREL Launch Supported by Targeted Commercialization Activities
- Extensive pre-launch program: EXPAREL data disseminated in more than 40 publications and presentations; interactions with more than 1700 potential customers through market research, advisory boards and strong presence at key medical meetings.
- Strategic partnerships: Programs in place with group purchasing organization partners and key opinion-leading hospitals to demonstrate the true cost of opioid-based postsurgical pain management.
- Phase 4 clinical program: Initiation of prospective Phase 4 clinical trials in surgical models of interest to our colorectal, plastic, general, urology and OB/GYN surgeon customers.
- Robust 2012 publication plan: More than 50 publications and data presentations planned for 2012.
Ambulatory Procedure Code (APC) received: APC received from
Centers for Medicare & Medicaid Servicesfor payment of EXPAREL in ambulatory surgery.
- Focused field force: Following mid-January deployment, the 63-person field-based specialty team has worked to initiate the formulary review process in targeted high volume hospitals to obtain access for EXPAREL.
“Our comprehensive pre-launch strategy in 2011, coupled with the
Full-Year 2011 Financial Results
Net loss for the year ended
December 31, 2011was $43.3 million, or $2.64per share (based on 16.4 million weighted average shares outstanding).
Total revenues for the year ended
December 31, 2011were $15.7 millioncompared with $14.6 millionfor the year ended December 31, 2010.
Total operating expenses for the year ended
December 31, 2011were $54.8 millioncompared with $37.3 millionfor the year ended 2010. The increase was primarily attributable to an increase in selling, general and administrative expenses and the impairment of certain long-lived assets. Selling expenses increased due to the hiring of commercial personnel and activities supporting the commercialization of EXPAREL, and general and administrative expenses increased due to additional compensation-related expenses and other expenses associated with being a public company.
Cash used in operating activities and for the purchase of fixed assets
used in investing activities (“cash burn”) was approximately
$37.2 millionfor the year ended December 31, 2011.
Pacira ended 2011 with cash and cash equivalents, restricted cash and
short-term investments of
For the full-year ending
Today's Conference Call and Webcast Reminder
The Pacira management team will host a conference call at
A live, listen-only webcast of the conference call can also be accessed by visiting the investors section of the Pacira website at investor.pacira.com. A replay of the webcast will be archived on the company's website for two weeks following the call.
EXPAREL® (bupivacaine liposome injectable suspension) is indicated for administration 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 in the same fashion as current local anesthetics. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing analgesia with reduced opioid requirements for up to 72 hours. Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures and additional studies are underway to further demonstrate the safety and efficacy in other procedures. 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 percent) following EXPAREL administration were nausea, constipation and vomiting.
Please see the full Prescribing Information for more details available at www.EXPAREL.com.
Forward Looking Statements
Any statements in this press release about our future expectations,
plans and prospects, including statements about EXPAREL's potential and
the expected timing of commercial launch, expected 2012 revenues 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: the success of our sales
and manufacturing efforts in support of the planned 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 final
prospectus related to our public offering filed with the
|Pacira Pharmaceuticals, Inc.|
|Consolidated Statement of Operations|
|(in thousands, except share and per share amounts)|
Ended December 31,
Ended December 31,
|Supply and royalty revenue||$||3,004||$||1,525||$||10,615||$||11,345|
|Collaborative licensing and development revenue||1,229||666||5,074||3,217|
|Cost of revenues||6,601||2,108||16,739||12,276|
|Research and development||2,636||3,674||14,873||18,628|
|Selling, general and administrative||6,694||2,419||20,159||6,367|
|Impairment of long-lived assets||3,019||-||3,019||-|
|Total operating expenses||18,950||8,201||54,790||37,271|
|Loss from operations||(14,717||)||(6,010||)||(39,101||)||(22,709||)|
|Other (expense) income:|
|Royalty interest obligation||(8||)||118||227||(930||)|
|Loss on early extinguishment of debt||-||(184||)||-||(184||)|
|Total other expense, net||(566||)||(1,034||)||(4,227||)||(4,440||)|
|Basic and diluted net loss per common share||$||(0.72||)||$||(12.27||)||$||(2.64||)||$||(47.29||)|
|Weighted average common shares outstanding - basic and diluted||21,271,680||573,990||16,437,464||574,072|
|Pacira Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets|
|December 31,||December 31,|
|Cash and cash equivalents and short-term investments||$||76,153||$||26,133|
|Other current assets||5,197||3,608|
|Fixed assets, net||25,103||23,950|
|Intangibles and other assets, net||5,738||11,557|
|Liabilities and stockholders' equity (deficit)|
|Related party debt, including accrued interest||-||49,795|
|Long-term debt and royalty interest obligation||20,074||24,865|
|Other long-term liabilities||13,236||23,963|
|Stockholders' equity (deficit)||48,269||(48,383||)|
|Total liabilities and stockholders' equity||$||113,490||$||66,562|
Pacira Pharmaceuticals, Inc.
James S. Scibetta, 973-254-3570
Pure Communications, Inc.
Dan Budwick, 973-271-6085