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Pacira Pharmaceuticals, Inc. Reports $2.3 Million in Second Quarter EXPAREL® Revenue and Full Second Quarter 2012 Financial Results
Company Will Host Conference Call Today at
“With our first quarter of EXPAREL sales behind us, we are extremely
pleased with the launch trajectory and where we are today,” said
Recent Highlights and Upcoming Events:
EXPAREL Commercialization: In the second quarter ended
June 30, 2012, EXPAREL sales totaled $2.3 million. As of August 3, 2012, 428 accounts had ordered EXPAREL compared to 164 accounts as of May 8, 2012. Among the accounts that have placed an initial order of EXPAREL, 49 percent of the total accounts have now reordered and 55 percent of hospital accounts have reordered.
Exploring Additional Indications for EXPAREL: Based on a recent
meeting with the
U.S. Food and Drug Administration, Pacira currently expects to launch a Phase 2/3 clinical program in the second half of 2012 to study the safety and efficacy of EXPAREL for a nerve block indication. Bupivacaine is a standard of care in many nerve block procedures, creating what Pacira believes to be a potential customer base already familiar with the drug and injection techniques.
Investor Meetings: Pacira management will present at the
Wedbush PacGrow 2012
Life Sciences Management Access Conferenceon Tuesday August 14, 2012at 8:35 am ETin New York City. Pacira is also planning its first corporate investor event in mid-October, 2012. Attendance will be by invitation only; however, the presentation will be made available via live webcast.
Second Quarter 2012 Financial Results
Total revenues for the quarter ended
June 30, 2012were $12.3 millioncompared with $3.6 millionfor the quarter ended June 30, 2011. Revenues in the second quarter included $2.3 millionof net product sales of EXPAREL, which was launched in April 2012, and represents the sale of product shipped directly to end-users, including hospitals and ambulatory surgery centers. Net product sales of DepoCyt(e) in the second quarter increased $1.2 millionyear over year due to a higher number of lots sold to commercial partners. Collaborative licensing and development revenue in the second quarter of 2012 increased $5.3 millionversus the second quarter of 2011 primarily due to the recognition of revenue in connection with the termination by EKR Therapeutics, Inc.of the licensing, distribution and marketing agreement for DepoDur.
Net loss for the quarter ended
June 30, 2012was $8.3 million, or $0.27per share (based on 31.0 million weighted average shares outstanding) compared to $8.8 millionfor the quarter ended June 30, 2011. As of June 30, 2012, the Company had 32.4 million shares outstanding.
Total operating expenses for the quarter ended
June 30, 2012were $19.0 millioncompared with $12.2 millionfor the quarter ended June 30, 2011. The increase was primarily driven by the commercialization efforts for EXPAREL and manufacturing costs in operating two cGMP facilities.
Pacira ended the second quarter of 2012 with cash and cash
equivalents, restricted cash and short-term investments of
$86.1 million. In April 2012, the Company received approximately $63 millionin net cash proceeds from a secondary common stock offering. Also in April 2012, the Company recorded its first commercial sale of EXPAREL, triggering a $10.0 millioncontingent payment obligation to SkyePharma Holding, Inc.
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 and upcoming developments on
The live, listen-only webcast of the conference call can be accessed by visiting the investors 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.
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 our plans to manufacture
and commercialize EXPAREL and the success of our commercialization of
EXPAREL, and other statements containing the words “believes,”
“anticipates,” “plans,” “expects,” and similar expressions, constitute
forward-looking statements within the meaning of
|Pacira Pharmaceuticals, Inc.|
|Consolidated Statement of Operations|
|(in thousands, except share and per share amounts)|
Three Months Ended
Six Months Ended
|Net product sales||$||4,981||$||1,469||$||5,427||$||3,185|
|Collaborative licensing and development revenue||6,600||1,283||13,090||2,493|
|Cost of revenues||6,685||3,115||13,180||6,781|
|Research and development||1,872||4,586||3,166||8,382|
|Selling, general and administrative||10,413||4,466||21,565||7,988|
|Total operating expenses||18,970||12,167||37,911||23,151|
|Loss from operations||(6,626||)||(8,531||)||(17,763||)||(15,651||)|
|Other (expense) income:|
|Loss on early extinguishment of debt||(1,062||)||-||(1,062||)||-|
|Royalty interest obligation||(143||)||429||(425||)||118|
|Total other expense, net||(1,670||)||(232||)||(2,427||)||(2,886||)|
|Basic and diluted net loss per common share||$||(0.27||)||$||(0.51||)||$||(0.72||)||$||(1.36||)|
|Weighted average common shares outstanding - basic and diluted||30,953,635||17,233,146||28,160,471||13,623,668|
|Pacira Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets|
|June 30,||December 31,|
|Cash and cash equivalents, restricted cash and short-term investments||$||86,132||$||77,452|
|Other current assets||13,944||5,197|
|Fixed assets, net||29,966||25,103|
|Intangibles and other assets, net||12,811||5,738|
|Liabilities and stockholders' equity|
|Long-term debt and royalty interest obligation||25,940||20,074|
|Other long-term liabilities||7,172||13,236|
|Total liabilities and stockholders' equity||$||142,853||$||113,490|
Pacira Pharmaceuticals, Inc.
James S. Scibetta, 973-254-3570
Pure Communications, Inc.
Dan Budwick, 973-271-6085