Pacira Pharmaceuticals, Inc. Reports Third Quarter EXPAREL® Revenue of $20.0 Million and Full Third Quarter 2013 Financial Results
Company Will Host Conference Call Today at
“The strong third quarter for EXPAREL sales was accelerated by increased
traction in orthopedic surgeries and infiltration into the transversus
abdominis plane (or iTAP) procedures,” said
Recent Highlights
-
EXPAREL Commercialization: In the third quarter ended
September 30, 2013 , EXPAREL sales totaled$20.0 million , up from$15.2 million in the second quarter. Pacira continued its steady expansion of EXPAREL sales, reporting 297 total new accounts in the third quarter, an average of 23 new customers per week. As ofSeptember 30, 2013 , 1,732 total accounts ordered EXPAREL since launch, with 165 accounts each ordering more than$100,000 . The customer base has continued to grow along with acceptance and use of EXPAREL in hospitals that adopted the product early in the launch. -
Data Continues to Shift the Pain Control Paradigm and Support the
Utility of EXPAREL Among Surgeons and Anesthesiologists: As an
increasing number of surgeons and anesthesiologists gain experience
with EXPAREL, they are conducting and presenting their own independent
findings across multiple surgical models. Last month, a 200-patient
study evaluating the benefits of EXPAREL infiltration as the
foundation of a multimodal postsurgical pain management regimen in
patients undergoing total knee arthroplasty (TKA) versus femoral nerve
block with a local anesthetic was presented at the 7th
Annual Marshall Steele Orthopedic and Spine Summit in
San Antonio . The study showed better pain control with improved knee flexion, shorter length of hospital stay and substantial cost savings among patients receiving EXPAREL. -
Strategic Partnerships: Earlier this month, Pacira launched
into a promotional, 5-year agreement with
CrossLink Bioscience, LLC , an orthopedic device distributor based inAtlanta . With CrossLink acting as a local agent and lead partner in current collaboration with additional distributors in select markets acrossthe United States , the arrangement allows Pacira to partner with several hundred orthopedic distributor representatives to promote and sell EXPAREL.
Third Quarter 2013 Financial Results
-
EXPAREL net product sales for the third quarter of 2013 totaled
$20.0 million , a 340% increase compared to$4.6 million for the third quarter of 2012. -
Total revenues for the third quarter of 2013 were
$23.3 million , a 174% increase compared to$8.5 million for the third quarter of 2012. -
Total operating expenses for the third quarter of 2013 were
$36.1 million , compared to$24.2 million for the third quarter of 2012. -
Net loss for the third quarter of 2013 was
$14.8 million , or$0.44 per share, compared to$15.7 million , or$0.49 per share, for the third quarter of 2012. -
Non-GAAP net loss was
$10.0 million , or$0.30 per share, for the third quarter of 2013 compared to$14.0 million , or$0.43 per share, for the third quarter of 2012. -
Pacira ended the third quarter of 2013 with cash and cash equivalents,
restricted cash and short-term investments (“cash”) of
$83.8 million . -
As of
September 30, 2013 , the Company had approximately 33.5 million shares of common stock outstanding.
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 today,
A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-888-286-8010 (domestic) or 1-617-801-6888 (international), and providing the passcode 62860661. 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 a financial measure, non-GAAP net loss, that
does not comply with
About Pacira
About EXPAREL®
EXPAREL (bupivacaine liposome injectable suspension) is 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 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%) 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 and prospects, including statements about our plans and
expectations regarding EXPAREL, 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 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 indications of EXPAREL to include nerve block, including
the timing and success of an sNDA; our plans to continue to manufacture
and provide support services for our commercial partners who have
licensed DepoCyt(e); our commercialization and marketing capabilities;
and other factors discussed in the “Risk Factors” of our most recent
Annual Report on Form 10-K for the fiscal year ended
Pacira Pharmaceuticals, Inc. | ||||||||||
Condensed Consolidated Balance Sheets | ||||||||||
(unaudited) | ||||||||||
(in thousands) | ||||||||||
September 30, | December 31, | |||||||||
2013 | 2012 | |||||||||
ASSETS | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents, restricted cash and short-term investments | $ | 83,822 | $ | 42,573 | ||||||
Accounts receivable, net | 9,771 | 4,352 | ||||||||
Inventories | 15,606 | 12,077 | ||||||||
Prepaid expenses and other current assets | 2,486 | 1,920 | ||||||||
Total current assets | 111,685 | 60,922 | ||||||||
Fixed assets, net | 45,944 | 39,116 | ||||||||
Goodwill | 9,539 | 8,297 | ||||||||
Intangibles, net | 1,670 | 3,208 | ||||||||
Other assets | 3,557 | 511 | ||||||||
Total assets | $ | 172,395 | $ | 112,054 | ||||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||||
Current liabilities: | ||||||||||
Accounts payable | $ | 1,559 | $ | 2,569 | ||||||
Accrued expenses | 15,573 | 9,792 | ||||||||
Convertible senior notes (*) | 97,927 | - | ||||||||
Current portion of royalty interest obligation | 941 | 823 | ||||||||
Current portion of deferred revenue | 972 | 972 | ||||||||
Total current liabilities | 116,972 | 14,156 | ||||||||
Long-term debt | - | 25,191 | ||||||||
Royalty interest obligation | 403 | 857 | ||||||||
Deferred revenue | 2,991 | 3,720 | ||||||||
Other liabilities | 2,911 | 2,275 | ||||||||
Total stockholders' equity | 49,118 | 65,855 | ||||||||
Total liabilities and stockholders' equity | $ | 172,395 | $ | 112,054 | ||||||
(*) The convertible senior notes are contractually due in 2019. However, because of certain conditions that were met during the three months ended September 30, 2013, the note holders can redeem any time during the quarter ended December 31, 2013. |
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Pacira Pharmaceuticals, Inc. | ||||||||||||||||||||||||||
Consolidated Statements of Operations | ||||||||||||||||||||||||||
(unaudited) | ||||||||||||||||||||||||||
(in thousands, except share and per share amounts) | ||||||||||||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||||||||||||
September 30, | September 30, | |||||||||||||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||||||||||||
Revenues: | ||||||||||||||||||||||||||
Net product sales | $ | 22,408 | $ | 4,550 | $ | 49,520 | $ | 9,978 | ||||||||||||||||||
Collaborative licensing and development revenue | 243 | 3,484 | 729 | 16,574 | ||||||||||||||||||||||
Royalty revenue | 608 | 452 | 1,737 | 2,082 | ||||||||||||||||||||||
Total revenues | 23,259 | 8,486 | 51,986 | 28,634 | ||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||
Cost of revenues | 14,791 | 9,287 | 36,396 | 22,467 | ||||||||||||||||||||||
Research and development | 5,962 | 3,527 | 16,724 | 6,693 | ||||||||||||||||||||||
Selling, general and administrative | 15,320 | 11,378 | 42,336 | 32,943 | ||||||||||||||||||||||
Total operating expenses | 36,073 | 24,192 | 95,456 | 62,103 | ||||||||||||||||||||||
Loss from operations | (12,814 | ) | (15,706 | ) | (43,470 | ) | (33,469 | ) | ||||||||||||||||||
Other (expense) income: | ||||||||||||||||||||||||||
Interest income | 62 | 87 | 207 | 218 | ||||||||||||||||||||||
Interest expense | (1,892 | ) | (456 | ) | (5,325 | ) | (1,464 | ) | ||||||||||||||||||
Loss on early extinguishment of debt | - | - | (3,398 | ) | (1,062 | ) | ||||||||||||||||||||
Royalty interest obligation | (132 | ) | 378 | (379 | ) | (47 | ) | |||||||||||||||||||
Other, net | (8 | ) | (48 | ) | (30 | ) | (111 | ) | ||||||||||||||||||
Total other expense, net | (1,970 | ) | (39 | ) | (8,925 | ) | (2,466 | ) | ||||||||||||||||||
Loss before income taxes | (14,784 | ) | (15,745 | ) | (52,395 | ) | (35,935 | ) | ||||||||||||||||||
Income tax benefit | - | - | 442 | - | ||||||||||||||||||||||
Net loss | $ | (14,784 | ) | $ | (15,745 | ) | $ | (51,953 | ) | $ | (35,935 | ) | ||||||||||||||
Net loss per share: | ||||||||||||||||||||||||||
Basic and diluted net loss per common share | $ | (0.44 | ) | $ | (0.49 | ) | $ | (1.57 | ) | $ | (1.21 | ) | ||||||||||||||
Weighted average common shares outstanding: | ||||||||||||||||||||||||||
Basic and diluted | 33,359,576 | 32,436,207 | 33,050,721 | 29,585,716 | ||||||||||||||||||||||
Pacira Pharmaceuticals, Inc. | |||||||||||||||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Information | |||||||||||||||||||||||||||
(unaudited) | |||||||||||||||||||||||||||
(in thousands, except share and per share amounts) | |||||||||||||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||||||||||||
September 30, | September 30, | ||||||||||||||||||||||||||
2013 | 2012 | 2013 | 2012 | ||||||||||||||||||||||||
GAAP net loss | $ | (14,784 | ) | $ | (15,745 | ) | $ | (51,953 | ) | $ | (35,935 | ) | |||||||||||||||
Non-GAAP adjustments: | |||||||||||||||||||||||||||
Stock-based compensation | 3,777 | 1,469 | 8,227 | 3,220 | |||||||||||||||||||||||
Loss on extinguishment of debt | - | - | 3,398 | 1,062 | |||||||||||||||||||||||
Non-cash debt discount amortization | 1,035 | 260 | 2,924 | 571 | |||||||||||||||||||||||
Total Non-GAAP adjustments | $ | 4,812 | $ | 1,729 | $ | 14,549 | $ | 4,853 | |||||||||||||||||||
Non-GAAP net loss | $ | (9,972 | ) | $ | (14,016 | ) | $ | (37,404 | ) | $ | (31,082 | ) | |||||||||||||||
GAAP basic and diluted net loss per common share | $ | (0.44 | ) | $ | (0.49 | ) | $ | (1.57 | ) | $ | (1.21 | ) | |||||||||||||||
Non-GAAP basic and diluted net loss per common share | $ | (0.30 | ) | $ | (0.43 | ) | $ | (1.13 | ) | $ | (1.05 | ) | |||||||||||||||
Weighted average common shares outstanding - basic and diluted | 33,359,576 | 32,436,207 | 33,050,721 | 29,585,716 |
Source:
Pacira Pharmaceuticals, Inc.
Jessica Cho, 973-254-3574
or
Pure
Communications, Inc.
Susan Heins, 864-286-9597