Company Will Host Conference Call Today at 9 a.m. ET
PARSIPPANY, N.J.--(BUSINESS WIRE)--May. 8, 2013--
Pacira
Pharmaceuticals, Inc. (NASDAQ:PCRX) today announced consolidated
financial results for the quarter ended March 31, 2013 and provided
updates on the commercial launch of EXPAREL®
(bupivacaine liposome injectable suspension) for postsurgical pain in
the United States.
“We saw a solid quarter in what was the fourth quarter of our EXPAREL
launch,” said Dave Stack, president and chief executive officer of
Pacira. “We continue to see growth from new customers as well as
expansion with existing customers who have had access to the product for
some time. Especially important is the recent pattern where we have
achieved formulary approval without restrictions for several major
centers of influence based on the clinical evidence and the broad base
of surgical specialties expressing interest in EXPAREL. At the same
time, many early-adopting institutions, where EXPAREL was made available
with restrictions, have removed these restrictions based on their
success in utilizing reduced opioid pain management strategies.”
Recent Highlights and Upcoming Events
-
EXPAREL Commercialization: In the first quarter ended March 31,
2013, EXPAREL sales totaled $10.4 million, up from $7.8 million in the
fourth quarter of 2012. As of March 31, 2013, 1,065 accounts ordered
EXPAREL, compared to 819 accounts as of December 31, 2012. Of these,
308 accounts ordered EXPAREL six times or more and 175 accounts
ordered 10 times or more. Pacira continues its steady expansion since
launch with an average of 22 new customers per week as of March 31,
2013.
-
EXPAREL as Part of a Multimodal Approach to Postsurgical Pain
Management: Recently published national and regional analyses of
more than 400,000 patients receiving opioids for postsurgical pain
management show that patients who experienced opioid-related adverse
events (ORAEs) had longer lengths of hospital stay, higher costs of
care, greater rates of 30-day readmission to the hospital and a
significantly increased risk of mortality. Although opioids have long
been the mainstay of postsurgical pain control, these analyses are
part of a growing body of evidence that suggests the need to
re-examine the benefit-risk profile of an opioid-centric pain
management paradigm and to explore a multimodal approach that uses
alternative modalities to decrease the amount of opioids needed.
-
Recent Data Supporting the Utility of EXPAREL Among Surgical
Audiences: Last month, Pacira announced results from EXCLAIM, its
Phase 4 prospective, observational study, to assess the use of EXPAREL
for postsurgical analgesia in patients undergoing four common plastic
surgery procedures.
-
Investor Meetings: Pacira management will be presenting at the
Bank of America Merrill Lynch 2013 Health Care Conference on May 15,
2013 in Las Vegas and will be presenting at the Jefferies 2013 Global
Healthcare Conference on June 3, 2013 in New York City.
First Quarter 2013 Financial Results
-
Total revenues for the quarter ended March 31, 2013 were $11.6 million
compared with $7.8 million for the quarter ended March 31, 2012. The
increase in revenues was primarily driven by $10.4 million of net
product sales of EXPAREL, which represents the sale of product shipped
directly to end-users, including hospitals and ambulatory surgery
centers. This was partially offset by a decrease in collaborative
licensing and development revenue of $6.2 million due to the
recognition of deferred revenue during 2012 associated with the
termination of certain licensing agreements.
-
Total operating expenses for the quarter ended March 31, 2013 were
$30.2 million compared with $18.9 million for the quarter ended March
31, 2012. The increase was primarily driven by the cost of EXPAREL
product sold. Additionally, clinical development costs increased due
to the ongoing pivotal trials of EXPAREL administered as a femoral
nerve block for total knee arthroplasty surgery and as an intercostal
nerve block for thoracotomy.
-
Net loss for the quarter ended March 31, 2013 was $23.1 million, or
$0.71 per share (based on 32.7 million weighted average shares
outstanding) compared to $11.9 million, or $0.47 per share (based on
25.4 million shares outstanding) for the quarter ended March 31, 2012.
The increase in net loss was the result of increased operating
expenses and a $3.4 million loss on early extinguishment of debt
recognized during the quarter ended March 31, 2013. As of March 31,
2013, the Company had 33.0 million shares of common stock outstanding.
-
Pacira ended the first quarter of 2013 with cash and cash equivalents,
restricted cash and short-term investments (“cash”) of $110.2 million.
During the quarter ended March 31, 2013, Pacira closed an offering of
$120.0 million in aggregate principal amount of 3.25 percent
convertible senior notes due February 1, 2019.
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,
Wednesday, May 8, 2013, at 9 a.m. ET. The call can be accessed by
dialing 1-866-700-0133 (domestic) or 1-617-213-8831 (international) five
minutes prior to the start of the call and providing the passcode
29560281.
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
60916641. 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.
About Pacira
Pacira 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 commercially launched in the United States in April 2012. EXPAREL
and two other products have utilized 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.
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; 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 December 31, 2012, 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.
|
Consolidated Statements of Operations
|
(unaudited)
|
(in thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
|
|
|
|
March 31,
|
|
|
|
|
|
|
|
2013
|
|
|
|
2012
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
|
|
|
|
|
$
|
10,835
|
|
|
|
|
$
|
446
|
|
Collaborative licensing and development revenue
|
|
|
|
|
|
|
|
243
|
|
|
|
|
|
6,490
|
|
Royalty revenue
|
|
|
|
|
|
|
|
509
|
|
|
|
|
|
868
|
|
Total revenues
|
|
|
|
|
|
|
|
11,587
|
|
|
|
|
|
7,804
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues
|
|
|
|
|
|
|
|
11,391
|
|
|
|
|
|
6,495
|
|
Research and development
|
|
|
|
|
|
|
|
5,905
|
|
|
|
|
|
1,294
|
|
Selling, general and administrative
|
|
|
|
|
|
|
|
12,936
|
|
|
|
|
|
11,152
|
|
Total operating expenses
|
|
|
|
|
|
|
|
30,232
|
|
|
|
|
|
18,941
|
|
Loss from operations
|
|
|
|
|
|
|
|
(18,645
|
)
|
|
|
|
|
(11,137
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
|
|
|
|
|
73
|
|
|
|
|
|
63
|
|
Interest expense
|
|
|
|
|
|
|
|
(1,519
|
)
|
|
|
|
|
(514
|
)
|
Loss on early extinguishment of debt
|
|
|
|
|
|
|
|
(3,398
|
)
|
|
|
|
|
-
|
|
Royalty interest obligation
|
|
|
|
|
|
|
|
(86
|
)
|
|
|
|
|
(282
|
)
|
Other, net
|
|
|
|
|
|
|
|
(5
|
)
|
|
|
|
|
(24
|
)
|
Total other expense, net
|
|
|
|
|
|
|
|
(4,935
|
)
|
|
|
|
|
(757
|
)
|
Loss before income taxes
|
|
|
|
|
|
|
|
(23,580
|
)
|
|
|
|
|
(11,894
|
)
|
Income tax benefit
|
|
|
|
|
|
|
|
442
|
|
|
|
|
|
-
|
|
Net loss
|
|
|
|
|
|
|
$
|
(23,138
|
)
|
|
|
|
$
|
(11,894
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
|
|
|
|
|
|
$
|
(0.71
|
)
|
|
|
|
$
|
(0.47
|
)
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
|
|
|
|
|
32,709,298
|
|
|
|
|
|
25,367,306
|
|
|
Pacira Pharmaceuticals, Inc.
|
Condensed Consolidated Balance Sheets
|
(unaudited)
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
|
December 31,
|
|
|
|
|
|
|
|
|
2013
|
|
|
|
2012
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, restricted cash and short-term investments
|
|
|
|
|
|
|
|
$
|
|
|
|
|
110,246
|
|
|
|
$
|
42,573
|
Accounts receivable, net
|
|
|
|
|
|
|
|
|
|
|
|
|
5,243
|
|
|
|
|
4,352
|
Inventories
|
|
|
|
|
|
|
|
|
|
|
|
|
10,760
|
|
|
|
|
12,077
|
Prepaid expenses and other current assets
|
|
|
|
|
|
|
|
|
|
|
|
|
2,740
|
|
|
|
|
1,920
|
Total current assets
|
|
|
|
|
|
|
|
|
|
|
|
|
128,989
|
|
|
|
|
60,922
|
Fixed assets, net
|
|
|
|
|
|
|
|
|
|
|
|
|
41,130
|
|
|
|
|
39,116
|
Goodwill
|
|
|
|
|
|
|
|
|
|
|
|
|
8,582
|
|
|
|
|
8,297
|
Intangibles, net
|
|
|
|
|
|
|
|
|
|
|
|
|
2,695
|
|
|
|
|
3,208
|
Other assets
|
|
|
|
|
|
|
|
|
|
|
|
|
3,845
|
|
|
|
|
511
|
Total assets
|
|
|
|
|
|
|
|
$
|
|
|
|
|
185,241
|
|
|
|
$
|
112,054
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
|
|
|
|
|
|
$
|
|
|
|
|
1,001
|
|
|
|
$
|
2,569
|
Accrued expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
9,872
|
|
|
|
|
9,792
|
Current portion of royalty interest obligation
|
|
|
|
|
|
|
|
|
|
|
|
|
853
|
|
|
|
|
823
|
Current portion of deferred revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
972
|
|
|
|
|
972
|
Total current liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
12,698
|
|
|
|
|
14,156
|
Long-term debt, net of discount
|
|
|
|
|
|
|
|
|
|
|
|
|
95,857
|
|
|
|
|
25,191
|
Royalty interest obligation
|
|
|
|
|
|
|
|
|
|
|
|
|
723
|
|
|
|
|
857
|
Deferred revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
3,477
|
|
|
|
|
3,720
|
Other liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
2,694
|
|
|
|
|
2,275
|
Total stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
69,792
|
|
|
|
|
65,855
|
Total liabilities and stockholders' equity
|
|
|
|
|
|
|
|
$
|
|
|
|
|
185,241
|
|
|
|
$
|
112,054
|

Source: Pacira Pharmaceuticals, Inc.
Pacira Pharmaceuticals, Inc. Company Contact: Jessica
Cho, 973-254-3574 or Pure Communications, Inc. Media
Contact: Susan Heins, 864-286-9597
|