Company Will Host Conference Call Today at 9 a.m. ET
PARSIPPANY, N.J.--(BUSINESS WIRE)--Oct. 30, 2014--
Pacira
Pharmaceuticals, Inc. (NASDAQ: PCRX) today provided updates on the
success of EXPAREL®
(bupivacaine liposome injectable suspension) for postsurgical pain in
the United States and announced consolidated financial results for the
third quarter ended September 30, 2014.
“The third quarter marked another period of consistent growth for
EXPAREL across a broad array of surgical procedures,” said Dave Stack,
president, chief executive officer and chairman of Pacira. “We believe
that this quarter-over-quarter traction continues to underscore the
marketplace need for an alternative to opioid-based therapies for
managing postsurgical pain. Over the next couple of quarters, we expect
several important data sets will be presented which demonstrate the
value of postsurgical pain control with reduced opioids to improve
patient care. As we prepare for a potential nerve block indication, we
are excited by the prospect of new EXPAREL opportunities to replace
catheter-based pain management strategies and to provide another option
for improved patient care.”
Recent Highlights
-
EXPAREL Commercialization: EXPAREL net product sales were $50.2
million in the third quarter of 2014, compared to $20.0 million in the
third quarter of 2013 and up 12 percent from $44.9 million in the
second quarter of 2014.
Third Quarter 2014 Financial Results
-
Total revenues were $52.0 million, compared to $23.3 million in the
third quarter of 2013.
-
Total operating expenses were $53.0 million, compared to $36.1 million
in the third quarter of 2013.
-
Net loss was $3.0 million, or $0.08 per share (basic and diluted),
compared to $14.8 million, or $0.44 per share (basic and diluted), in
the third quarter of 2013.
-
Non-GAAP net income was $5.7 million, or $0.16 per share (basic) and
$0.14 per share (diluted), compared to a non-GAAP net loss of $10.0
million, or $0.30 per share (basic and diluted), in the third quarter
of 2013.
-
Pacira ended the third quarter of 2014 with cash and cash equivalents,
restricted cash, short-term investments and long-term investments
(“cash”) of $176.1 million.
-
Pacira had approximately 35.9 million weighted average shares of
common stock outstanding in the third quarter of 2014.
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,
Thursday, October 30, 2014, at 9 a.m. ET. The call can be accessed by
dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international)
fifteen minutes prior to the start of the call and providing the
Conference ID 2794612.
A replay of the call will be available approximately two hours after the
completion of the call and can be accessed by dialing 1-855-859-2056
(domestic) or 1-404-537-3406 (international) and providing the
Conference ID 2794612. 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 financial measures that do not comply with
U.S. generally accepted accounting principles (GAAP), non-GAAP net
income (loss), because such measures exclude stock-based compensation,
loss on early extinguishment of debt and other non-cash charges. These
measures supplement our financial results prepared in accordance with
GAAP. Pacira management uses these measures to better analyze its
financial results and to help make managerial decisions. In management’s
opinion, these non-GAAP measures are useful to investors and other users
of our financial statements by providing greater transparency into the
operating performance at Pacira. Such measures should not be
deemed to be an alternative to GAAP requirements or a measure of
liquidity for Pacira. Non-GAAP net income (loss) measures are also
unlikely to be comparable with non-GAAP disclosures released by other
companies. See a reconciliation of non-GAAP net income (loss) to GAAP
net loss below.
About Pacira
Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) is a 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 significant reductions in cumulative pain scores
with a 45% decrease in opioid consumption; the clinical benefit of the
opioid reduction was not demonstrated. 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, including for nerve block and the
related timing and success of an sNDA; the adverse effects and impacts
of FDA warning letters; our plans to evaluate, develop and pursue
additional DepoFoam-based product candidates; clinical studies in
support of an existing or potential DepoFoam-based product; our plans to
continue to manufacture and provide support services for our commercial
partners who have licensed DepoCyt(e); our commercialization and
marketing capabilities; our and Patheon’s ability to successfully and
timely construct dedicated EXPAREL manufacturing suites; 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, 2013, 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.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
|
|
2014
|
|
2013
|
|
ASSETS
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
Cash and cash equivalents, restricted cash and short-term investments
|
|
$
|
151,557
|
|
$
|
73,785
|
|
Accounts receivable, net
|
|
|
20,517
|
|
|
14,590
|
|
Inventories
|
|
|
23,662
|
|
|
15,557
|
|
Prepaid expenses and other current assets
|
|
|
3,504
|
|
|
2,819
|
|
Total current assets
|
|
|
199,240
|
|
|
106,751
|
|
Long-term investments
|
|
|
24,527
|
|
|
-
|
|
Fixed assets, net
|
|
|
56,148
|
|
|
48,182
|
|
Goodwill
|
|
|
22,048
|
|
|
10,328
|
|
Intangibles, net
|
|
|
483
|
|
|
1,157
|
|
Other assets
|
|
|
2,948
|
|
|
3,402
|
|
Total assets
|
|
$
|
305,394
|
|
$
|
169,820
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
Accounts payable
|
|
$
|
7,747
|
|
$
|
3,069
|
|
Accrued expenses
|
|
|
23,383
|
|
|
17,885
|
|
Convertible senior notes (*)
|
|
|
102,065
|
|
|
98,961
|
|
Current portion of royalty interest obligation
|
|
|
602
|
|
|
1,020
|
|
Current portion of deferred revenue
|
|
|
1,426
|
|
|
1,008
|
|
Total current liabilities
|
|
|
135,223
|
|
|
121,943
|
|
Royalty interest obligation
|
|
|
-
|
|
|
226
|
|
Deferred revenue
|
|
|
9,864
|
|
|
3,212
|
|
Other liabilities
|
|
|
5,235
|
|
|
3,190
|
|
Total stockholders' equity
|
|
|
155,072
|
|
|
41,249
|
|
Total liabilities and stockholders' equity
|
|
$
|
305,394
|
|
$
|
169,820
|
|
|
|
|
|
|
|
(*) The convertible senior notes are contractually due in 2019.
However, because of certain conditions that were met during the
three months ended September 30, 2014, the note holders can
convert any time during the quarter ending December 31, 2014.
|
|
|
|
|
|
|
|
|
|
|
|
|
Pacira Pharmaceuticals, Inc.
|
|
Consolidated Statements of Operations
|
|
(unaudited)
|
|
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
September 30,
|
|
September 30,
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product sales
|
$
|
50,920
|
|
|
$
|
22,408
|
|
|
$
|
132,697
|
|
|
$
|
49,520
|
|
|
Collaborative licensing and development revenue
|
|
357
|
|
|
|
243
|
|
|
|
930
|
|
|
|
729
|
|
|
Royalty revenue
|
|
771
|
|
|
|
608
|
|
|
|
2,249
|
|
|
|
1,737
|
|
|
Total revenues
|
|
52,048
|
|
|
|
23,259
|
|
|
|
135,876
|
|
|
|
51,986
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Cost of goods sold
|
|
20,391
|
|
|
|
14,791
|
|
|
|
58,472
|
|
|
|
36,396
|
|
|
Research and development
|
|
4,425
|
|
|
|
5,962
|
|
|
|
14,844
|
|
|
|
16,724
|
|
|
Selling, general and administrative
|
|
28,217
|
|
|
|
15,320
|
|
|
|
75,643
|
|
|
|
42,336
|
|
|
Total operating expenses
|
|
53,033
|
|
|
|
36,073
|
|
|
|
148,959
|
|
|
|
95,456
|
|
|
Loss from operations
|
|
(985
|
)
|
|
|
(12,814
|
)
|
|
|
(13,083
|
)
|
|
|
(43,470
|
)
|
|
|
|
|
|
|
|
|
|
|
Other (expense) income:
|
|
|
|
|
|
|
|
|
Interest income
|
|
134
|
|
|
|
62
|
|
|
|
237
|
|
|
|
207
|
|
|
Interest expense
|
|
(2,037
|
)
|
|
|
(1,892
|
)
|
|
|
(6,222
|
)
|
|
|
(5,325
|
)
|
|
Loss on early extinguishment of debt
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(3,398
|
)
|
|
Royalty interest obligation
|
|
(73
|
)
|
|
|
(132
|
)
|
|
|
(330
|
)
|
|
|
(379
|
)
|
|
Other, net
|
|
(43
|
)
|
|
|
(8
|
)
|
|
|
(120
|
)
|
|
|
(30
|
)
|
|
Total other expense, net
|
|
(2,019
|
)
|
|
|
(1,970
|
)
|
|
|
(6,435
|
)
|
|
|
(8,925
|
)
|
|
Loss before income taxes
|
|
(3,004
|
)
|
|
|
(14,784
|
)
|
|
|
(19,518
|
)
|
|
|
(52,395
|
)
|
|
Income tax benefit
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
442
|
|
|
Net loss
|
$
|
(3,004
|
)
|
|
$
|
(14,784
|
)
|
|
$
|
(19,518
|
)
|
|
$
|
(51,953
|
)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share:
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share
|
$
|
(0.08
|
)
|
|
$
|
(0.44
|
)
|
|
$
|
(0.56
|
)
|
|
$
|
(1.57
|
)
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
35,943
|
|
|
|
33,360
|
|
|
|
35,039
|
|
|
|
33,051
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pacira Pharmaceuticals, Inc.
|
|
|
Reconciliation of GAAP to Non-GAAP Financial Information
|
|
|
(unaudited)
|
|
|
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
|
|
|
September 30,
|
|
September 30,
|
|
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss
|
|
$
|
(3,004
|
)
|
|
$
|
(14,784
|
)
|
|
$
|
(19,518
|
)
|
|
$
|
(51,953
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP adjustments:
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation
|
|
|
7,686
|
|
|
|
3,777
|
|
|
|
17,199
|
|
|
|
8,227
|
|
|
|
Loss on early extinguishment of debt
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
3,398
|
|
|
|
Non-cash debt discount amortization
|
|
|
1,035
|
|
|
|
1,035
|
|
|
|
3,104
|
|
|
|
2,924
|
|
|
|
Total Non-GAAP adjustments
|
|
|
8,721
|
|
|
|
4,812
|
|
|
|
20,303
|
|
|
|
14,549
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP net income (loss)
|
|
$
|
5,717
|
|
|
$
|
(9,972
|
)
|
|
$
|
785
|
|
|
$
|
(37,404
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP basic and diluted net loss per common share
|
|
$
|
(0.08
|
)
|
|
$
|
(0.44
|
)
|
|
$
|
(0.56
|
)
|
|
$
|
(1.57
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-GAAP basic net income (loss) per common share
|
|
$
|
0.16
|
|
|
$
|
(0.30
|
)
|
|
$
|
0.02
|
|
|
$
|
(1.13
|
)
|
|
|
Non-GAAP diluted net income (loss) per common share
|
|
$
|
0.14
|
|
|
$
|
(0.30
|
)
|
|
$
|
0.02
|
|
|
$
|
(1.13
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding - basic
|
|
|
35,943
|
|
|
|
33,360
|
|
|
|
35,039
|
|
|
|
33,051
|
|
|
|
Weighted average common shares outstanding - diluted
|
|
|
41,554
|
|
|
|
33,360
|
|
|
|
40,379
|
|
|
|
33,051
|
|
Source: Pacira Pharmaceuticals, Inc.
Company Contact:
Pacira Pharmaceuticals, Inc.
Jessica
Cho, 973-254-3574
or
Media Contact:
Pure
Communications, Inc.
Susan Heins, 864-286-9597
|
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