Company Will Host Conference Call Today at 9 a.m. ET
PARSIPPANY, N.J.--(BUSINESS WIRE)--Aug. 9, 2012--
Pacira
Pharmaceuticals, Inc. (NASDAQ: PCRX) today announced consolidated
financial results for the quarter ended June 30, 2012 and provided
updates on the commercial launch of EXPAREL®
(bupivacaine liposome injectable suspension) for postsurgical pain in
the United States.
“With our first quarter of EXPAREL sales behind us, we are extremely
pleased with the launch trajectory and where we are today,” said Dave
Stack, president and chief executive officer of Pacira. “Based on our
sales numbers, initial feedback from the physician community and what we
believe to be the market potential for EXPAREL, we feel we have only
scratched the surface and look forward to updating you on our commercial
success as we expand our market share and explore additional therapeutic
indications for EXPAREL.”
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.
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Investor Meetings: Pacira management will present at the
Wedbush PacGrow 2012 Life Sciences Management Access Conference on
Tuesday August 14, 2012 at 8:35 am ET in 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, 2012 were $12.3 million
compared with $3.6 million for the quarter ended June 30, 2011.
Revenues in the second quarter included $2.3 million of 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 million year 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
million versus 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, 2012 was $8.3 million, or
$0.27 per share (based on 31.0 million weighted average shares
outstanding) compared to $8.8 million for 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, 2012 were
$19.0 million compared with $12.2 million for 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 million
in 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 million contingent 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
Thursday, August 9, 2012, at 9 a.m. ET. The call can be accessed by
dialing 1-866-770-7120 (domestic) or 1-617-213-8065 (international) five
minutes prior to the start of the call and providing the passcode
32008208. 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 95762478. 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 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.
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 approved products utilize 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 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 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 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, 2011,
our most recent Quarterly Report on Form 10-Q for the quarter ended June
30, 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.
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Consolidated Statement of Operations
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(unaudited)
|
(in thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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Three Months Ended
June 30,
|
Six Months Ended
June 30,
|
|
|
2012
|
|
|
2011
|
|
|
2012
|
|
|
2011
|
|
Revenues:
|
|
|
|
|
|
|
|
|
Net product sales
|
|
$
|
4,981
|
|
|
$
|
1,469
|
|
|
$
|
5,427
|
|
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$
|
3,185
|
|
Collaborative licensing and development revenue
|
|
|
6,600
|
|
|
|
1,283
|
|
|
|
13,090
|
|
|
|
2,493
|
|
Royalty revenue
|
|
|
763
|
|
|
|
884
|
|
|
|
1,631
|
|
|
|
1,822
|
|
Total revenues
|
|
|
12,344
|
|
|
|
3,636
|
|
|
|
20,148
|
|
|
|
7,500
|
|
Operating expenses:
|
|
|
|
|
|
|
|
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Cost of revenues
|
|
|
6,685
|
|
|
|
3,115
|
|
|
|
13,180
|
|
|
|
6,781
|
|
Research and development
|
|
|
1,872
|
|
|
|
4,586
|
|
|
|
3,166
|
|
|
|
8,382
|
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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
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)
|
|
|
(15,651
|
)
|
Other (expense) income:
|
|
|
|
|
|
|
|
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Interest income
|
|
|
68
|
|
|
|
37
|
|
|
|
131
|
|
|
|
65
|
|
Interest expense
|
|
|
(494
|
)
|
|
|
(676
|
)
|
|
|
(1,008
|
)
|
|
|
(3,157
|
)
|
Loss on early extinguishment of debt
|
|
|
(1,062
|
)
|
|
|
-
|
|
|
|
(1,062
|
)
|
|
|
-
|
|
Royalty interest obligation
|
|
|
(143
|
)
|
|
|
429
|
|
|
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(425
|
)
|
|
|
118
|
|
Other, net
|
|
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(39
|
)
|
|
|
(22
|
)
|
|
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(63
|
)
|
|
|
88
|
|
Total other expense, net
|
|
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(1,670
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)
|
|
|
(232
|
)
|
|
|
(2,427
|
)
|
|
|
(2,886
|
)
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Net loss
|
|
$
|
(8,296
|
)
|
|
$
|
(8,763
|
)
|
|
$
|
(20,190
|
)
|
|
$
|
(18,537
|
)
|
|
|
|
|
|
|
|
|
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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
|
|
|
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28,160,471
|
|
|
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13,623,668
|
|
|
|
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Pacira Pharmaceuticals, Inc.
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Condensed Consolidated Balance Sheets
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(unaudited)
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(in thousands)
|
|
|
|
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|
|
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|
|
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June 30,
|
|
December 31,
|
|
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2012
|
|
2011
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Assets
|
|
|
|
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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
|
Total assets
|
|
$
|
142,853
|
|
$
|
113,490
|
|
|
|
|
|
Liabilities and stockholders' equity
|
|
|
|
|
Current liabilities
|
|
$
|
15,236
|
|
$
|
31,911
|
Long-term debt and royalty interest obligation
|
|
|
25,940
|
|
|
20,074
|
Other long-term liabilities
|
|
|
7,172
|
|
|
13,236
|
Stockholders' equity
|
|
|
94,505
|
|
|
48,269
|
Total liabilities and stockholders' equity
|
|
$
|
142,853
|
|
$
|
113,490
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Source: Pacira Pharmaceuticals, Inc.
Company Contact: Pacira Pharmaceuticals, Inc. James S.
Scibetta, 973-254-3570 or Media Contact: Pure
Communications, Inc. Dan Budwick, 973-271-6085
|