UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): October 30, 2014

 

PACIRA PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-35060

 

51-0619477

(State or other jurisdiction

 

(Commission

 

(IRS Employer

of incorporation)

 

File Number)

 

Identification No.)

 

5 Sylvan Way, Suite 300, Parsippany, New Jersey 07054
(Address of principal executive offices) (Zip Code)

 

(973) 254-3560
Registrant’s telephone number, including area code

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 2.02. Results of Operations and Financial Condition.

 

On October 30, 2014, we issued a press release announcing our results for the third quarter ended September 30, 2014.  The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Item 2.02 of Form 8-K and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) The following exhibits are included in this report:

 

Exhibit
No.

 

Description

99.1

 

Earnings Press Release dated October 30, 2014

 

2



 

Signatures

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Pacira Pharmaceuticals, Inc.

 

 

 

Date: October 30, 2014

By:

/s/ James Scibetta

 

 

James Scibetta

 

 

Senior Vice President and Chief Financial Officer

 

3


Exhibit 99.1

 

NEWS RELEASE

 

Pacira Pharmaceuticals, Inc. Reports Third Quarter EXPAREL Revenue of

$50.2 Million and Third Quarter 2014 Results

 

Company Will Host Conference Call Today at 9 a.m. ET

 

PARSIPPANY, N.J., October 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.

 

Company Contact:

Pacira Pharmaceuticals, Inc.

Jessica Cho, (973) 254-3574

 

Media Contact:

Pure Communications, Inc.

Susan Heins, (864) 286-9597

 

(Tables Follow)

 



 

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