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): February 25, 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 100, 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 February 25, 2014, we issued a press release announcing our results for the fourth quarter and full year ended December 31, 2013.  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 February 25, 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: February 25, 2014

By:

/s/ James Scibetta

 

 

James Scibetta
Senior Vice President and Chief Financial Officer

 

3


Exhibit 99.1

 

 

 

 

NEWS RELEASE

 

FOR IMMEDIATE RELEASE

 

Pacira Pharmaceuticals, Inc. Reports 2013 Financial Results: Fourth Quarter

EXPAREL Revenues Increase 53 Percent Over Third Quarter

 

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

 

PARSIPPANY, N.J., February 25, 2014 — Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today provided updates on the commercial success of EXPAREL® (bupivacaine liposome injectable suspension) for postsurgical pain in the United States and announced consolidated financial results for the fourth quarter and full year ended December 31, 2013.

 

“We are very pleased with the overall performance and trajectory that we have seen in the marketplace for EXPAREL this past year,” said Dave Stack, president, chief executive officer and chairman of Pacira. “Driven by the increase in sales among existing accounts as well as new customers purchasing EXPAREL, we saw a surge across all procedure types, with orthopedic and infiltration into the transversus abdominis plane (iTAP) procedures fueling rapid growth.”

 

Recent Highlights

 

·                  EXPAREL Commercialization: EXPAREL net product sales were $76.2 million in 2013, compared to $14.6 million in 2012, and EXPAREL net sales in the fourth quarter of 2013 were $30.5 million, up from $7.8 million in the fourth quarter of 2012. Since launch, 2,106 total accounts have ordered EXPAREL as of December 31, 2013, with approximately 250 accounts each ordering more than $100,000. The Company also reported 374 new accounts in the fourth quarter of 2013, averaging approximately 29 new accounts per week.

 

·                  Capacity Expansion for EXPAREL: Pacira announced in early December the submission of a Prior Approval Supplement (PAS) with the U.S. Food and Drug Administration (FDA) for an additional bulk manufacturing suite for EXPAREL at the Pacira FDA-approved Science Center Campus in San Diego. The FDA established a 4-month PDUFA goal, April 5, 2014, for approval of the manufacturing PAS.

 

Fourth Quarter 2013 Financial Results

 

·                  Total revenues were $33.6 million, compared to $10.5 million in the fourth quarter of 2012.

 

·                  Total operating expenses were $43.4 million, compared to $26.3 million in the fourth quarter of 2012.

 



 

·                  Net loss was $12.0 million, or $0.36 per share, compared to $16.3 million, or $0.50 per share, in the fourth quarter of 2012.

 

·                  Non-GAAP net loss was $7.6 million, or $0.23 per share, compared to $14.5 million, or $0.45 per share, in the fourth quarter of 2012.

 

Full-Year 2013 Financial Results

 

·                  Total revenues were $85.6 million, compared to $39.1 million in 2012.

 

·                  Total operating expenses were $138.8 million, compared to $88.4 million in 2012.

 

·                  Net loss was $63.9 million, or $1.93 per share, compared to $52.3 million, or $1.72 per share, in 2012.

 

·                  Non-GAAP net loss was $45.0 million, or $1.36 per share, compared to $45.6 million, or $1.50 per share, in 2012.

 

·                  Pacira ended 2013 with cash and cash equivalents, restricted cash and short-term investments (“cash”) of $73.8 million.

 

·                  As of December 31, 2013, the Company had approximately 33.6 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, Tuesday, February 25, 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.

 

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).  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 that does not comply with U.S. generally accepted accounting principles (GAAP), non-GAAP net loss, because it excludes stock-based compensation and other non-cash charges. This measure supplements our financial results prepared in accordance with GAAP. Pacira management uses this measure to better analyze its

 



 

financial results and to help make managerial decisions. In management’s opinion, this non-GAAP measure is useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira. Such a measure should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Such a non-GAAP net loss measure is also unlikely to be comparable with non-GAAP disclosures released by other companies. See a reconciliation of non-GAAP net 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 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, including for nerve block and the related timing and success of an sNDA; 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; 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)

 

 

 

December 31,

 

 

 

2013

 

2012

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents, restricted cash and short-term investments

 

$

73,785

 

$

42,573

 

Accounts receivable, net

 

14,590

 

4,352

 

Inventories

 

15,557

 

12,077

 

Prepaid expenses and other current assets

 

2,819

 

1,920

 

Total current assets

 

106,751

 

60,922

 

Fixed assets, net

 

48,182

 

39,116

 

Goodwill

 

10,328

 

8,297

 

Intangibles, net

 

1,157

 

3,208

 

Other assets

 

3,402

 

511

 

Total assets

 

$

169,820

 

$

112,054

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

3,069

 

$

2,569

 

Accrued expenses

 

17,885

 

9,792

 

Convertible senior notes (*)

 

98,961

 

 

Current portion of royalty interest obligation

 

1,020

 

823

 

Current portion of deferred revenue

 

1,008

 

972

 

Total current liabilities

 

121,943

 

14,156

 

Long-term debt

 

 

25,191

 

Royalty interest obligation

 

226

 

857

 

Deferred revenue

 

3,212

 

3,720

 

Other liabilities

 

3,190

 

2,275

 

Total stockholders’ equity

 

41,249

 

65,855

 

Total liabilities and stockholders’ equity

 

$

169,820

 

$

112,054

 

 

(*) The convertible senior notes are contractually due in 2019. However, because of certain conditions that were met during the three months ended December 31, 2013, the note holders can convert any time during the quarter ended March 31, 2014.

 



 

Pacira Pharmaceuticals, Inc.

Consolidated Statements of Operations

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended

 

Year Ended

 

 

 

December 31,

 

December 31,

 

 

 

2013

 

2012

 

2013

 

2012

 

Revenues:

 

 

 

 

 

 

 

 

 

Net product sales

 

$

32,435

 

$

8,213

 

$

81,956

 

$

18,191

 

Collaborative licensing and development revenue

 

243

 

1,816

 

972

 

18,390

 

Royalty revenue

 

886

 

421

 

2,623

 

2,503

 

Total revenues

 

33,564

 

10,450

 

85,551

 

39,084

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Cost of revenues

 

18,376

 

9,672

 

54,772

 

32,139

 

Research and development

 

4,836

 

3,244

 

21,560

 

9,937

 

Selling, general and administrative

 

20,172

 

13,363

 

62,508

 

46,306

 

Total operating expenses

 

43,384

 

26,279

 

138,840

 

88,382

 

Loss from operations

 

(9,820

)

(15,829

)

(53,289

)

(49,298

)

 

 

 

 

 

 

 

 

 

 

Other (expense) income:

 

 

 

 

 

 

 

 

 

Interest income

 

52

 

57

 

259

 

275

 

Interest expense

 

(1,928

)

(343

)

(7,253

)

(1,807

)

Loss on early extinguishment of debt

 

 

 

(3,398

)

(1,062

)

Royalty interest obligation

 

(244

)

(230

)

(623

)

(278

)

Other, net

 

(16

)

(1

)

(47

)

(111

)

Total other expense, net

 

(2,136

)

(517

)

(11,062

)

(2,983

)

Loss before income taxes

 

(11,956

)

(16,346

)

(64,351

)

(52,281

)

Income tax benefit

 

 

 

442

 

 

Net loss

 

$

(11,956

)

$

(16,346

)

$

(63,909

)

$

(52,281

)

Net loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.36

)

$

(0.50

)

$

(1.93

)

$

(1.72

)

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

33,575,416

 

32,570,711

 

33,181,895

 

30,331,965

 

 



 

Pacira Pharmaceuticals, Inc.

Reconciliation of GAAP to Non-GAAP Financial Information

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended

 

Year Ended

 

 

 

December 31,

 

December 31,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

 

$

(11,956

)

$

(16,346

)

$

(63,909

)

$

(52,281

)

 

 

 

 

 

 

 

 

 

 

Non-GAAP adjustments:

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

3,286

 

1,556

 

11,513

 

4,776

 

Loss on early extinguishment of debt

 

 

 

3,398

 

1,062

 

Non-cash debt discount amortization

 

1,035

 

260

 

3,959

 

831

 

Total Non-GAAP adjustments

 

4,321

 

1,816

 

18,870

 

6,669

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP net loss

 

$

(7,635

)

$

(14,530

)

$

(45,039

)

$

(45,612

)

 

 

 

 

 

 

 

 

 

 

GAAP basic and diluted net loss per common share

 

$

(0.36

)

$

(0.50

)

$

(1.93

)

$

(1.72

)

Non-GAAP basic and diluted net loss per common share

 

$

(0.23

)

$

(0.45

)

$

(1.36

)

$

(1.50

)

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding - basic and diluted

 

33,575,416

 

32,570,711

 

33,181,895

 

30,331,965