8-K


 
 

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): May 2, 2016
PACIRA PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
 
001-35060
 
51-0619477
(State or other jurisdiction of incorporation)
 
(Commission File Number)
 
(IRS Employer Identification No.)

5 Sylvan Way, Suite 300
Parsippany, New Jersey 07054
(Address and Zip Code of Principal Executive Offices)

(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 May 2, 2016, we issued a press release announcing our results for the first quarter ended March 31, 2016. 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.

Exhibit
No.
 
Description
 
 
 
99.1
 
Earnings Press Release dated May 2, 2016






SIGNATURE

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

 
 
 
PACIRA PHARMACEUTICALS, INC.
(REGISTRANT)
 
 
 
 
Dated:
May 2, 2016
By:
/s/ KRISTEN WILLIAMS
 
 
 
Kristen Williams
 
 
 
Chief Administrative Officer
 
 
 
General Counsel and Secretary



Exhibit

NEWS RELEASE

FOR IMMEDIATE RELEASE


Pacira Pharmaceuticals, Inc. Reports First Quarter 2016 Financial Results

-- Total Net Revenues Up 12 Percent Year-Over-Year --
-- EXPAREL® Net Revenues Up 14 Percent Year-Over-Year --
-- Conference Call Today at 9 a.m. ET --

PARSIPPANY, N.J., May 2, 2016 - Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) today provided updates on EXPAREL® (bupivacaine liposome injectable suspension) for postsurgical pain in the United States and announced consolidated financial results for the first quarter ended March 31, 2016.

“With immense leverage across our organization from manufacturing to financials, we began our aggressive investment in the future growth of Pacira in the first quarter of 2016,” said Dave Stack, Chief Executive Officer and Chairman. “In this short amount of time, we were able to enhance our executive team with two important hires, initiate two Phase 3 studies for the EXPAREL nerve block indication and initiate a randomized controlled trial in total knee arthroplasty to establish best practice for best outcomes with EXPAREL. As we prepare for our oral surgery launch later this year, we look forward to further investments in the expanded use of EXPAREL and development of pipeline opportunities.”

Recent Highlights

Key Executive Appointments to Support Company’s Future Growth: Pacira recently announced the appointment of two key executives to the Pacira management team. As Chief Financial Officer, Charles A. Reinhart III will be responsible for all financial and capital market activities, including accounting, financial reporting, financial planning and analysis and investor relations. He will succeed former Chief Financial Officer Jim Scibetta, who will continue to serve as President, and will report to Dave Stack. As Chief Commercial Officer, Robert Weiland will oversee commercial activities for EXPAREL, which include marketing, sales, national accounts, training and commercial operations and analytics. He will report to Jim Scibetta.

Initiation of Important Clinical Studies for EXPAREL: Pacira initiated two Phase 3 clinical trials that will serve as the basis of the supplemental New Drug Application (sNDA) to be filed for EXPAREL use in nerve block to provide postsurgical analgesia. One study will assess brachial plexus block with EXPAREL in patients undergoing total shoulder arthroplasty or rotator cuff repair. The second study will evaluate femoral nerve





block with EXPAREL for patients undergoing total knee arthroplasty. Pacira also initiated a randomized controlled trial comparing local infiltration analgesia with EXPAREL to local infiltration analgesia without EXPAREL in total knee arthroplasty. This study is intended to provide a procedure-specific protocol on appropriate technique and administration for producing optimal outcomes with EXPAREL.

First Quarter 2016 Financial Results

EXPAREL net product revenues were $63.8 million in the first quarter of 2016, compared to $56.0 million in the first quarter of 2015.

Total revenues were $65.5 million in the first quarter of 2016, compared to $58.3 million in the first quarter of 2015.

Total operating expenses were $67.7 million in the first quarter of 2016, compared to $55.0 million in the first quarter of 2015.

GAAP net loss was $3.9 million, or $(0.10) per share (basic and diluted), in the first quarter of 2016, compared to GAAP net income of $1.3 million, or $0.03 per share (basic and diluted), in the first quarter of 2015.

Non-GAAP net income was $5.7 million, or $0.15 per share (basic) and $0.14 per share (diluted), in the first quarter of 2016, compared to non-GAAP net income of $9.8 million, or $0.27 per share (basic) and $0.23 per share (diluted), in the first quarter of 2015.

Pacira ended the first quarter of 2016 with cash and cash equivalents, short-term investments and long-term investments (“cash”) of $163.5 million.

Pacira had 37.0 million basic and 41.1 million diluted weighted average shares of common stock outstanding in the first quarter of 2016.

2016 Outlook

Pacira affirms that it expects the following operating expenses for 2016:

Non-GAAP research and development (R&D) expense of $60 million to $70 million.

Non-GAAP selling, general and administrative (SG&A) expense of $125 million to $135 million.

Stock-based compensation expense of $35 million to $40 million.








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 developments today, Monday, May 2, 2016, at 9 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 54803652.

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 54803652. 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, because such measures exclude stock-based compensation and amortization of debt discount. These measures supplement our financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future R&D, SG&A and stock-based compensation outlook for 2016 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 and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP net income measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See a reconciliation of non-GAAP net income to GAAP net income (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 flagship product, EXPAREL® (bupivacaine liposome injectable suspension), indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia, was commercially launched in the United States in April 2012. EXPAREL and two other products have successfully utilized DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and 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 currently 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. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain score with up to a 45 percent 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, outlook and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may” 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 use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications; the outcome of the U.S. Department of Justice inquiry; 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 UK Limited’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, 2015 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. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such 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
jessica.cho@pacira.com
    
Media Contact:
Coyne Public Relations
Alyssa Schneider, (973) 588-2270
aschneider@coynepr.com
 
(Tables to Follow)



Pacira Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
 
March 31,
2016
 
December 31,
2015
ASSETS
 

 
 

Current assets:
 

 
 

     Cash, cash equivalents and short-term investments
$
150,021

 
$
158,965

     Accounts receivable, net
25,901

 
25,855

     Inventories, net
63,744

 
61,645

     Prepaid expenses and other current assets
8,959

 
6,117

          Total current assets
248,625

 
252,582

Long-term investments
13,470

 
13,462

Fixed assets, net
95,846

 
90,324

Goodwill
32,784

 
30,880

Intangibles, net

 
81

Other assets
481

 
406

          Total assets
$
391,206

 
$
387,735

 
 
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
 

 
 

Current liabilities:
 

 
 

     Accounts payable
$
10,484

 
$
8,739

     Accrued expenses
29,067

 
35,375

     Convertible senior notes (*)
105,215

 
104,040

     Current portion of deferred revenue
1,275

 
1,426

     Income taxes payable
98

 
208

          Total current liabilities
146,139

 
149,788

Deferred revenue
7,877

 
8,082

Other liabilities
11,020

 
11,473

Total stockholders’ equity
226,170

 
218,392

          Total liabilities and stockholders’ equity
$
391,206

 
$
387,735


(*) The convertible senior notes are contractually due in 2019. However, because of certain conditions that were met during the three months ended March 31, 2016, the note holders can convert any time during the quarter ended June 30, 2016.




Pacira Pharmaceuticals, Inc.
Consolidated Statements of Operations
(unaudited)
(in thousands, except per share amounts)
 
Three Months Ended
 
March 31,
 
2016
 
2015
 Net product sales:
 
 
 
      EXPAREL
$
63,752

 
$
55,951

      DepoCyt(e)
750

 
1,135

 Total net product sales
64,502

 
57,086

 Collaborative licensing and milestone revenue
356

 
356

 Royalty revenue
616

 
874

      Total revenues
65,474

 
58,316

 
 
 
 
Operating expenses:
 

 
 

     Cost of goods sold
20,278

 
17,580

     Research and development
9,493

 
5,967

     Selling, general and administrative
37,957

 
31,428

          Total operating expenses
67,728

 
54,975

Income (loss) from operations
(2,254
)
 
3,341

 
 
 
 
Other (expense) income:
 

 
 

     Interest income
252

 
155

     Interest expense
(1,868
)
 
(1,996
)
     Royalty interest obligation

 
(71
)
     Other, net
48

 
(117
)
          Total other expense, net
(1,568
)
 
(2,029
)
Income (loss) before income taxes
(3,822
)
 
1,312

     Income tax expense
(32
)
 
(52
)
Net income (loss)
$
(3,854
)
 
$
1,260

 
 
 
 
Net income (loss) per share:
 

 
 

     Basic and diluted net income (loss) per common share
$
(0.10
)
 
$
0.03

Weighted average common shares outstanding:
 

 
 

     Basic
37,020

 
36,235

     Diluted
37,020

 
41,779





Pacira Pharmaceuticals, Inc.
Reconciliation of GAAP to Non-GAAP Financial Information
(unaudited)
(in thousands, except per share amounts)
 
Three Months Ended
 
March 31,
 
2016
 
2015
 
 
 
 
GAAP net income (loss)
$
(3,854
)
 
$
1,260

 
 
 
 
Non-GAAP adjustments:
 
 
 
     Stock-based compensation
8,490

 
7,517

     Non-cash debt discount amortization
1,022

 
1,035

          Total Non-GAAP adjustments
9,512

 
8,552

 
 
 
 
Non-GAAP net income
$
5,658

 
$
9,812

 
 
 
 
GAAP basic and diluted net income (loss) per common share
$
(0.10
)
 
$
0.03

 
 
 
 
Non-GAAP basic net income per common share
$
0.15

 
$
0.27

Non-GAAP diluted net income per common share
$
0.14

 
$
0.23

 
 
 
 
Weighted average common shares outstanding - basic
37,020

 
36,235

Weighted average common shares outstanding - diluted
41,144

 
41,779

 
 
 
 
Cost of goods sold reconciliation:
 
 
 
GAAP cost of goods sold
$
20,278

 
$
17,580

     Stock-based compensation expense
(1,549
)
 
(1,103
)
Non-GAAP cost of goods sold
$
18,729

 
$
16,477

 
 
 
 
Research and development reconciliation:
 
 
 
GAAP research and development
$
9,493

 
$
5,967

     Stock-based compensation expense
(893
)
 
(1,510
)
Non-GAAP research and development
$
8,600

 
$
4,457

 
 
 
 
Selling, general and administrative reconciliation:
 
 
 
GAAP selling, general and administrative
$
37,957

 
$
31,428

     Stock-based compensation expense
(6,048
)
 
(4,904
)
Non-GAAP selling, general and administrative
$
31,909

 
$
26,524