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8-K - 8-K - Pacira BioSciences, Inc.a13-23147_18k.htm

Exhibit 99.1

 

 

 

NEWS RELEASE

 

FOR IMMEDIATE RELEASE

 

Pacira Pharmaceuticals, Inc. Reports Third Quarter EXPAREL® Revenue of $20.0 Million and Full Third Quarter 2013 Financial Results

 

Company Will Host Conference Call Today at 9:00 a.m. ET

 

PARSIPPANY, N.J., October 31, 2013 — 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 quarter ended September 30, 2013.

 

“The strong third quarter for EXPAREL sales was accelerated by increased traction in orthopedic surgeries and infiltration into the transversus abdominis plane (or iTAP) procedures,” said Dave Stack, president, chief executive officer and chairman of Pacira. “Driven by strategic partnerships, specialized education and training, as well as new clinical evidence, we are changing the standard of care for postsurgical pain management across different surgical specialties and audiences.”

 

Recent Highlights

 

·                  EXPAREL Commercialization: In the third quarter ended September 30, 2013, EXPAREL sales totaled $20.0 million, up from $15.2 million in the second quarter. Pacira continued its steady expansion of EXPAREL sales, reporting 297 total new accounts in the third quarter, an average of 23 new customers per week. As of September 30, 2013, 1,732 total accounts ordered EXPAREL since launch, with 165 accounts each ordering more than $100,000. The customer base has continued to grow along with acceptance and use of EXPAREL in hospitals that adopted the product early in the launch.

 

·                  Data Continues to Shift the Pain Control Paradigm and Support the Utility of EXPAREL Among Surgeons and Anesthesiologists:  As an increasing number of surgeons and anesthesiologists gain experience with EXPAREL, they are conducting and presenting their own independent findings across multiple surgical models. Last month, a 200-patient study evaluating the benefits of EXPAREL infiltration as the foundation of a multimodal postsurgical pain management regimen in patients undergoing total knee arthroplasty (TKA) versus femoral nerve block with a local anesthetic was presented at the 7th Annual Marshall Steele Orthopedic and Spine Summit in San Antonio. The study showed better pain control with improved knee flexion, shorter length of hospital stay and substantial cost savings among patients receiving EXPAREL.

 



 

·                  Strategic Partnerships: Earlier this month, Pacira launched into a promotional, 5-year agreement with CrossLink Bioscience, LLC, an orthopedic device distributor based in Atlanta. With CrossLink acting as a local agent and lead partner in current collaboration with additional distributors in select markets across the United States, the arrangement allows Pacira to partner with several hundred orthopedic distributor representatives to promote and sell EXPAREL.

 

Third Quarter 2013 Financial Results

 

·                  EXPAREL net product sales for the third quarter of 2013 totaled $20.0 million, a 340% increase compared to $4.6 million for the third quarter of 2012.

 

·                  Total revenues for the third quarter of 2013 were $23.3 million, a 174% increase compared to $8.5 million for the third quarter of 2012.

 

·                  Total operating expenses for the third quarter of 2013 were $36.1 million, compared to $24.2 million for the third quarter of 2012.

 

·                  Net loss for the third quarter of 2013 was $14.8 million, or $0.44 per share, compared to $15.7 million, or $0.49 per share, for the third quarter of 2012.

 

·                  Non-GAAP net loss was $10.0 million, or $0.30 per share, for the third quarter of 2013 compared to $14.0 million, or $0.43 per share, for the third quarter of 2012.

 

·                  Pacira ended the third quarter of 2013 with cash and cash equivalents, restricted cash and short-term investments (“cash”) of $83.8 million.

 

·                  As of September 30, 2013, the Company had approximately 33.5 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, Thursday, October 31, 2013, at 9 a.m. ET. The call can be accessed by dialing 1-866-318-8618 (domestic) or 1-617-399-5137 (international) five minutes prior to the start of the call and providing the passcode 26728091.

 

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 62860661.  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, non-GAAP net loss, that does not comply with United States generally accepted accounting principles (GAAP) 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 net loss below.

 

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 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 to include nerve block, including the timing and success of an sNDA; 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, 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.

 

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,

 

 

 

2013

 

2012

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

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

 

$

83,822

 

$

42,573

 

Accounts receivable, net

 

9,771

 

4,352

 

Inventories

 

15,606

 

12,077

 

Prepaid expenses and other current assets

 

2,486

 

1,920

 

Total current assets

 

111,685

 

60,922

 

Fixed assets, net

 

45,944

 

39,116

 

Goodwill

 

9,539

 

8,297

 

Intangibles, net

 

1,670

 

3,208

 

Other assets

 

3,557

 

511

 

Total assets

 

$

172,395

 

$

112,054

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

1,559

 

$

2,569

 

Accrued expenses

 

15,573

 

9,792

 

Convertible senior notes (*)

 

97,927

 

 

Current portion of royalty interest obligation

 

941

 

823

 

Current portion of deferred revenue

 

972

 

972

 

Total current liabilities

 

116,972

 

14,156

 

Long-term debt

 

 

25,191

 

Royalty interest obligation

 

403

 

857

 

Deferred revenue

 

2,991

 

3,720

 

Other liabilities

 

2,911

 

2,275

 

Total stockholders’ equity

 

49,118

 

65,855

 

Total liabilities and stockholders’ equity

 

$

172,395

 

$

112,054

 

 


(*) The convertible senior notes are contractually due in 2019. However, because of certain conditions that were met during the three months ended September 30, 2013, the note holders can redeem any time during the quarter ended December 31, 2013.

 



 

Pacira Pharmaceuticals, Inc.

Consolidated Statements of Operations

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

Revenues:

 

 

 

 

 

 

 

 

 

Net product sales

 

$

22,408

 

$

4,550

 

$

49,520

 

$

9,978

 

Collaborative licensing and development revenue

 

243

 

3,484

 

729

 

16,574

 

Royalty revenue

 

608

 

452

 

1,737

 

2,082

 

Total revenues

 

23,259

 

8,486

 

51,986

 

28,634

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Cost of revenues

 

14,791

 

9,287

 

36,396

 

22,467

 

Research and development

 

5,962

 

3,527

 

16,724

 

6,693

 

Selling, general and administrative

 

15,320

 

11,378

 

42,336

 

32,943

 

Total operating expenses

 

36,073

 

24,192

 

95,456

 

62,103

 

Loss from operations

 

(12,814

)

(15,706

)

(43,470

)

(33,469

)

 

 

 

 

 

 

 

 

 

 

Other (expense) income:

 

 

 

 

 

 

 

 

 

Interest income

 

62

 

87

 

207

 

218

 

Interest expense

 

(1,892

)

(456

)

(5,325

)

(1,464

)

Loss on early extinguishment of debt

 

 

 

(3,398

)

(1,062

)

Royalty interest obligation

 

(132

)

378

 

(379

)

(47

)

Other, net

 

(8

)

(48

)

(30

)

(111

)

Total other expense, net

 

(1,970

)

(39

)

(8,925

)

(2,466

)

Loss before income taxes

 

(14,784

)

(15,745

)

(52,395

)

(35,935

)

Income tax benefit

 

 

 

442

 

 

Net loss

 

$

(14,784

)

$

(15,745

)

$

(51,953

)

$

(35,935

)

 

 

 

 

 

 

 

 

 

 

Net loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.44

)

$

(0.49

)

$

(1.57

)

$

(1.21

)

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

33,359,576

 

32,436,207

 

33,050,721

 

29,585,716

 

 



 

Pacira Pharmaceuticals, Inc.

Reconciliation of GAAP to Non-GAAP Financial Information

(unaudited)

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

 

 

 

 

 

 

 

 

 

 

GAAP net loss

 

$

(14,784

)

$

(15,745

)

$

(51,953

)

$

(35,935

)

 

 

 

 

 

 

 

 

 

 

Non-GAAP adjustments:

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

3,777

 

1,469

 

8,227

 

3,220

 

Loss on extinguishment of debt

 

 

 

3,398

 

1,062

 

Non-cash debt discount amortization

 

1,035

 

260

 

2,924

 

571

 

Total Non-GAAP adjustments

 

$

4,812

 

$

1,729

 

$

14,549

 

$

4,853

 

 

 

 

 

 

 

 

 

 

 

Non-GAAP net loss

 

$

(9,972

)

$

(14,016

)

$

(37,404

)

$

(31,082

)

 

 

 

 

 

 

 

 

 

 

GAAP basic and diluted net loss per common share

 

$

(0.44

)

$

(0.49

)

$

(1.57

)

$

(1.21

)

Non-GAAP basic and diluted net loss per common share

 

$

(0.30

)

$

(0.43

)

$

(1.13

)

$

(1.05

)

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding - basic and diluted

 

33,359,576

 

32,436,207

 

33,050,721

 

29,585,716