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): November 7, 2019
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||
(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:
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading symbol | Name of each exchange on which registered | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02. Results of Operations and Financial Condition.
On November 7, 2019, Pacira BioSciences, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2019. 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 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 Number | Description | |
99.1 | ||
104 | Cover Page Interactive Data File (Formatted as Inline XBRL) | |
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 BIOSCIENCES, INC. (REGISTRANT) | |||
Dated: | November 7, 2019 | By: | /s/ KRISTEN WILLIAMS |
Kristen Williams | |||
Chief Administrative Officer and Secretary | |||
FOR IMMEDIATE RELEASE
NEWS RELEASE
Pacira BioSciences Reports Third Quarter 2019 Financial Results and Business Update
-- Total revenues increased 25 percent over prior year to $104.7 million in third quarter --
-- Conference call today at 8:30 a.m. ET --
PARSIPPANY, N.J., November 7, 2019 - Pacira BioSciences, Inc. (Nasdaq: PCRX), a leading provider of innovative non-opioid pain management options, today reported financial results for the third quarter of 2019.
“This continues to be an outstanding year for Pacira marked by significant growth in our EXPAREL business and by an important and promising asset addition in iovera,” said Dave Stack, chairman and chief executive officer of Pacira BioSciences. “Anesthesia remains a key driver of our business through the increasing use of nerve and field blocks, as well as the accelerating volume of ambulatory procedures. Our Phase 3 EXPAREL label expansion studies are on track with topline results from the pediatric study expected later this year and patient enrollment in the lower extremity nerve block study set to begin soon. We are also advancing Phase 4 studies to expand utilization in high potential procedures, such as cesarean section, spine, and hip fracture. Our significant orthopedic partnership with Johnson & Johnson is solidifying the role of EXPAREL in opioid-sparing protocols that are enabling the shift of painful procedures to the ambulatory setting. On the regulatory front, the team is advancing our strategy to introduce EXPAREL into target markets outside of the U.S. As for iovera°, commercial initiatives are well underway and we are very encouraged by the loyalty of our existing customers and the interest we are generating for new business within large health systems.”
Third Quarter 2019 Financial Results
• | Total revenues were $104.7 million in the third quarter of 2019, a 25 percent increase over the $83.4 million reported for the third quarter of 2018. |
• | Total net product sales were $104.4 million in the third quarter of 2019, a 26 percent increase over the $82.7 million reported for the third quarter of 2018. |
• | Net product sales of EXPAREL/bupivacaine liposome injectable suspension were $101.7 million in the third quarter of 2019, a 23 percent increase over the $82.7 million reported for the third quarter of 2018. |
• | EXPAREL net product sales were $101.5 million in the third quarter of 2019, compared to $82.2 million in the third quarter of 2018. Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in animals were $0.3 million in the third quarter of 2019, compared to $0.5 million in the third quarter of 2018. |
• | iovera° net product sales during the third quarter of 2019 were $2.6 million. Pacira began recognizing sales of iovera° in April 2019 after completing its acquisition of MyoScience, Inc., a privately held medical technology company. |
• | Total operating expenses were $102.3 million in the third quarter of 2019, compared to $79.4 million in the third quarter of 2018. |
• | GAAP net loss was $6.1 million, or $0.15 per diluted share, in the third quarter of 2019, compared to $0.6 million, or $0.02 per diluted share, in the third quarter of 2018. |
• | Non-GAAP net income was $20.2 million, or $0.48 per diluted share, in the third quarter of 2019, compared to $12.8 million, or $0.31 per diluted share, in the third quarter of 2018. |
• | Pacira ended the third quarter of 2019 with cash, cash equivalents, short-term and long-term investments (“cash”) of $336.2 million. Cash provided by operations was $44.6 million in the nine months ended September 30, 2019, compared to $27.7 million in the nine months ended September 30, 2018. |
See “Non-GAAP Financial Information” below.
Recent Business Highlights
• | Appointment of Chris Christie to board of directors. In September, Pacira announced the appointment of Christopher J. Christie to its board of directors. Mr. Christie served as the 55th Governor of the State of New Jersey from January 2010 to January 2018. During these two successful terms, Christie significantly raised public consciousness around the acceleration of opioid and other drug-related deaths. His administration mandated new approaches to address the stigma around drug addiction and focused on making treatments more broadly available. |
• | Enrollment completion in multicenter registration study of EXPAREL in pediatric patients In September, Pacira announced completion of enrollment in its Phase 3 study of EXPAREL administered as a single-dose infiltration in pediatric patients aged six to less than 17 years undergoing spinal or cardiac surgeries. Pacira expects these study results to provide the foundation for a supplemental New Drug Application submission to the U.S. Food and Drug Administration (FDA) seeking expansion of the EXPAREL label to include children aged six and over. |
2019 Financial Guidance
Pacira reiterated its full year 2019 financial guidance as follows:
• | EXPAREL net product sales in the range of $400 million to $410 million. |
• | iovera° net product sales in the range of $8 million to $10 million. |
• | Non-GAAP gross margins in the range of 75% to 76%. |
• | Non-GAAP research and development (R&D) expense in the range of $60 million to $70 million. |
• | Non-GAAP SG&A expense in the range of $180 million to $190 million. |
• | Stock-based compensation in the range of $30 million to $35 million. |
See “Reconciliation of GAAP to Non-GAAP 2019 Financial Guidance” below.
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, Thursday, November 7, 2019, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 8077145. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the “Events” page on the Pacira website at investor.pacira.com.
For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 8077145. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately 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), such as non-GAAP net income, non-GAAP net income per share, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) expense and non-GAAP selling, general and administrative (SG&A) expense, because such measures exclude milestone revenue; acquisition-related charges and product discontinuation costs; stock-based compensation; amortization of debt discount; amortization of acquired intangible assets; an income tax benefit and step-up in basis of inventory in connection with the acquisition of MyoScience, Inc.; and loss on investment and other non-operating income.
These measures supplement Pacira’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D expense and SG&A expense outlook for 2019 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 its future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, and a reconciliation of our GAAP to non-GAAP 2019 financial guidance for gross margins, R&D expense and SG&A expense.
About Pacira BioSciences
Pacira BioSciences, Inc. (Nasdaq: PCRX) is a leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company’s long-acting local analgesic, EXPAREL® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes 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. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more
about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.
About EXPAREL®
EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. 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 scores with up to a 78 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 for Patients
EXPAREL should not be used in obstetrical paracervical block anesthesia.
In studies where EXPAREL was injected into the wound, the most common side effects were nausea, constipation, and vomiting.
In studies where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation.
EXPAREL is not recommended to be used in patients younger than 18 years old or in pregnant women.
Tell your healthcare provider if you have liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from your body.
EXPAREL should not be injected into the spine, joints, or veins.
The active ingredient in EXPAREL:
• | Can affect your nervous system and your cardiovascular system |
• | May cause an allergic reaction |
• | May cause damage if injected into your joints. |
About iovera°
The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.1 The iovera° system’s “1×90” Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.
Important Safety Information
The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud’s disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the counter analgesics.
Forward-Looking Statements
Any statements in this press release about the company’s future expectations, plans, outlook, projections and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,” “will,” “would,” “could,” “can” 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 the company’s 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 the company’s ability to serve those markets; the company’s plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company’s existing business; the commercial success of iovera° and other factors discussed in the “Risk Factors” of the company’s most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company’s views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated
1Radnovich, R. et al. “Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial.” Osteoarthritis and Cartilage (2017) p1-10.
or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.
###
Investor Contact:
Susan Mesco, (973) 451-4030
susan.mesco@pacira.com
Media Contact:
Coyne Public Relations
Alyssa Schneider, (973) 588-2270
aschneider@coynepr.com
(Tables to Follow)
Pacira BioSciences, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
September 30, 2019 | December 31, 2018 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash, cash equivalents and short-term investments | $ | 265,644 | $ | 383,454 | |||
Accounts receivable, net | 42,573 | 38,000 | |||||
Inventories, net | 60,238 | 48,569 | |||||
Prepaid expenses and other current assets | 10,392 | 7,946 | |||||
Total current assets | 378,847 | 477,969 | |||||
Long-term investments | 70,577 | 25,871 | |||||
Fixed assets, net | 104,856 | 108,670 | |||||
Right-of-use assets, net | 35,756 | — | |||||
Goodwill | 99,547 | 62,040 | |||||
Intangible assets, net | 106,354 | — | |||||
Equity investment and other assets | 11,552 | 14,803 | |||||
Total assets | $ | 807,489 | $ | 689,353 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 16,064 | $ | 14,368 | |||
Accrued expenses | 61,002 | 45,865 | |||||
Lease liabilities | 5,043 | — | |||||
Convertible senior notes (1) | — | 338 | |||||
Contingent consideration | 13,591 | — | |||||
Income taxes payable | 138 | 90 | |||||
Total current liabilities | 95,838 | 60,661 | |||||
Convertible senior notes (2) | 302,081 | 290,592 | |||||
Lease liabilities | 38,882 | — | |||||
Contingent consideration | 22,206 | — | |||||
Other liabilities | 2,320 | 16,874 | |||||
Total stockholders’ equity | 346,162 | 321,226 | |||||
Total liabilities and stockholders’ equity | $ | 807,489 | $ | 689,353 | |||
(1) Relates to our 3.25% convertible senior notes due 2019 that matured on February 1, 2019.
(2) Relates to our 2.375% convertible senior notes due 2022 that are not currently convertible.
Pacira BioSciences, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
Three Months Ended | Nine Months Ended | ||||||||||||||
September 30, | September 30, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Net product sales: | |||||||||||||||
EXPAREL | $ | 101,456 | $ | 82,226 | $ | 290,938 | $ | 236,690 | |||||||
Bupivacaine liposome injectable suspension | 255 | 482 | 1,468 | 1,023 | |||||||||||
Total EXPAREL / bupivacaine liposome injectable suspension net product sales | 101,711 | 82,708 | 292,406 | 237,713 | |||||||||||
iovera° | 2,639 | — | 4,674 | — | |||||||||||
Total net product sales | 104,350 | 82,708 | 297,080 | 237,713 | |||||||||||
Collaborative licensing and milestone revenue | — | — | — | 3,000 | |||||||||||
Royalty revenue | 335 | 740 | 1,522 | 1,450 | |||||||||||
Total revenues | 104,685 | 83,448 | 298,602 | 242,163 | |||||||||||
Operating expenses: | |||||||||||||||
Cost of goods sold | 22,304 | 19,065 | 74,809 | 62,866 | |||||||||||
Research and development | 20,255 | 14,897 | 52,466 | 41,514 | |||||||||||
Selling, general and administrative | 50,128 | 44,179 | 146,559 | 132,619 | |||||||||||
Amortization of acquired intangible assets | 1,967 | — | 3,736 | — | |||||||||||
Acquisition-related charges and product discontinuation, net | 7,618 | 1,259 | 12,266 | 1,511 | |||||||||||
Total operating expenses | 102,272 | 79,400 | 289,836 | 238,510 | |||||||||||
Income from operations | 2,413 | 4,048 | 8,766 | 3,653 | |||||||||||
Other (expense) income: | |||||||||||||||
Interest income | 1,736 | 1,586 | 5,709 | 4,493 | |||||||||||
Interest expense | (5,940 | ) | (5,642 | ) | (17,631 | ) | (16,195 | ) | |||||||
Other, net | (4,025 | ) | (694 | ) | (4,051 | ) | (699 | ) | |||||||
Total other expense, net | (8,229 | ) | (4,750 | ) | (15,973 | ) | (12,401 | ) | |||||||
Loss before income taxes | (5,816 | ) | (702 | ) | (7,207 | ) | (8,748 | ) | |||||||
Income tax (expense) benefit | (271 | ) | 62 | 1,079 | (8 | ) | |||||||||
Net loss | $ | (6,087 | ) | $ | (640 | ) | $ | (6,128 | ) | $ | (8,756 | ) | |||
Net loss per share: | |||||||||||||||
Basic and diluted net loss per common share | $ | (0.15 | ) | $ | (0.02 | ) | $ | (0.15 | ) | $ | (0.21 | ) | |||
Weighted average common shares outstanding: | |||||||||||||||
Basic and diluted | 41,645 | 40,995 | 41,423 | 40,833 | |||||||||||
Pacira BioSciences, Inc.
Reconciliation of GAAP to Non-GAAP Financial Information
(in thousands, except per share amounts)
(unaudited)
Three Months Ended | Nine Months Ended | ||||||||||||||
September 30, | September 30, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
GAAP net loss | $ | (6,087 | ) | $ | (640 | ) | $ | (6,128 | ) | $ | (8,756 | ) | |||
Non-GAAP adjustments: | |||||||||||||||
Milestone revenue | — | — | — | (3,000 | ) | ||||||||||
Acquisition-related charges and product discontinuation, net | 7,618 | 1,259 | 12,266 | 1,511 | |||||||||||
Stock-based compensation | 9,244 | 8,108 | 24,461 | 23,539 | |||||||||||
Amortization of debt discount | 3,467 | 3,228 | 10,216 | 9,512 | |||||||||||
Amortization of acquired intangible assets | 1,967 | — | 3,736 | — | |||||||||||
Income tax benefit in connection with acquisition | — | — | (1,828 | ) | — | ||||||||||
Recognition of step-up basis in inventory from acquisition | — | — | 220 | — | |||||||||||
Loss on investment and other non-operating income, net | 3,957 | 854 | 3,957 | 854 | |||||||||||
Total Non-GAAP adjustments | 26,253 | 13,449 | 53,028 | 32,416 | |||||||||||
Non-GAAP net income | $ | 20,166 | $ | 12,809 | $ | 46,900 | $ | 23,660 | |||||||
GAAP basic and diluted net loss per common share | $ | (0.15 | ) | $ | (0.02 | ) | $ | (0.15 | ) | $ | (0.21 | ) | |||
Non-GAAP basic net income per common share | $ | 0.48 | $ | 0.31 | $ | 1.13 | $ | 0.58 | |||||||
Non-GAAP diluted net income per common share | $ | 0.48 | $ | 0.31 | $ | 1.11 | $ | 0.57 | |||||||
Weighted average common shares outstanding - basic | 41,645 | 40,995 | 41,423 | 40,833 | |||||||||||
Weighted average common shares outstanding - diluted | 42,404 | 41,974 | 42,289 | 41,752 | |||||||||||
Cost of goods sold reconciliation: | |||||||||||||||
GAAP cost of goods sold | $ | 22,304 | $ | 19,065 | $ | 74,809 | $ | 62,866 | |||||||
Recognition of step-up basis in inventory from acquisition | — | — | (220 | ) | — | ||||||||||
Stock-based compensation | (1,243 | ) | (1,179 | ) | (3,490 | ) | (3,431 | ) | |||||||
Non-GAAP cost of goods sold | $ | 21,061 | $ | 17,886 | $ | 71,099 | $ | 59,435 | |||||||
Research and development reconciliation: | |||||||||||||||
GAAP research and development | $ | 20,255 | $ | 14,897 | $ | 52,466 | $ | 41,514 | |||||||
Stock-based compensation | (1,297 | ) | (1,122 | ) | (3,772 | ) | (2,770 | ) | |||||||
Non-GAAP research and development | $ | 18,958 | $ | 13,775 | $ | 48,694 | $ | 38,744 | |||||||
Selling, general and administrative reconciliation: | |||||||||||||||
GAAP selling, general and administrative | $ | 50,128 | $ | 44,179 | $ | 146,559 | $ | 132,619 | |||||||
Stock-based compensation | (6,704 | ) | (5,807 | ) | (17,199 | ) | (17,338 | ) | |||||||
Non-GAAP selling, general and administrative | $ | 43,424 | $ | 38,372 | $ | 129,360 | $ | 115,281 | |||||||
Pacira BioSciences, Inc.
Reconciliation of GAAP to Non-GAAP 2019 Financial Guidance
(dollars in millions)
(unaudited)
GAAP to Non-GAAP Guidance | GAAP | Stock-Based Compensation and Other | Non-GAAP | |||
EXPAREL net product sales | $400 to $410 | — | — | |||
iovera° net product sales (1) | $8 to $10 | — | — | |||
Gross margin | 74% to 75% | Approx. 1% | 75% to 76% | |||
Research and development expense | $65 to $76 | $5 to $6 | $60 to $70 | |||
Selling, general and administrative expense | $202 to $214 | $22 to $24 | $180 to $190 | |||
Stock-based compensation | $30 to $35 | — | — | |||
(1) From the April 9, 2019 acquisition date onward.