PACIRA BIOSCIENCES, INC. -- Third quarter GAAP net income of
-- Conference call today at
Third Quarter 2021 Financial Highlights
- Total revenues of
$127.7 million - GAAP net income of
$17.7 million , or$0.40 per share (basic) and$0.39 per share (diluted) - Adjusted EBITDA (non-GAAP) of
$48.1 million
“Throughout the third quarter we made significant progress advancing our corporate growth strategy. We delivered solid topline growth and EXPAREL continues to significantly outpace the recovery of the elective surgery market, which is facing ongoing pandemic-related challenges. This underscores the growing adoption of EXPAREL in outpatient settings, non-elective procedures and beyond. October saw a positive shift in market dynamics, and we expect the fourth quarter to return to more robust year-over-year topline growth,” said
The company provides weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com.
Third Quarter 2021 Financial Results
- Total revenues were
$127.7 million in the third quarter of 2021, versus the$117.5 million reported for the third quarter of 2020. - EXPAREL net product sales were
$121.9 million in the third quarter of 2021, versus the$113.7 million reported for the third quarter of 2020. The number of EXPAREL selling days were 64 in the third quarter of 2021, versus 65 in the third quarter of 2020. - Third quarter 2021 iovera° net product sales were
$4.2 million , versus the$2.7 million reported for the third quarter of 2020. - Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were
$0.7 million in the third quarter of 2021, versus the$0.4 million reported for the third quarter of 2020. - Third quarter 2021 royalty and collaborative licensing and milestone revenues were
$0 .9 million, versus the$0.6 million reported for the third quarter of 2020. - Total operating expenses were
$96.3 million in the third quarter of 2021, versus the$99.9 million reported for the third quarter of 2020. - Research and development (R&D) expenses were
$11.6 million in the third quarter of 2021, compared to$14.7 million in the third quarter of 2020. R&D expenses included$4.7 million and$5.6 million of product development and manufacturing capacity expansion costs in the third quarters of 2021 and 2020, respectively. - Selling, general and administrative (SG&A) expenses were
$48.8 million in the third quarter of 2021, compared to$52.6 million in the third quarter of 2020. - GAAP net income was
$17.7 million , or$0.40 per share (basic) and$0.39 per share (diluted), in the third quarter of 2021, compared to GAAP net income of$130.1 million , or$3.03 per share (basic) and$2.94 per share (diluted), in the third quarter of 2020. Included in GAAP net income in the third quarter of 2020 was a$124.6 million income tax benefit related to the release of a valuation allowance on deferred tax assets. - Non-GAAP net income was
$32.5 million , or$0.73 per share (basic) and$0.72 per share (diluted), in the third quarter of 2021, compared to non-GAAP net income of$29.9 million , or$0.70 per share (basic) and$0.68 per share (diluted), in the third quarter of 2020. - Adjusted EBITDA (non-GAAP) was
$48.1 million in the third quarter of 2021, compared to$34.2 million in the third quarter of 2020. - Pacira ended the third quarter of 2021 with cash, cash equivalents and short-term available-for-sale investments (“cash”) of
$693.9 million . Cash provided by operations was$60.3 million in the third quarter of 2021, compared to$39.8 million in the third quarter of 2020. - Pacira had 44.5 million basic and 45.5 million diluted weighted average shares of common stock outstanding in the third quarter of 2021.
See “Non-GAAP Financial Information” below.
Recent Business Highlights
- Acquisition of Flexion Therapeutics further expanding leadership position in non-opioid pain management. On
October 11, 2021 ,Pacira and Flexion Therapeutics, Inc. announced a definitive agreement for Pacira to acquire Flexion for$8.50 per share in cash, plus one non-tradeable contingent value right (CVR) worth up to$8.00 per share in cash. The CVR is payable (subject to certain terms and conditions) in the event certain sales and/or regulatory milestones are achieved. - New EXPAREL Patents. In
October 2021 , Pacira received two Notices of Allowance from the United States Patent and Trademark Office. One patent claims chemical composition of EXPAREL and the other claims a novel manufacturing process. After issuance, Pacira will submit the composition patent for listing in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). The patents will have an expiration date ofJanuary 22, 2041 . - Commercial production underway with enhanced EXPAREL manufacturing process at
Swindon facility. InSeptember 2021 , Pacira announced that it had successfully completed process validation and EXPAREL commercial production is underway at its custom 200-liter manufacturing suite inSwindon, England . - Publication of Phase 3 study of EXPAREL infiltration in pediatric patients undergoing spinal or cardiac surgeries. In
September 2021 , Pacira announced that full results of its Phase 3 PLAY study of EXPAREL administered via infiltration in pediatric patients undergoing spinal or cardiac surgeries have been published inJournal of Clinical Anesthesia . The study, which was designed to establish the safety and pharmacokinetics (PK) of EXPAREL in a pediatric population, found the PK profile was comparable across age groups and generally consistent with the profile in adult patients.
Financial Guidance
The company’s net product sales were negatively impacted by the COVID-19 pandemic in 2020 due to the significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in
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,
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 5562638. 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
These measures supplement the company’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, R&D expense and SG&A expense outlook for 2021 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 of 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.
About
About EXPAREL®
EXPAREL (bupivacaine liposome injectable suspension) is indicated in patients 6 years of age and older for single-dose infiltration to produce postsurgical local analgesia, and in adults 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 multivesicular liposomes, 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 multivesicular liposome 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 in adults where EXPAREL was injected into a wound, the most common side effects were nausea, constipation, and vomiting. In studies in adults where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. In the study where EXPAREL was given to children, the most common side effects were nausea, vomiting, constipation, low blood pressure, low number of red blood cells, muscle twitching, blurred vision, itching, and rapid heartbeat. EXPAREL can cause a temporary loss of feeling and/or loss of muscle movement. How much and how long the loss of feeling and/or muscle movement depends on where and how much of EXPAREL was injected and may last for up to 5 days. EXPAREL is not recommended to be used in patients younger than 6 years old for injection into the wound, for patients younger than 18 years old for injection near a nerve, and/or in pregnant women. Tell your health care provider if you or your child has liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from the body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL can affect the nervous system and the cardiovascular system; may cause an allergic reaction; may cause damage if injected into the joints; and can cause a rare blood disorder.
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. 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 Pacira’s future expectations, plans, trends, 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. These forward-looking statements include, without limitation, statements related to the anticipated consummation of the acquisition of Flexion and the timing and benefits thereof, Pacira’s strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, anticipated product portfolio, development programs, patent terms and other statements that are not historical facts. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: risks related to Pacira’s ability to complete the transaction on the proposed terms and schedule or at all; whether the tender offer conditions will be satisfied; whether sufficient stockholders of Flexion tender their shares in the transaction; the outcome of legal proceedings that may be instituted against Flexion and/or others relating to the transaction; the failure (or delay) to receive the required regulatory approvals relating to the transaction; the possibility that competing offers will be made; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; the commercial success of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension); risks related to future opportunities and plans for Flexion and its products, including uncertainty of the expected financial performance of Flexion and its products, including whether the milestones will ever be achieved; disruption from the proposed transaction, making it more difficult to conduct business as usual or maintain relationships with customers, employees or suppliers; the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement; the possibility that if Pacira does not achieve the perceived benefits of the proposed transaction as rapidly or to the extent anticipated by financial analysts or investors, the market price of Pacira’s shares could decline; the impact of the COVID-19 pandemic on elective surgeries, our manufacturing and supply chain, global and
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
2021 | 2020 | ||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 134,036 | $ | 99,957 | |||
| Short-term available-for-sale investments | 559,822 | 421,705 | |||||
| Accounts receivable, net | 49,975 | 53,046 | |||||
| Inventories, net | 67,209 | 64,650 | |||||
| Prepaid expenses and other current assets | 11,310 | 12,265 | |||||
| Total current assets | 822,352 | 651,623 | |||||
| Long-term available-for-sale investments | — | 95,459 | |||||
| Fixed assets, net | 159,235 | 136,688 | |||||
| Right-of-use assets, net | 69,790 | 74,492 | |||||
| 99,547 | 99,547 | ||||||
| Intangible assets, net | 90,621 | 96,521 | |||||
| Deferred tax assets | 93,265 | 106,164 | |||||
| Investments and other assets | 21,192 | 14,019 | |||||
| Total assets | $ | 1,356,002 | $ | 1,274,513 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 7,895 | $ | 10,431 | |||
| Accrued expenses | 50,798 | 70,974 | |||||
| Lease liabilities | 5,879 | 7,425 | |||||
| Convertible senior notes (1) | 155,751 | 149,648 | |||||
| Contingent consideration | 5,070 | 14,736 | |||||
| Income taxes payable | 395 | 114 | |||||
| Total current liabilities | 225,788 | 253,328 | |||||
| Convertible senior notes (2) | 326,146 | 313,030 | |||||
| Lease liabilities | 66,784 | 71,025 | |||||
| Contingent consideration | 11,129 | 13,610 | |||||
| Other liabilities | 7,553 | 3,832 | |||||
| Total stockholders’ equity | 718,602 | 619,688 | |||||
| Total liabilities and stockholders’ equity | $ | 1,356,002 | $ | 1,274,513 | |||
(1) Relates to our 2.375% convertible senior notes due 2022, which are currently convertible.
(2) Relates to our 0.750% convertible senior notes due 2025, which are not currently convertible.
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
| Three Months Ended | Nine Months Ended | ||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||
| Net product sales: | |||||||||||||||||||
| EXPAREL | $ | 121,926 | $ | 113,714 | $ | 366,663 | $ | 288,029 | |||||||||||
| Bupivacaine liposome injectable suspension | 683 | 449 | 2,465 | 2,430 | |||||||||||||||
| Total EXPAREL / bupivacaine liposome injectable suspension net product sales | 122,609 | 114,163 | 369,128 | 290,459 | |||||||||||||||
| iovera° | 4,182 | 2,726 | 11,264 | 6,391 | |||||||||||||||
| Total net product sales | 126,791 | 116,889 | 380,392 | 296,850 | |||||||||||||||
| Collaborative licensing and milestone revenue | — | — | 125 | — | |||||||||||||||
| Royalty revenue | 931 | 595 | 1,822 | 1,823 | |||||||||||||||
| Total revenues | 127,722 | 117,484 | 382,339 | 298,673 | |||||||||||||||
| Operating expenses: | |||||||||||||||||||
| Cost of goods sold | 34,651 | 29,993 | 101,248 | 82,031 | |||||||||||||||
| Research and development | 11,578 | 14,651 | 40,031 | 44,090 | |||||||||||||||
| Selling, general and administrative | 48,807 | 52,561 | 148,142 | 140,683 | |||||||||||||||
| Amortization of acquired intangible assets | 1,967 | 1,967 | 5,900 | 5,900 | |||||||||||||||
| Acquisition-related (gains) charges, product discontinuation and other | (714 | ) | 692 | 1,305 | (1,599 | ) | |||||||||||||
| Total operating expenses | 96,289 | 99,864 | 296,626 | 271,105 | |||||||||||||||
| Income from operations | 31,433 | 17,620 | 85,713 | 27,568 | |||||||||||||||
| Other (expense) income: | |||||||||||||||||||
| Interest income | 177 | 1,025 | 816 | 3,936 | |||||||||||||||
| Interest expense | (7,333 | ) | (7,132 | ) | (21,327 | ) | (18,609 | ) | |||||||||||
| Loss on early extinguishment of debt | — | (8,071 | ) | — | (8,071 | ) | |||||||||||||
| Other, net | (46 | ) | 2,708 | (2,600 | ) | 2,571 | |||||||||||||
| Total other expense, net | (7,202 | ) | (11,470 | ) | (23,111 | ) | (20,173 | ) | |||||||||||
| Income before income taxes | 24,231 | 6,150 | 62,602 | 7,395 | |||||||||||||||
| Income tax (expense) benefit | (6,571 | ) | 123,969 | (15,492 | ) | 123,613 | |||||||||||||
| Net income | $ | 17,660 | $ | 130,119 | $ | 47,110 | $ | 131,008 | |||||||||||
| Net income per share: | |||||||||||||||||||
| Basic net income per common share | $ | 0.40 | $ | 3.03 | $ | 1.07 | $ | 3.09 | |||||||||||
| Diluted net income per common share | $ | 0.39 | $ | 2.94 | $ | 1.03 | $ | 3.02 | |||||||||||
| Weighted average common shares outstanding: | |||||||||||||||||||
| Basic | 44,476 | 42,928 | 44,151 | 42,393 | |||||||||||||||
| Diluted | 45,463 | 44,275 | 45,674 | 43,333 | |||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Information
(in thousands, except per share amounts)
(unaudited)
| Three Months Ended | Nine Months Ended | ||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||
| GAAP net income | $ | 17,660 | $ | 130,119 | $ | 47,110 | $ | 131,008 | |||||||||||
| Non-GAAP adjustments: | |||||||||||||||||||
| Collaborative licensing and milestone revenue | — | — | (125 | ) | — | ||||||||||||||
| Acquisition-related (gains) charges, product discontinuation and other | (714 | ) | 692 | 1,305 | (1,599 | ) | |||||||||||||
| Flexion transaction costs | 951 | — | 951 | — | |||||||||||||||
| Stock-based compensation | 10,784 | 10,954 | 31,356 | 29,024 | |||||||||||||||
| Loss on early extinguishment of debt | — | 8,071 | — | 8,071 | |||||||||||||||
| Amortization of debt discount | 5,844 | 5,430 | 17,245 | 12,684 | |||||||||||||||
| Amortization of acquired intangible assets | 1,967 | 1,967 | 5,900 | 5,900 | |||||||||||||||
| Loss (gain) on investment | — | (2,771 | ) | 2,584 | (2,779 | ) | |||||||||||||
| Release of valuation allowance on deferred tax assets | — | (124,572 | ) | — | (124,572 | ) | |||||||||||||
| Tax impact of non-GAAP adjustments | (3,959 | ) | — | (14,007 | ) | — | |||||||||||||
| Total Non-GAAP adjustments | 14,873 | (100,229 | ) | 45,209 | (73,271 | ) | |||||||||||||
| Non-GAAP net income | $ | 32,533 | $ | 29,890 | $ | 92,319 | $ | 57,737 | |||||||||||
| GAAP basic net income per common share | $ | 0.40 | $ | 3.03 | $ | 1.07 | $ | 3.09 | |||||||||||
| GAAP diluted net income per common share | $ | 0.39 | $ | 2.94 | $ | 1.03 | $ | 3.02 | |||||||||||
| Non-GAAP basic net income per common share | $ | 0.73 | $ | 0.70 | $ | 2.09 | $ | 1.36 | |||||||||||
| Non-GAAP diluted net income per common share | $ | 0.72 | $ | 0.68 | $ | 2.02 | $ | 1.33 | |||||||||||
| Weighted average common shares outstanding - basic | 44,476 | 42,928 | 44,151 | 42,393 | |||||||||||||||
| Weighted average common shares outstanding - diluted | 45,463 | 44,275 | 45,674 | 43,333 | |||||||||||||||
| Cost of goods sold reconciliation: | |||||||||||||||||||
| GAAP cost of goods sold | $ | 34,651 | $ | 29,993 | $ | 101,248 | $ | 82,031 | |||||||||||
| Stock-based compensation | (1,512 | ) | (1,546 | ) | (4,429 | ) | (4,050 | ) | |||||||||||
| Non-GAAP cost of goods sold | $ | 33,139 | $ | 28,447 | $ | 96,819 | $ | 77,981 | |||||||||||
| Research and development reconciliation: | |||||||||||||||||||
| GAAP research and development | $ | 11,578 | $ | 14,651 | $ | 40,031 | $ | 44,090 | |||||||||||
| Stock-based compensation | (1,156 | ) | (1,401 | ) | (3,591 | ) | (3,944 | ) | |||||||||||
| Non-GAAP research and development | $ | 10,422 | $ | 13,250 | $ | 36,440 | $ | 40,146 | |||||||||||
| Selling, general and administrative reconciliation: | |||||||||||||||||||
| GAAP selling, general and administrative | $ | 48,807 | $ | 52,561 | $ | 148,142 | $ | 140,683 | |||||||||||
| Flexion transaction costs | (951 | ) | — | (951 | ) | — | |||||||||||||
| Stock-based compensation | (8,116 | ) | (8,007 | ) | (23,336 | ) | (21,030 | ) | |||||||||||
| Non-GAAP selling, general and administrative | $ | 39,740 | $ | 44,554 | $ | 123,855 | $ | 119,653 | |||||||||||
Reconciliation of GAAP Net Income to Adjusted EBITDA (Non-GAAP)
(in thousands)
(unaudited)
| Three Months Ended | Nine Months Ended | ||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||||||
| GAAP net income | $ | 17,660 | $ | 130,119 | $ | 47,110 | $ | 131,008 | |||||||||||
| Interest income | (177 | ) | (1,025 | ) | (816 | ) | (3,936 | ) | |||||||||||
| Interest expense (1) | 7,333 | 7,132 | 21,327 | 18,609 | |||||||||||||||
| Income tax expense (benefit) | 6,571 | (123,969 | ) | 15,492 | (123,613 | ) | |||||||||||||
| Depreciation expense | 3,763 | 3,070 | 9,578 | 8,947 | |||||||||||||||
| Amortization of acquired intangible assets | 1,967 | 1,967 | 5,900 | 5,900 | |||||||||||||||
| EBITDA | 37,117 | 17,294 | 98,591 | 36,915 | |||||||||||||||
| Other adjustments: | |||||||||||||||||||
| Acquisition-related (gains) charges, product discontinuation and other | (714 | ) | 692 | 1,305 | (1,599 | ) | |||||||||||||
| Flexion transaction costs | 951 | — | 951 | — | |||||||||||||||
| Stock-based compensation | 10,784 | 10,954 | 31,356 | 29,024 | |||||||||||||||
| Loss on early extinguishment of debt | — | 8,071 | — | 8,071 | |||||||||||||||
| Collaborative licensing and milestone revenue | — | — | (125 | ) | — | ||||||||||||||
| Loss (gain) on investment | — | (2,771 | ) | 2,584 | (2,779 | ) | |||||||||||||
| Adjusted EBITDA (Non-GAAP) | $ | 48,138 | $ | 34,240 | $ | 134,662 | $ | 69,632 | |||||||||||
(1) Includes amortization of debt discount
Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) includes GAAP to non-GAAP adjustments that reflect how the Company’s management analyzes its financial results. The adjusted EBITDA figures presented here are unlikely to be comparable with adjusted EBITDA disclosures released by other companies.
Investor Contact:Susan Mesco , (973) 451-4030 susan.mesco@pacira.com Media Contact:Coyne Public Relations Kristin Capone , (973) 588-2108 kcapone@coynepr.com
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