— EXPAREL average daily sales 109% of the prior year for the third quarter and 113% of the prior year for the month of September —
TAMPA, Fla., Oct. 13, 2022 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today reported preliminary unaudited revenues of $167.5 million for the third quarter of 2022, compared with $127.7 million for the third quarter of 2021. The company’s revenues include net product sales of EXPAREL® (bupivacaine liposome injectable suspension), ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), and the iovera° system. The company began recognizing sales of ZILRETTA in November 2021 after completing its acquisition of Flexion Therapeutics, Inc.
“The second half of the third quarter saw meaningful improvement in year-over-year EXPAREL growth trends, culminating with September average daily sales exceeding 2021 by 13 percent,” said Dave Stack, chairman and chief executive officer of Pacira BioSciences. “EXPAREL utilization has continued to outperform the elective surgery market’s recovery with expansion taking place across all target markets and sites of care despite a challenging macro environment. For ZILRETTA and iovera°, recent trends show we are leveraging the complementary value proposition as demonstrated by increasing utilization in target markets. On the clinical and regulatory front, we have made strong progress and expect to deliver significant milestones across our product portfolio in the next 12 to 18 months, including the approval and launch of EXPAREL in additional nerve block indications. Looking ahead to the remainder of 2022 and beyond, we remain confident in our ability to achieve strong revenue growth, robust earnings, and continued leadership in opioid-sparing pain management.”
Third Quarter and September 2022 Preliminary Revenue Highlights
EXPAREL net product sales were $132.6 million and $121.9 million for the third quarters of 2022 and 2021 and $45.0 million and $39.7 million for the months of September 2022 and 2021, respectively. EXPAREL average daily sales were 109 percent of the prior year for the third quarter of 2022 and 113 percent of the prior year for the month of September 2022. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. For the third quarter, the number of EXPAREL selling days were 64 in 2022 and 2021. For the month of September, the number of EXPAREL selling days were 21 in 2022 and 2021.
ZILRETTA net product sales were $26.5 million for the third quarter of 2022 and $8.6 million for the month of September 2022. ZILRETTA sales in the third quarter of 2021 occurred prior to the completion of the company’s acquisition of Flexion in November 2021.
iovera° net product sales were $4.5 million and $4.2 million for the third quarters of 2022 and 2021 and $1.9 million and $2.3 million for the months of September 2022 and 2021, respectively.
Sales and royalties related to a third-party licensee of bupivacaine liposome injectable suspension for use in veterinary practice were $3.9 million and $1.6 million in the third quarters of 2022 and 2021 and $2.0 million and $1.1 million for the months of September 2022 and 2021, respectively.
Since early 2020, the company’s revenues have been impacted by COVID-19 and pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives. While the degree of impact of the pandemic has diminished due to the introduction of vaccines and the lessening of elective surgery restrictions, certain pandemic-related operational challenges persist. It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise.
The company is not providing 2022 revenue or gross margin guidance at this time given the continued uncertainty around labor shortages, COVID-19, and the pace of recovery for the elective surgery market. To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales for EXPAREL, ZILRETTA, and iovera° until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. Pacira completed its acquisition of Flexion Therapeutics on November 19, 2021, which added ZILRETTA® to its commercial offering.
The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the third quarter or full year 2022.
About Pacira BioSciences
Pacira BioSciences, Inc. (Nasdaq: PCRX) is committed to providing a non-opioid option to as many patients as possible to redefine the role of opioids as rescue therapy only. The company is also developing innovative interventions to address debilitating conditions involving the sympathetic nervous system, such as cardiac electrical storm, chronic pain, and spasticity. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting, local analgesia currently approved for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular, injection indicated for the management of osteoarthritis knee pain; and ioveraº®, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. 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 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. Since its launch, EXPAREL has been used in over nine million patients. EXPAREL utilizes the company’s proprietary multivesicular liposomal drug delivery technology composed of a honeycomb of numerous, non-concentric, internal aqueous chambers containing bupivacaine. After injection, bupivacaine is released over time, as the lipid membranes are absorbed, prolonging the duration of action. EXPAREL is the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. A single dose of EXPAREL provides 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 about EXPAREL 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 ZILRETTA®
On October 6, 2017, ZILRETTA (triamcinolone acetonide extended-release injectable suspension) was approved by the U.S. Food and Drug Administration as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis (OA)- related knee pain. ZILRETTA employs proprietary microsphere technology combining triamcinolone acetonide—a commonly administered, short-acting corticosteroid—with a poly lactic-co-glycolic acid (PLGA) matrix to provide extended pain relief. The pivotal Phase 3 trial on which the approval of ZILRETTA was based showed that ZILRETTA significantly reduced OA knee pain for 12 weeks, with some people experiencing pain relief through Week 16. Learn more at www.zilretta.com.
Indication and Select Important Safety Information for ZILRETTA
Indication: ZILRETTA is indicated as an intra-articular injection for the management of OA pain of the knee. Limitation of Use: The efficacy and safety of repeat administration of ZILRETTA have not been demonstrated.
Contraindication: ZILRETTA is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.
Warnings and Precautions:
Intra-articular Use Only: ZILRETTA has not been evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. ZILRETTA should not be considered safe for epidural or intrathecal administration.
Serious Neurologic Adverse Reactions with Epidural and Intrathecal Administration: Serious neurologic events have been reported following epidural or intrathecal corticosteroid administration. Corticosteroids are not approved for this use.
Hypersensitivity reactions: Serious reactions have been reported with triamcinolone acetonide injection. Institute appropriate care if an anaphylactic reaction occurs.
Joint infection and damage: A marked increase in joint pain, joint swelling, restricted motion, fever and malaise may suggest septic arthritis. If this occurs, conduct appropriate evaluation and if confirmed, institute appropriate antimicrobial treatment.
Adverse Reactions: The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis, cough, and contusions.
Please see ZILRETTALabel.com for full Prescribing Information.
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. Additional information is available at www.iovera.com.
Important Safety Information for iovera°®
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 acquisition of Flexion Therapeutics, Inc. and the costs and benefits thereof, our growth and future operating results and trends, our strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, anticipated product portfolio, development programs, strategic alliances, patent terms and intellectual property and other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from these indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: 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 possibility that if we do not achieve the perceived benefits of the Flexion acquisition as rapidly or to the extent anticipated by financial analysts or investors, the market price of our shares could decline; the impact of the COVID-19 pandemic on elective surgeries, our manufacturing and supply chain, global and United States economic conditions, and our business, including our revenues, financial condition and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera° and the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA and iovera°; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications, and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (pMVL) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities, our ability to successfully construct an additional EXPAREL manufacturing suite in San Diego, California; our ability to successfully complete a ZILRETTA capacity expansion project in Swindon, England; the outcome of any litigation; the ability to successfully integrate Flexion or any future acquisitions into our existing business; the recoverability of our deferred tax assets; and assumptions associated with contingent consideration payments; and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission. 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 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, except as required by law. 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.
Related Quotes
You can do anything in Las Vegas (more or less) but some employees want to end one vice that has long been associated with casinos.
Medical stocks don't generally have high dividends, but Abbvie (NYSE: ABBV), Pfizer (NYSE: PFE), and Gilead Sciences (NASDAQ: GILD) all have dividends with yields of 3.5% or more, and these pharmaceuticals stocks serve as a great hedge against inflation because their business models are largely resistant to recessions. A high-yielding dividend without sound fundamentals can easily become a dividend trap, but all three of these companies have pipelines with great potential and a strong history of increasing revenue — and none appear to be overpriced yet. AbbVie is a new Dividend King.
Photo Illustration by Erin O'Flynn/The Daily Beast/GettyA new subvariant of the novel-coronavirus called XBB dramatically announced itself earlier this week, in Singapore. New COVID-19 cases more than doubled in a day, from 4,700 on Monday to 11,700 on Tuesday—and XBB is almost certainly why. The same subvariant just appeared in Hong Kong, too.A highly mutated descendant of the Omicron variant of the SARS-CoV-2 virus that drove a record wave of infections starting around a year ago, XBB is in ma
The things to remember about dementia are that it is absolutely horrible for you and everyone around you; it’s a high probability; and when it comes to fighting it or avoiding it you are pretty much on your own. Alzheimer’s disease and related dementias are currently killing 6.5 million people in the United States and devastating the lives of many times that when you count the patients’ friends and family. The National Institutes of Health reckons this number is likely to double in the next four decades.
The minimum treatment for a snake bite is 10 vials of antivenom and the cost of each vial is in the four digits.
Getting rest days in between workouts is important for recovery
As a new study confirms drinking too much really does make you look older, Lisa Salmon looks into other lifestyle factors that may contribute too
When it comes to convenient and nourishing snacks, you can't beat an apple. It's a satiating option you can grab on your way out the door to run errands, or throw into your lunch bag for work. Fortunately, apples are also available year-round in the U.S. and loaded with vitamins, minerals, fiber, and antioxidants—all the nutrients your body needs to fend off viruses and other infections and ailments.So, does an apple a day really keep the doctor away? The jury is still out on that one, but 2015
Sugar and artificial sweeteners comes in many shapes and colors. New Africa/Shutterstock.comWandering through the grocery store, it is easy to be overwhelmed by the numerous brands and health claims on the dozens of sugar substitutes. It can be particularly confusing for those with diabetes or pre-diabetes who must keep their blood sugar in check and control their weight. With the growing diabetes and obesity epidemic, there has been increasing awareness around the use of added sugars in foods.
2 counties near the Tri-Cities received worse COVID community ratings from the CDC.
Patients should work with their health care professionals to determine their best treatment option until supply is restored.
A mom in Denver, Colorado learned that her delivery nurses shared the same name as her newborn daughters in a sweet coincidence.
In August, President Biden signed into law the Inflation Reduction Act (IRA) of 2022, aimed at lowering prescription drug prices for seniors.
After 54 years at the National Institutes of Health and 38 years as the director of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci will be stepping down from public service at the end of the year. "I have been driving onto that campus every single day, every single weekend for the last 54 years," Fauci told ABC News' chief Washington correspondent and "This Week" co-anchor Jonathan Karl in an interview that aired Sunday. In an intimate interview at his home, Fauci sat down with ABC News to talk about his tenure in public service, the COVID-19 pandemic during which he became perhaps the country's most famous doctor and the controversies that have consumed the last two and a half years — and sometimes ensnared him.
BQ.1.1's extreme immune evasiveness "sets it up to be the principal driver of the next U.S. wave in the weeks ahead," a leading expert said Friday.
Around one in every 10 Americans deals with diabetes, and of those people, anywhere from 90% to 95% have type 2 diabetes. Due to the fact that it's a condition that affects the insulin and blood sugar levels in the body, you might focus on ensuring that you're eating healthy food when trying to prevent diabetes. However, you might also want to add tea to your daily routine for the very same purpose, according to a new 2022 study.Research from a study that was presented at the European Associatio
Pac-12 football coaches & student-athletes share their thoughts on the importance of mental health in their lives, and what they do to focus on their own personal mental health. To learn more about mental health resources across Pac-12 campuses, visit Pac-12.com/MentalHealth.
A San Diego high school seemingly has a flu outbreak, causing 1,400 students to call out this week.
Although it feels like the pandemic is over in many ways, the medical community warns it's not and learning to live with the virus is the direction we're heading. While COVID is here to stay for now, keeping updated on the latest information and taking safety precautions is vital to staying healthy. Eat This, Not That! Health spoke with experts who share what to know about COVID right now and how to help prevent catching it. Read on—and to ensure your health and the health of others, don't miss
Or, more importantly, should you? Here’s everything you need to know