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Share Name | Share Symbol | Market | Type |
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Pacira BioSciences Inc | NASDAQ:PCRX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.37 | 1.37% | 27.32 | 26.75 | 29.31 | 27.40 | 26.65 | 27.15 | 340,710 | 23:02:25 |
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(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
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51-0619477
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(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.)
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5 Sylvan Way, Suite 300
Parsippany, New Jersey 07054
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(Address and Zip Code of Principal Executive Offices)
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(973) 254-3560
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(Registrant’s Telephone Number, Including Area Code)
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Title of each class
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Name of each exchange
on which registered
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Common Stock, $0.001 par value
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The NASDAQ
Global Select Market
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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Smaller reporting company
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(Do not check if a smaller reporting company)
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Emerging growth company
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Page No.
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commercializing EXPAREL in the U.S. for postsurgical analgesia by infiltration;
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maintaining a streamlined commercial organization concentrating on major hospitals and ambulatory surgery centers in the U.S. and targeting surgeons, anesthesiologists, pharmacists and nurses;
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utilizing strategic commercial partnerships to broaden the use of EXPAREL;
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demonstrating the economic benefits of EXPAREL, working directly with managed care payers, quality improvement organizations, Key Opinion Leaders, or KOLs, in the field of postsurgical pain management and leading influential hospitals in conducting Phase 4 retrospective and prospective trials and drug utilization evaluations;
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educating strategic commercial audiences for local infiltration procedures, including soft tissue, orthopedic, anesthesia (such as infiltration into the transversus abdominis plane, or TAP block) and oral and maxillofacial surgeries, to ensure appropriate use of the product;
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obtaining FDA approval for additional indications for EXPAREL, including expanding the label to include the pediatric population, as well as administration via nerve block for regional analgesia;
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manufacturing our DepoFoam-based products, including EXPAREL, in facilities compliant with the FDA’s current Good Manufacturing Practices, or cGMP, and expanding such manufacturing capacity to meet demand;
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continuing to expand our marketed product portfolio through development of additional DepoFoam-based hospital products utilizing a Section 505(b)(2) strategy, which permits the reliance upon previous findings of safety and effectiveness for an approved product; and
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continuing research and development partnerships to provide DepoFoam-based products to enhance the duration of action and patient compliance for partner products.
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First, we are advancing the understanding among our customers and patients that the operating room, in the absence of EXPAREL as part of non-narcotic multimodal pain management, has served as a gateway to the opioid epidemic. In 2016, we launched
Choices Matter
, our national educational campaign aimed at empowering patients to proactively discuss postsurgical pain management, including non-opioid options, with their doctors. We are building a coalition of like-minded individuals and organizations to generate widespread public awareness of the role that postsurgical opioids play in this public health crisis in the U.S., while highlighting the opportunity to alleviate the risks associated with opioid dependence and/or addiction through the utilization of non-opioid pain management approaches.
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Second, we are investing in clinical trials in key surgical procedures to expand the EXPAREL label to include nerve block for regional analgesia and to demonstrate procedure-specific pain reduction, opioid reduction and best-practice surgical infiltration techniques within the currently approved indication. We have submitted a supplemental New Drug Application, or sNDA, with the FDA. The sNDA filing is based on positive data from a Phase 3 study of EXPAREL in femoral nerve block for total knee arthroplasty, or TKA, (lower extremity) and a Phase 3 study of EXPAREL in brachial plexus block for shoulder surgeries (upper extremity). It includes data from eight company-sponsored studies with safety and pharmacokinetic data through 120 hours. In addition, the sNDA includes data from two investigator-initiated studies that provide additional experience in smaller, peripheral nerve block settings. Our sNDA for EXPAREL as a nerve block for regional analgesia was discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, or AADPAC, on February 14-15, 2018. The AADPAC committee members voted six to four against approval of the EXPAREL sNDA. The committee’s feedback will be considered by the FDA in its review of the sNDA. The FDA’s Prescription Drug User Fee Act (PDUFA) goal date for completion of its review is April 6, 2018. For our currently approved infiltration indication, we have published positive results from our completed Phase 4 multicenter, randomized, double-blind trial in TKA and we are currently enrolling a C-Section study. We also expect to initiate additional Phase 4 studies in key procedures, such as hip fracture, spine, colorectal and breast reconstruction surgeries. We believe positive data from our Phase 4 studies will lead to improved patient outcomes and customer satisfaction.
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Third, we are forming strategic collaborations to expand education on the importance of non-opioid multimodal alternatives for post-surgical pain management and broaden our commercial reach. These include agreements with industry partners, as well as healthcare providers and hospital systems to support their implementation of opioid-sparing enhanced recovery protocols. In January 2017, we formed a partnership with DePuy Synthes Sales Inc., or DePuy Synthes, part of the Johnson & Johnson family of companies, to support the promotion, education and training
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provides long-lasting postsurgical analgesia;
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is a ready-to-use formulation;
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expands easily with saline or lactated Ringer’s to reach a desired volume;
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leverages existing postsurgical infiltration administration techniques; and
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facilitates treatment of both small and large surgical sites.
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delayed the median time to rescue analgesic use (opioids) to 15 hours for patients treated with EXPAREL and one hour for patients treated with placebo;
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significantly increased the percentage of patients requiring no opioid rescue medication through 72 hours post-surgery to 28%, compared to 10% for placebo;
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resulted in 45% less opioid usage through 72 hours post-surgery compared to placebo; and
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increased the percentage of patients who were pain free at 24 hours post-surgery compared to placebo.
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decreased total opioid consumption by 78 percent (18.7 mg versus 84.9 mg in the bupivacaine group; p=0.0048) expressed as morphine equivalents from zero to 48 hours after surgery; and
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reduced pain scores (180.8 versus 209.3 in the bupivacaine group; p=0.0381), using the area under the curve of the pain intensity scores measured on a visual analog scale from 12 to 48 hours after surgery, which required 78 percent fewer opioids through 72 hours than those in the bupivacaine arm (20.9 mg versus 93.6 mg, respectively; p=0.0108), with 10 percent remaining opioid-free through 48 and 72 hours (compared to zero patients in the bupivacaine arm; p<0.01).
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provides effective pain control without the need for expensive and difficult-to-use delivery technologies that extend the duration of action for bupivacaine, such as elastomeric bags, or opioids administered through patient-controlled analgesia, or PCA, when used as part of a multimodal postsurgical pain regimen;
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reduces the need for patients to be constrained by elastomeric bags and PCA systems, which are barriers to earlier ambulation and may introduce catheter-related issues, including infection; and
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promotes maintenance of early postsurgical pain management, which may reduce the time spent in the intensive care unit.
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eliminate catheters and pumps by turning off pain at the surgical site;
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engage the anesthesiologist audience;
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increase adoption in key procedures, such as shoulder, wrist/hand and foot/ankle; and
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shift inpatient procedures to ambulatory surgery centers.
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publishing procedure-specific technique and best-practice protocol to demonstrate (i) volume expansion to ensure proper coverage of the surgical field, (ii) admixing with bupivacaine to ensure pain relief that spans both the acute and later postsurgical periods and (iii) proper infiltration technique;
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creating KOL educational videos of proper technique; and
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publishing trial results.
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Convenience.
Our DepoFoam products are ready to use, do not require reconstitution or mixing with another solution, and can be used with patient-friendly narrow gauge needles and pen systems;
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Multiple regulatory precedents.
Our current and past DepoFoam products have been approved in the U.S. and Europe, making regulatory authorities familiar with our DepoFoam technology;
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Extensive safety history.
Our DepoFoam products have nearly 20 years of safety data;
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Proven manufacturing capabilities.
We make EXPAREL, a DepoFoam-based product, in our cGMP facilities;
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Flexible time release.
Encapsulated drug releases over a desired period, from 1 to 30 days;
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Favorable pharmacokinetics.
Decrease in adverse events associated with high peak blood levels, thereby improving the utility of the product;
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Shortened development timeline.
Does not alter the native molecule, potentially enabling the filing of a 505(b)(2) application; and
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Aseptic manufacturing and filling.
Enables use with proteins, peptides, nucleic acids, vaccines and small molecules.
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providing publications and abstracts showing the EXPAREL clinical program efficacy and safety, health outcomes program and review articles on pain management;
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working in tandem with hospital staff, such as registered nurses, surgeons, heads of quality, pharmacists and executives, to provide access and resources for drug utilization or medication use evaluations and health outcomes studies, which provide retrospective and prospective analyses for our hospital customers using their own hospital data to demonstrate the true cost of opioid-based postsurgical pain control;
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working with KOLs and advisory boards to address topics of best practice techniques as well as guidelines and protocols for the use of EXPAREL, meeting the educational and training needs of our physician, surgeon, anesthesiologist, pharmacist and registered nurse customers;
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undertaking education initiatives such as center of excellence programs; preceptorship programs; pain protocols and predictive models for enhanced patient care; interactive discussion forums; patient education platforms leveraging public relations, advocacy partnerships and public affairs efforts where appropriate; web-based training and virtual launch programs; and
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collaborating with surgeons towards improving the knowledge and management of pain in surgical patients with a focus on opioid risk and non-opioid alternatives and engaging our field-based medical teams in system-wide partnerships to address the national opioid epidemic, with a goal of studying alternative postsurgical pain management options that focus on optimization and opioid alternative strategies.
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completion of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s Good Laboratory Practice regulations (21 CFR 58);
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submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin for unapproved use in the U.S.;
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approval by an independent Institutional Review Board, or IRB, at each clinical trial site before each trial may be initiated;
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performance of adequate and well-controlled human clinical trials in accordance with the FDA’s Good Clinical Practices, or GCP, to establish the safety and efficacy of the proposed drug product for each intended use;
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completion of process validation, quality product release and stability;
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submission of an NDA to the FDA;
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satisfactory completion of an FDA pre-approval inspection of the product’s manufacturing facility or facilities to assess compliance with cGMP requirements and to ensure that the facilities, methods and controls are adequate to preserve the drug’s identity, quality and purity;
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satisfactory completion of an FDA advisory committee review, if applicable; and
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review and approval by the FDA of the NDA.
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Phase 1:
Sponsors initially conduct clinical trials in a limited population, either patients or healthy volunteers, to test the product candidate for safety, dose tolerance, absorption, metabolism, distribution, excretion and clinical pharmacology, and, if possible, to gain early evidence of effectiveness. In the cases of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing often is conducted only on patients having the specific disease.
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Phase 2:
Sponsors conduct clinical trials generally in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted indications and to determine dose tolerance, optimal dosage and dosing schedule. Sponsors may conduct multiple Phase 2 clinical trials to obtain information prior to beginning larger and more extensive Phase 3 clinical trials.
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Phase 3:
These include expanded controlled and uncontrolled trials, including pivotal clinical trials. When Phase 2 evaluations suggest the effectiveness of a dose range of the product and acceptability of such product’s safety profile, sponsors undertake Phase 3 clinical trials in larger patient populations to obtain additional information needed to evaluate the overall benefit and risk balance of the drug and to provide an adequate basis to develop labeling.
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restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or product recalls;
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fines, warning letters or holds on post-approval clinical trials;
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refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals;
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product seizure or detention, or refusal to permit the import or export of products; or
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injunctions or the imposition of civil or criminal penalties.
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create market demand for EXPAREL through our marketing and sales activities and other arrangements established for the promotion of EXPAREL;
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train, deploy and support a qualified sales force;
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secure formulary approvals for EXPAREL at a substantial number of targeted hospitals;
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manufacture EXPAREL in sufficient quantities in compliance with requirements of the FDA and similar foreign regulatory agencies and at acceptable quality and pricing levels in order to meet commercial demand;
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implement and maintain agreements with wholesalers and distributors on commercially reasonable terms;
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receive adequate levels of coverage and reimbursement for EXPAREL from commercial health plans and governmental health programs;
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maintain compliance with regulatory requirements;
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obtain regulatory approvals for additional indications for the use of EXPAREL;
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ensure that our entire supply chain efficiently and consistently delivers EXPAREL to our customers; and
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maintain and defend our patent protection and regulatory exclusivity for EXPAREL.
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changes in the standard of care for the targeted indications for EXPAREL, which could reduce the marketing impact of any claims that we can make;
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the relative efficacy, convenience and ease of administration of EXPAREL;
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the prevalence and severity of adverse events associated with EXPAREL;
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cost of treatment versus economic and clinical benefit, both in absolute terms and in relation to alternative treatments;
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the availability of adequate coverage or reimbursement by third parties, such as insurance companies and other healthcare payers, and by government healthcare programs, including Medicare and Medicaid;
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the extent and strength of our marketing and distribution of EXPAREL;
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the safety, efficacy and other potential advantages over, and availability of, alternative treatments, including, in the case of EXPAREL, a number of products already used to treat pain in the hospital setting; and
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distribution and use restrictions imposed by the FDA or to which we agree as part of a mandatory risk evaluation and mitigation strategy or voluntary risk management plan.
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not effectively distribute or support our products;
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not provide us with accurate or timely information regarding their inventories, the number of accounts using our products or complaints about our products;
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fail to comply with their obligations to us;
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fail to comply with laws and regulations to which they are subject, whether in the U.S. or in foreign jurisdictions;
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reduce or discontinue their efforts to sell or promote our products; or
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cease operations.
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continue the hiring and training of an effective commercial organization for the commercialization of EXPAREL, and establish appropriate systems, policies and infrastructure to support that organization;
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continue to establish and maintain effective relationships with distributors and commercial partners for the promotion and sale of our products;
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ensure that our distributors, partners, suppliers, consultants and other service providers successfully carry out their contractual obligations, provide high quality results and meet expected deadlines;
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manage our development efforts and clinical trials effectively;
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expand our manufacturing capabilities and effectively manage our co-production arrangement with Patheon;
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continue to carry out our own contractual obligations to our licensors and other third parties; and
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continue to improve our operational, financial and management controls, reporting systems and procedures.
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loss of revenue from decreased demand for our products and/or product candidates;
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impairment of our business reputation or financial stability;
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costs of related litigation;
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substantial monetary awards to patients or other claimants;
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diversion of management attention;
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loss of revenues;
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withdrawal of clinical trial participants and potential termination of clinical trial sites or entire clinical programs; and
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the inability to commercialize our product candidates.
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significant capital expenditures;
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difficulty or inability to secure financing to fund development activities for such development, acquisition or in-licensed products or technologies;
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incurrence of substantial debt or dilutive issuances of securities to pay for development, acquisition or in-licensing of new products;
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disruption of our business and diversion of our management’s time and attention;
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higher than expected development, acquisition or in-license and integration costs;
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exposure to unknown liabilities;
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difficulty and cost in combining the operations and personnel of any acquired businesses with our operations and personnel;
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inability to retain key employees of any acquired businesses;
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difficulty entering markets in which we have limited or no direct experience;
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difficulty in managing multiple product development programs; and
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inability to successfully develop new products or clinical failure.
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regulatory authorities may require the addition of unfavorable labeling statements, specific warnings or contraindications (including boxed warnings);
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regulatory authorities may suspend or withdraw their approval of the product, or require it to be removed from the market;
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regulatory authorities may impose restrictions on the distribution or use of the product;
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we may be required to change the way the product is administered, conduct additional clinical trials, reformulate the product, change the labeling of the product or change or obtain re-approvals of manufacturing facilities;
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sales of the product may be significantly decreased from projected sales;
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we may be subject to government investigations, product liability claims and litigation; and
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our reputation may suffer.
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the Federal Anti-Kickback Law, which prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce either the referral of an individual or furnishing or arranging for a good or service for which payment may be made under federal health care programs such as Medicare and Medicaid;
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other Medicare laws and regulations that prescribe the requirements for coverage and payment for services performed by our customers, including the amount of such payment;
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the Federal False Claims Act, which imposes civil and criminal liability on individuals and entities who submit, or cause to be submitted, false or fraudulent claims for payment to the government;
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the Federal False Statements Act, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with delivery of or payment for health care benefits, items or services; and
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various state laws that impose similar requirements and liability with respect to state healthcare reimbursement and other programs.
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product recall or seizure;
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suspension or withdrawal of an approved product from the market;
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interruption of production;
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reputational concerns of our customers or the medical community;
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operating restrictions;
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warning letters;
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injunctions;
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refusal to permit import or export of an approved product;
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refusal to approve pending applications or supplements to approved applications that we submit;
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denial of permission to file an application or supplement in a jurisdiction;
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consent decrees;
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suspension or termination of ongoing clinical trials;
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fines and other monetary penalties;
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criminal prosecutions; and
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unanticipated expenditures.
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we may not have been the first to make the inventions covered by each of our pending patent applications and issued patents;
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we may not have been the first to file patent applications for these inventions;
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others may independently develop similar or alternative technologies or duplicate any of our product candidates or technologies;
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it is possible that none of the pending patent applications will result in issued patents;
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the issued patents covering our product candidates may not provide a basis for commercially viable active products, may not provide us with any competitive advantages, may not have sufficient scope or strength to protect the technologies they were intended to protect or may be challenged by third parties;
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others may design around our patent claims to produce competitive products that fall outside the scope of our patents;
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we may not develop or in-license additional proprietary technologies that are patentable;
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patents of others may have an adverse effect on our business; or
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competitors may infringe our patents and we may not have adequate resources to enforce our patents.
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infringement and other intellectual property claims which, with or without merit, can be expensive and time consuming to litigate and can divert management’s attention from our core business;
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substantial damages for past infringement which we may have to pay if a court decides that our product infringes on a competitor’s patent;
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a court prohibiting us from selling or licensing our product unless the patent holder licenses the patent to us, which it would not be required to do;
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if a license is available from a patent holder, we may have to pay substantial royalties or grant cross licenses to our patents; and
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redesigning our processes so they do not infringe, which may not be possible or could require substantial funds and time.
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manufacture commercial quantities of EXPAREL at acceptable cost levels; and
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continue to develop a commercial organization and the supporting infrastructure required to successfully market and sell EXPAREL.
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continue to fund our operations;
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continue our efforts to hire additional personnel and build a commercial infrastructure to commercialize EXPAREL;
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qualify, outsource or build additional commercial-scale manufacturing of our products under cGMP;
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in-license and develop additional product candidates; and
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refinance our current 2.375% convertible senior notes, due April 2022.
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the costs of maintaining a commercial organization to sell, market and distribute EXPAREL;
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the success of the commercialization of EXPAREL;
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the cost and timing of manufacturing sufficient supplies of EXPAREL to meet customer demand, including the cost of expanding our manufacturing facilities to produce EXPAREL;
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the rate of progress and costs of our efforts to prepare for the submission of an NDA for any product candidates that we may in-license or acquire in the future, and the potential that we may need to conduct additional clinical trials to support applications for regulatory approval;
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the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights associated with our product candidates, including any such costs we may be required to expend if our licensors are unwilling or unable to do so;
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the effect of competing technological and market developments;
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the terms and timing of any collaborative, licensing, co-promotion or other arrangements that we may establish; and
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the potential that we may be required to file a lawsuit to defend our patent rights or regulatory exclusivities from challenges by companies seeking to market generic versions of extended-release liposome injection of bupivacaine.
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the level of underlying hospital demand for EXPAREL and end-user buying patterns;
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maintaining our existing manufacturing facilities and expanding our manufacturing capacity and constructing facilities for the manufacture of EXPAREL with our co-production partner, Patheon, including installing specialized processing equipment for the manufacturing of EXPAREL;
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our execution of other collaborative, licensing, distribution, manufacturing or similar arrangements and the timing of payments we may make or receive under these arrangements;
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variations in the level of expenses related to our future development programs;
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any product liability or intellectual property infringement lawsuit in which we may become involved; and
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regulatory developments, lawsuits and investigations affecting EXPAREL or the product candidates of our competitors;
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the commercial success of EXPAREL;
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results of clinical trials of our product candidates or those of our competitors;
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changes or developments in laws or regulations applicable to our product candidates;
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introduction of competitive products or technologies;
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failure to meet or exceed financial projections we provide to the public;
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actual or anticipated variations in quarterly operating results;
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failure to meet or exceed the estimates and projections of the investment community;
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the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;
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regulatory concerns or government actions
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general economic and market conditions and overall fluctuations in U.S. equity markets;
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developments concerning our sources of manufacturing supply;
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disputes or other developments relating to patents or other proprietary rights;
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additions or departures of key scientific or management personnel;
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issuances of debt, equity or convertible securities;
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changes in the market valuations of similar companies; and
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the other factors described in this “Risk Factors” section.
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authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval;
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prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders;
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eliminating the ability of stockholders to call a special meeting of stockholders; and
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establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings.
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Year Ended 2017
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High
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Low
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Fourth Quarter
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$
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47.55
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$
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29.81
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Third Quarter
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51.10
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34.35
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Second Quarter
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52.48
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41.70
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First Quarter
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58.95
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31.70
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Year Ended 2016
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High
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Low
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Fourth Quarter
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$
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38.20
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$
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29.95
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Third Quarter
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46.22
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32.16
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Second Quarter
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65.64
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31.08
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First Quarter
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76.75
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44.15
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|
|
Cumulative Total Return as of December 31,
|
||||||||||||||||||||||
|
2012
|
|
2013
|
|
2014
|
|
2015
|
|
2016
|
|
2017
|
||||||||||||
Pacira Pharmaceuticals, Inc. (PCRX)
|
$
|
100.00
|
|
|
$
|
329.08
|
|
|
$
|
507.50
|
|
|
$
|
439.55
|
|
|
$
|
184.89
|
|
|
$
|
261.31
|
|
NASDAQ Composite (^IXIC)
|
100.00
|
|
|
138.32
|
|
|
156.85
|
|
|
165.84
|
|
|
178.28
|
|
|
228.63
|
|
||||||
NASDAQ Biotechnology (^NBI)
|
100.00
|
|
|
165.61
|
|
|
222.08
|
|
|
247.44
|
|
|
193.79
|
|
|
234.59
|
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
Consolidated Statements of Operations Data
|
(In thousands, except per share data)
|
||||||||||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
||||||||||
Net product sales
|
$
|
284,342
|
|
|
$
|
270,073
|
|
|
$
|
244,487
|
|
|
$
|
193,526
|
|
|
$
|
81,956
|
|
Collaborative licensing and milestone revenue
|
387
|
|
|
3,426
|
|
|
1,426
|
|
|
1,287
|
|
|
972
|
|
|||||
Royalty revenue
|
1,901
|
|
|
2,872
|
|
|
3,084
|
|
|
2,855
|
|
|
2,623
|
|
|||||
Total revenues
|
286,630
|
|
|
276,371
|
|
|
248,997
|
|
|
197,668
|
|
|
85,551
|
|
|||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of goods sold
|
87,915
|
|
|
110,104
|
|
2
|
71,837
|
|
|
77,440
|
|
|
54,772
|
|
|||||
Research and development
|
57,290
|
|
|
45,678
|
|
|
28,662
|
|
|
18,731
|
|
|
21,560
|
|
|||||
Selling, general and administrative
|
161,494
|
|
|
152,613
|
|
3
|
139,043
|
|
|
106,662
|
|
|
62,508
|
|
|||||
Product discontinuation
|
4,868
|
|
1
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Total operating expenses
|
311,567
|
|
|
308,395
|
|
|
239,542
|
|
|
202,833
|
|
|
138,840
|
|
|||||
Income (loss) from operations
|
(24,937
|
)
|
|
(32,024
|
)
|
|
9,455
|
|
|
(5,165
|
)
|
|
(53,289
|
)
|
|||||
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest income
|
4,078
|
|
|
1,323
|
|
|
678
|
|
|
382
|
|
|
259
|
|
|||||
Interest expense
|
(18,047
|
)
|
|
(7,061
|
)
|
|
(7,725
|
)
|
|
(8,278
|
)
|
|
(7,253
|
)
|
|||||
Loss on early extinguishment of debt
|
(3,732
|
)
|
|
—
|
|
|
(52
|
)
|
|
—
|
|
|
(3,398
|
)
|
|||||
Royalty interest obligation
|
—
|
|
|
—
|
|
|
(71
|
)
|
|
(323
|
)
|
|
(623
|
)
|
|||||
Other, net
|
167
|
|
|
(82
|
)
|
|
(165
|
)
|
|
(159
|
)
|
|
(47
|
)
|
|||||
Total other expense, net
|
(17,534
|
)
|
|
(5,820
|
)
|
|
(7,335
|
)
|
|
(8,378
|
)
|
|
(11,062
|
)
|
|||||
Income (loss) before income taxes
|
(42,471
|
)
|
|
(37,844
|
)
|
|
2,120
|
|
|
(13,543
|
)
|
|
(64,351
|
)
|
|||||
Income tax (expense) benefit
|
(140
|
)
|
|
(105
|
)
|
|
(264
|
)
|
|
(173
|
)
|
|
442
|
|
|||||
Net income (loss)
|
$
|
(42,611
|
)
|
|
$
|
(37,949
|
)
|
|
$
|
1,856
|
|
|
$
|
(13,716
|
)
|
|
$
|
(63,909
|
)
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income (loss) per share:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic net income (loss) per common share
|
$
|
(1.07
|
)
|
|
$
|
(1.02
|
)
|
|
$
|
0.05
|
|
|
$
|
(0.39
|
)
|
|
$
|
(1.93
|
)
|
Diluted net income (loss) per common share
|
$
|
(1.07
|
)
|
|
$
|
(1.02
|
)
|
|
$
|
0.04
|
|
|
$
|
(0.39
|
)
|
|
$
|
(1.93
|
)
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
|
39,806
|
|
|
37,236
|
|
|
36,540
|
|
|
35,299
|
|
|
33,182
|
|
|||||
Diluted
|
39,806
|
|
|
37,236
|
|
|
41,301
|
|
|
35,299
|
|
|
33,182
|
|
|
December 31,
|
||||||||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
2014
|
|
2013
|
||||||||||
Consolidated Balance Sheet Data
|
(In thousands)
|
||||||||||||||||||
Cash and cash equivalents, restricted cash,
short-term and long-term investments |
$
|
371,394
|
|
|
$
|
172,597
|
|
|
$
|
172,427
|
|
|
$
|
182,598
|
|
|
$
|
73,785
|
|
Working capital (deficit)
|
334,893
|
|
|
198,251
|
|
|
102,794
|
|
|
71,715
|
|
|
(18,345
|
)
|
|||||
Total assets
|
628,371
|
|
|
391,466
|
|
|
387,735
|
|
|
323,540
|
|
|
166,668
|
|
|||||
Long-term liabilities
|
292,671
|
|
|
127,652
|
|
|
19,555
|
|
|
14,917
|
|
|
6,628
|
|
|||||
Accumulated deficit
|
(389,136
|
)
|
|
(346,238
|
)
|
|
(308,289
|
)
|
|
(310,145
|
)
|
|
(296,429
|
)
|
|||||
Total stockholders’ equity
|
279,483
|
|
|
218,976
|
|
|
218,392
|
|
|
171,145
|
|
|
41,249
|
|
•
|
In October 2017, we announced that the FDA accepted the resubmission of our supplemental New Drug Application, or sNDA, seeking expansion of the EXPAREL label to include administration via nerve block for prolonged regional analgesia. Our sNDA for EXPAREL as a nerve block for regional analgesia was discussed at a meeting of the Anesthetic and Analgesic Drug Products Advisory Committee, or AADPAC, on February 14-15, 2018. The AADPAC committee members voted six to four against approval of the EXPAREL sNDA. The committee’s feedback will be considered by the FDA in its review of the sNDA. The FDA’s Prescription Drug User Fee Act (PDUFA) goal date for completion of its review is April 6, 2018. The sNDA is based on the positive data from a Phase 3 study of EXPAREL in femoral nerve block for total knee arthroplasty, or TKA, (lower extremity) and a Phase 3 study of EXPAREL in brachial plexus block for shoulder surgeries (upper extremity). It also includes safety and pharmacokinetic data through 120 hours.
|
•
|
In October 2017, we made a cash investment of $15.0 million in convertible preferred B shares of TELA Bio Inc., or TELA Bio, a privately-held surgical reconstruction company that markets its proprietary OviTex
TM
portfolio of products for ventral hernia repair and abdominal wall reconstruction. OviTex Reinforced BioScaffolds (RBSs) are intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. In conjunction with the investment in TELA Bio, we acquired an option to purchase an additional $10.0 million of convertible preferred B shares of TELA Bio under the same terms and conditions as existed on the initial purchase date. The purchase option expires on September 15, 2018. If we do not exercise our purchase option, we may be required to invest up to $10.0 million in TELA Bio convertible preferred B shares under certain conditions. This contingent purchase obligation expires on October 31, 2018.
|
•
|
In September 2017, we announced a collaboration with Aetna, one of the nation’s leading diversified health care benefits companies, with the support of the American Association of Oral and Maxillofacial Surgeons. This national program aims to reduce the number of opioid tablets dispensed to patients undergoing impacted third molar (wisdom tooth) extractions by at least 50 percent through the utilization of EXPAREL to provide prolonged non-opioid postsurgical pain control. Aetna will include the cost of EXPAREL as a covered expense for impacted third molar extractions performed by surgeons who have completed training on use of the product.
|
•
|
In February 2017, we received an issue notification from the U.S. Patent and Trademark Office stating that a patent relating to product-by-process and process claims in connection with the production of multivesicular liposomes was issued on March 7, 2017. This patent is listed on the Orange Book for EXPAREL, and includes a patent term adjustment that equates to an expiration date of December 24, 2021. For further discussion, see “Intellectual Property and Exclusivity” in Item 1. “Business” included in this report.
|
•
|
In January 2017, we announced the initiation of an agreement with DePuy Synthes Sales, Inc., or DePuy Synthes, to market and promote the use of EXPAREL for orthopedic procedures in the U.S. market. DePuy Synthes field representatives, specializing in joint reconstruction, spine, sports medicine and trauma, will collaborate with, and supplement our field teams by expanding the reach and frequency of EXPAREL education in the hospital surgical suite and ambulatory surgery center settings. We believe our collaboration with DePuy Synthes will accelerate and enhance our education and training efforts with orthopedic customers as we aim to broaden and strengthen the adoption and use of EXPAREL. In addition to supporting orthopedic specialties, we will focus on soft tissue surgeons in key specialties and anesthesiologists, and continue to act as the overall EXPAREL account manager.
|
|
Year Ended December 31,
|
|
2017 versus
2016 |
|
2016 versus
2015 |
||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
% Increase / (Decrease)
|
||||||||||
Cost of goods sold
|
$
|
87,915
|
|
|
$
|
110,104
|
|
|
$
|
71,837
|
|
|
(20
|
)%
|
|
53
|
%
|
Gross margin
|
69
|
%
|
|
60
|
%
|
|
71
|
%
|
|
|
|
|
|
Year Ended December 31,
|
|
2017 versus
2016 |
|
2016 versus
2015 |
||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
% Increase / (Decrease)
|
||||||||||
Clinical development
|
$
|
33,138
|
|
|
$
|
23,566
|
|
|
$
|
12,609
|
|
|
41
|
%
|
|
87
|
%
|
Product development and other
|
20,811
|
|
|
18,815
|
|
|
10,919
|
|
|
11
|
%
|
|
72
|
%
|
|||
Stock-based compensation
|
3,341
|
|
|
3,297
|
|
|
5,134
|
|
|
1
|
%
|
|
(36
|
)%
|
|||
Total research and development expense
|
$
|
57,290
|
|
|
$
|
45,678
|
|
|
$
|
28,662
|
|
|
25
|
%
|
|
59
|
%
|
% of total revenue
|
20
|
%
|
|
17
|
%
|
|
12
|
%
|
|
|
|
|
|
Year Ended December 31,
|
|
2017 versus
2016 |
|
2016 versus
2015 |
||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
% Increase / (Decrease)
|
||||||||||
Sales and marketing
|
$
|
94,803
|
|
|
$
|
89,218
|
|
|
$
|
77,733
|
|
|
6
|
%
|
|
15
|
%
|
General and administrative
|
43,898
|
|
|
41,882
|
|
|
39,088
|
|
|
5
|
%
|
|
7
|
%
|
|||
Stock-based compensation
|
22,793
|
|
|
21,513
|
|
|
22,222
|
|
|
6
|
%
|
|
(3
|
)%
|
|||
Total selling, general and administrative expenses
|
$
|
161,494
|
|
|
$
|
152,613
|
|
|
$
|
139,043
|
|
|
6
|
%
|
|
10
|
%
|
% of total revenue
|
56
|
%
|
|
55
|
%
|
|
56
|
%
|
|
|
|
|
|
Year Ended December 31,
|
|
2017 versus
2016 |
|
2016 versus
2015 |
||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
% Increase / (Decrease)
|
||||||||||
Interest income
|
$
|
4,078
|
|
|
$
|
1,323
|
|
|
$
|
678
|
|
|
208
|
%
|
|
95
|
%
|
Interest expense
|
(18,047
|
)
|
|
(7,061
|
)
|
|
(7,725
|
)
|
|
156
|
%
|
|
(9
|
)%
|
|||
Loss on early extinguishment of debt
|
(3,732
|
)
|
|
—
|
|
|
(52
|
)
|
|
N/A
|
|
|
(100
|
)%
|
|||
Royalty interest obligation
|
—
|
|
|
—
|
|
|
(71
|
)
|
|
N/A
|
|
|
(100
|
)%
|
|||
Other, net
|
167
|
|
|
(82
|
)
|
|
(165
|
)
|
|
N/A
|
|
|
(50
|
)%
|
|||
Total other expense, net
|
$
|
(17,534
|
)
|
|
$
|
(5,820
|
)
|
|
$
|
(7,335
|
)
|
|
201
|
%
|
|
(21
|
)%
|
% of total revenue
|
(6
|
)%
|
|
(2
|
)%
|
|
(3
|
)%
|
|
|
|
|
|
Year Ended December 31,
|
|
2017 versus
2016 |
|
2016 versus
2015 |
||||||||||||
|
2017
|
|
2016
|
|
2015
|
|
% Increase / (Decrease)
|
||||||||||
Income tax expense
|
$
|
140
|
|
|
$
|
105
|
|
|
$
|
264
|
|
|
33
|
%
|
|
(60
|
)%
|
Effective tax rate
|
0
|
%
|
|
0
|
%
|
|
12
|
%
|
|
|
|
|
|
|
Year Ended December 31,
|
||||||||||
Consolidated Statement of Cash Flows Data:
|
|
2017
|
|
2016
|
|
2015
|
||||||
Net cash provided by (used in):
|
|
|
|
|
|
|
||||||
Operating activities
|
|
$
|
17,785
|
|
|
$
|
33,453
|
|
|
$
|
28,021
|
|
Investing activities
|
|
(223,765
|
)
|
|
(61,754
|
)
|
|
(19,256
|
)
|
|||
Financing activities
|
|
224,162
|
|
|
7,261
|
|
|
10,699
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
|
$
|
18,182
|
|
|
$
|
(21,040
|
)
|
|
$
|
19,464
|
|
•
|
our ability to successfully continue to expand the commercialization of EXPAREL;
|
•
|
the cost and timing of expanding our manufacturing facilities for EXPAREL and our other product candidates, including costs associated with certain technical transfer activities and the construction of manufacturing suites at Patheon’s facility;
|
•
|
the timing of and extent to which the holders of our 2022 Notes elect to convert their notes;
|
•
|
the cost and timing of potential milestone payments to Skyepharma, which could be up to an aggregate of $36.0 million if certain milestones pertaining to net sales of DepoBupivacaine products, including EXPAREL, are met;
|
•
|
costs related to legal and regulatory issues;
|
•
|
the costs of performing additional clinical trials for EXPAREL, including the pediatric trials required by the FDA as a condition of approval;
|
•
|
the costs for the development and commercialization of other product candidates; and
|
•
|
the extent to which we acquire or invest in products, businesses and technologies.
|
|
Payments Due by Period
|
||||||||||||||||||
Contractual Obligations (1)
|
Total
|
|
Less Than One Year
|
|
1-3 Years
|
|
3-5 Years
|
|
More Than
5 Years |
||||||||||
Senior convertible notes - principal (2)
|
$
|
345,338
|
|
|
$
|
—
|
|
|
$
|
338
|
|
|
$
|
345,000
|
|
|
$
|
—
|
|
Senior convertible notes - interest
|
36,888
|
|
|
8,204
|
|
|
16,393
|
|
|
12,291
|
|
|
—
|
|
|||||
Lease obligations (3)
|
53,733
|
|
|
7,886
|
|
|
15,659
|
|
|
10,611
|
|
|
19,577
|
|
|||||
Purchase obligations (4)
|
290
|
|
|
290
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Total
|
$
|
436,249
|
|
|
$
|
16,380
|
|
|
$
|
32,390
|
|
|
$
|
367,902
|
|
|
$
|
19,577
|
|
|
Returns Allowances
|
|
Prompt Payment Discounts
|
|
Wholesaler Service Fees
|
|
Volume Rebates and Chargebacks
|
|
Total
|
||||||||||
Balance at December 31, 2014
|
$
|
1,559
|
|
|
$
|
575
|
|
|
$
|
588
|
|
|
$
|
321
|
|
|
$
|
3,043
|
|
Provision
|
339
|
|
|
4,905
|
|
|
3,482
|
|
|
2,020
|
|
|
10,746
|
|
|||||
Payments/credits
|
(165
|
)
|
|
(4,855
|
)
|
|
(3,325
|
)
|
|
(1,544
|
)
|
|
(9,889
|
)
|
|||||
Balance at December 31, 2015
|
1,733
|
|
|
625
|
|
|
745
|
|
|
797
|
|
|
3,900
|
|
|||||
Provision
|
694
|
|
|
5,448
|
|
|
4,118
|
|
|
2,611
|
|
|
12,871
|
|
|||||
Payments/credits
|
(1,081
|
)
|
|
(5,478
|
)
|
|
(4,128
|
)
|
|
(2,284
|
)
|
|
(12,971
|
)
|
|||||
Balance at December 31, 2016
|
1,346
|
|
|
595
|
|
|
735
|
|
|
1,124
|
|
|
3,800
|
|
|||||
Provision
|
716
|
|
|
5,806
|
|
|
4,403
|
|
|
4,656
|
|
|
15,581
|
|
|||||
Payments/credits
|
(1,241
|
)
|
|
(5,744
|
)
|
|
(4,299
|
)
|
|
(5,084
|
)
|
|
(16,368
|
)
|
|||||
Balance at December 31, 2017
|
$
|
821
|
|
|
$
|
657
|
|
|
$
|
839
|
|
|
$
|
696
|
|
|
$
|
3,013
|
|
/s/ KPMG LLP
|
|
|
|
Short Hills, NJ
|
|
February 28, 2018
|
|
(1)
|
Awards issuable under our 2011 Plan include common stock, stock options, restricted stock, restricted stock units, stock appreciation rights, dividend equivalents, Operating Partnership units and other incentive awards.
|
(2)
|
Does not include 499,546 unvested shares outstanding as of
December 31, 2017
in the form of restricted stock units under our 2011 Plan, which do not require the payment of any consideration by the recipients.
|
(3)
|
See Note 11,
Stock Plans
, to our consolidated financial statements included herein for further descriptions of our equity compensation plans.
|
(a)
|
Documents filed as part of Form 10-K.
|
(1)
|
Financial Statements
|
|
Report of KPMG LLP, Independent Registered Public Accounting Firm
|
|
Report of CohnReznick LLP, Independent Registered Public Accounting Firm
|
|
Consolidated Balance Sheets
|
|
Consolidated Statements of Operations
|
|
Consolidated Statements of Comprehensive Income (Loss)
|
|
Consolidated Statements of Stockholders’ Equity
|
|
Consolidated Statements of Cash Flows
|
|
Notes to Consolidated Financial Statements
|
(2)
|
Schedules
|
(3)
|
Exhibits
|
|
|
|
|
PACIRA PHARMACEUTICALS, INC.
/s/ DAVID STACK
|
Date:
|
February 28, 2018
|
By:
|
|
David Stack
Chief Executive Officer and Chairman
|
Signature
|
|
Title
|
|
Date
|
/s/ DAVID STACK
|
|
Director, Chief Executive Officer and Chairman
(Principal Executive Officer)
|
|
February 28, 2018
|
David Stack
|
|
|
|
|
|
|
|
|
|
/s/ CHARLES A. REINHART, III
|
|
Chief Financial Officer
(Principal Financial Officer)
|
|
February 28, 2018
|
Charles A. Reinhart, III
|
|
|
|
|
|
|
|
|
|
/s/ LAUREN RIKER
|
|
Vice President, Finance
(Principal Accounting Officer)
|
|
February 28, 2018
|
Lauren Riker
|
|
|
|
|
|
|
|
|
|
/s/ LAURA BREGE
|
|
Director
|
|
February 28, 2018
|
Laura Brege
|
|
|
|
|
|
|
|
|
|
/s/ MARK FROIMSON
|
|
Director
|
|
February 28, 2018
|
Mark Froimson
|
|
|
|
|
|
|
|
|
|
/s/ YVONNE GREENSTREET
|
|
Director
|
|
February 28, 2018
|
Yvonne Greenstreet
|
|
|
|
|
|
|
|
|
|
/s/ MARK KRONENFELD
|
|
Director
|
|
February 28, 2018
|
Mark Kronenfeld
|
|
|
|
|
|
|
|
|
|
/s/ JOHN LONGENECKER
|
|
Director
|
|
February 28, 2018
|
John Longenecker
|
|
|
|
|
|
|
|
|
|
/s/ GARY PACE
|
|
Director
|
|
February 28, 2018
|
Gary Pace
|
|
|
|
|
|
|
|
|
|
/s/ ANDREAS WICKI
|
|
Director
|
|
February 28, 2018
|
Andreas Wicki
|
|
|
|
|
|
|
|
|
|
/s/ DENNIS WINGER
|
|
Director
|
|
February 28, 2018
|
Dennis Winger
|
|
|
|
|
|
|
|
|
|
/s/ PAUL HASTINGS
|
|
Lead Director
|
|
February 28, 2018
|
Paul Hastings
|
|
|
|
|
/s/ KPMG LLP
|
|
|
|
We have served as the Company’s auditor since 2015.
|
|
|
|
Short Hills, NJ
|
|
February 28, 2018
|
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
54,126
|
|
|
$
|
35,944
|
|
Short-term investments
|
257,221
|
|
|
136,653
|
|
||
Accounts receivable, net
|
31,658
|
|
|
29,937
|
|
||
Inventories, net
|
41,411
|
|
|
31,278
|
|
||
Prepaid expenses and other current assets
|
6,694
|
|
|
9,277
|
|
||
Total current assets
|
391,110
|
|
|
243,089
|
|
||
Long-term investments
|
60,047
|
|
|
—
|
|
||
Fixed assets, net
|
107,046
|
|
|
101,016
|
|
||
Goodwill
|
55,197
|
|
|
46,737
|
|
||
Equity investment
|
14,146
|
|
|
—
|
|
||
Other assets
|
825
|
|
|
624
|
|
||
Total assets
|
$
|
628,371
|
|
|
$
|
391,466
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
14,658
|
|
|
$
|
7,511
|
|
Accrued expenses
|
41,057
|
|
|
36,666
|
|
||
Convertible senior notes
|
324
|
|
|
—
|
|
||
Current portion of deferred revenue
|
102
|
|
|
595
|
|
||
Income taxes payable
|
76
|
|
|
66
|
|
||
Total current liabilities
|
56,217
|
|
|
44,838
|
|
||
Convertible senior notes
|
276,173
|
|
|
108,738
|
|
||
Other liabilities
|
16,498
|
|
|
18,914
|
|
||
Total liabilities
|
348,888
|
|
|
172,490
|
|
||
Commitments and contingencies (Note 17)
|
|
|
|
||||
Stockholders’ equity:
|
|
|
|
||||
Preferred stock, par value $0.001; 5,000,000 shares authorized; none issued and outstanding at December 31, 2017 and 2016
|
—
|
|
|
—
|
|
||
Common stock, par value $0.001; 250,000,000 shares authorized; 40,668,877 shares issued and outstanding at December 31, 2017; 37,480,952 shares issued and outstanding at December 31, 2016
|
41
|
|
|
37
|
|
||
Additional paid-in capital
|
669,032
|
|
|
565,207
|
|
||
Accumulated deficit
|
(389,136
|
)
|
|
(346,238
|
)
|
||
Accumulated other comprehensive loss
|
(454
|
)
|
|
(30
|
)
|
||
Total stockholders’ equity
|
279,483
|
|
|
218,976
|
|
||
Total liabilities and stockholders’ equity
|
$
|
628,371
|
|
|
$
|
391,466
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Net product sales
|
$
|
284,342
|
|
|
$
|
270,073
|
|
|
$
|
244,487
|
|
Collaborative licensing and milestone revenue
|
387
|
|
|
3,426
|
|
|
1,426
|
|
|||
Royalty revenue
|
1,901
|
|
|
2,872
|
|
|
3,084
|
|
|||
Total revenues
|
286,630
|
|
|
276,371
|
|
|
248,997
|
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
Cost of goods sold
|
87,915
|
|
|
110,104
|
|
|
71,837
|
|
|||
Research and development
|
57,290
|
|
|
45,678
|
|
|
28,662
|
|
|||
Selling, general and administrative
|
161,494
|
|
|
152,613
|
|
|
139,043
|
|
|||
Product discontinuation
|
4,868
|
|
|
—
|
|
|
—
|
|
|||
Total operating expenses
|
311,567
|
|
|
308,395
|
|
|
239,542
|
|
|||
Income (loss) from operations
|
(24,937
|
)
|
|
(32,024
|
)
|
|
9,455
|
|
|||
Other (expense) income:
|
|
|
|
|
|
||||||
Interest income
|
4,078
|
|
|
1,323
|
|
|
678
|
|
|||
Interest expense
|
(18,047
|
)
|
|
(7,061
|
)
|
|
(7,725
|
)
|
|||
Loss on early extinguishment of debt
|
(3,732
|
)
|
|
—
|
|
|
(52
|
)
|
|||
Royalty interest obligation
|
—
|
|
|
—
|
|
|
(71
|
)
|
|||
Other, net
|
167
|
|
|
(82
|
)
|
|
(165
|
)
|
|||
Total other expense, net
|
(17,534
|
)
|
|
(5,820
|
)
|
|
(7,335
|
)
|
|||
Income (loss) before income taxes
|
(42,471
|
)
|
|
(37,844
|
)
|
|
2,120
|
|
|||
Income tax expense
|
(140
|
)
|
|
(105
|
)
|
|
(264
|
)
|
|||
Net income (loss)
|
$
|
(42,611
|
)
|
|
$
|
(37,949
|
)
|
|
$
|
1,856
|
|
|
|
|
|
|
|
||||||
Net income (loss) per share:
|
|
|
|
|
|
||||||
Basic net income (loss) per common share
|
$
|
(1.07
|
)
|
|
$
|
(1.02
|
)
|
|
$
|
0.05
|
|
Diluted net income (loss) per common share
|
$
|
(1.07
|
)
|
|
$
|
(1.02
|
)
|
|
$
|
0.04
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
||||||
Basic
|
39,806
|
|
|
37,236
|
|
|
36,540
|
|
|||
Diluted
|
39,806
|
|
|
37,236
|
|
|
41,301
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Net income (loss)
|
$
|
(42,611
|
)
|
|
$
|
(37,949
|
)
|
|
$
|
1,856
|
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|||
Net unrealized gain (loss) on investments
|
(424
|
)
|
|
22
|
|
|
28
|
|
|||
Total other comprehensive income (loss)
|
(424
|
)
|
|
22
|
|
|
28
|
|
|||
Comprehensive income (loss)
|
$
|
(43,035
|
)
|
|
$
|
(37,927
|
)
|
|
$
|
1,884
|
|
|
Common
Stock |
|
Additional
Paid-In
Capital
|
|
Accumulated
Deficit
|
|
Accumulated
Other
Comprehensive
Income (Loss)
|
|
Total
|
|||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balance at December 31, 2014
|
36,151
|
|
|
$
|
36
|
|
|
$
|
481,334
|
|
|
$
|
(310,145
|
)
|
|
$
|
(80
|
)
|
|
$
|
171,145
|
|
Exercise of stock options
|
618
|
|
|
1
|
|
|
10,072
|
|
|
—
|
|
|
—
|
|
|
10,073
|
|
|||||
Shares issued under employee
stock purchase plan |
35
|
|
|
—
|
|
|
2,093
|
|
|
—
|
|
|
—
|
|
|
2,093
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
33,368
|
|
|
—
|
|
|
—
|
|
|
33,368
|
|
|||||
Issuance of common stock upon
conversion of 2019 convertible senior notes |
44
|
|
|
—
|
|
|
3,929
|
|
|
—
|
|
|
—
|
|
|
3,929
|
|
|||||
Retirement of equity component
of 2019 convertible senior notes |
—
|
|
|
—
|
|
|
(4,100
|
)
|
|
—
|
|
|
—
|
|
|
(4,100
|
)
|
|||||
Net unrealized gain on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
28
|
|
|
28
|
|
|||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
1,856
|
|
|
—
|
|
|
1,856
|
|
|||||
Balance at December 31, 2015
|
36,848
|
|
|
37
|
|
|
526,696
|
|
|
(308,289
|
)
|
|
(52
|
)
|
|
218,392
|
|
|||||
Exercise of stock options
|
518
|
|
|
—
|
|
|
5,770
|
|
|
—
|
|
|
—
|
|
|
5,770
|
|
|||||
Vested restricted stock units
|
62
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Shares issued under employee
stock purchase plan |
53
|
|
|
—
|
|
|
1,495
|
|
|
—
|
|
|
—
|
|
|
1,495
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
31,248
|
|
|
—
|
|
|
—
|
|
|
31,248
|
|
|||||
Retirement of equity component
of 2019 convertible senior notes |
—
|
|
|
—
|
|
|
(2
|
)
|
|
—
|
|
|
—
|
|
|
(2
|
)
|
|||||
Net unrealized gain on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
22
|
|
|
22
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(37,949
|
)
|
|
—
|
|
|
(37,949
|
)
|
|||||
Balance at December 31, 2016
|
37,481
|
|
|
37
|
|
|
565,207
|
|
|
(346,238
|
)
|
|
(30
|
)
|
|
218,976
|
|
|||||
Cumulative effect adjustment of the adoption
of Accounting Standards Update 2016-09 (Note 3) |
—
|
|
|
—
|
|
|
287
|
|
|
(287
|
)
|
|
—
|
|
|
—
|
|
|||||
Exercise of stock options
|
540
|
|
|
1
|
|
|
6,777
|
|
|
—
|
|
|
—
|
|
|
6,778
|
|
|||||
Vested restricted stock units
|
101
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Shares issued under employee stock
purchase plan |
57
|
|
|
—
|
|
|
1,862
|
|
|
—
|
|
|
—
|
|
|
1,862
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
31,601
|
|
|
—
|
|
|
—
|
|
|
31,601
|
|
|||||
Issuance of common stock upon
conversion of 2019 convertible senior notes |
2,490
|
|
|
3
|
|
|
120,957
|
|
|
—
|
|
|
—
|
|
|
120,960
|
|
|||||
Retirement of equity component
of 2019 convertible senior notes |
—
|
|
|
—
|
|
|
(126,328
|
)
|
|
—
|
|
|
—
|
|
|
(126,328
|
)
|
|||||
Equity component of 2022 convertible
senior notes issued, net |
—
|
|
|
—
|
|
|
68,669
|
|
|
—
|
|
|
—
|
|
|
68,669
|
|
|||||
Net unrealized loss on investments
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(424
|
)
|
|
(424
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(42,611
|
)
|
|
—
|
|
|
(42,611
|
)
|
|||||
Balance at December 31, 2017
|
40,669
|
|
|
$
|
41
|
|
|
$
|
669,032
|
|
|
$
|
(389,136
|
)
|
|
$
|
(454
|
)
|
|
$
|
279,483
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
|
|||||||||||
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Operating activities:
|
|
|
|
|
|
||||||
Net income (loss)
|
$
|
(42,611
|
)
|
|
$
|
(37,949
|
)
|
|
$
|
1,856
|
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
|
|
|
|
|
||||||
Depreciation of fixed assets and amortization of intangibles
|
13,833
|
|
|
12,919
|
|
|
11,475
|
|
|||
Amortization of unfavorable lease obligation and debt issuance costs
|
1,248
|
|
|
479
|
|
|
481
|
|
|||
Amortization of debt discount
|
10,423
|
|
|
4,088
|
|
|
4,102
|
|
|||
Loss on disposal of fixed assets
|
2,133
|
|
|
389
|
|
|
6
|
|
|||
Loss on early extinguishment of debt
|
3,732
|
|
|
—
|
|
|
52
|
|
|||
Stock-based compensation
|
31,601
|
|
|
31,248
|
|
|
33,368
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Restricted cash
|
—
|
|
|
—
|
|
|
1,509
|
|
|||
Accounts receivable, net
|
(1,721
|
)
|
|
(4,082
|
)
|
|
(3,489
|
)
|
|||
Inventories, net
|
(10,133
|
)
|
|
30,367
|
|
|
(32,382
|
)
|
|||
Prepaid expenses and other assets
|
3,476
|
|
|
(3,377
|
)
|
|
(2,007
|
)
|
|||
Accounts payable, accrued expenses and income taxes payable
|
9,359
|
|
|
710
|
|
|
8,966
|
|
|||
Royalty interest obligation
|
—
|
|
|
—
|
|
|
(276
|
)
|
|||
Other liabilities
|
(3,555
|
)
|
|
(1,339
|
)
|
|
4,360
|
|
|||
Net cash provided by operating activities
|
17,785
|
|
|
33,453
|
|
|
28,021
|
|
|||
Investing activities:
|
|
|
|
|
|
||||||
Purchases of fixed assets
|
(19,266
|
)
|
|
(24,709
|
)
|
|
(40,295
|
)
|
|||
Purchases of investments
|
(502,752
|
)
|
|
(192,815
|
)
|
|
(189,082
|
)
|
|||
Sales of investments
|
321,713
|
|
|
171,627
|
|
|
217,240
|
|
|||
Payment of contingent consideration
|
(8,460
|
)
|
|
(15,857
|
)
|
|
(7,119
|
)
|
|||
Equity investment
|
(15,000
|
)
|
|
—
|
|
|
—
|
|
|||
Net cash used in investing activities
|
(223,765
|
)
|
|
(61,754
|
)
|
|
(19,256
|
)
|
|||
Financing activities:
|
|
|
|
|
|
||||||
Proceeds from exercise of stock options
|
6,778
|
|
|
5,770
|
|
|
10,073
|
|
|||
Proceeds from shares issued under employee stock purchase plan
|
1,862
|
|
|
1,495
|
|
|
2,093
|
|
|||
Proceeds from 2022 convertible senior notes
|
345,000
|
|
|
—
|
|
|
—
|
|
|||
Repayment of 2019 convertible senior notes
|
(118,193
|
)
|
|
(4
|
)
|
|
(1,467
|
)
|
|||
Payment of debt issuance and financing costs
|
(11,000
|
)
|
|
—
|
|
|
—
|
|
|||
Costs for conversion of convertible senior notes
|
(285
|
)
|
|
—
|
|
|
—
|
|
|||
Net cash provided by financing activities
|
224,162
|
|
|
7,261
|
|
|
10,699
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
18,182
|
|
|
(21,040
|
)
|
|
19,464
|
|
|||
Cash and cash equivalents, beginning of year
|
35,944
|
|
|
56,984
|
|
|
37,520
|
|
|||
Cash and cash equivalents, end of year
|
$
|
54,126
|
|
|
$
|
35,944
|
|
|
$
|
56,984
|
|
Supplemental cash flow information:
|
|
|
|
|
|
||||||
Cash paid for interest, including royalty interest obligation
|
$
|
6,896
|
|
|
$
|
3,852
|
|
|
$
|
4,224
|
|
Cash paid for income taxes, net of refunds
|
$
|
129
|
|
|
$
|
247
|
|
|
$
|
195
|
|
Non-cash investing and financing activities:
|
|
|
|
|
|
||||||
Issuance of common stock from conversion of 2019 convertible senior notes
|
$
|
120,960
|
|
|
$
|
—
|
|
|
$
|
3,929
|
|
Retirement of equity component of 2019 convertible senior notes
|
$
|
(126,328
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
Net increase (decrease) in accrued fixed assets
|
$
|
2,189
|
|
|
$
|
(789
|
)
|
|
$
|
1,393
|
|
|
Returns Allowances
|
|
Prompt Payment Discounts
|
|
Wholesaler Service Fees
|
|
Volume Rebates and Chargebacks
|
|
Total
|
||||||||||
Balance at December 31, 2014
|
$
|
1,559
|
|
|
$
|
575
|
|
|
$
|
588
|
|
|
$
|
321
|
|
|
$
|
3,043
|
|
Provision
|
339
|
|
|
4,905
|
|
|
3,482
|
|
|
2,020
|
|
|
10,746
|
|
|||||
Payments/credits
|
(165
|
)
|
|
(4,855
|
)
|
|
(3,325
|
)
|
|
(1,544
|
)
|
|
(9,889
|
)
|
|||||
Balance at December 31, 2015
|
1,733
|
|
|
625
|
|
|
745
|
|
|
797
|
|
|
3,900
|
|
|||||
Provision
|
694
|
|
|
5,448
|
|
|
4,118
|
|
|
2,611
|
|
|
12,871
|
|
|||||
Payments/credits
|
(1,081
|
)
|
|
(5,478
|
)
|
|
(4,128
|
)
|
|
(2,284
|
)
|
|
(12,971
|
)
|
|||||
Balance at December 31, 2016
|
1,346
|
|
|
595
|
|
|
735
|
|
|
1,124
|
|
|
3,800
|
|
|||||
Provision
|
716
|
|
|
5,806
|
|
|
4,403
|
|
|
4,656
|
|
|
15,581
|
|
|||||
Payments/credits
|
(1,241
|
)
|
|
(5,744
|
)
|
|
(4,299
|
)
|
|
(5,084
|
)
|
|
(16,368
|
)
|
|||||
Balance at December 31, 2017
|
$
|
821
|
|
|
$
|
657
|
|
|
$
|
839
|
|
|
$
|
696
|
|
|
$
|
3,013
|
|
|
Year Ended December 31,
|
|||||||
|
2017
|
|
2016
|
|
2015
|
|||
Largest wholesaler
|
35
|
%
|
|
32
|
%
|
|
33
|
%
|
Second largest wholesaler
|
30
|
%
|
|
28
|
%
|
|
29
|
%
|
Third largest wholesaler
|
26
|
%
|
|
26
|
%
|
|
28
|
%
|
|
91
|
%
|
|
86
|
%
|
|
90
|
%
|
•
|
Expected term of the option
|
•
|
Expected volatility
|
•
|
Expected dividends
|
•
|
Risk-free interest rate
|
Asset Category
|
|
Useful Life
|
Computer equipment and software
|
|
1 to 3 years
|
Office furniture and equipment
|
|
5 years
|
Manufacturing and laboratory equipment
|
|
5 to 10 years
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Raw materials
|
$
|
16,500
|
|
|
$
|
11,742
|
|
Work-in-process
|
8,371
|
|
|
11,621
|
|
||
Finished goods
|
16,540
|
|
|
7,915
|
|
||
Total
|
$
|
41,411
|
|
|
$
|
31,278
|
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Machinery and laboratory equipment
|
$
|
39,002
|
|
|
$
|
34,309
|
|
Leasehold improvements
|
34,933
|
|
|
33,787
|
|
||
Computer equipment and software
|
7,086
|
|
|
5,623
|
|
||
Office furniture and equipment
|
1,603
|
|
|
1,606
|
|
||
Construction in progress
|
73,632
|
|
|
63,201
|
|
||
Total
|
156,256
|
|
|
138,526
|
|
||
Less: accumulated depreciation
|
(49,210
|
)
|
|
(37,510
|
)
|
||
Fixed assets, net
|
$
|
107,046
|
|
|
$
|
101,016
|
|
(i)
|
$10.0 million
upon the first commercial sale in the U.S. (met April 2012);
|
(ii)
|
$4.0 million
upon the first commercial sale in a major E.U. country (United Kingdom, France, Germany, Italy and Spain);
|
(iii)
|
$8.0 million
when annual net sales collected reach
$100.0 million
(met September 2014);
|
(iv)
|
$8.0 million
when annual net sales collected reach
$250.0 million
(met June 2016); and
|
(v)
|
$32.0 million
when annual net sales collected reach
$500.0 million
.
|
|
|
Carrying Value
|
||
Balance at December 31, 2015
|
|
$
|
30,880
|
|
Percentage payments on collections of net sales of DepoBupivacaine products
|
|
7,857
|
|
|
Milestone payment triggered by collections of net sales of DepoBupivacaine products
|
|
8,000
|
|
|
Balance at December 31, 2016
|
|
46,737
|
|
|
Percentage payments on collections of net sales of DepoBupivacaine products
|
|
8,460
|
|
|
Balance at December 31, 2017
|
|
$
|
55,197
|
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Compensation and benefits
|
$
|
12,295
|
|
|
$
|
11,228
|
|
Accrued operating expenses
|
20,646
|
|
|
16,538
|
|
||
Accrued royalties
|
4,091
|
|
|
3,822
|
|
||
Accrued interest
|
2,053
|
|
|
1,605
|
|
||
Product returns, rebates and other fees
|
1,972
|
|
|
3,473
|
|
||
Total
|
$
|
41,057
|
|
|
$
|
36,666
|
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
2.375% convertible senior notes due 2022
|
$
|
345,000
|
|
|
$
|
—
|
|
Deferred financing costs
|
(7,482
|
)
|
|
—
|
|
||
Discount on debt
|
(61,345
|
)
|
|
—
|
|
||
Total debt, net of debt discount and deferred financing costs
|
$
|
276,173
|
|
|
$
|
—
|
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
3.25% convertible senior notes due 2019
|
$
|
338
|
|
|
$
|
118,531
|
|
Deferred financing costs
|
(2
|
)
|
|
(1,276
|
)
|
||
Discount on debt
|
(12
|
)
|
|
(8,517
|
)
|
||
Total debt, net of debt discount and deferred financing costs
|
$
|
324
|
|
|
$
|
108,738
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Contractual interest expense
|
$
|
7,344
|
|
|
$
|
3,852
|
|
|
$
|
3,856
|
|
Amortization of debt issuance costs
|
1,381
|
|
|
612
|
|
|
615
|
|
|||
Amortization of debt discount
|
10,423
|
|
|
4,088
|
|
|
4,102
|
|
|||
Capitalized interest and other (Note 5)
|
(1,101
|
)
|
|
(1,491
|
)
|
|
(848
|
)
|
|||
Total
|
$
|
18,047
|
|
|
$
|
7,061
|
|
|
$
|
7,725
|
|
|
|
|
|
|
|
||||||
Effective interest rate on convertible senior notes
|
7.77
|
%
|
|
7.22
|
%
|
|
7.21
|
%
|
•
|
Level 1:
Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
|
•
|
Level 2:
Observable prices that are based on inputs not quoted on active markets, but corroborated by market data.
|
•
|
Level 3:
Unobservable inputs that are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
|
Financial Liabilities Carried at Historical Cost
|
|
Carrying
Value |
|
Fair Value Measurements Using
|
||||||||||||
December 31, 2017
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|||||||||
2.375% convertible senior notes due 2022
(1)
|
|
$
|
276,173
|
|
|
$
|
—
|
|
|
$
|
361,526
|
|
|
$
|
—
|
|
3.25% convertible senior notes due 2019
(2)
|
|
$
|
324
|
|
|
$
|
—
|
|
|
$
|
644
|
|
|
$
|
—
|
|
December 31, 2017 Debt Securities:
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
Short-term:
|
|
|
|
|
|
|
|
|
||||||||
Asset-backed securities
|
|
$
|
28,338
|
|
|
$
|
—
|
|
|
$
|
(37
|
)
|
|
$
|
28,301
|
|
Commercial paper
|
|
48,999
|
|
|
—
|
|
|
(23
|
)
|
|
48,976
|
|
||||
Corporate bonds
|
|
180,119
|
|
|
—
|
|
|
(175
|
)
|
|
179,944
|
|
||||
Subtotal
|
|
257,456
|
|
|
—
|
|
|
(235
|
)
|
|
257,221
|
|
||||
Long-term:
|
|
|
|
|
|
|
|
|
||||||||
Asset-backed securities
|
|
23,836
|
|
|
—
|
|
|
(79
|
)
|
|
23,757
|
|
||||
Corporate bonds
|
|
36,430
|
|
|
—
|
|
|
(140
|
)
|
|
36,290
|
|
||||
Subtotal
|
|
60,266
|
|
|
—
|
|
|
(219
|
)
|
|
60,047
|
|
||||
Total
|
|
$
|
317,722
|
|
|
$
|
—
|
|
|
$
|
(454
|
)
|
|
$
|
317,268
|
|
December 31, 2016 Debt Securities:
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
Short-term:
|
|
|
|
|
|
|
|
|
||||||||
Asset-backed securities
|
|
$
|
9,012
|
|
|
$
|
—
|
|
|
$
|
(2
|
)
|
|
$
|
9,010
|
|
Commercial paper
|
|
39,530
|
|
|
8
|
|
|
(15
|
)
|
|
39,523
|
|
||||
Corporate bonds
|
|
88,141
|
|
|
11
|
|
|
(32
|
)
|
|
88,120
|
|
||||
Total
|
|
$
|
136,683
|
|
|
$
|
19
|
|
|
$
|
(49
|
)
|
|
$
|
136,653
|
|
|
Net Unrealized Gains
(Losses) From Available
For Sale Investments
|
||
Balance at December 31, 2015
|
$
|
(52
|
)
|
Other comprehensive income before reclassifications
|
22
|
|
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
—
|
|
|
Balance at December 31, 2016
|
(30
|
)
|
|
Other comprehensive loss before reclassifications
|
(424
|
)
|
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
—
|
|
|
Balance at December 31, 2017
|
$
|
(454
|
)
|
Stock Incentive Plans
|
|
Awards Reserved for Issuance
|
|
Awards
Issued |
|
Awards Available for Grant
|
|||
2007 Plan
|
|
2,022,837
|
|
|
2,022,837
|
|
|
—
|
|
2011 Plan
|
|
9,931,700
|
|
|
7,037,947
|
|
|
2,893,753
|
|
2014 Inducement plan
|
|
175,000
|
|
|
52,276
|
|
|
122,724
|
|
|
|
12,129,537
|
|
|
9,113,060
|
|
|
3,016,477
|
|
|
|
|
|
|
|
|
|||
Employee Stock Purchase Plan
|
|
Shares Reserved
for Purchase |
|
Shares
Purchased |
|
Shares Available
for Purchase |
|||
2014 ESPP
|
|
500,000
|
|
|
160,147
|
|
|
339,853
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2017
|
|
2016
|
|
2015
|
||||||
Cost of goods sold
|
|
$
|
5,467
|
|
|
$
|
6,438
|
|
|
$
|
6,012
|
|
Research and development
|
|
3,341
|
|
|
3,297
|
|
|
5,134
|
|
|||
Selling, general and administrative
|
|
22,793
|
|
|
21,513
|
|
|
22,222
|
|
|||
Total
|
|
$
|
31,601
|
|
|
$
|
31,248
|
|
|
$
|
33,368
|
|
|
|
|
|
|
|
|
||||||
Stock-based compensation from:
|
|
|
|
|
|
|
||||||
Stock options (employee awards)
|
|
$
|
24,056
|
|
|
$
|
24,505
|
|
|
$
|
27,262
|
|
Stock options (consultant awards)
|
|
167
|
|
|
841
|
|
|
2,367
|
|
|||
RSUs
|
|
6,698
|
|
|
5,117
|
|
|
2,887
|
|
|||
ESPP
|
|
680
|
|
|
785
|
|
|
852
|
|
|||
Total
|
|
$
|
31,601
|
|
|
$
|
31,248
|
|
|
$
|
33,368
|
|
|
Number of
Options |
|
Weighted
Average Exercise Price (Per Share) |
|
Weighted Average
Remaining Contractual Term (Years) |
|
Aggregate
Intrinsic Value (in Thousands) |
|||||
Outstanding at December 31, 2014
|
4,677,856
|
|
|
$
|
35.78
|
|
|
7.86
|
|
$
|
248,276
|
|
Granted
|
906,706
|
|
|
75.35
|
|
|
|
|
|
|
||
Exercised
|
(618,434
|
)
|
|
16.29
|
|
|
|
|
$
|
39,401
|
|
|
Forfeited
|
(294,880
|
)
|
|
64.29
|
|
|
|
|
|
|
||
Expired
|
(25,526
|
)
|
|
81.94
|
|
|
|
|
|
|
||
Outstanding at December 31, 2015
|
4,645,722
|
|
|
44.03
|
|
|
7.31
|
|
$
|
162,340
|
|
|
Granted
|
1,656,598
|
|
|
38.20
|
|
|
|
|
|
|
||
Exercised
|
(518,226
|
)
|
|
11.13
|
|
|
|
|
$
|
21,750
|
|
|
Forfeited
|
(401,048
|
)
|
|
70.27
|
|
|
|
|
|
|
||
Expired
|
(175,303
|
)
|
|
80.91
|
|
|
|
|
|
|
||
Outstanding at December 31, 2016
|
5,207,743
|
|
|
42.16
|
|
|
7.39
|
|
$
|
37,581
|
|
|
Granted
|
1,072,625
|
|
|
43.93
|
|
|
|
|
|
|
||
Exercised
|
(539,989
|
)
|
|
12.55
|
|
|
|
|
$
|
15,865
|
|
|
Forfeited
|
(555,897
|
)
|
|
48.66
|
|
|
|
|
|
|
||
Expired
|
(232,989
|
)
|
|
74.65
|
|
|
|
|
|
|
||
Outstanding at December 31, 2017
|
4,951,493
|
|
|
$
|
43.51
|
|
|
6.91
|
|
$
|
57,021
|
|
Exercisable at December 31, 2017
|
2,882,384
|
|
|
$
|
42.20
|
|
|
5.51
|
|
$
|
47,082
|
|
Vested and expected to vest at December 31, 2017
|
4,951,493
|
|
|
$
|
43.51
|
|
|
6.91
|
|
$
|
57,021
|
|
|
Year Ended December 31,
|
||||
|
2017
|
|
2016
|
|
2015
|
Expected dividend yield
|
None
|
|
None
|
|
None
|
Risk-free interest rate
|
1.68% - 2.42%
|
|
1.03% - 2.48%
|
|
1.40% - 2.28%
|
Expected volatility
|
51.4%
|
|
53.5%
|
|
52.9%
|
Expected term of options
|
5.31 years
|
|
5.77 years
|
|
5.76 years
|
|
Number
of Units |
|
Weighted
Average Grant Date Fair Value (Per Share) |
|
Aggregate
Intrinsic Value (in Thousands) |
|||||
Unvested at December 31, 2014
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Granted
|
232,046
|
|
|
78.65
|
|
|
|
|
||
Vested
|
—
|
|
|
—
|
|
|
|
|||
Forfeited
|
(15,848
|
)
|
|
79.43
|
|
|
|
|
||
Unvested at December 31, 2015
|
216,198
|
|
|
78.59
|
|
|
$
|
16,602
|
|
|
Granted
|
256,631
|
|
|
40.21
|
|
|
|
|||
Vested
|
(61,487
|
)
|
|
78.33
|
|
|
|
|||
Forfeited
|
(46,939
|
)
|
|
68.84
|
|
|
|
|||
Unvested at December 31, 2016
|
364,403
|
|
|
52.85
|
|
|
$
|
11,824
|
|
|
Granted
|
343,583
|
|
|
44.23
|
|
|
|
|||
Vested
|
(101,379
|
)
|
|
53.76
|
|
|
|
|||
Forfeited
|
(107,061
|
)
|
|
49.98
|
|
|
|
|||
Unvested and expected to vest at December 31, 2017
|
499,546
|
|
|
$
|
47.32
|
|
|
$
|
22,804
|
|
|
Year Ended December 31,
|
||||
|
2017
|
|
2016
|
|
2015
|
ESPP option fair value
|
$10.80 - $13.85
|
|
$10.57 - $25.28
|
|
$21.93 - $25.24
|
Expected dividend yield
|
None
|
|
None
|
|
None
|
Risk-free interest rate
|
0.62% - 1.14%
|
|
0.37% - 0.49%
|
|
0.11% - 0.13%
|
Expected volatility
|
53.8%
|
|
63.4%
|
|
50.7%
|
Expected term of ESPP share options
|
6 months
|
|
6 months
|
|
6 months
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Numerator:
|
|
|
|
|
|
||||||
Net income (loss)
|
$
|
(42,611
|
)
|
|
$
|
(37,949
|
)
|
|
$
|
1,856
|
|
Denominator:
|
|
|
|
|
|
||||||
Weighted average common shares outstanding—basic
|
39,806
|
|
|
37,236
|
|
|
36,540
|
|
|||
Computation of diluted securities:
|
|
|
|
|
|
||||||
Dilutive effect of stock options
|
—
|
|
|
—
|
|
|
1,638
|
|
|||
Dilutive effect of RSUs
|
—
|
|
|
—
|
|
|
3
|
|
|||
Dilutive effect of conversion premium on the 2019 Notes
|
—
|
|
|
—
|
|
|
3,113
|
|
|||
Dilutive effect of warrants
|
—
|
|
|
—
|
|
|
6
|
|
|||
Dilutive effect of ESPP purchase options
|
—
|
|
|
—
|
|
|
1
|
|
|||
Weighted average common shares outstanding—diluted
|
39,806
|
|
|
37,236
|
|
|
41,301
|
|
|||
Net income (loss) per share:
|
|
|
|
|
|
||||||
Basic net income (loss) per common share
|
$
|
(1.07
|
)
|
|
$
|
(1.02
|
)
|
|
$
|
0.05
|
|
Diluted net income (loss) per common share
|
$
|
(1.07
|
)
|
|
$
|
(1.02
|
)
|
|
$
|
0.04
|
|
|
Year Ended December 31,
|
|||||||
|
2017
|
|
2016
|
|
2015
|
|||
Weighted average number of stock options
|
5,171
|
|
|
4,482
|
|
|
1,891
|
|
Weighted average number of RSUs
|
449
|
|
|
290
|
|
|
99
|
|
Conversion premium on the 2019 Notes
|
411
|
|
|
2,022
|
|
|
—
|
|
Weighted average number of warrants
|
—
|
|
|
1
|
|
|
—
|
|
Weighted average ESPP purchase options
|
29
|
|
|
21
|
|
|
8
|
|
Total
|
6,060
|
|
|
6,816
|
|
|
1,998
|
|
|
Year Ended December 31,
|
||||||||||
|
2017
|
|
2016
|
|
2015
|
||||||
Income (loss) before income taxes:
|
|
|
|
|
|
||||||
Domestic
|
$
|
(39,898
|
)
|
|
$
|
(36,339
|
)
|
|
$
|
3,760
|
|
Foreign
|
(2,573
|
)
|
|
(1,505
|
)
|
|
(1,640
|
)
|
|||
Total income (loss) before income taxes
|
$
|
(42,471
|
)
|
|
$
|
(37,844
|
)
|
|
$
|
2,120
|
|
|
|
|
|
|
|
||||||
Current taxes:
|
|
|
|
|
|
||||||
Federal
|
$
|
—
|
|
|
$
|
11
|
|
|
$
|
92
|
|
State
|
140
|
|
|
94
|
|
|
172
|
|
|||
Total income tax expense
|
$
|
140
|
|
|
$
|
105
|
|
|
$
|
264
|
|
|
Year Ended December 31,
|
|||||||
|
2017
|
|
2016
|
|
2015
|
|||
U.S. federal statutory rate
|
35.00
|
%
|
|
35.00
|
%
|
|
35.00
|
%
|
State taxes
|
2.26
|
%
|
|
2.20
|
%
|
|
0.71
|
%
|
Foreign taxes
|
(1.28
|
)%
|
|
(0.81
|
)%
|
|
12.03
|
%
|
Change in valuation allowance
|
4.58
|
%
|
|
(43.96
|
)%
|
|
10.32
|
%
|
Stock-based compensation
|
(1.21
|
)%
|
|
(0.54
|
)%
|
|
7.26
|
%
|
Tax credits
|
4.96
|
%
|
|
8.77
|
%
|
|
(30.63
|
)%
|
Interest expense
|
2.90
|
%
|
|
5.75
|
%
|
|
(37.57
|
)%
|
Effect of rate changes
|
(130.88
|
)%
|
|
(4.65
|
)%
|
|
—
|
%
|
Convertible senior notes refinancing
|
6.55
|
%
|
|
—
|
%
|
|
—
|
%
|
Effect of the adoption of ASU 2016-09
|
68.89
|
%
|
|
—
|
%
|
|
—
|
%
|
Other
|
7.90
|
%
|
|
(2.04
|
)%
|
|
15.33
|
%
|
Effective tax rate
|
(0.33
|
)%
|
|
(0.28
|
)%
|
|
12.45
|
%
|
|
December 31,
|
||||||
|
2017
|
|
2016
|
||||
Deferred tax assets:
|
|
|
|
||||
Net operating loss carry-forwards
|
$
|
95,067
|
|
|
$
|
96,163
|
|
Federal and state credits
|
15,048
|
|
|
13,724
|
|
||
Depreciation and amortization
|
2,593
|
|
|
2,604
|
|
||
Accruals and reserves
|
2,743
|
|
|
4,672
|
|
||
Deferred revenue
|
1,841
|
|
|
3,023
|
|
||
Stock based compensation
|
16,925
|
|
|
21,890
|
|
||
Inventory
|
552
|
|
|
9,811
|
|
||
Other
|
139
|
|
|
52
|
|
||
Total deferred tax assets
|
134,908
|
|
|
151,939
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Discount on convertible senior notes
|
(14,678
|
)
|
|
(3,186
|
)
|
||
|
120,230
|
|
|
148,753
|
|
||
Less: valuation allowance
|
(120,230
|
)
|
|
(148,753
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
|
Severance and Related Costs
|
|
Lease Costs
|
|
Write-Off of Property, Plant & Equipment and Inventory
|
|
Asset Retirement Obligations and Other Discontinuation Costs
|
|
Total
|
||||||||||
Balance at December 31, 2016
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Charges incurred
|
303
|
|
|
2,018
|
|
|
2,470
|
|
|
656
|
|
|
5,447
|
|
|||||
Cash payments made
|
(303
|
)
|
|
(744
|
)
|
|
—
|
|
|
(420
|
)
|
|
(1,467
|
)
|
|||||
Disposal of property, plant &
equipment and inventory |
—
|
|
|
—
|
|
|
(2,470
|
)
|
|
—
|
|
|
(2,470
|
)
|
|||||
Balance at December 31, 2017
|
$
|
—
|
|
|
$
|
1,274
|
|
|
$
|
—
|
|
|
$
|
236
|
|
|
$
|
1,510
|
|
Year
|
|
Aggregate Minimum Payments
|
||
2018
|
|
$
|
7,886
|
|
2019
|
|
8,089
|
|
|
2020
|
|
7,570
|
|
|
2021
|
|
5,245
|
|
|
2022
|
|
5,366
|
|
|
2023 through 2028
|
|
19,577
|
|
|
Total
|
|
$
|
53,733
|
|
|
Three Months Ended
|
||||||||||||||
|
March 31,
2017 |
|
June 30,
2017 |
|
September 30,
2017 |
|
December 31,
2017 |
||||||||
Total revenues
|
$
|
69,283
|
|
|
$
|
70,934
|
|
|
$
|
67,335
|
|
|
$
|
79,078
|
|
Cost of goods sold
|
24,581
|
|
|
23,811
|
|
|
18,228
|
|
|
21,295
|
|
||||
Total operating expenses
|
83,333
|
|
|
86,714
|
|
|
70,907
|
|
|
70,613
|
|
||||
Net income (loss)
|
(19,866
|
)
|
|
(19,743
|
)
|
|
(7,597
|
)
|
|
4,595
|
|
||||
Basic and diluted net income (loss) per common share
|
$
|
(0.52
|
)
|
|
$
|
(0.49
|
)
|
|
$
|
(0.19
|
)
|
|
$
|
0.11
|
|
|
Three Months Ended
|
||||||||||||||
|
March 31,
2016 |
|
June 30,
2016 |
|
September 30,
2016 |
|
December 31,
2016 |
||||||||
Total revenues
|
$
|
65,474
|
|
|
$
|
69,640
|
|
|
$
|
68,355
|
|
|
$
|
72,902
|
|
Cost of goods sold
|
20,278
|
|
|
23,053
|
|
|
43,152
|
|
|
23,621
|
|
||||
Total operating expenses
|
67,728
|
|
|
76,084
|
|
|
89,220
|
|
|
75,363
|
|
||||
Net loss
|
(3,854
|
)
|
|
(7,958
|
)
|
|
(22,164
|
)
|
|
(3,973
|
)
|
||||
Basic and diluted net loss per common share
|
$
|
(0.10
|
)
|
|
$
|
(0.21
|
)
|
|
$
|
(0.59
|
)
|
|
$
|
(0.11
|
)
|
Exhibit
Number
|
|
Description
|
||
3.1
|
|
|
|
|
3.2
|
|
|
|
|
4.1
|
|
|
|
|
4.2
|
|
|
|
|
4.3
|
|
|
|
|
10.1
|
|
|
|
|
10.2
|
|
|
|
|
10.3
|
|
|
|
|
10.4
|
|
|
|
|
10.5
|
|
|
|
|
10.6
|
|
|
|
|
10.7
|
|
|
|
|
10.8
|
|
|
|
|
10.9
|
|
|
|
|
10.10
|
|
|
|
|
10.11
|
|
|
|
|
10.12
|
|
|
|
|
10.13
|
|
|
|
|
10.14
|
|
|
|
|
10.15
|
|
|
|
|
10.16
|
|
|
|
|
10.17
|
|
|
|
|
10.18
|
|
|
|
|
10.19
|
|
|
|
|
10.20
|
|
|
|
|
10.21
|
|
|
|
|
10.22
|
|
|
|
|
10.23
|
|
|
|
|
10.24†
|
|
|
|
|
10.25†
|
|
|
|
|
10.26†
|
|
|
|
10.27†
|
|
|
|
|
10.28
|
|
|
|
|
10.29
|
|
|
|
|
10.30
|
|
|
|
|
10.31
|
|
|
|
|
10.32
|
|
|
|
|
10.33
|
|
|
|
|
10.34
|
|
|
|
2014 Inducement Plan.
(10)***
|
10.35
|
|
|
|
|
10.36†
|
|
|
|
|
10.37†
|
|
|
|
|
10.38†
|
|
|
|
|
10.39
|
|
|
|
(6)***
|
10.40
|
|
|
|
|
10.41
|
|
|
|
|
10.42
|
|
|
|
|
10.43†
|
|
|
|
|
10.44
|
|
|
|
|
21.1
|
|
|
|
|
23.1
|
|
|
|
|
23.2
|
|
|
|
|
31.1
|
|
|
|
|
31.2
|
|
|
|
|
32.1
|
|
|
|
|
32.2
|
|
|
|
|
|
|
|
|
|
101.INS
|
|
XBRL Instance Document.*
|
||
101.SCH
|
|
XBRL Taxonomy Schema Document.*
|
||
101.CAL
|
|
XBRL Taxonomy Calculation Linkbase Document.*
|
||
101.LAB
|
|
XBRL Taxonomy Label Linkbase Document.*
|
||
101.PRE
|
|
XBRL Taxonomy Presentation Linkbase Document.*
|
||
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document.*
|
(1)
|
Incorporated by reference to the Registrant’s Current Report on Form 8-K, filed on February 11, 2011.
|
(2)
|
Incorporated by reference to the exhibits to the Registrant’s Registration Statement on Form S-1 (SEC File 333-170245).
|
(3)
|
Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on January 23, 2013.
|
(4)
|
Incorporated by reference to the exhibits to the Registrant’s Current Report on Form 8-K, filed on March 18, 2013.
|
(5)
|
Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q, filed on October 31, 2011.
|
(6)
|
Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q, filed on May 9, 2012.
|
(7)
|
Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q, filed on October 31, 2013.
|
(8)
|
Incorporated by reference to the exhibits to the Registrant’s Current Report on Form 8-K, filed on June 4, 2014.
|
(9)
|
Incorporated by reference to the exhibits to the Registrant’s Annual Report on Form 10-K, filed on March 7, 2013.
|
(10)
|
Incorporated by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q, filed on May 1, 2014.
|
(11)
|
Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q, filed on July 31, 2014.
|
(12)
|
Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q, filed on October 30, 2014.
|
(13)
|
Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q, filed on April 30, 2015.
|
(14)
|
Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q, filed on July 30, 2015.
|
(15)
|
Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q, filed on November 1, 2012.
|
(16)
|
Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q, filed on May 2, 2016.
|
(17)
|
Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q, filed on August 4, 2016.
|
(18)
|
Incorporated by reference to Exhibit 10.57 to the Registrant’s Annual Report on Form 10-K, filed on February 25, 2016.
|
(19)
|
Incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K, filed on March 13, 2017.
|
(20)
|
Incorporated by reference to the exhibits to the Registrant’s Quarterly Report on Form 10-Q, filed on May 4, 2017.
|
*
|
Filed herewith.
|
**
|
Furnished herewith.
|
***
|
Denotes management contract or compensatory plan or arrangement.
|
†
|
Confidential treatment has been granted as to certain portions, which portions were omitted and filed separately with the Securities and Exchange Commission pursuant to a Confidential Treatment Request.
|
1 Year Pacira BioSciences Chart |
1 Month Pacira BioSciences Chart |
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