(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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¨
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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
x
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Accelerated filer
o
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Non-accelerated filer
o
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Smaller reporting company
o
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(Do not check if a smaller
reporting company)
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Page No.
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1.
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Expected initiation of Phase 3 pediatric study in 2016. FDA meeting planned in Q1 2016.
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2.
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Timeline may be updated at an appropriate time following further progress and development of the nerve block indication.
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3.
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Expected approval (dogs) in late 2016. Source: Aratana Therapeutics, Inc.
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fully commercializing EXPAREL in the United States for postsurgical analgesia by infiltration;
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continuing to build and expand a streamlined commercial organization concentrating on major hospitals and ambulatory surgery centers in the United States and targeting surgeons, anesthesiologists, pharmacists and nurses; further, we plan to launch EXPAREL into the oral surgery market by targeting oral surgeons late in the third quarter of 2016;
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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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servicing and educating strategic commercial audiences for local infiltration procedures, including soft tissue, orthopedic, spine, 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 nerve block;
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leveraging the development success of EXPAREL in the animal health market through our commercial partner Aratana Therapeutics, Inc., which intends to market the product as Nocita
®
(bupivacaine liposome injectable suspension) to serve animal health indications;
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manufacturing all our DepoFoam-based products, including EXPAREL, in facilities compliant with 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 us to rely upon the FDA’s previous findings of safety and effectiveness for an approved product. A Section 505(b)(2) strategy may not succeed if there are successful challenges to the FDA’s interpretation of Section 505(b)(2) under the Federal Food, Drug and Cosmetic Act; 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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extends postsurgical analgesia;
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leverages existing postsurgical infiltration administration techniques;
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dilutes easily with saline to reach desired volume;
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is a ready-to-use formulation; and
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facilitates treatment of both small and large surgical sites.
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delayed 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 are pain free at 24 hours post-surgery compared to placebo.
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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 clumsy, difficult to use 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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presents a relatively low-cost opportunity for a new indication; and
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enables us to fully leverage our manufacturing and sales infrastructure.
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Bupivacaine, a well-characterized generic anesthetic/analgesic, has an established safety profile and over 20 years of use in the United States.
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DepoFoam, modified to meet the requirements of each product, is used to extend the release of the active drug substances.
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The U.S. Food and Drug Administration, or FDA, confirms that EXPAREL has, since its approval on October 28, 2011, been approved for “administration into the surgical site to produce postsurgical analgesia” in a variety of surgeries not limited to those studied in its pivotal trials.
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The FDA approved a labeling supplement which amends the EXPAREL Package Insert to clarify and reinforce that:
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The use, efficacy and safety of EXPAREL is not limited to any specific surgery type or site;
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The proper dosage and administration of EXPAREL is based on various patient and procedure-specific factors, with the two surgical models utilized in the pivotal trials provided as examples for the purpose of providing general guidance;
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There was a significant treatment effect for EXPAREL compared to placebo over the first 72 hours in the pivotal hemorrhoidectomy study;
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The description of that duration of effect now includes a graphical representation of the mean pain intensity scores over time for the EXPAREL and placebo groups for the full 72-hour efficacy period, as well as information about median time to first opioid use and percentage of opioid-free patients in each treatment group.
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EXPAREL may be admixed with bupivacaine—including co-administered in the same syringe—provided certain medication ratios are observed.
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The September 2014 FDA Warning Letter was formally withdrawn via a “Rescission Letter” from the Director of the FDA Center for Drug Evaluation and Research (CDER).
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At the request of Pacira, the Rescission Letter included FDA guidance related to two key procedures:
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TAP block, which is a field block technique covered by the approved indication for EXPAREL.
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Infiltration to produce postsurgical analgesia at the site of oral surgery procedures, including tooth extractions, which is also covered by the approved indication for EXPAREL.
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The United States acknowledged that the rescission of the Warning Letter and approval of the labeling supplement reflect the scope of the indication in the NDA that FDA approved on October 28, 2011.
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Pacira and the FDA agreed that in future interactions, they will deal with each other in an open, forthright and fair manner.
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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 C-level 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; and
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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.
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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, including DepoCyt(e) and DepoDur, have been approved in the United States and Europe, making regulatory authorities familiar with our DepoFoam technology;
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Extensive safety history.
Our DepoFoam products have over fifteen years of safety data as DepoCyt(e) has been sold in the United States since 1999;
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Proven manufacturing capabilities.
We make the DepoFoam-based products, EXPAREL and DepoCyt(e), in our cGMP facilities;
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Flexible time release.
Encapsulated drug releases over a desired period of time, 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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completion of preclinical laboratory and animal testing and formulation studies in compliance with the FDA’s Good Laboratory Practice regulations;
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submission to the FDA of an investigational new drug, or IND, application for human clinical testing, which must become effective before human clinical trials may begin in the United States;
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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 a new drug application, or 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 the FDA’s current Good Manufacturing Practice, or cGMP, requirement 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, distributors and group purchasing organizations 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; and
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in-license and develop additional product candidates.
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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 2015
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High
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Low
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||||
Fourth Quarter
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$
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80.25
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$
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35.78
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Third Quarter
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72.98
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39.29
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Second Quarter
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93.22
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65.00
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First Quarter
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121.95
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82.00
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Year Ended 2014
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High
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Low
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||||
Fourth Quarter
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$
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112.00
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$
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84.93
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Third Quarter
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109.94
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81.51
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Second Quarter
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93.13
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60.30
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First Quarter
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83.41
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54.23
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Cumulative Total Return
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||||||||||||||||||||||
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February 3,
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December 31,
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December 31,
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December 31,
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December 31,
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December 31,
|
||||||||||||
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2011
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2011
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2012
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2013
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2014
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2015
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||||||||||||
Pacira Pharmaceuticals, Inc. (PCRX)
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$
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100.00
|
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$
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123.22
|
|
|
$
|
248.86
|
|
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$
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818.95
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$
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1,262.96
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|
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$
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1,093.87
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NASDAQ Composite (^IXIC)
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100.00
|
|
|
94.60
|
|
|
109.65
|
|
|
151.66
|
|
|
171.98
|
|
|
181.83
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|
||||||
NASDAQ Biotechnology (^NBI)
|
100.00
|
|
|
111.01
|
|
|
146.42
|
|
|
242.49
|
|
|
325.17
|
|
|
362.31
|
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||||
Statement of Operations Data
|
(In thousands, except per share data)
|
||||||||||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
||||||||||
Net product sales
|
$
|
244,487
|
|
|
$
|
193,526
|
|
|
$
|
81,956
|
|
|
$
|
18,191
|
|
|
$
|
6,895
|
|
Collaborative licensing and milestone revenue
|
1,426
|
|
|
1,287
|
|
|
972
|
|
|
18,390
|
|
|
5,074
|
|
|||||
Royalty revenue
|
3,084
|
|
|
2,855
|
|
|
2,623
|
|
|
2,503
|
|
|
3,720
|
|
|||||
Total revenues
|
248,997
|
|
|
197,668
|
|
|
85,551
|
|
|
39,084
|
|
|
15,689
|
|
|||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cost of goods sold
|
71,837
|
|
|
77,440
|
|
|
54,772
|
|
|
32,139
|
|
|
16,739
|
|
|||||
Research and development
|
28,662
|
|
|
18,731
|
|
|
21,560
|
|
|
9,937
|
|
|
14,873
|
|
|||||
Selling, general and administrative
|
139,043
|
|
|
106,662
|
|
|
62,508
|
|
|
46,306
|
|
|
20,159
|
|
|||||
Impairment of long-lived assets
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,019
|
|
|||||
Total operating expenses
|
239,542
|
|
|
202,833
|
|
|
138,840
|
|
|
88,382
|
|
|
54,790
|
|
|||||
Income (loss) from operations
|
9,455
|
|
|
(5,165
|
)
|
|
(53,289
|
)
|
|
(49,298
|
)
|
|
(39,101
|
)
|
|||||
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
||||||||||
Interest income
|
678
|
|
|
382
|
|
|
259
|
|
|
275
|
|
|
255
|
|
|||||
Interest expense
|
(7,725
|
)
|
|
(8,278
|
)
|
|
(7,253
|
)
|
|
(1,807
|
)
|
|
(4,780
|
)
|
|||||
Loss on early extinguishment of debt
|
(52
|
)
|
|
—
|
|
|
(3,398
|
)
|
|
(1,062
|
)
|
|
—
|
|
|||||
Royalty interest obligation
|
(71
|
)
|
|
(323
|
)
|
|
(623
|
)
|
|
(278
|
)
|
|
227
|
|
|||||
Other, net
|
(165
|
)
|
|
(159
|
)
|
|
(47
|
)
|
|
(111
|
)
|
|
71
|
|
|||||
Total other expense, net
|
(7,335
|
)
|
|
(8,378
|
)
|
|
(11,062
|
)
|
|
(2,983
|
)
|
|
(4,227
|
)
|
|||||
Income (loss) before income taxes
|
2,120
|
|
|
(13,543
|
)
|
|
(64,351
|
)
|
|
(52,281
|
)
|
|
(43,328
|
)
|
|||||
Income tax (expense) benefit
|
(264
|
)
|
|
(173
|
)
|
|
442
|
|
|
—
|
|
|
—
|
|
|||||
Net income (loss)
|
$
|
1,856
|
|
|
$
|
(13,716
|
)
|
|
$
|
(63,909
|
)
|
|
$
|
(52,281
|
)
|
|
$
|
(43,328
|
)
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Net income (loss) per share:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic net income (loss) per common share
|
$
|
0.05
|
|
|
$
|
(0.39
|
)
|
|
$
|
(1.93
|
)
|
|
$
|
(1.72
|
)
|
|
$
|
(2.64
|
)
|
Diluted net income (loss) per common share
|
$
|
0.04
|
|
|
$
|
(0.39
|
)
|
|
$
|
(1.93
|
)
|
|
$
|
(1.72
|
)
|
|
$
|
(2.64
|
)
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic
|
36,540
|
|
|
35,299
|
|
|
33,182
|
|
|
30,332
|
|
|
16,437
|
|
|||||
Diluted
|
41,301
|
|
|
35,299
|
|
|
33,182
|
|
|
30,332
|
|
|
16,437
|
|
|
December 31,
|
||||||||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
2012
|
|
2011
|
||||||||||
Balance Sheet Data
|
(In thousands)
|
||||||||||||||||||
Cash and cash equivalents, restricted cash,
short-term and long-term investments |
$
|
172,427
|
|
|
$
|
182,598
|
|
|
$
|
73,785
|
|
|
$
|
42,573
|
|
|
$
|
77,452
|
|
Working capital (deficit)
|
100,906
|
|
|
74,247
|
|
|
(15,192
|
)
|
|
46,766
|
|
|
50,738
|
|
|||||
Total assets
|
389,623
|
|
|
326,072
|
|
|
169,820
|
|
|
112,054
|
|
|
113,490
|
|
|||||
Long-term liabilities
|
19,555
|
|
|
14,917
|
|
|
6,628
|
|
|
32,043
|
|
|
33,310
|
|
|||||
Accumulated deficit
|
(308,289
|
)
|
|
(310,145
|
)
|
|
(296,429
|
)
|
|
(232,520
|
)
|
|
(180,239
|
)
|
|||||
Total stockholders’ equity
|
218,392
|
|
|
171,145
|
|
|
41,249
|
|
|
65,855
|
|
|
48,269
|
|
•
|
EXPAREL is a liposome injection of bupivacaine, an amide-type local anesthetic indicated for single-dose administration into the surgical site to produce postsurgical analgesia, which was approved by the United States Food and Drug Administration, or FDA, on October 28, 2011. We commercially launched EXPAREL in April 2012. We drop-ship EXPAREL directly to the end user based on orders placed to wholesalers or directly to us, and we have no product held by wholesalers.
|
•
|
DepoCyt(e) is a sustained release liposomal formulation of the chemotherapeutic agent cytarabine and is indicated for the intrathecal treatment of lymphomatous meningitis. DepoCyt(e) was granted accelerated approval by the FDA in 1999 and full approval in 2007. We sell DepoCyt(e) to our commercial partners located in the United States and Europe.
|
•
|
The proper dosage and administration of EXPAREL is based on various patient and procedure-specific factors, with the two surgical models utilized in the pivotal trials provided as examples for the purpose of providing general guidance;
|
•
|
There was a significant treatment effect for EXPAREL compared to placebo over the first 72 hours in the pivotal hemorrhoidectomy study. The description of that duration of effect now includes a graphical representation of the mean pain intensity scores over time for the EXPAREL and placebo groups for the full 72-hour efficacy period, as well as information about median time to first opioid use and percentage of opioid-free patients in each treatment group; and
|
•
|
EXPAREL may be admixed with bupivacaine—including co-administered in the same syringe—provided certain medication ratios are observed.
|
•
|
Infiltration into the transversus abdominis plane, or TAP block, which is a field block technique covered by the approved indication for EXPAREL; and
|
•
|
Infiltration to produce postsurgical analgesia at the site of oral surgery procedures including tooth extractions, which is also covered by the approved indication for EXPAREL.
|
•
|
Total revenues increased $51.3 million, or 26%, in the year ended December 31, 2015, as compared to 2014, primarily driven by EXPAREL product sales of $239.9 million, net of allowances for sales returns, prompt payment discounts, volume rebates, chargebacks and distribution service fees payable to wholesalers.
|
•
|
In February 2016, we announced topline results of a randomized controlled trial in third molar, or “wisdom teeth”, procedures, with a per-protocol analysis demonstrating statistical significance and an intention-to-treat analysis strongly trending towards significance in spite of the underpowered study size resulting from one of three clinical sites being eliminated for protocol violations. We plan to generate Phase 4 studies in additional oral and maxillofacial surgeries to provide clinical guidance to the oral and maxillofacial community. We anticipate a late third quarter 2016 launch for oral surgery.
|
•
|
In May 2015, we received feedback from the FDA’s Division of Anesthesia, Analgesia and Addiction Products, or DAAAP, that the proposed approach to demonstrate comparability and to provide adequate data in support of our new DepoFoam spray process appears acceptable. Based on this feedback, we intend to pursue the manufacturing of DepoFoam-based products using the spray process.
|
•
|
In April 2015, we delivered manufacturing process equipment to the first of two manufacturing suites dedicated to the production of EXPAREL at Patheon U.K. Limited’s, or Patheon, Swindon, England facility. We currently expect, subject to receipt of regulatory approvals, the first commercial manufacturing suite at Patheon’s facility to commence commercial production in 2017. We expect production capacity for EXPAREL at the first commercial manufacturing suite at Patheon’s facility to be similar to that of our Suite C manufacturing location in San Diego, California.
|
•
|
In April 2015, we received a subpoena from the U.S. Department of Justice, or DOJ, U.S. Attorney’s Office for the District of New Jersey requiring the production of a broad range of documents pertaining to marketing and promotional practices related to EXPAREL. We are cooperating with the government’s inquiry. We can make no assurances as to the time or resources that will need to be devoted to this inquiry or its final outcome, or the impact, if any, of this inquiry or any proceedings on our business, financial condition, results of operations and cash flows.
|
•
|
In March 2015, we received a Complete Response Letter from the FDA following a review of our sNDA for the use of EXPAREL in nerve block to provide postsurgical analgesia, and in May 2015 we conducted an end-of-review conference with the DAAAP. Based upon FDA guidance that the expected use of EXPAREL will be for a broad spectrum of nerve blocks and not limited to the narrow indication of a single nerve block, we plan to conduct additional Phase 3 studies for upper extremity and lower extremity nerve blocks, specifically a brachial plexus nerve block for patients undergoing total shoulder arthroplasty or rotator cuff repair and a femoral nerve block for patients undergoing total knee arthroplasty. As of February 2016, we have initiated these studies.
|
|
Year Ended December 31,
|
|
2015 versus
2014 |
|
2014 versus
2013 |
||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
% Increase / (Decrease)
|
||||||||||
Cost of goods sold
|
$
|
71,837
|
|
|
$
|
77,440
|
|
|
$
|
54,772
|
|
|
(7
|
)%
|
|
41
|
%
|
Gross margin *
|
71
|
%
|
|
61
|
%
|
|
35
|
%
|
|
|
|
|
|
Year Ended December 31,
|
|
2015 versus
2014 |
|
2014 versus
2013 |
||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
% Increase / (Decrease)
|
||||||||||
Clinical development
|
$
|
10,001
|
|
|
$
|
5,518
|
|
|
$
|
11,202
|
|
|
81
|
%
|
|
(51
|
)%
|
Product development and other
|
13,527
|
|
|
6,723
|
|
|
6,013
|
|
|
101
|
%
|
|
12
|
%
|
|||
Stock-based compensation
|
5,134
|
|
|
6,490
|
|
|
4,345
|
|
|
(21
|
)%
|
|
49
|
%
|
|||
Total research and development expense
|
$
|
28,662
|
|
|
$
|
18,731
|
|
|
$
|
21,560
|
|
|
53
|
%
|
|
(13
|
)%
|
% of total revenue
|
12
|
%
|
|
9
|
%
|
|
25
|
%
|
|
|
|
|
|
Year Ended December 31,
|
|
2015 versus
2014 |
|
2014 versus
2013 |
||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
% Increase / (Decrease)
|
||||||||||
Sales and marketing
|
$
|
77,733
|
|
|
$
|
65,010
|
|
|
$
|
39,298
|
|
|
20
|
%
|
|
65
|
%
|
General and administrative
|
39,088
|
|
|
26,902
|
|
|
17,568
|
|
|
45
|
%
|
|
53
|
%
|
|||
Stock-based compensation
|
22,222
|
|
|
14,750
|
|
|
5,642
|
|
|
51
|
%
|
|
161
|
%
|
|||
Total selling, general and administrative expenses
|
$
|
139,043
|
|
|
$
|
106,662
|
|
|
$
|
62,508
|
|
|
30
|
%
|
|
71
|
%
|
% of total revenue
|
56
|
%
|
|
54
|
%
|
|
73
|
%
|
|
|
|
|
|
Year Ended December 31,
|
|
2015 versus
2014 |
|
2014 versus
2013 |
||||||||||||
|
2015
|
|
2014
|
|
2013
|
|
% Increase / (Decrease)
|
||||||||||
Interest income
|
$
|
678
|
|
|
$
|
382
|
|
|
$
|
259
|
|
|
77
|
%
|
|
47
|
%
|
Interest expense
|
(7,725
|
)
|
|
(8,278
|
)
|
|
(7,253
|
)
|
|
(7
|
)%
|
|
14
|
%
|
|||
Loss on early extinguishment of debt
|
(52
|
)
|
|
—
|
|
|
(3,398
|
)
|
|
N/A
|
|
|
(100
|
)%
|
|||
Royalty interest obligation
|
(71
|
)
|
|
(323
|
)
|
|
(623
|
)
|
|
(78
|
)%
|
|
(48
|
)%
|
|||
Other, net
|
(165
|
)
|
|
(159
|
)
|
|
(47
|
)
|
|
4
|
%
|
|
238
|
%
|
|||
Total other expense, net
|
$
|
(7,335
|
)
|
|
$
|
(8,378
|
)
|
|
$
|
(11,062
|
)
|
|
(12
|
)%
|
|
(24
|
)%
|
% of total revenue
|
(3
|
)%
|
|
(4
|
)%
|
|
(13
|
)%
|
|
|
|
|
|
Year Ended December 31,
|
|
2015 versus
2014 |
|
2014 versus
2013 |
|||||||||||
|
2015
|
|
2014
|
|
2013
|
|
% Increase / (Decrease)
|
|||||||||
Income tax expense (benefit)
|
$
|
264
|
|
|
$
|
173
|
|
|
$
|
(442
|
)
|
|
53
|
%
|
|
N/A
|
Effective tax rate
|
12
|
%
|
|
(1
|
)%
|
|
1
|
%
|
|
|
|
|
|
Year Ended December 31,
|
||||||||||
Consolidated Statement of Cash Flows Data:
|
2015
|
|
2014
|
|
2013
|
||||||
Net cash provided by (used in):
|
|
|
|
|
|
||||||
Operating activities
|
$
|
28,996
|
|
|
$
|
26,564
|
|
|
$
|
(43,838
|
)
|
Investing activities
|
(20,231
|
)
|
|
(120,434
|
)
|
|
(42,938
|
)
|
|||
Financing activities
|
10,699
|
|
|
118,875
|
|
|
89,165
|
|
|||
Net increase in cash and cash equivalents
|
$
|
19,464
|
|
|
$
|
25,005
|
|
|
$
|
2,389
|
|
•
|
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 Swindon, England facility;
|
•
|
the timing of and extent to which the holders of our Notes elect to convert the Notes;
|
•
|
the cost and timing of potential milestone payments to Skyepharma, which could be up to an aggregate of $44.0 million if certain milestones pertaining to net sales of 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, and costs of development for our 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)
|
$
|
118,533
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
118,533
|
|
|
$
|
—
|
|
Senior convertible notes - interest
|
11,878
|
|
|
3,852
|
|
|
7,705
|
|
|
321
|
|
|
—
|
|
|||||
Lease obligations (3)
|
47,156
|
|
|
7,743
|
|
|
15,959
|
|
|
14,723
|
|
|
8,731
|
|
|||||
Purchase obligations (4)
|
869
|
|
|
281
|
|
|
588
|
|
|
—
|
|
|
—
|
|
|||||
Total
|
$
|
178,436
|
|
|
$
|
11,876
|
|
|
$
|
24,252
|
|
|
$
|
133,577
|
|
|
$
|
8,731
|
|
|
Returns Allowances
|
|
Prompt Payment Discounts
|
|
Wholesaler Service Fees
|
|
Volume Rebates and Chargebacks
|
|
Total
|
||||||||||
Balance at January 1, 2013
|
$
|
134
|
|
|
$
|
80
|
|
|
$
|
68
|
|
|
$
|
111
|
|
|
$
|
393
|
|
Provision
|
802
|
|
|
1,559
|
|
|
1,078
|
|
|
590
|
|
|
4,029
|
|
|||||
Payments/credits
|
(39
|
)
|
|
(1,326
|
)
|
|
(880
|
)
|
|
(299
|
)
|
|
(2,544
|
)
|
|||||
Balance at December 31, 2013
|
897
|
|
|
313
|
|
|
266
|
|
|
402
|
|
|
1,878
|
|
|||||
Provision
|
829
|
|
|
3,833
|
|
|
2,780
|
|
|
881
|
|
|
8,323
|
|
|||||
Payments/credits
|
(167
|
)
|
|
(3,571
|
)
|
|
(2,458
|
)
|
|
(962
|
)
|
|
(7,158
|
)
|
|||||
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
|
|
•
|
manufacturing overhead and fixed costs associated with running two cGMP manufacturing facilities, including allocated rent, utilities, insurance, depreciation and salaries and related costs of personnel, including stock-based compensation;
|
•
|
costs of active pharmaceutical ingredients;
|
•
|
royalties due to third parties on our revenues;
|
•
|
packaging, testing and freight;
|
•
|
amortization of our intangible assets; and
|
•
|
costs associated with excess manufacturing capacity.
|
•
|
Expected Volatility
—Since our initial public offering, we have utilized our available historic volatility data combined with a publicly traded peer group’s historic volatility to determine our expected volatility over the expected option term. The peer group was developed based on companies in the pharmaceutical and biotechnology industry in a similar stage of development. The expected volatility rate used to value ESPP options is based solely on our historic volatility data.
|
•
|
Expected Term
—In 2015, we used an expected term based on a weighted average combination of our historical data from stock option exercises and the simplified method. In prior years, we utilized the “simplified” method for “plain vanilla” options to estimate the expected term of stock option grants. Under that approach, the weighted average expected life was presumed to be the average of the vesting term and the contractual term of the option.
|
•
|
Risk-Free Interest Rate
—The risk-free interest rate assumption is based on zero coupon United States Department of the Treasury instruments for periods commensurate with the expected term of our stock option grants.
|
•
|
Expected Dividend Yield
—We have never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable future.
|
(a)
|
Documents filed as part of Form 10-K.
|
(1)
|
Financial Statements
|
|
Report of 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 25, 2016
|
By:
|
|
David Stack
Chief Executive Officer and Chairman
|
Signature
|
|
Title
|
|
Date
|
/s/ DAVID STACK
|
|
Director, Chief Executive Officer and Chairman
(Principal Executive Officer)
|
|
February 25, 2016
|
David Stack
|
|
|
|
|
|
|
|
|
|
/s/ JAMES SCIBETTA
|
|
President and Chief Financial Officer
(Principal Financial Officer)
|
|
February 25, 2016
|
James Scibetta
|
|
|
|
|
|
|
|
|
|
/s/ LAUREN RIKER
|
|
Vice President, Finance
(Principal Accounting Officer)
|
|
February 25, 2016
|
Lauren Riker
|
|
|
|
|
|
|
|
|
|
/s/ LAURA BREGE
|
|
Director
|
|
February 25, 2016
|
Laura Brege
|
|
|
|
|
|
|
|
|
|
/s/ YVONNE GREENSTREET
|
|
Director
|
|
February 25, 2016
|
Yvonne Greenstreet
|
|
|
|
|
|
|
|
|
|
/s/ MARK KRONENFELD
|
|
Director
|
|
February 25, 2016
|
Mark Kronenfeld
|
|
|
|
|
|
|
|
|
|
/s/ JOHN LONGENECKER
|
|
Director
|
|
February 25, 2016
|
John Longenecker
|
|
|
|
|
|
|
|
|
|
/s/ GARY PACE
|
|
Director
|
|
February 25, 2016
|
Gary Pace
|
|
|
|
|
|
|
|
|
|
/s/ ANDREAS WICKI
|
|
Director
|
|
February 25, 2016
|
Andreas Wicki
|
|
|
|
|
|
|
|
|
|
/s/ DENNIS WINGER
|
|
Director
|
|
February 25, 2016
|
Dennis Winger
|
|
|
|
|
|
|
|
|
|
/s/ PAUL HASTINGS
|
|
Lead Director
|
|
February 25, 2016
|
Paul Hastings
|
|
|
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
56,984
|
|
|
$
|
37,520
|
|
Restricted cash
|
—
|
|
|
1,509
|
|
||
Short-term investments
|
101,981
|
|
|
119,138
|
|
||
Accounts receivable, net
|
25,855
|
|
|
22,366
|
|
||
Inventories, net
|
61,645
|
|
|
29,263
|
|
||
Prepaid expenses and other current assets
|
6,117
|
|
|
4,461
|
|
||
Total current assets
|
252,582
|
|
|
214,257
|
|
||
Long-term investments
|
13,462
|
|
|
24,431
|
|
||
Fixed assets, net
|
90,324
|
|
|
60,632
|
|
||
Goodwill
|
30,880
|
|
|
23,761
|
|
||
Intangibles, net
|
81
|
|
|
403
|
|
||
Other assets
|
2,294
|
|
|
2,588
|
|
||
Total assets
|
$
|
389,623
|
|
|
$
|
326,072
|
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
8,739
|
|
|
$
|
6,758
|
|
Accrued expenses
|
35,375
|
|
|
28,311
|
|
||
Convertible senior notes
|
105,928
|
|
|
103,100
|
|
||
Current portion of royalty interest obligation
|
—
|
|
|
276
|
|
||
Current portion of deferred revenue
|
1,426
|
|
|
1,426
|
|
||
Income taxes payable
|
208
|
|
|
139
|
|
||
Total current liabilities
|
151,676
|
|
|
140,010
|
|
||
Deferred revenue
|
8,082
|
|
|
9,508
|
|
||
Other liabilities
|
11,473
|
|
|
5,409
|
|
||
Total liabilities
|
171,231
|
|
|
154,927
|
|
||
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, 2015 and 2014
|
—
|
|
|
—
|
|
||
Common stock, par value $0.001 and 250,000,000 shares authorized; 36,848,319 shares issued and outstanding at December 31, 2015; 36,150,620 shares issued and outstanding at December 31, 2014
|
37
|
|
|
36
|
|
||
Additional paid-in capital
|
526,696
|
|
|
481,334
|
|
||
Accumulated deficit
|
(308,289
|
)
|
|
(310,145
|
)
|
||
Accumulated other comprehensive loss
|
(52
|
)
|
|
(80
|
)
|
||
Total stockholders’ equity
|
218,392
|
|
|
171,145
|
|
||
Total liabilities and stockholders’ equity
|
$
|
389,623
|
|
|
$
|
326,072
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Net product sales
|
$
|
244,487
|
|
|
$
|
193,526
|
|
|
$
|
81,956
|
|
Collaborative licensing and milestone revenue
|
1,426
|
|
|
1,287
|
|
|
972
|
|
|||
Royalty revenue
|
3,084
|
|
|
2,855
|
|
|
2,623
|
|
|||
Total revenues
|
248,997
|
|
|
197,668
|
|
|
85,551
|
|
|||
Operating expenses:
|
|
|
|
|
|
||||||
Cost of goods sold
|
71,837
|
|
|
77,440
|
|
|
54,772
|
|
|||
Research and development
|
28,662
|
|
|
18,731
|
|
|
21,560
|
|
|||
Selling, general and administrative
|
139,043
|
|
|
106,662
|
|
|
62,508
|
|
|||
Total operating expenses
|
239,542
|
|
|
202,833
|
|
|
138,840
|
|
|||
Income (loss) from operations
|
9,455
|
|
|
(5,165
|
)
|
|
(53,289
|
)
|
|||
Other (expense) income:
|
|
|
|
|
|
||||||
Interest income
|
678
|
|
|
382
|
|
|
259
|
|
|||
Interest expense
|
(7,725
|
)
|
|
(8,278
|
)
|
|
(7,253
|
)
|
|||
Loss on early extinguishment of debt
|
(52
|
)
|
|
—
|
|
|
(3,398
|
)
|
|||
Royalty interest obligation
|
(71
|
)
|
|
(323
|
)
|
|
(623
|
)
|
|||
Other, net
|
(165
|
)
|
|
(159
|
)
|
|
(47
|
)
|
|||
Total other expense, net
|
(7,335
|
)
|
|
(8,378
|
)
|
|
(11,062
|
)
|
|||
Income (loss) before income taxes
|
2,120
|
|
|
(13,543
|
)
|
|
(64,351
|
)
|
|||
Income tax (expense) benefit
|
(264
|
)
|
|
(173
|
)
|
|
442
|
|
|||
Net income (loss)
|
$
|
1,856
|
|
|
$
|
(13,716
|
)
|
|
$
|
(63,909
|
)
|
|
|
|
|
|
|
||||||
Net income (loss) per share:
|
|
|
|
|
|
||||||
Basic net income (loss) per common share
|
$
|
0.05
|
|
|
$
|
(0.39
|
)
|
|
$
|
(1.93
|
)
|
Diluted net income (loss) per common share
|
$
|
0.04
|
|
|
$
|
(0.39
|
)
|
|
$
|
(1.93
|
)
|
Weighted average common shares outstanding:
|
|
|
|
|
|
||||||
Basic
|
36,540
|
|
|
35,299
|
|
|
33,182
|
|
|||
Diluted
|
41,301
|
|
|
35,299
|
|
|
33,182
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Net income (loss)
|
$
|
1,856
|
|
|
$
|
(13,716
|
)
|
|
$
|
(63,909
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|||
Net unrealized gain (loss) on investments
|
28
|
|
|
(85
|
)
|
|
(22
|
)
|
|||
Total other comprehensive income (loss)
|
28
|
|
|
(85
|
)
|
|
(22
|
)
|
|||
Comprehensive income (loss)
|
$
|
1,884
|
|
|
$
|
(13,801
|
)
|
|
$
|
(63,931
|
)
|
|
Common
Stock |
|
Additional
Paid-In
Capital
|
|
Accumulated
Deficit
|
|
Treasury
Stock
|
|
Accumulated
Other
Comprehensive
Income (Loss)
|
|
Total
|
|||||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|
||||||||||||||||||
Balances at December 31, 2012
|
32,623
|
|
|
$
|
33
|
|
|
$
|
298,317
|
|
|
$
|
(232,520
|
)
|
|
$
|
(2
|
)
|
|
$
|
27
|
|
|
$
|
65,855
|
|
Exercise of stock options
|
741
|
|
|
1
|
|
|
3,855
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,856
|
|
||||||
Cashless exercise of warrants
|
271
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
11,513
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
11,513
|
|
||||||
Net unrealized loss on
investments |
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(22
|
)
|
|
(22
|
)
|
||||||
Equity component of convertible
senior notes, net of issuance costs |
—
|
|
|
—
|
|
|
23,956
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
23,956
|
|
||||||
Issuance of common stock from
treasury |
1
|
|
|
—
|
|
|
(2
|
)
|
|
—
|
|
|
2
|
|
|
—
|
|
|
—
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(63,909
|
)
|
|
—
|
|
|
—
|
|
|
(63,909
|
)
|
||||||
Balances at December 31, 2013
|
33,636
|
|
|
34
|
|
|
337,639
|
|
|
(296,429
|
)
|
|
—
|
|
|
5
|
|
|
41,249
|
|
||||||
Follow-on public offering, net
|
1,840
|
|
|
2
|
|
|
110,450
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
110,452
|
|
||||||
Exercise of stock options
|
624
|
|
|
—
|
|
|
7,239
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,239
|
|
||||||
Shares issued under employee
stock purchase plan |
16
|
|
|
—
|
|
|
1,184
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,184
|
|
||||||
Cashless exercise of warrants
|
35
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
24,822
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
24,822
|
|
||||||
Net unrealized loss on
investments |
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(85
|
)
|
|
(85
|
)
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(13,716
|
)
|
|
—
|
|
|
—
|
|
|
(13,716
|
)
|
||||||
Balances 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 convertible senior notes |
44
|
|
|
—
|
|
|
3,929
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,929
|
|
||||||
Retirement of equity component
of convertible senior notes |
—
|
|
|
—
|
|
|
(4,100
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,100
|
)
|
||||||
Net unrealized gain on
investments |
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
28
|
|
|
28
|
|
||||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
1,856
|
|
|
—
|
|
|
—
|
|
|
1,856
|
|
||||||
Balances at December 31, 2015
|
36,848
|
|
|
$
|
37
|
|
|
$
|
526,696
|
|
|
$
|
(308,289
|
)
|
|
$
|
—
|
|
|
$
|
(52
|
)
|
|
$
|
218,392
|
|
PACIRA PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
|
|||||||||||
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Operating activities:
|
|
|
|
|
|
||||||
Net income (loss)
|
$
|
1,856
|
|
|
$
|
(13,716
|
)
|
|
$
|
(63,909
|
)
|
Adjustments to reconcile net income (loss) to net cash provided by (used in)
operating activities:
|
|
|
|
|
|
||||||
Depreciation of fixed assets and amortization of intangibles
|
11,475
|
|
|
10,035
|
|
|
5,747
|
|
|||
Amortization of unfavorable lease obligation and debt issuance costs
|
481
|
|
|
487
|
|
|
459
|
|
|||
Amortization of debt discount
|
4,102
|
|
|
4,139
|
|
|
3,959
|
|
|||
Loss on disposal of fixed assets
|
6
|
|
|
158
|
|
|
32
|
|
|||
Loss on early extinguishment of debt
|
52
|
|
|
—
|
|
|
3,398
|
|
|||
Stock-based compensation
|
33,368
|
|
|
24,822
|
|
|
11,513
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Restricted cash
|
1,509
|
|
|
124
|
|
|
(110
|
)
|
|||
Accounts receivable, net
|
(3,489
|
)
|
|
(7,776
|
)
|
|
(10,238
|
)
|
|||
Inventories
|
(32,382
|
)
|
|
(13,706
|
)
|
|
(3,480
|
)
|
|||
Prepaid expenses and other assets
|
(2,007
|
)
|
|
(1,621
|
)
|
|
(972
|
)
|
|||
Accounts payable and accrued expenses
|
9,941
|
|
|
15,349
|
|
|
9,622
|
|
|||
Royalty interest obligation
|
(276
|
)
|
|
(970
|
)
|
|
(434
|
)
|
|||
Other liabilities
|
5,786
|
|
|
2,526
|
|
|
1,047
|
|
|||
Deferred revenue
|
(1,426
|
)
|
|
6,713
|
|
|
(472
|
)
|
|||
Net cash provided by (used in) operating activities
|
28,996
|
|
|
26,564
|
|
|
(43,838
|
)
|
|||
Investing activities:
|
|
|
|
|
|
||||||
Purchases of fixed assets
|
(41,270
|
)
|
|
(22,984
|
)
|
|
(12,172
|
)
|
|||
Purchases of investments
|
(189,082
|
)
|
|
(164,303
|
)
|
|
(114,299
|
)
|
|||
Sales of investments
|
217,240
|
|
|
80,286
|
|
|
85,564
|
|
|||
Payment of contingent consideration
|
(7,119
|
)
|
|
(13,433
|
)
|
|
(2,031
|
)
|
|||
Net cash used in investing activities
|
(20,231
|
)
|
|
(120,434
|
)
|
|
(42,938
|
)
|
|||
Financing activities:
|
|
|
|
|
|
||||||
Proceeds from follow-on public offering, net
|
—
|
|
|
110,452
|
|
|
—
|
|
|||
Proceeds from exercise of stock options and warrants
|
10,073
|
|
|
7,239
|
|
|
3,856
|
|
|||
Proceeds from shares issued under employee stock purchase plan
|
2,093
|
|
|
1,184
|
|
|
—
|
|
|||
Conversion of principal and equity component of convertible senior notes
|
(1,467
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from convertible senior notes
|
—
|
|
|
—
|
|
|
120,000
|
|
|||
Repayment of debt
|
—
|
|
|
—
|
|
|
(27,500
|
)
|
|||
Payment of debt issuance and financing costs
|
—
|
|
|
—
|
|
|
(7,191
|
)
|
|||
Net cash provided by financing activities
|
10,699
|
|
|
118,875
|
|
|
89,165
|
|
|||
Net increase in cash and cash equivalents
|
19,464
|
|
|
25,005
|
|
|
2,389
|
|
|||
Cash and cash equivalents, beginning of year
|
37,520
|
|
|
12,515
|
|
|
10,126
|
|
|||
Cash and cash equivalents, end of year
|
$
|
56,984
|
|
|
$
|
37,520
|
|
|
$
|
12,515
|
|
Supplemental cash flow information:
|
|
|
|
|
|
||||||
Cash paid for interest, including royalty interest obligation
|
$
|
4,224
|
|
|
$
|
5,193
|
|
|
$
|
3,500
|
|
Cash paid for income taxes, net of refunds
|
$
|
195
|
|
|
$
|
34
|
|
|
$
|
—
|
|
Non-cash investing and financing activities:
|
|
|
|
|
|
||||||
Equity component of convertible senior notes
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
24,936
|
|
Issuance of stock from conversion of convertible senior notes
|
$
|
3,929
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Net increase (decrease) in accrued fixed assets
|
$
|
418
|
|
|
$
|
(1,095
|
)
|
|
$
|
622
|
|
|
|
Beginning of Period
|
|
Accruals
|
|
Payments (Credits)
|
|
End of Period
|
||||||||
Year Ended December 31, 2015
|
|
|
|
|
|
|
|
|
||||||||
Accrued rebates and chargebacks (1)
|
|
$
|
321
|
|
|
$
|
2,020
|
|
|
$
|
(1,544
|
)
|
|
$
|
797
|
|
Accrued returns
|
|
1,559
|
|
|
339
|
|
|
(165
|
)
|
|
1,733
|
|
||||
Accrued wholesaler service fees
|
|
588
|
|
|
3,482
|
|
|
(3,325
|
)
|
|
745
|
|
||||
Subtotal
|
|
2,468
|
|
|
5,841
|
|
|
(5,034
|
)
|
|
3,275
|
|
||||
Reserves for prompt pay discounts
|
|
575
|
|
|
4,905
|
|
|
(4,855
|
)
|
|
625
|
|
||||
Total
|
|
$
|
3,043
|
|
|
$
|
10,746
|
|
|
$
|
(9,889
|
)
|
|
$
|
3,900
|
|
|
|
|
|
|
|
|
|
|
||||||||
Year Ended December 31, 2014
|
|
|
|
|
|
|
|
|
||||||||
Accrued rebates and chargebacks
|
|
$
|
402
|
|
|
$
|
881
|
|
|
$
|
(962
|
)
|
|
$
|
321
|
|
Accrued returns
|
|
897
|
|
|
829
|
|
|
(167
|
)
|
|
1,559
|
|
||||
Accrued wholesaler service fees
|
|
266
|
|
|
2,780
|
|
|
(2,458
|
)
|
|
588
|
|
||||
Subtotal
|
|
1,565
|
|
|
4,490
|
|
|
(3,587
|
)
|
|
2,468
|
|
||||
Reserves for prompt pay discounts
|
|
313
|
|
|
3,833
|
|
|
(3,571
|
)
|
|
575
|
|
||||
Total
|
|
$
|
1,878
|
|
|
$
|
8,323
|
|
|
$
|
(7,158
|
)
|
|
$
|
3,043
|
|
|
|
|
|
|
|
|
|
|
||||||||
Year Ended December 31, 2013
|
|
|
|
|
|
|
|
|
||||||||
Accrued rebates and chargebacks (1)
|
|
$
|
111
|
|
|
$
|
590
|
|
|
$
|
(299
|
)
|
|
$
|
402
|
|
Accrued returns
|
|
134
|
|
|
802
|
|
|
(39
|
)
|
|
897
|
|
||||
Accrued wholesaler service fees
|
|
68
|
|
|
1,078
|
|
|
(880
|
)
|
|
266
|
|
||||
Subtotal
|
|
313
|
|
|
2,470
|
|
|
(1,218
|
)
|
|
1,565
|
|
||||
Reserves for prompt pay discounts
|
|
80
|
|
|
1,559
|
|
|
(1,326
|
)
|
|
313
|
|
||||
Total
|
|
$
|
393
|
|
|
$
|
4,029
|
|
|
$
|
(2,544
|
)
|
|
$
|
1,878
|
|
|
Year Ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Largest customer
|
33
|
%
|
|
33
|
%
|
|
33
|
%
|
Second largest customer
|
29
|
%
|
|
29
|
%
|
|
28
|
%
|
Third largest customer
|
28
|
%
|
|
24
|
%
|
|
18
|
%
|
|
90
|
%
|
|
86
|
%
|
|
79
|
%
|
Asset Category
|
|
Useful Lives
|
Computer equipment and software
|
|
1 to 3 years
|
Office furniture and equipment
|
|
5 years
|
Manufacturing and laboratory equipment
|
|
5 to 10 years
|
•
|
Expected term of the option
|
•
|
Expected volatility
|
•
|
Expected dividends
|
•
|
Risk-free interest rate
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Raw materials
|
$
|
16,712
|
|
|
$
|
9,263
|
|
Work-in-process
|
12,152
|
|
|
8,617
|
|
||
Finished goods
|
32,781
|
|
|
11,383
|
|
||
Total
|
$
|
61,645
|
|
|
$
|
29,263
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Machinery and laboratory equipment
|
$
|
29,864
|
|
|
$
|
29,697
|
|
Leasehold improvements
|
30,834
|
|
|
26,350
|
|
||
Computer equipment and software
|
4,007
|
|
|
3,754
|
|
||
Office furniture and equipment
|
1,439
|
|
|
1,001
|
|
||
Construction in progress
|
49,097
|
|
|
19,944
|
|
||
Total
|
115,241
|
|
|
80,746
|
|
||
Less: accumulated depreciation
|
(24,917
|
)
|
|
(20,114
|
)
|
||
Fixed assets, net
|
$
|
90,324
|
|
|
$
|
60,632
|
|
(i)
|
$10.0 million
upon the first commercial sale in the United States;
|
(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
;
|
(iv)
|
$8.0 million
when annual net sales collected reach
$250.0 million
; and
|
(v)
|
$32.0 million
when annual net sales collected reach
$500.0 million
.
|
|
|
Carrying Value
|
||
Balance at December 31, 2013
|
|
$
|
10,328
|
|
Milestone payment triggered by collections of net sales of EXPAREL
|
|
8,000
|
|
|
Percentage payments on collections of net sales of EXPAREL
|
|
5,433
|
|
|
Balance at December 31, 2014
|
|
23,761
|
|
|
Percentage payments on collections of net sales of EXPAREL
|
|
7,119
|
|
|
Balance at December 31, 2015
|
|
$
|
30,880
|
|
December 31, 2015
|
Gross
Carrying Value |
|
Accumulated
Amortization |
|
Intangible
Assets, Net |
|
Estimated
Useful Life |
||||||
Amortizable intangible assets:
|
|
|
|
|
|
|
|
||||||
Core technology
|
$
|
2,900
|
|
|
$
|
(2,819
|
)
|
|
$
|
81
|
|
|
9 Years
|
Developed technology
|
11,700
|
|
|
(11,700
|
)
|
|
—
|
|
|
7 Years
|
|||
Trademarks and trade names
|
400
|
|
|
(400
|
)
|
|
—
|
|
|
7 Years
|
|||
Total intangible assets
|
$
|
15,000
|
|
|
$
|
(14,919
|
)
|
|
$
|
81
|
|
|
|
December 31, 2014
|
Gross
Carrying Value |
|
Accumulated
Amortization |
|
Intangible
Assets, Net |
|
Estimated
Useful Life |
||||||
Amortizable intangible assets:
|
|
|
|
|
|
|
|
||||||
Core technology
|
$
|
2,900
|
|
|
$
|
(2,497
|
)
|
|
$
|
403
|
|
|
9 years
|
Developed technology
|
11,700
|
|
|
(11,700
|
)
|
|
—
|
|
|
7 years
|
|||
Trademarks and trade names
|
400
|
|
|
(400
|
)
|
|
—
|
|
|
7 years
|
|||
Total intangible assets
|
$
|
15,000
|
|
|
$
|
(14,597
|
)
|
|
$
|
403
|
|
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Compensation and benefits
|
$
|
11,944
|
|
|
$
|
8,909
|
|
Accrued operating expenses
|
14,984
|
|
|
12,094
|
|
||
Accrued royalties
|
3,731
|
|
|
3,213
|
|
||
Accrued interest
|
1,605
|
|
|
1,625
|
|
||
Product returns, rebates and other fees
|
3,111
|
|
|
2,470
|
|
||
Total
|
$
|
35,375
|
|
|
$
|
28,311
|
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Debt:
|
|
|
|
||||
Convertible senior notes
|
$
|
118,533
|
|
|
$
|
120,000
|
|
Discount on debt
|
(12,605
|
)
|
|
(16,900
|
)
|
||
Total debt, net of discount
|
105,928
|
|
|
103,100
|
|
||
Royalty interest obligation
|
—
|
|
|
276
|
|
||
Total debt and financing obligations
|
$
|
105,928
|
|
|
$
|
103,376
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Contractual interest expense
|
$
|
3,856
|
|
|
$
|
3,900
|
|
|
$
|
3,833
|
|
Amortization of debt issuance costs
|
615
|
|
|
620
|
|
|
593
|
|
|||
Amortization of debt discount
|
4,102
|
|
|
4,139
|
|
|
3,959
|
|
|||
Capitalized interest
|
(848
|
)
|
|
(381
|
)
|
|
(1,132
|
)
|
|||
Total
|
$
|
7,725
|
|
|
$
|
8,278
|
|
|
$
|
7,253
|
|
|
|
|
|
|
|
||||||
Effective interest rate on the Notes
|
7.21
|
%
|
|
7.22
|
%
|
|
7.22
|
%
|
•
|
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.
|
|
|
Carrying
Value |
|
Fair Value Measurements Using
|
||||||||||||
Financial Liabilities Carried at Historical Cost
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|||||||||
December 31, 2015
|
|
|
|
|
|
|
|
|
||||||||
Convertible senior notes *
|
|
$
|
105,928
|
|
|
$
|
—
|
|
|
$
|
369,971
|
|
|
$
|
—
|
|
December 31, 2015
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
Debt securities:
|
|
|
|
|
|
|
|
|
||||||||
Short-term:
|
|
|
|
|
|
|
|
|
||||||||
Asset-backed securities
|
|
$
|
27,484
|
|
|
$
|
—
|
|
|
$
|
(15
|
)
|
|
$
|
27,469
|
|
Commercial paper
|
|
35,191
|
|
|
31
|
|
|
—
|
|
|
35,222
|
|
||||
Corporate bonds
|
|
39,319
|
|
|
2
|
|
|
(31
|
)
|
|
39,290
|
|
||||
Subtotal
|
|
101,994
|
|
|
33
|
|
|
(46
|
)
|
|
101,981
|
|
||||
Long-term:
|
|
|
|
|
|
|
|
|
||||||||
Corporate bonds
|
|
13,501
|
|
|
—
|
|
|
(39
|
)
|
|
13,462
|
|
||||
Total
|
|
$
|
115,495
|
|
|
$
|
33
|
|
|
$
|
(85
|
)
|
|
$
|
115,443
|
|
December 31, 2014
|
|
Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
(Level 2) |
||||||||
Debt securities:
|
|
|
|
|
|
|
|
|
||||||||
Short-term:
|
|
|
|
|
|
|
|
|
||||||||
Asset-backed securities
|
|
$
|
15,009
|
|
|
$
|
—
|
|
|
$
|
(9
|
)
|
|
$
|
15,000
|
|
Commercial paper
|
|
1,747
|
|
|
3
|
|
|
—
|
|
|
1,750
|
|
||||
Corporate bonds
|
|
102,430
|
|
|
—
|
|
|
(42
|
)
|
|
102,388
|
|
||||
Subtotal
|
|
119,186
|
|
|
3
|
|
|
(51
|
)
|
|
119,138
|
|
||||
Long-term:
|
|
|
|
|
|
|
|
|
||||||||
Corporate bonds
|
|
24,463
|
|
|
10
|
|
|
(42
|
)
|
|
24,431
|
|
||||
Total
|
|
$
|
143,649
|
|
|
$
|
13
|
|
|
$
|
(93
|
)
|
|
$
|
143,569
|
|
|
Net Unrealized Gains
(Losses) From Available
For Sale Investments
|
||
Balance at December 31, 2013
|
$
|
5
|
|
Other comprehensive loss before reclassifications
|
(85
|
)
|
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
—
|
|
|
Balance at December 31, 2014
|
(80
|
)
|
|
Other comprehensive loss before reclassifications
|
28
|
|
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
—
|
|
|
Balance at December 31, 2015
|
$
|
(52
|
)
|
Stock Incentive Plans
|
|
Awards Reserved for Issuance
|
|
Awards Issued
|
|
Awards Available for Grant
|
|||
2007 Plan
|
|
2,022,837
|
|
|
2,022,837
|
|
|
—
|
|
2011 Plan
|
|
5,931,700
|
|
|
5,213,023
|
|
|
718,677
|
|
2014 Inducement plan
|
|
175,000
|
|
|
67,000
|
|
|
108,000
|
|
|
|
8,129,537
|
|
|
7,302,860
|
|
|
826,677
|
|
|
|
|
|
|
|
|
|||
Employee Stock Purchase Plan
|
|
Shares Reserved for Purchase
|
|
Shares Purchased
|
|
Shares Available for Purchase
|
|||
2014 ESPP
|
|
500,000
|
|
|
50,700
|
|
|
449,300
|
|
|
|
Year Ended December 31,
|
||||||||||
|
|
2015
|
|
2014
|
|
2013
|
||||||
Cost of goods sold
|
|
$
|
6,012
|
|
|
$
|
3,582
|
|
|
$
|
1,526
|
|
Research and development
|
|
5,134
|
|
|
6,490
|
|
|
4,345
|
|
|||
Selling, general and administrative
|
|
22,222
|
|
|
14,750
|
|
|
5,642
|
|
|||
Total
|
|
$
|
33,368
|
|
|
$
|
24,822
|
|
|
$
|
11,513
|
|
|
|
|
|
|
|
|
||||||
Stock-based compensation from:
|
|
|
|
|
|
|
||||||
Stock options (employee awards)
|
|
$
|
27,262
|
|
|
$
|
19,182
|
|
|
$
|
7,133
|
|
Stock options (consultant awards)
|
|
2,367
|
|
|
5,295
|
|
|
4,380
|
|
|||
RSUs
|
|
2,887
|
|
|
—
|
|
|
—
|
|
|||
ESPP
|
|
852
|
|
|
345
|
|
|
—
|
|
|||
Total
|
|
$
|
33,368
|
|
|
$
|
24,822
|
|
|
$
|
11,513
|
|
|
Number of
Options |
|
Weighted
Average Exercise Price (Per Share) |
|
Weighted Average
Remaining Contractual Term (Years) |
|
Aggregate
Intrinsic Value (in Thousands) |
|||||
Outstanding at January 1, 2013
|
4,003,166
|
|
|
$
|
7.86
|
|
|
8.66
|
|
$
|
38,485
|
|
Granted
|
918,915
|
|
|
30.42
|
|
|
|
|
|
|
||
Exercised
|
(742,211
|
)
|
|
5.19
|
|
|
|
|
$
|
21,679
|
|
|
Forfeited
|
(338,145
|
)
|
|
10.93
|
|
|
|
|
|
|
||
Expired
|
(1,687
|
)
|
|
7.24
|
|
|
|
|
|
|
||
Outstanding at December 31, 2013
|
3,840,038
|
|
|
13.50
|
|
|
8.01
|
|
$
|
168,905
|
|
|
Granted
|
1,638,575
|
|
|
79.68
|
|
|
|
|
|
|
||
Exercised
|
(624,229
|
)
|
|
11.60
|
|
|
|
|
$
|
45,289
|
|
|
Forfeited
|
(175,967
|
)
|
|
44.32
|
|
|
|
|
|
|
||
Expired
|
(561
|
)
|
|
21.70
|
|
|
|
|
|
|
||
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
|
|
Exercisable at December 31, 2015
|
2,618,881
|
|
|
$
|
26.08
|
|
|
6.32
|
|
$
|
135,576
|
|
Vested and expected to vest at December 31, 2015
|
4,499,941
|
|
|
$
|
43.08
|
|
|
7.26
|
|
$
|
161,272
|
|
|
Year Ended December 31,
|
||||
|
2015
|
|
2014
|
|
2013
|
Expected dividend yield
|
None
|
|
None
|
|
None
|
Risk free interest rate
|
1.40 - 2.28%
|
|
0.02 - 2.16%
|
|
0.33 - 2.83%
|
Expected volatility
|
52.9%
|
|
57.2%
|
|
68.7%
|
Expected term of options
|
5.76 years
|
|
5.86 years
|
|
6.22 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
|
|
Expected to vest at December 31, 2015
|
194,290
|
|
|
$
|
78.61
|
|
|
$
|
14,920
|
|
Grant Date
|
Per Share
Fair Value |
|
Expected
Dividend Yield |
|
Risk Free
Interest Rate |
|
Expected
Volatility |
|
Expected
Term |
||
September 2014
|
$
|
23.27
|
|
|
None
|
|
0.37%
|
|
28.2%
|
|
4 months
|
January 2015
|
25.24
|
|
|
None
|
|
0.11%
|
|
45.0%
|
|
6 months
|
|
July 2015
|
21.93
|
|
|
None
|
|
0.13%
|
|
58.2%
|
|
6 months
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Numerator:
|
|
|
|
|
|
||||||
Net income (loss)
|
$
|
1,856
|
|
|
$
|
(13,716
|
)
|
|
$
|
(63,909
|
)
|
Denominator:
|
|
|
|
|
|
||||||
Weighted average shares of common stock outstanding—basic
|
36,540
|
|
|
35,299
|
|
|
33,182
|
|
|||
Computation of diluted securities:
|
|
|
|
|
|
||||||
Dilutive effect of stock options
|
1,638
|
|
|
—
|
|
|
—
|
|
|||
Dilutive effect of RSUs
|
3
|
|
|
—
|
|
|
—
|
|
|||
Dilutive effect of conversion premium on the Notes
|
3,113
|
|
|
—
|
|
|
—
|
|
|||
Dilutive effect of warrants
|
6
|
|
|
—
|
|
|
—
|
|
|||
Dilutive effect of ESPP
|
1
|
|
|
—
|
|
|
—
|
|
|||
Weighted average shares of common stock outstanding—diluted
|
41,301
|
|
|
35,299
|
|
|
33,182
|
|
|||
Net income (loss) per share:
|
|
|
|
|
|
||||||
Basic net income (loss) per share of common stock
|
$
|
0.05
|
|
|
$
|
(0.39
|
)
|
|
$
|
(1.93
|
)
|
Diluted net income (loss) per share of common stock
|
$
|
0.04
|
|
|
$
|
(0.39
|
)
|
|
$
|
(1.93
|
)
|
|
Year Ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
Weighted average number of stock options
|
1,891
|
|
|
3,534
|
|
|
3,980
|
|
Weighted average number of RSUs
|
99
|
|
|
—
|
|
|
—
|
|
Conversion premium on the Notes
|
—
|
|
|
2,483
|
|
|
1,194
|
|
Weighted average number of warrants
|
—
|
|
|
21
|
|
|
204
|
|
Weighted average purchase options under ESPP
|
8
|
|
|
1
|
|
|
—
|
|
Total
|
1,998
|
|
|
6,039
|
|
|
5,378
|
|
|
Year Ended December 31,
|
||||||||||
|
2015
|
|
2014
|
|
2013
|
||||||
Income (loss) before income taxes:
|
|
|
|
|
|
||||||
Domestic
|
$
|
4,033
|
|
|
$
|
(13,271
|
)
|
|
$
|
(64,351
|
)
|
Foreign
|
(1,913
|
)
|
|
(272
|
)
|
|
—
|
|
|||
Total income (loss) before income taxes
|
$
|
2,120
|
|
|
$
|
(13,543
|
)
|
|
$
|
(64,351
|
)
|
|
|
|
|
|
|
||||||
Current taxes:
|
|
|
|
|
|
||||||
Federal
|
$
|
(92
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
State
|
(172
|
)
|
|
(173
|
)
|
|
442
|
|
|||
Total income tax (expense) benefit
|
$
|
(264
|
)
|
|
$
|
(173
|
)
|
|
$
|
442
|
|
|
Year Ended December 31,
|
|||||||
|
2015
|
|
2014
|
|
2013
|
|||
U.S. federal statutory rate
|
35.00
|
%
|
|
35.00
|
%
|
|
35.00
|
%
|
State taxes
|
0.71
|
%
|
|
(32.62
|
)%
|
|
4.79
|
%
|
Foreign taxes
|
12.03
|
%
|
|
(0.13
|
)%
|
|
—
|
%
|
Increase (decrease) in valuation allowance
|
10.32
|
%
|
|
(17.71
|
)%
|
|
(42.91
|
)%
|
Stock-based compensation
|
7.26
|
%
|
|
(0.44
|
)%
|
|
1.72
|
%
|
Tax credits
|
(30.63
|
)%
|
|
5.49
|
%
|
|
1.69
|
%
|
Interest expense
|
(37.57
|
)%
|
|
10.68
|
%
|
|
0.30
|
%
|
Other permanent items
|
15.33
|
%
|
|
(1.55
|
)%
|
|
0.10
|
%
|
Effective tax rate
|
12.45
|
%
|
|
(1.28
|
)%
|
|
0.69
|
%
|
|
December 31,
|
||||||
|
2015
|
|
2014
|
||||
Deferred tax assets:
|
|
|
|
||||
Net operating loss carry-forwards
|
$
|
101,011
|
|
|
$
|
111,086
|
|
Federal and state research credits
|
7,140
|
|
|
6,043
|
|
||
Depreciation and amortization
|
1,310
|
|
|
3,494
|
|
||
Accruals and reserves
|
5,558
|
|
|
3,861
|
|
||
Deferred revenue
|
3,530
|
|
|
4,065
|
|
||
Stock based compensation
|
17,201
|
|
|
8,487
|
|
||
Other
|
1,045
|
|
|
588
|
|
||
Total deferred tax assets
|
136,795
|
|
|
137,624
|
|
||
Deferred tax liabilities:
|
|
|
|
||||
Discount on convertible senior notes
|
(4,679
|
)
|
|
(6,283
|
)
|
||
|
132,116
|
|
|
131,341
|
|
||
Less: valuation allowance
|
(132,116
|
)
|
|
(131,341
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
Year
|
|
Annual Minimum Payments Due
|
||
2016
|
|
$
|
7,743
|
|
2017
|
|
7,878
|
|
|
2018
|
|
8,081
|
|
|
2019
|
|
8,303
|
|
|
2020
|
|
6,420
|
|
|
2021 through 2028
|
|
8,731
|
|
|
Total
|
|
$
|
47,156
|
|
|
Three Months Ended
|
||||||||||||||
|
March 31,
2015 |
|
June 30,
2015 |
|
September 30,
2015 |
|
December 31,
2015 |
||||||||
Total revenues
|
$
|
58,316
|
|
|
$
|
59,148
|
|
|
$
|
62,213
|
|
|
$
|
69,320
|
|
Cost of goods sold
|
17,580
|
|
|
18,929
|
|
|
15,901
|
|
|
19,427
|
|
||||
Total operating expenses
|
54,975
|
|
|
57,330
|
|
|
57,104
|
|
|
70,133
|
|
||||
Net income (loss)
|
1,260
|
|
|
8
|
|
|
3,086
|
|
|
(2,498
|
)
|
||||
Basic and diluted net income (loss) per common share
|
$
|
0.03
|
|
|
$
|
0.00
|
|
|
$
|
0.08
|
|
|
$
|
(0.07
|
)
|
|
Three Months Ended
|
||||||||||||||
|
March 31,
2014
|
|
June 30,
2014
|
|
September 30,
2014
|
|
December 31,
2014
|
||||||||
Total revenues
|
$
|
36,662
|
|
|
$
|
47,165
|
|
|
$
|
52,048
|
|
|
$
|
61,793
|
|
Cost of goods sold
|
18,127
|
|
|
19,954
|
|
|
20,391
|
|
|
18,968
|
|
||||
Total operating expenses
|
45,920
|
|
|
50,007
|
|
|
53,033
|
|
|
53,873
|
|
||||
Net income (loss)
|
(11,477
|
)
|
|
(5,037
|
)
|
|
(3,004
|
)
|
|
5,802
|
|
||||
Basic net income (loss) per common share
|
$
|
(0.34
|
)
|
|
$
|
(0.14
|
)
|
|
$
|
(0.08
|
)
|
|
$
|
0.16
|
|
Diluted net income (loss) per common share
|
$
|
(0.34
|
)
|
|
$
|
(0.14
|
)
|
|
$
|
(0.08
|
)
|
|
$
|
0.14
|
|
Exhibit
Number
|
|
Description
|
||
3.1
|
|
|
|
Amended and Restated Certificate of Incorporation of the Registrant.(1)
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3.2
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Amended and Restated Bylaws of the Registrant.(1)
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4.1
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Specimen Certificate evidencing shares of common stock.(2)
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4.2
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Indenture (including form of Notes), dated January 23, 2013, between the Registrant and Wells Fargo Bank, National Association, as trustee.(3)
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10.1
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Second Amended and Restated 2007 Stock Option/Stock Issuance Plan.(2)***
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10.2
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Form of Stock Option Agreement under the Second Amended and Restated 2007 Stock Option/Stock Issuance Plan.(2)***
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10.3
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Investors’ Rights Agreement, dated March 23, 2007, among the Registrant and the parties named therein.(2)
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10.4
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Assignment Agreement, dated February 9, 1994, amended April 15, 2004, between the Registrant and Research Development Foundation.(2)
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10.5
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Stock Purchase Agreement, dated January 8, 2007, between SkyePharma, Inc. and the Registrant.(2)
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10.6
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Supply Agreement, dated June 30, 2003, between SkyePharma, Inc. and Mundipharma Medical Company.(2)
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10.7
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Distribution Agreement, dated June 30, 2003, between SkyePharma, Inc. and Mundipharma International Holdings Limited.(2)
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10.8
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Distribution Agreement, dated July 27, 2005, between SkyePharma, Inc. and Mundipharma International Holdings Limited.(2)
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10.9
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DepoCyt Supply and Distribution Agreement, dated December 31, 2002, between SkyePharma, Inc. and Enzon Pharmaceuticals, Inc.(2)
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10.10
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Industrial Real Estate Triple Net Lease, dated August 17, 1993, between Pacira Pharmaceuticals, Inc. and HCP TPSP, LLC.(2)
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10.11
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Fifth Amendment, dated March 13, 2013, to the Industrial Real Estate Triple Net Lease, dated August 17, 1993, among the Registrant, Pacira Pharmaceuticals, Inc. and HCP TPSP, LLC (and successor-in-interest to Equitable Life Assurance Society of the United States).(4)
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10.12
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Industrial Real Estate Lease, dated December 8, 1994, amended July 2, 2009, between Pacira Pharmaceuticals, Inc. and LASDK Limited Partnership.(2)
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10.13
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Third Amendment, dated March 13, 2013, to the Industrial Real Estate Lease, dated December 8, 1994, among the Registrant, Pacira Pharmaceuticals, Inc. and LASDK Limited Partnership.(4)
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10.14
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Services Agreement, dated October 28, 2010, between the Registrant, MPM Asset Management LLC and Gary Patou.(2)***
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10.15
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Amendment to Services Agreement, dated October 28, 2010, between the Registrant, MPM Asset Management LLC and Gary Patou.(6)***
|
10.16
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Amendment #2 to Services Agreement, between the Registrant and MPM Asset Management LLC, and Gary Patou, dated November 29, 2012.(10)***
|
10.17
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Amendment #3 to Services Agreement, dated September 11, 2013, among the Registrant, MPM Asset Management LLC, and Gary Patou.(8)***
|
10.18
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|
Amendment #4 to Services Agreement, dated November 17, 2014, among the Registrant, MPM Asset Management LLC, and Gary Patou.(16)***
|
10.19
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|
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|
Amendment #5 to Services Agreement, dated March 17, 2015, among the Registrant, MPM Asset Management LLC, and Gary Patou.(16)***
|
10.20
|
|
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|
Employment Agreement between the Registrant and David Stack.(2)***
|
10.21
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Amendment No. 1 to Executive Employment Agreement, dated March 13, 2013, between the Registrant and David Stack.(4)***
|
10.22
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|
Amendment No. 2 to Executive Employment Agreement, dated June 30, 2015, between the Registrant and David Stack.(17)***
|
10.23
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|
Employment Agreement between the Registrant and James Scibetta.(2)***
|
10.24
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Amendment No. 1 to Executive Employment Agreement, dated March 13, 2013, between the Registrant and James Scibetta.(4)***
|
10.25
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|
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Amendment No. 2 to Executive Employment Agreement, dated June 30, 2015, between the Registrant and James Scibetta.(17)***
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10.26
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|
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|
Executive Employment Agreement, dated November 1, 2010, between the Registrant and Taunia Markvicka.(7)***
|
10.27
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|
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|
Amendment No. 1 to Executive Employment Agreement, dated March 13, 2013, between the Registrant and Taunia Markvicka.(4)***
|
10.28
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|
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|
Amendment No. 2 to Executive Employment Agreement, dated June 30, 2015, between the Registrant and Taunia Markvicka.(17)***
|
10.29
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|
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|
Employment Agreement, dated November 29, 2012, between the Registrant and Kristen Williams.(16)***
|
10.30
|
|
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|
Amendment No. 1 to Employment Agreement, dated March 13, 2013, between the Registrant and Kristen Williams.(16)***
|
10.31
|
|
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|
Amendment No. 2 to Employment Agreement, dated June 30, 2015, between the Registrant and Kristen Williams.(17)***
|
10.32
|
|
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|
Form of Warrant to purchase common stock of the Registrant, dated January 22, 2009.(2)
|
10.33
|
|
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|
Form of Warrant to purchase common stock of the Registrant, dated December 29, 2010.(2)
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10.34
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|
Form of Indemnification Agreement between the Registrant and its directors and officers.(2)***
|
10.35†
|
|
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Commercial Outsourcing Services Agreement entered into as of August 25, 2011 by the Registrant and Integrated Commercialization Solutions, Inc.(5)
|
10.36†
|
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First Amendment to Commercial Outsourcing Services Agreement, dated August 1, 2013, between the Registrant and Integrated Commercialization Solutions, Inc.(8)
|
10.37†
|
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Second Amendment to Commercial Outsourcing Services Agreement, dated August 25, 2014, between Pacira Pharmaceuticals, Inc. and Integrated Commercialization Solutions, Inc.(15)
|
10.38†
|
|
|
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Third Amendment to Commercial Outsourcing Services Agreement, dated April 29, 2015, between Pacira Pharmaceuticals, Inc. and Integrated Commercialization Solutions, Inc.(17)
|
10.39
|
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|
Amended and Restated 2011 Stock Incentive Plan.(9)***
|
10.40
|
|
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|
Form of Nonstatutory Stock Option Agreement under the Amended and Restated 2011 Stock Incentive Plan.(9)***
|
10.41
|
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Form of Restricted Stock Unit Award Agreement (Employees) under the Amended and Restated 2011 Stock Incentive Plan.(17)***
|
10.42
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|
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Form of Restricted Stock Unit Award Agreement (Non-Employee Directors) under the Amended and Restated 2011 Stock Incentive Plan.(17)***
|
10.43†
|
|
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|
License, Development and Commercialization Agreement, dated December 5, 2012 between the Registrant and Aratana Therapeutics, Inc.(11)
|
10.44†
|
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Supply Agreement, dated December 5, 2012 between the Registrant and Aratana Therapeutics, Inc.(11)
|
10.45†
|
|
|
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Master Distributor Agreement, dated March 11, 2013, between the Registrant and CrossLink BioScience, LLC.(12)
|
10.46†
|
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|
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First Amendment to Master Distributor Agreement, dated April 1, 2013, between the Registrant and CrossLink BioScience, LLC.(12)
|
10.47†
|
|
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Second Amendment to Master Distributor Agreement, dated September 5, 2013, between the Registrant and Crosslink BioScience, LLC.(12)
|
10.48†
|
|
|
|
Third Amendment to Master Distributor Agreement, dated February 20, 2015, between the Registrant and Crosslink BioScience, LLC.(16)
|
10.49
|
|
|
|
2014 Inducement Plan.(13)***
|
10.50
|
|
|
|
2014 Employee Stock Purchase Plan.(9)***
|
10.51†
|
|
|
|
Strategic Co-Production Agreement dated April 4, 2014, by and between Pacira Pharmaceuticals, Inc. and Patheon UK Limited.(14)
|
10.52†
|
|
|
|
Manufacturing and Supply Agreement dated April 4, 2014, by and between Pacira Pharmaceuticals, Inc. and Patheon UK Limited.(14)
|
10.53†
|
|
|
|
Technical Transfer and Service Agreement dated April 4, 2014, by and between Pacira Pharmaceuticals, Inc. and Patheon UK Limited.(14)
|
10.54
|
|
|
|
Amended and Restated Consulting Agreement, dated April 3, 2012, between the Registrant and Gary Pace.(7)***
|
10.55
|
|
|
|
Second Amended and Restated Consulting Agreement, dated August 17, 2012, between the Registrant and Gary Pace.(18)***
|
10.56
|
|
|
|
Third Amendment to Consulting Agreement, dated September 11, 2013, between the Registrant and Gary Pace.(8)***
|
10.57
|
|
|
|
Fourth Amendment to Consulting Agreement, dated November 25, 2015, between Pacira Pharmaceuticals, Inc. and Gary Pace.***
|
21.1
|
|
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|
Subsidiaries of Registrant.*
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23.1
|
|
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|
Consent of CohnReznick LLP.*
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31.1
|
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|
Certification of Chief Executive Officer and Chairman pursuant to Exchange Act Rule 13a-14(a).*
|
(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 Current Report on Form 8-K, filed on December 9, 2011.
|
(7)
|
Incorporated by reference to the exhibits to the registrant’s Quarterly Report on Form 10-Q, filed on May 9, 2012.
|
(8)
|
Incorporated by reference to the exhibits to the registrant’s Quarterly Report on Form 10-Q, filed on October 31, 2013.
|
(9)
|
Incorporated by reference to the exhibits to the registrant’s Current Report on Form 8-K, filed on June 4, 2014.
|
(10)
|
Incorporated by reference to the exhibits to the registrant’s Current Report on Form 8-K, filed on December 4, 2012.
|
(11)
|
Incorporated by reference to the exhibits to the registrant’s Annual Report on Form 10-K, filed on March 7, 2013.
|
(12)
|
Incorporated by reference to the exhibits to the registrant’s Annual Report on Form 10-K, filed on February 25, 2014.
|
(13)
|
Incorporated by reference to Exhibit 10.1 to the registrant’s Quarterly Report on Form 10-Q, filed on May 1, 2014.
|
(14)
|
Incorporated by reference to the exhibits to the registrant’s Quarterly Report on Form 10-Q, filed on July 31, 2014.
|
(15)
|
Incorporated by reference to the exhibits to the registrant’s Quarterly Report on Form 10-Q, filed on October 30, 2014.
|
(16)
|
Incorporated by reference to the exhibits to the registrant’s Quarterly Report on Form 10-Q, filed on April 30, 2015.
|
(17)
|
Incorporated by reference to the exhibits to the registrant’s Quarterly Report on Form 10-Q, filed on July 30, 2015.
|
(18)
|
Incorporated by reference to the exhibits to the registrant’s Quarterly Report on Form 10-Q, filed on November 1, 2012.
|
*
|
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.
|
PACIRA PHARMACEUTICALS, INC.
|
|
GARY PACE
|
|
|
|
/s/ Daina Borteck
|
|
/s/ Gary W. Pace
|
|
|
|
Daina Borteck
|
|
Gary W. Pace
|
Assistant General Counsel
|
|
Consultant
|
December 22, 2015
|
|
November 27, 2015
|
•
|
Pacira Pharmaceuticals will reimburse consultant for all pre-approved travel and related expenses.
|
•
|
The consultant is responsible for making all travel arrangements through his/her travel agent, unless otherwise instructed.
|
•
|
Expense reports should be submitted to Pacira with corresponding receipts within five (5) days of the completed travel.
|
/s/ CohnReznick LLP
Roseland, New Jersey
February 25, 2016
|
|
|
(a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and
|
(a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.
|
Date:
|
February 25, 2016
|
/s/ DAVID STACK
David Stack
Chief Executive Officer and Chairman
(Principal Executive Officer)
|
(a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
evaluated the effectiveness of the Registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
disclosed in this report any change in the Registrant’s internal control over financial reporting that occurred during the Registrant’s most recent fiscal quarter (the Registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the Registrant’s internal control over financial reporting; and
|
(a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant’s internal control over financial reporting.
|
Date:
|
February 25, 2016
|
/s/ JAMES SCIBETTA
James Scibetta
President and Chief Financial Officer
(Principal Financial Officer)
|
Date:
|
February 25, 2016
|
/s/ DAVID STACK
David Stack
Chief Executive Officer and Chairman
(Principal Executive Officer)
|
Date:
|
February 25, 2016
|
/s/ JAMES SCIBETTA
James Scibetta
President and Chief Financial Officer
(Principal Financial Officer)
|