NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Organization
Assertio is a specialty pharmaceutical company focused on neurology, orphan and specialty medicines. The Company’s current specialty pharmaceutical business includes the following
three
products which the Company markets in the U.S.:
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•
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Gralise
®
(gabapentin), a once daily product for the management of postherpetic neuralgia (PHN), that was launched in October 2011.
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•
|
CAMBIA
®
(diclofenac potassium for oral solution), a non-steroidal anti-inflammatory drug for the acute treatment of migraine attacks, that was acquired by the Company in December 2013.
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•
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Zipsor
®
(diclofenac potassium liquid filled capsules), a non-steroidal anti-inflammatory drug for the treatment of mild to moderate acute pain, that was acquired by the Company in June 2012.
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The Company also has the exclusive rights to market long-acting cosyntropin (synthetic adrenocorticotropic hormone, or ACTH) in the U.S. and Canada. Long-acting cosyntropin is an alcohol-free formulation of a synthetic analogue of ACTH. In February 2019, notification of acceptance for filing was received from the U.S. Food and Drug Administration (FDA) for our 505(b)(2) New Drug Application (NDA) for the novel injectable formulation of long-acting cosyntropin. The Company, together with its development partner, seek approval for the use of this product as a diagnostic drug in the screening of patients presumed to have adrenocortical insufficiency.
The Company maintains a Commercialization Agreement with Collegium Pharmaceutical, Inc. (Collegium) pursuant to which the Company granted Collegium the right to commercialize the NUCYNTA
®
franchise of pain products in the United States. Pursuant to the Commercialization Agreement, Collegium assumed all commercialization responsibilities for the NUCYNTA franchise effective January 9, 2018, including sales and marketing. The Company receives a royalty on all NUCYNTA revenues based on certain net sales thresholds.
Basis of Preparation
The Company’s consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles, or U.S. GAAP, and US Securities and Exchange Commission (SEC) regulations for annual reporting.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Depomed Bermuda Ltd (Depo Bermuda), Depo NF Sub, LLC (Depo NF Sub) and Depo DR Sub, LLC (Depo DR Sub). All intercompany accounts and transactions have been eliminated on consolidation.
On November 17, 2015, the Company entered into a definitive agreement to acquire the U.S. and Canadian rights to cebranopadol and its related follow-on compound from Grünenthal GmbH (Grünenthal). The acquisition of these rights closed on December 30, 2015 at which point the Company assigned its rights under the agreement to Depo Bermuda, a Company which was formed in Bermuda on December 22, 2015.
Depo NF Sub was formed on March 26, 2015, in connection with a Note Purchase Agreement dated March 12, 2015 (Note Purchase Agreement) governing the Company’s issuance of
$575.0 million
aggregate principal amount of Senior Notes on April 2, 2015, for aggregate gross proceeds of approximately
$562.0 million
. On April 2, 2015, the Company and Depo NF Sub entered into a Pledge and Security Agreement with the Collateral Agent pursuant to which the Company and Depo NF Sub each granted the Collateral Agent (on behalf of the Purchasers) a security interest in substantially all of their assets, other than specifically excluded assets.
Depo DR Sub was formed in October 2013 for the sole purpose of facilitating the PDL Transaction. The Company contributed to Depo DR Sub all of its rights, title and interests in each of the license agreements to receive royalty and contingent milestone payments. Immediately following the transaction, Depo DR Sub sold to PDL, among other things, such rights to receive royalty and contingent milestone payments, for an upfront cash purchase price of
$240.5 million
.
The Company and Depo DR Sub continue to retain certain administrative duties and obligations under the specified license agreements. These include the collection of the royalty and milestone amounts due and enforcement of related provisions under the specified license agreements, among others. In addition, the Company and Depo DR Sub must prepare a quarterly distribution report relating to the specified license agreements, containing, among other items, the amount of royalty payments received by the Company, reimbursable expenses and set‑offs. The Company and Depo DR Sub must also provide PDL with notice of certain communications, events or actions with respect to the specified license agreements and infringement of any underlying intellectual property.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Estimates are used when accounting for amounts recorded in connection with acquisitions, including initial fair value determinations of assets and liabilities as well as subsequent fair value measurements. Additionally, estimates are used in determining items such as sales discounts and returns, depreciable and amortizable lives, share-based compensation assumptions and taxes on income. Although management believes these estimates are based upon reasonable assumptions within the bounds of its knowledge of the Company’s business and operations, actual results could differ materially from these estimates.
Cash, Cash Equivalents, Short-term Investments and Marketable Securities
The Company considers all highly liquid investments with an original maturity (at date of purchase) of three months or less to be cash equivalents. All marketable securities with original maturities at the date of purchase greater than three months and remaining maturities of less than one year are classified as short-term investments. Cash and cash equivalents consist of cash on deposit with banks, money market instruments and commercial paper. The Company places its cash, cash equivalents, short-term investments and marketable securities with high quality U.S. government and financial institutions and to date has not experienced material losses on any of its balances.
Accounts Receivable
Trade accounts receivable are recorded net of allowances for cash discounts for prompt payment. To date the Company has not recorded a bad debt allowance since the majority of its product revenue comes from sales to a limited number of financially sound companies who have historically paid their balances timely. The need for a bad debt allowance is evaluated each reporting period based on the Company’s assessment of the credit worthiness of its customers or any other potential circumstances that could result in bad debt.
Inventories
Inventories are stated at the lower of cost or net realizable value with cost determined by specific manufactured lot. Inventories consist of costs of the active pharmaceutical ingredient, contract manufacturing and packaging costs. The Company writes-off the value of inventory for potentially excess, dated or obsolete inventories based on an analysis of inventory on hand and projected demand.
Investments
Assertio has
two
long-term investments as of December 31, 2018. During the year ended December 31, 2018, Assertio invested
$3.0 million
in a company engaged in medical research. This investment is structured as a long-term loan receivable with a convertible feature. The loan is valued at recoverable cost, which is
$3.0 million
and following an impairment assessment, it has been concluded that there is
no
impairment.
Assertio received warrants to purchase Collegium stock in conjunction with the November 2018 amendment to the Commercialization Agreement. Such warrants are measured at fair value with changes in fair value recorded in other income and expense on the Company’s Consolidated Statements of Operation.
Acquisitions
The Company accounts for acquired businesses using the acquisition method of accounting, which requires that assets acquired and liabilities assumed be recorded at date of acquisition at their respective fair values. The fair value of the consideration paid, including contingent consideration, is assigned to the underlying net assets of the acquired business based
on their respective fair values. Any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill.
Significant judgments are used in determining the estimated fair values assigned to the assets acquired and liabilities assumed and in determining estimates of useful lives of long-lived assets. Fair value determinations and useful life estimates are based on, among other factors, estimates of expected future net cash flows, estimates of appropriate discount rates used to present value expected future net cash flows, the assessment of each asset’s life cycle, and the impact of competitive trends on each asset’s life cycle and other factors. These judgments can materially impact the estimates used to allocate acquisition date fair values to assets acquired and liabilities assumed and the resulting timing and amounts charged to, or recognized in current and future operating results. For these and other reasons, actual results may vary significantly from estimated results.
Any changes in the fair value of contingent consideration resulting from a change in the underlying inputs is recognized in operating expenses until the contingent consideration arrangement is settled. Changes in the fair value of contingent consideration resulting from the passage of time are recorded within interest expense until the contingent consideration is settled.
If the acquired net assets do not constitute a business under the acquisition method of accounting, the transaction is accounted for as an asset acquisition and no goodwill is recognized. In an asset acquisition, the amount allocated to acquired in-process research and development (IPR&D) with no alternative future use is charged to expense at the acquisition date.
Property and Equipment
Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is calculated using the straight-line method over the estimated useful lives of the respective assets, as follows:
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Furniture and office equipment
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3 - 5 years
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Machinery and equipment
|
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5 - 7 years
|
Laboratory equipment
|
|
3 - 5 years
|
Leasehold improvements
|
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Shorter of estimated useful life or lease term
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Intangible Assets
Intangible assets consist of purchased developed technology and trademarks. The Company determines the fair values of acquired intangible assets as of the acquisition date. Discounted cash flow models are typically used in these valuations, which require the use of significant estimates and assumptions, including but not limited to, developing appropriate discount rates and estimating future cash flows from product sales and related expenses. The fair value recorded is amortized on a straight-line basis over the estimated useful life of the asset. The Company evaluates purchased intangibles for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. An impairment loss would be recognized when the fair value of the asset is lower than the carrying amount. To test for impairment, the Company estimates undiscounted future cash flows expected to result from the use of the asset and its eventual disposition and compares that amount to the asset’s carrying amount. Estimating future cash flows related to an intangible asset involves significant estimates and assumptions.
Revenue Recognition
The Company adopted ASC 606, Revenue from Contracts with Customers (ASC 606) on January 1, 2018 using the modified retrospective transition method. There was
no
adjustment to the Company’s opening balance of accumulated deficit resulting from the adoption of this guidance.
Prior to the adoption of ASC 606, the Company recognized revenue from the sale of its products, royalties earned, and payments received and services performed under contractual arrangements in accordance with ASC 605. Under ASC 605, Revenue is recognized when there is persuasive evidence that an arrangement exists, delivery has occurred and title has passed, the price is fixed or determinable and the Company is reasonably assured of collecting the resulting receivable. Revenue arrangements with multiple elements are evaluated to determine whether the multiple elements meet certain criteria for dividing the arrangement into separate units of accounting, including whether the delivered element(s) have stand-alone value to the Company’s customer or licensee. Where there are multiple deliverables combined as a single unit of accounting, revenues are deferred and recognized over the performance period.
Under ASC 606, the Company recognizes revenue when its customer obtains control of the promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation, when (or as) the performance obligation is satisfied. The Company assesses the term of the contract based upon the contractual period in which the Company and Collegium have enforceable rights and obligations.
Variable consideration arising from sales or usage-based royalties, promised in exchange for a license of the Company’s Intellectual Property, is recognized at the later of (i) when the subsequent product sales occur or (ii) the performance obligation, to which some or all of the sales-based royalty has been allocated, has been satisfied.
The Company recognizes a contract asset relating to its conditional right to consideration for completed performance obligations. Accounts receivable are recorded when the right to consideration becomes unconditional. A contract liability is recorded for payments received in advance of the related performance obligation being satisfied under the contract.
Commercialization Agreement
The Company derives revenue under its Commercialization Agreement with Collegium whereby the Company granted Collegium the right to commercialize the NUCYNTA franchise of pain products in the United States. The Company entered into the Commercialization Agreement in December 2017, which became effective in January 2018, and amended the agreement in August 2018 and again in November 2018. The Company views its performance obligations as a series of distinct goods or services that are substantially the same and that have the same pattern of transfer. Prior to the November 2018 amendment, the consideration related to the license and facilitation services was fixed and recognized ratably over the contract term. Following the November 2018 amendment, the royalty payments owed to the Company from Collegium, pursuant to the terms of the Commercialization Agreement, represent variable compensation that is subject to the sales based royalty exception for licenses of intellectual property because the License is the predominant component of this arrangement.
The Company is responsible for royalty payments to a third party related to sales of NUCYNTA. Under the terms of the Commercialization Agreement, a portion of these payments are remitted from Collegium to the third party and a portion are the responsibility of the Company. Following the November 2018 amendment, Collegium will reimburse the Company for all royalties paid to the third party. As the Company is not actively commercializing NUCYNTA, such royalties are recorded by the Company on a systematic basis in proportion to the underlying net product sales and are included as gross-to-net adjustments in the related revenue line in the Company’s Statements of Operations.
Product Sales
The Company sells commercial products to wholesale distributors, specialty pharmacies and retail pharmacies. Product sales revenue is recognized when title has transferred to the customer and the customer has assumed the risks and rewards of ownership, which typically occurs on delivery to the customer. The Company’s performance obligation is to deliver product to the customer, and the performance obligation is completed upon delivery. The transaction price consists of a fixed invoice price and variable product sales allowances, which include rebates, discounts and returns. Product sales revenues are recorded net of applicable reserves for these product sales allowances. Receivables related to product sales are typically collected
one
to
two months
after delivery.
Product Sales Allowances—The Company considers products sales allowances to be variable consideration and estimates and recognizes product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on actual or estimated amounts owed on the related sales. These estimates take into consideration the terms of the Company’s agreements with customers, historical product returns, rebates or discounts taken, estimated levels of inventory in the distribution channel, the shelf life of the product and specific known market events, such as competitive pricing and new product introductions. The Company uses the most likely method in estimating product sales allowances. If actual future results vary from the Company’s estimates, the Company may need to adjust these estimates,
which could have an effect on product sales and earnings in the period of adjustment. The Company’s sales allowances include:
Product Returns—The Company allows customers to return product for credit with respect to that product within
six months
before and up to
12 months
after its product expiration date. The Company estimates product returns and associated credit on NUCYNTA ER and NUCYNTA, Gralise, CAMBIA, Zipsor and Lazanda. Estimates for returns are based on historical return trends by product or by return trends of similar products, taking into consideration the shelf life of the product at the time of shipment, shipment and prescription trends, estimated distribution channel inventory levels and consideration of the introduction of competitive products. The Company did not assume financial responsibility for returns of NUCYNTA ER and NUCYNTA previously sold by Janssen Pharma or Lazanda product previously sold by Archimedes Pharma US Inc. Under the Commercialization Agreement with Collegium for NUCYNTA ER and NUCYNTA and the divestiture of Lazanda to Slán, the Company is only financially responsible for product returns for product that were sold by the Company, which are identified by specific lot numbers.
The shelf life of NUCYNTA ER and NUCYNTA is
24
months to
36
months from the date of tablet manufacture. The shelf life of Gralise is
24
months to
36
months from the date of tablet manufacture. The shelf life of CAMBIA is
24
months to
48
months from the manufacture date. The shelf life of Zipsor is
36
months from the date of tablet manufacture. The shelf life of Lazanda is
24
to
36
months from the manufacture date. Because of the shelf life of the Company’s products and its return policy of issuing credits with respect to product that is returned within
six
months before and up to
12
months after its product expiration date, there may be a significant period of time between when the product is shipped and when the Company issues credit on a returned product. Accordingly, the Company may have to adjust these estimates, which could have an effect on product sales and earnings in the period of adjustments.
Wholesaler and Retail Pharmacy Discounts — The Company offers contractually determined discounts to certain wholesale distributors and retail pharmacies that purchase directly from it. These discounts are either taken off invoice at the time of shipment or paid to the customer on a quarterly basis
one
to
two
months after the quarter in which product was shipped to the customer.
Prompt Pay Discounts—The Company offers cash discounts to its customers (generally
2%
of the sales price) as an incentive for prompt payment. Based on the Company’s experience, the Company expects its customers to comply with the payment terms to earn the cash discount.
Patient Discount Programs—The Company offers patient discount co-pay assistance programs in which patients receive certain discounts off their prescriptions at participating retail pharmacies. The discounts are reimbursed by the Company approximately
one
month after the prescriptions subject to the discount are filled.
Medicaid Rebates—The Company participates in Medicaid rebate programs, which provide assistance to certain low income patients based on each individual state’s guidelines regarding eligibility and services. Under the Medicaid rebate programs, the Company pays a rebate to each participating state, generally
two
to
three
months after the quarter in which prescriptions subject to the rebate are filled.
Chargebacks—The Company provides discounts to authorized users of the Federal Supply Schedule (FSS) of the General Services Administration under an FSS contract with the Department of Veterans Affairs. These federal entities purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to the Company the difference between the current retail price and the price the federal entity paid for the product.
Managed Care Rebates—The Company offers discounts under contracts with certain managed care providers. The Company generally pays managed care rebates
one
to
three
months after the quarter in which prescriptions subject to the rebate are filled.
Medicare Part D Coverage Gap Rebates—The Company participates in the Medicare Part D Coverage Gap Discount Program under which it provides rebates on prescriptions that fall within the “donut hole” coverage gap. The Company generally pays Medicare Part D Coverage Gap rebates
two
to
three
months after the quarter in which prescriptions subject to the rebate are filled.
Royalties
For arrangements that include sales-based royalties and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes royalty revenue at the later of (1) when the related sales occur, or (2) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Milestones
For arrangements that include milestones, the Company recognizes such revenue using the most likely method. As part of adopting ASC 606, the Company evaluated whether the future milestones should have been included as part of the transaction price in periods before January 1, 2018. The Company concluded that because of development and regulatory risks at the time, it was probable that a significant revenue reversal could have occurred. At the end of each subsequent reporting period, the Company re-evaluates the probability or achievement of each such milestone and any related constraint, and if necessary, adjusts its estimates of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue in the period of adjustment.
Stock‑Based Compensation
The Company uses the Black Scholes option valuation model to determine the fair value of stock options and employee stock purchase plan (ESPP) shares. The determination of the fair value of these awards on the date of grant uses an option valuation model and is affected by the Company’s stock price as well as assumptions, which include the Company’s expected term of the award, the expected stock price volatility, risk free interest rate and expected dividends over the expected term of the award. The Company uses historical option exercise data to estimate the expected term of the options. The Company estimates the volatility of its common stock price by using the historical volatility over the expected term of the options. The Company bases the risk free interest rate on U.S. Treasury zero coupon issues with terms similar to the expected term of the options as of the date of grant. The Company does not anticipate paying any cash dividends in the foreseeable future and therefore uses an expected dividend yield of zero in the option valuation model. The fair value of restricted stock units equals the market value of the underlying stock on the date of grant.
As a result of adopting ASU 2016-9
Improvements to Employee Share-Based Payment Accounting
, the Company made an accounting policy election to account for forfeitures as they occur, rather than estimating expected forfeitures at the time of the grant.
Research and Development Expense and Accruals
Research and development expenses include salaries, clinical trial costs, consultant fees, supplies, manufacturing costs for research and development programs and allocations of corporate costs. All such costs are charged to research and development expense as incurred. These expenses result from the Company’s independent research and development efforts as well as efforts associated with collaborations. The Company reviews and accrues clinical trial expenses based on work performed, which relies on estimates of total costs incurred based on patient enrollment, completion of patient studies and other events. The Company follows this method since reasonably dependable estimates of the costs applicable to various stages of a research agreement or clinical trial can be made. Accrued clinical costs are subject to revisions as trials progress to completion. Revisions are charged to expense in the period in which the facts that give rise to the revision become known.
Acquired In-Process Research and Development
The initial costs of rights to IPR&D projects acquired in an asset acquisition are expensed as IPR&D unless the project has an alternative future use. Development costs incurred after an acquisition are expensed as incurred.
Shipping and Handling Costs
Shipping and handling costs incurred for product shipments are recorded in cost of sales in the Statements of Operations.
Advertising Costs
Costs associated with advertising are expensed as incurred. Advertising expense for the years ended
December 31, 2018
,
2017
and
2016
were
$0.8 million
,
$3.7 million
and
$4.1 million
, respectively.
Restructuring
Restructuring costs are included in income (loss) from operations in the consolidated statements of operations. The Company has accounted for these costs in accordance with ASC Topic 420,
Exit or Disposal Cost Obligations
. One-time termination benefits are recorded at the time they are communicated to the affected employees. In December 2017, the Company announced a restructuring plan which was substantially complete as of December 31, 2018.
Income Taxes
The Company’s income tax policy is to record the estimated future tax effects of temporary differences between the tax bases of assets and liabilities and amounts reported in the Company’s accompanying consolidated balance sheets, as well as operating loss and tax credit carryforwards. The Company follows the guidelines set forth in the applicable accounting guidance regarding the recoverability of any tax assets recorded on the consolidated balance sheet and provides any necessary allowances as required. Determining necessary allowances requires the Company to make assessments about the timing of future events, including the probability of expected future taxable income and available tax planning opportunities.
The Company is subject to examination of its income tax returns by various tax authorities on a periodic basis. The Company regularly assesses the likelihood of adverse outcomes resulting from such examinations to determine the adequacy of its provision for income taxes. The Company has applied the provisions of the applicable accounting guidance on accounting for uncertainty in income taxes, which requires application of a more-likely-than-not threshold to the recognition and de-recognition of uncertain tax positions. If the recognition threshold is met, the applicable accounting guidance permits the Company to recognize a tax benefit measured at the largest amount of tax benefit that, in the Company’s judgment, is more than 50 percent likely to be realized upon settlement. It further requires that a change in judgment related to the expected ultimate resolution of uncertain tax positions be recognized in earnings in the period of such change.
Segment Information
The Company operates in
one
operating segment and has operations and long-lived assets solely in the United States. To date, all of the Company’s revenues from product sales are related to sales in the United States.
Concentration of Risk
The Company invests cash that is currently not being used for operational purposes in accordance with its investment policy in low‑risk debt securities of the U.S. Treasury, U.S. government sponsored agencies and very highly rated banks and corporations. The Company is exposed to credit risk in the event of a default by the institutions holding the cash equivalents and available‑for sale securities to the extent recorded on the consolidated balance sheet.
The Company is subject to credit risk from its accounts receivable related to product sales and royalties. The
three
large, national wholesale distributors represent the vast majority of the Company’s business and represented the following percentages of product shipments and accounts receivable for the years ended
December 31, 2018
,
2017
and
2016
.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated revenue
|
|
Accounts Receivable related to product sales
|
|
2018
|
|
2017
|
|
2016
|
|
2018
|
|
2017
|
|
2016
|
McKesson Corporation
|
14
|
%
|
|
36
|
%
|
|
36
|
%
|
|
28
|
%
|
|
41
|
%
|
|
39
|
%
|
AmerisourceBergen Corporation
|
13
|
%
|
|
27
|
%
|
|
27
|
%
|
|
28
|
%
|
|
27
|
%
|
|
33
|
%
|
Cardinal Health
|
11
|
%
|
|
26
|
%
|
|
25
|
%
|
|
32
|
%
|
|
23
|
%
|
|
20
|
%
|
Collegium
|
55
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
All others
|
7
|
%
|
|
11
|
%
|
|
12
|
%
|
|
12
|
%
|
|
9
|
%
|
|
8
|
%
|
Total
|
100
|
%
|
|
100
|
%
|
|
100
|
%
|
|
100
|
%
|
|
100
|
%
|
|
100
|
%
|
Accounts receivable balances related to product sales were
$23.1 million
and
$71.9 million
for the years ended
December 31, 2018
and
2017
, respectively. The Company relies on a single third‑party contract manufacturer organization in Puerto Rico to manufacture Gralise and
one
third‑party supplier for the supply of gabapentin, the active pharmaceutical ingredient in Gralise. The Company also relies on single third party contract suppliers: MiPharm, S.p.A., Catalent Ontario
Limited and Renaissance Lakewood, Inc. for supply of CAMBIA, Zipsor and Lazanda respectively. Janssen Pharmaceuticals is the sole source supplier of NUCYNTA ER and Halo is the sole supplier of NUCNYTA.
Receivables related to Collegium following the commencement of the Commercialization Agreement in 2018 were
$14.0 million
at December 31, 2018. Inventory held on behalf of Collegium, which is in production at contract manufacturers and will be provided to Collegium following the completion of production of
$2.8 million
is held in prepaid and other assets on the Company’s Consolidated Balance Sheets as of December 31, 2018. The Company had a receivable related to the Cosyntropin collaboration from our collaboration partner, an affiliate of Slán Medicinal Holdings of
$4.6 million
. Accounts receivable related to royalties were
zero
and
$0.5 million
at
December 31, 2018
and
2017
, respectively.
To date, the Company has not experienced any losses with respect to the collection of its accounts receivable and believes that its entire accounts receivable balances are collectible.
The Company is dependent upon third-party manufacturers to supply product for commercialize use. In particular, the Company relies and expects to continue to rely on a small number of manufacturers to supply it with its requirements for all commercialized products. Such production arrangements could be adversely affected by a significant interruption which would negatively impact the supply of final drug product.
Recently Adopted Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (FASB) issued ASU 2014-9, Revenue from Contracts with Customers. This guidance outlines a new, single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance, including industry-specific guidance. This new revenue recognition model provides a five-step analysis in determining when and how revenue is recognized. The new model requires revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration a company expects to receive in exchange for those goods or services.
The Company adopted ASC 606 using the modified retrospective method as of January 1, 2018. The Company determined that there was no cumulative effect of applying the new guidance to all contracts with customers that were not completed as of January 1, 2018, therefore no adjustment was required to the accumulated deficit as of the adoption date. Furthermore, upon adoption of the new guidance no adjustments to any prior year periods would have been reportable to present the condensed consolidated balance sheets, statements of operations, or statements of cash flows on a comparable basis to any current year reported balances or amounts.
In January 2017, the FASB issued ASU No. 2017-1, Business Combinations (Topic 805): Clarifying the Definition of a Business, which provides clarification on the definition of a business and adds guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The standard was effective for the Company beginning January 1, 2018. The future impact of ASU No. 2017-1 will be dependent upon the nature of the Company’s future acquisition or disposition transactions, if any.
In May 2017, the FASB issued accounting guidance to clarify which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. The new standard was required to be applied prospectively. The guidance was effective for the Company beginning January 1, 2018. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements.
In March 2018, the FASB issued ASU No. 2018-5, Income Taxes (Topic 740): Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118, which provides clarification and guidance on the income tax accounting implications of the Tax Cuts and Jobs Act. The standard was effective for the Company beginning January 1, 2018. The adoption of this guidance did not materially affect the Company’s consolidated financial statements.
In January 2016, the FASB issued ASU No. 2016-1, Financial Instruments – Overall (Subtopic 405-20), Recognition and Measurement of Financial Assets and Financial Liabilities. ASU 2016-1 changed accounting for equity investments, financial liabilities under the fair value option and the presentation and disclosure requirements for financial instruments. In addition, it clarified guidance related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The guidance became effective for the Company on January 1, 2018 and required adoption using a modified retrospective approach, with certain exceptions. The adoption of this guidance did not have a material impact on the Company’s consolidated financial statements.
Recently Issued Accounting Pronouncements
In February 2016, the FASB issued ASU No. 2016-2, Leases. This guidance requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of classification. The Company has adopted the standard as of January 1, 2019. The Company has elected the package of practical expedients permitted
under the transition guidance within the new standard, which among other things, allows for the carryforward of the historical lease classification. The Company did not elect the hindsight practical expedient to determine the reasonably certain lease term for existing leases and will make an accounting policy election to keep leases with an initial term of 12 months or less off of the balance sheet. The Company will recognize the cost of those leases in the Consolidated Statements of Operations on a straight-line basis over the lease term.
The Company estimates the adoption of the standard will result in recognition of additional lease assets and lease liabilities which are expected to be equal to each other, in the range of approximately
$8.5 million
to
$9.5 million
, as of January 1, 2019. The recognition of lease assets will be offset by deferred rent and tenant improvement allowances recognized by the Company as of December 31, 2018. The new standard will not materially affect the Company’s consolidated net income nor have a notable impact on its liquidity. The standard will have no impact on the Company’s debt-covenant compliance under its current agreements.
In June 2016, the FASB issued ASU 2016-13 (ASU 2016-13) Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss methodology, which will result in more timely recognition of credit losses. ASU 2016-13 is effective for annual reporting periods, and interim periods within those years beginning after December 15, 2019. The Company is currently in the process of evaluating the impact of the adoption of ASU 2016-13 on the Company’s consolidated financial statements.
In June 2018, the FASB issued ASU 2018-18 (ASU 2018-18) Collaborative Arrangements which clarifies the interaction between ASC 808, Collaborative Arrangements and ASC 606, Revenue from Contracts with Customers. The update clarifies that certain transactions between participants in a collaborative arrangement should be accounted for under ASC 606 when the counterparty is a customer. In addition, the update precludes an entity from presenting consideration from a transaction in a collaborative arrangement as revenue if the counterparty is not a customer for that transaction. This update will be effective for the Company for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. ASU 2018-18 should be applied retrospectively to the date of initial application of ASC 606 and early adoption is permitted. The Company is currently in the process of evaluating the impact of the adoption of ASU 2018-18 on the Company’s consolidated financial statements.
NOTE 2. LICENSE AND COLLABORATIVE ARRANGEMENTS
Ironwood Pharmaceuticals, Inc.
In July 2011, the Company entered into a collaboration and license agreement with Ironwood Pharmaceuticals, Inc. (Ironwood Agreement) granting Ironwood a license for worldwide rights to certain patents and other intellectual property rights to the Company’s Acuform drug delivery technology for IW 3718, an Ironwood product candidate under development for refractory GERD. During the third quarter of 2018, the Company recognized, within Royalties and Milestones on the Company’s Consolidated Statements of Operations, a
$5.0 million
milestone payment related to the dosing of the first patient in a Phase 3 trial for IW-3718. The Company will receive additional contingent milestone payments upon the occurrence of certain development milestones and royalties on net sales of the product, if approved.
Slan Medicinal Holdings, Ltd.
In November 2017, the Company entered into definitive agreements (Slán Agreements) with Slán Medicinal Holdings Limited and certain of its affiliates (Slán) pursuant to which the Company acquired Slán’s rights to market the specialty drug long-acting cosyntropin in the U.S. and Canada. As outlined in the Slán Agreements, each party will support the development, including clinical development, of the licensed product and efforts to obtain regulatory approval of the initial NDA. The Slán Agreements also detail commercialization activities which are included in the commercialization plan. Subsequent to approval of the initial NDA, Assertio and Slán will share in the net sales of long acting cosyntropin for a
10
-year period (after which
time the product will revert back to Slán). The Company has committed to invest
$15.0 million
in the collaboration with Slán for the commercialization efforts of long-acting cosyntropin. As of the December 31, 2018 the Company had incurred
$4.6 million
of development expenses which are reimbursable by Slán and have been recognized within Prepaid and Other Assets on the Company’s Consolidated Balance Sheet. The Company also recognized expenses of
$2.25 million
which are payable to Slán following the initial NDA filing in December 2018.
NOTE 3. CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS
Securities classified as cash and cash equivalents and short-term investments as of
December 31, 2018
and
2017
are summarized below (in thousands). Estimated fair value is based on quoted market prices for these investments.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2018
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
Cash and cash equivalents:
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
95,660
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
95,660
|
|
Money market funds
|
|
11
|
|
|
—
|
|
|
—
|
|
|
11
|
|
Agency Bond
|
|
1,250
|
|
|
|
|
|
|
1,250
|
|
Commercial paper
|
|
14,028
|
|
|
—
|
|
|
—
|
|
|
14,028
|
|
Total cash and cash equivalents
|
|
110,949
|
|
|
—
|
|
|
—
|
|
|
110,949
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2017
|
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
Cash and cash equivalents:
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
103,119
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
103,119
|
|
Money market funds
|
|
95
|
|
|
—
|
|
|
—
|
|
|
95
|
|
Commercial paper
|
|
23,670
|
|
|
—
|
|
|
—
|
|
|
23,670
|
|
Total cash and cash equivalents
|
|
126,884
|
|
|
—
|
|
|
—
|
|
|
126,884
|
|
Short-term investments
|
|
|
|
|
|
|
|
|
Corporate debt securities and commercial paper with maturities less than 1 year
|
|
1,210
|
|
|
—
|
|
|
(5
|
)
|
|
1,205
|
|
Total short-term investments
|
|
1,210
|
|
|
—
|
|
|
(5
|
)
|
|
1,205
|
|
Total
|
|
$
|
128,094
|
|
|
$
|
—
|
|
|
$
|
(5
|
)
|
|
$
|
128,089
|
|
The Company considers all highly liquid investments with a maturity at date of purchase of three months or less to be cash equivalents. Cash and cash equivalents generally consist of cash on deposit with banks, money market instruments, U.S. Agency discount notes, commercial paper and corporate debt securities.
The Company invests its cash in money market funds and marketable securities including U.S. Treasury and government agency securities, commercial paper, and high quality debt securities of financial and commercial institutions. To date, the Company has not experienced material losses on any of its balances. These securities are carried at fair value, which is based on readily available market information, with unrealized gains and losses included in “accumulated other comprehensive loss” within shareholders’ equity on the consolidated balance sheets. The Company uses the specific identification method to determine the amount of realized gains or losses on sales of marketable securities. Realized gains or losses have been insignificant and are included in “interest and other income” in the consolidated statement of operations.
At
December 31, 2018
, the Company had
zero
securities in an unrealized loss position. The following table shows the gross unrealized losses and fair value of the Company’s investments with unrealized losses that are not deemed to be other‑than‑temporarily impaired, aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position, at
December 31, 2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than 12 months
|
|
12 months or greater
|
|
Total
|
|
Fair Value
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
|
Gross
Unrealized
Losses
|
Corporate debt securities
|
$
|
1,205
|
|
|
$
|
(5
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,205
|
|
|
$
|
(5
|
)
|
The gross unrealized losses above were caused by interest rate increases. No significant facts or circumstances have arisen to indicate that there has been any deterioration in the creditworthiness of the issuers of the securities held by the Company. Based on the Company’s review of these securities, including the assessment of the duration and severity of the unrealized losses and the Company’s ability and intent to hold the investments until maturity, there were
no
material other‑than‑temporary impairments for these securities at
December 31, 2018
. Gross realized gains and losses on marketable securities were
no
t material for the years ended
December 31, 2018
,
2017
and
2016
.
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.
|
|
•
|
Level 1: Quoted prices in active markets for identical assets or liabilities.
|
|
|
•
|
Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
|
|
|
•
|
Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
|
The following table represents the Company’s fair value hierarchy for its financial assets and liabilities measured at fair value on a recurring basis as of
December 31, 2018
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2018
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
Assets:
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
11
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
11
|
|
Agency bond
|
|
—
|
|
|
1,250
|
|
|
—
|
|
|
1,250
|
|
Commercial paper
|
|
—
|
|
|
14,028
|
|
|
—
|
|
|
14,028
|
|
Collegium warrants
|
|
|
|
8,784
|
|
|
|
|
8,784
|
|
Total
|
|
$
|
11
|
|
|
$
|
24,062
|
|
|
$
|
—
|
|
|
$
|
24,073
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
Contingent consideration—Zipsor
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
531
|
|
|
$
|
531
|
|
Contingent consideration—CAMBIA
|
|
—
|
|
|
—
|
|
|
507
|
|
|
507
|
|
Total
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,038
|
|
|
$
|
1,038
|
|
The fair value of the warrants to purchase Collegium’s common stock was calculated using the Black-Scholes option pricing model. As of November 8, 2018, the significant inputs included the fair value of Collegium’s common stock of
$15.56
, an expected term of
4 years
and a risk-free rate of
3.05%
. As of Decemb
er 31
, 2018, the significant inputs included the fair value of Collegium’s common stock of
$17.17
, an expected term of
3.86
years and a risk-free rate of
2.48%
. The expected term was based on the remaining contractual period of
3.86
years, and the volatility was determined using Collegium’s historical common stock volatility over the expected term.
The fair value measurement of the contingent consideration obligations arises from the Zipsor, CAMBIA and Lazanda acquisitions and relates to fair value of the potential future contingent milestone payments and royalties payable under the respective agreements which are determined using Level 3 inputs. The remaining contingent consideration liability following the divestiture of Lazanda in November 2017 was
$0.2 million
. This liability was settled in the first quarter of 2018. The key assumptions in determining the fair value are the discount rate and the probability assigned to the potential milestones and royalties being achieved. At each reporting date, the Company re-measures the contingent consideration obligation arising from
the above acquisitions to their estimated fair values. Any changes in the fair value of contingent consideration resulting from a change in the underlying inputs are recognized in operating expenses until the contingent consideration arrangement is settled. Changes in the fair value of contingent consideration resulting from the passage of time are recorded within interest expense until the contingent consideration is settled.
The table below provides a summary of the changes in fair value recorded in interest expense, selling, general and administrative expense, and gain on divestiture of Lazanda measured at fair value on a recurring basis using significant unobservable inputs (Level 3) for the years ended
December 31, 2018
,
2017
and
2016
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
2018
|
|
2017
|
|
2016
|
Fair value, beginning of the period
|
$
|
1,613
|
|
|
$
|
14,825
|
|
|
$
|
14,971
|
|
Changes in fair value recorded in interest expense
|
124
|
|
|
1,079
|
|
|
2,408
|
|
Changes in fair value recorded in selling, general and administrative expenses
|
(515
|
)
|
|
(7,708
|
)
|
|
(122
|
)
|
Royalties and milestone paid
|
(184
|
)
|
|
(3,068
|
)
|
|
(2,432
|
)
|
Divestiture of Lazanda
|
—
|
|
|
(3,515
|
)
|
|
—
|
|
Total
|
$
|
1,038
|
|
|
$
|
1,613
|
|
|
$
|
14,825
|
|
The estimated fair value of the
2.50%
Convertible Senior Notes Due 2021, which the Company issued on September 9, 2014 (the 2021 Notes), is based on a market approach. The estimated fair value was approximately
$231.8 million
(par value
$345.0 million
) as of
December 31, 2018
and represents a Level 2 valuation. The principal amount of the Senior Notes approximates their fair value as of
December 31, 2018
and represents a Level 2 valuation. When determining the estimated fair value of the Company’s debt, the Company uses a commonly accepted valuation methodology and market-based risk measurements that are indirectly observable, such as credit risk.
There were no transfers between Level 1, Level 2 or Level 3 of the fair value hierarchy during the years ended
December 31, 2018
and
December 31, 2017
.
The following table represents the Company’s fair value hierarchy for its financial assets measured at fair value on a recurring basis as of
December 31, 2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2017
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
Assets:
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
95
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
95
|
|
Commercial paper
|
|
—
|
|
|
23,670
|
|
|
—
|
|
|
23,670
|
|
Corporate debt securities
|
|
—
|
|
|
1,205
|
|
|
—
|
|
|
1,205
|
|
Total
|
|
$
|
95
|
|
|
$
|
24,875
|
|
|
$
|
—
|
|
|
$
|
24,970
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
Contingent consideration—Zipsor
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
464
|
|
|
$
|
464
|
|
Contingent consideration—Lazanda
|
|
—
|
|
|
—
|
|
|
156
|
|
|
156
|
|
Contingent consideration—CAMBIA
|
|
—
|
|
|
—
|
|
|
993
|
|
|
993
|
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,613
|
|
|
$
|
1,613
|
|
NOTE 4. REVENUE
The following table summarizes revenue from contracts with customers for the years ended
December 31, 2018
,
2017
and
2016
(in thousands) into categories that depict how the nature, amount, timing and uncertainty of revenue and cash flows are affected by economic factors:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
2018
|
|
2017
|
|
2016
|
Product sales, net:
|
|
|
|
|
|
|
Gralise
|
|
$
|
58,077
|
|
|
$
|
77,034
|
|
|
$
|
88,446
|
|
CAMBIA
|
|
35,803
|
|
|
31,597
|
|
|
31,273
|
|
Zipsor
|
|
16,387
|
|
|
16,700
|
|
|
27,539
|
|
Total neurology product sales, net
|
|
110,267
|
|
|
125,331
|
|
|
147,258
|
|
NUCYNTA products
|
|
18,944
|
|
|
239,539
|
|
|
281,261
|
|
Lazanda
|
|
755
|
|
|
15,010
|
|
|
26,547
|
|
Total product sales, net
|
|
129,966
|
|
|
379,880
|
|
|
455,066
|
|
Commercialization agreement:
|
|
|
|
|
|
|
Commercialization rights and facilitation services, net
|
|
100,038
|
|
|
—
|
|
|
—
|
|
Revenue from transfer of inventory
|
|
55,705
|
|
|
—
|
|
|
—
|
|
Royalties and milestone revenue
|
|
26,061
|
|
|
844
|
|
|
831
|
|
Total revenues
|
|
$
|
311,770
|
|
|
$
|
380,724
|
|
|
$
|
455,897
|
|
NUCYNTA product sales for the year ended
December 31, 2018
reflect the Company’s sales of NUCYNTA between January 1 and January 8, 2018. During the year ended
December 31, 2018
the Company recognized sales reserve estimate adjustments related to sales recognized for NUCYNTA and Lazanda in prior periods. Separately, during the first quarter of 2018, in connection with the Collegium transaction, the Company recognized Nucynta product revenue of
$12.5 million
related to the release of NUCYNTA sales reserves which were primarily recorded in the fourth quarter of 2017, as financial responsibility for those reserves transferred to Collegium upon closing of the Commercialization Agreement.
Original Commercialization Agreement with Collegium
In December 2017, the Company, Collegium and Collegium NF, LLC, a Delaware limited liability company and wholly owned subsidiary of Collegium (Newco), entered into a Commercialization Agreement (Commercialization Agreement), pursuant to which the Company granted Collegium the right to commercialize the NUCYNTA franchise of pain products in the United States. Pursuant to the Commercialization Agreement, Collegium assumed all commercialization responsibilities for the NUCYNTA franchise effective January 9, 2018, including sales and marketing. The Company also agreed to provide services to Collegium, including to arrange for the supply of NUCYNTA products by the Company’s existing contract manufacturing organizations (“CMOs”) (the “Facilitation Services”). The Company identified the following
three
promised goods and services under the Commercialization Agreement: (1) the license to commercialize the NUCYNTA pain products (License), (2) services to arrange for supplies of NUCYNTA pain products using the Company’s existing contract manufacturing contracts with third parties (Facilitation Services); and (3) the transfer of control of all NUCYNTA finished goods held at closing (Inventory Transfer).
The Inventory Transfer was deemed to be a distinct performance obligation which was completed during the first quarter of 2018. The Company concluded that the License and the Facilitation Services are not distinct from one another as the Commercialization Agreement does not grant to Collegium a license to manufacture NUCYNTA. The Company (i) exclusively controls the intellectual property underlying the NUCYNTA products for the United States market, (ii) retains responsibility for facilitating NUCYNTA product supply through its CMOs, and (iii) exclusively maintains all CMO contractual relationships. As a result, Collegium’s right to commercialize NUCYNTA is inherently dependent upon the Facilitation Services. Because (i) Collegium is contractually required to use the Facilitation Services to arrange for product supply and (ii) tapentadol is a Schedule II controlled substance for which manufacturing arrangements are not easily transferred or bypassed, there is strong interdependency between the License and the Facilitation Services. These Facilitation Services are administrative in nature but necessary for the commercialization right to have utility to Collegium.
In January 2018, the Company determined the total fixed elements of the transaction price to be
$553.2 million
, which consisted of
$537.0 million
in total annual minimum royalty payments for years 2018 through 2021, a
$10.0 million
upfront fee, and a
$6.2 million
payment for NUCYNTA finished goods inventory. The Company determined that the duration of the Commercialization Agreement began on the effective date of January 9, 2018 and lasts through December 31, 2021, including the minimum royalty period and the period in which Collegium would incur a
$25.0 million
termination penalty on terminating the Commercialization Agreement. Beginning January 1, 2022 and for each year of the Commercialization Agreement thereafter, royalties are: (i)
58%
of net sales of NUCYNTA up to
$233 million
, payable quarterly within
45 days
of the end of each calendar quarter, plus (ii)
25%
of annual net sales of NUCYNTA between
$233 million
and
$258 million
, plus (iii)
17.5%
of annual net sales of NUCYNTA above
$258 million
. Payments described in clauses (ii) and (iii) hereof will be paid annually within
60 days
of the end of the calendar year.
The portion of the transaction price allocated to the Inventory Transfer was
$55.7 million
and was recognized on the closing date as the control of such inventory was transferred to Collegium. The portion of the transaction price allocated to the License and Facilitation Services, as a combined performance obligation, was
$497.5 million
and would be recognized over ratably though December 31, 2021.
In addition, Collegium assumed responsibility for a portion of the royalties owed by the Company to a third party on sales of NUCYNTA. The royalties owed by Collegium to the third party are
14%
of sales with the Company ensuring a minimum royalty of
$34.0 million
per year on net sales of NUCYNTA greater than
$180.0 million
. The Company is obligated to cover any shortfall between the minimum royalty amount of
$34.0 million
and the amounts paid to the third party by Collegium for each of the years ended
December 31, 2018
through 2021, as a result of which the Company could be obligated to pay up to
$8.8 million
per year for each of the years ended
December 31, 2018
through 2021.
Amended Commercialization Agreement with Collegium
On November 8, 2018, the Company, Collegium and Newco entered into a third amendment to the Commercialization Agreement (Amendment). Pursuant to the Amendment, the royalties payable by Collegium to the Company in connection with Collegium’s commercialization of NUCYNTA were amended such that effective as of January 1, 2019 through December 31, 2021, the Company will receive: (i)
65%
of net sales of NUCYNTA up to
$180 million
, plus (ii)
14%
of annual net sales of NUCYNTA between
$180 million
and up to
$210 million
, plus (iii)
58%
of annual net sales of NUCYNTA between
$210 million
and
$233 million
, plus (iv)
20%
of annual net sales of NUCYNTA between
$233 million
and up to
$258 million
, plus (v)
15%
of annual net sales of NUCYNTA above
$258 million
. The Amendment does not change the royalties that the Company will receive on annual net sales of NUCYNTA by Collegium for the period beginning January 1, 2022 and for each year of the Commercialization Agreement term thereafter.
The Amendment provides that Collegium shall reimburse the Company for the amount of any minimum annual royalties paid by the Company to the third party on net sales of NUCYNTA during the first
four years
of the Commercialization Agreement beginning in 2019. The Amendment also provides for Collegium to share certain costs related to the License. The reimbursement and the cost sharing are considered variable consideration. The Amendment is being accounted for prospectively.
In connection with the Amendment Collegium issued the Company a warrant to purchase up to
1,041,667
shares of Collegium common stock at an exercise price of
$19.20
per share (Warrant). The Warrant is exercisable for a period of
four years
and contains customary terms, including with regard to net exercise. The Warrant was valued at
$8.8 million
as of the date of the Amendment and is considered to be a component of the fixed consideration associated with the Commercialization Agreement. These Warrants are included in Investments on the Company’s Consolidated Balance Sheet, however, as they are non-cash they do not impact investing cash flows.
In November 2018, the Company determined the total fixed elements of the transaction price following the Amendment to be
$157.0 million
, which consisted of
$132.0 million
in total annual minimum royalty payments for 2018, the
$10.0 million
upfront fee, the
$6.2 million
payment for NUCYNTA finished goods inventory and the
$8.8 million
attributed to the Warrant. There were no new performance obligations following the modification of the Commercialization Agreement and at the time of the modification, the remaining periods in the series of services related to the single performance obligation to deliver the license and provide facilitation services are distinct from those prior to the modification. As a result, the modification was accounted for as a termination of the old arrangement and the entering into of a new agreement, in accordance with the guidance of ASC 606.
Pursuant to the Amendment, Collegium may only terminate the Commercialization Agreement after December 31, 2020, with 12-months’ notice. In the event any such termination notice has an effective date of termination prior to December
31, 2022, then Collegium shall pay a
$5 million
termination fee to the Company concurrent with the delivery of such notice. The Company determined that the
$5 million
termination fee is not substantive and therefore the duration of the Commercialization Agreement is unchanged by the Amendment and lasts through December 31, 2021, which is consistent with the contractual period in which the Company and Collegium have enforceable rights and obligations.
The Amendment provides that the Company may terminate the Commercialization Agreement upon
60
days’ prior written notice to Collegium in the event that (i) the net sales of NUCYNTA by Collegium during any period of
12
consecutive calendar months ending on or before December 31, 2021 are less than
$180 million
, or (ii) the net sales of NUCYNTA by Collegium during any period of
12
consecutive calendar months commencing on or after January 1, 2022 are less than
$170 million
.
2018 Revenue from the Commercialization Agreement
For the year ended December 31, 2018, the Company recognized royalty revenue from the Commercialization agreement of
$155.7 million
. The revenue recognized in 2018 under the Commercialization Agreement is impacted by both the original Commercialization Agreement and the Amendment and is comprised of the following components:
|
|
•
|
The Company recognized
$55.7 million
related to the transfer of inventory upon closing
|
|
|
•
|
From the effective date of the Commercialization Agreement, January 8, 2018 through the date of the Amendment on November 8, 2018 the Company recognized fixed consideration of
$103.8 million
which is the ratable recognition of the transaction price allocated to the combined license and facilitation performance obligation.
|
|
|
•
|
Assertio recognized revenue and expenses related to the third party royalties in 2018 which resulted in a net gross-to-net adjustment of
$3.7 million
, which reduces commercialization revenue, which is the Company’s obligation related to the shortfall discussed above.
|
|
|
•
|
Of the variable components of the amended Commercialization Agreement, recognition of the variable royalty revenue which becomes effective for sales beginning January 1, 2019 and Collegium’s payment of royalties to a third party were constrained by the sales based royalty exception and revenue related to the reimbursement for certain costs related to the NUCYNTA license was insignificant for the post-modification period.
|
Cash collected from Collegium in 2018 includes the upfront payments of
$10.0 million
for facilitation services and
$6.2 million
for inventory as well as the annual minimum royalty amounts, payable by Collegium in equal quarterly installments which are
$30.8 million
for the three months ended March 31, 2018 and
$33.8 million
per a quarter for the second, third and fourth quarters of 2018. For the year ended December 31, 2018,
$132.0 million
was received by the Company with respect to royalty payments.
Royalties obligations related to NUCYNTA sales for the year ended
December 31, 2018
were
$34.0 million
of which approximately
$29.5 million
were paid directly by Collegium to the third party.
Contract Assets
The following table presents changes in the Company’s contract assets as of
December 31, 2018
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance
|
|
|
|
|
|
Balance
|
|
as of
|
|
|
|
|
|
as of
|
|
December 31, 2017
|
|
Additions
|
|
Deductions
|
|
December 31, 2018
|
Contract assets:
|
|
|
|
|
|
|
|
|
|
|
Contract asset, net - Collegium
|
$
|
—
|
|
|
$
|
55,705
|
|
|
$
|
(53,289
|
)
|
|
$
|
2,416
|
|
Contract asset - Ironwood
|
—
|
|
|
5,000
|
|
|
(5,000
|
)
|
|
—
|
|
|
—
|
|
|
60,705
|
|
|
(58,289
|
)
|
|
2,416
|
|
The Collegium contract asset represents the conditional right to consideration for completed performance under the Commercialization Agreement arising from the transfer of inventory to Collegium on the date of closing of the agreement in January 2018 net of the contract liability of
$10.0 million
resulting from the upfront payment received and the
$8.8 million
of warrants received. Portions of the contract asset are reclassified to accounts receivable when the right to consideration becomes
unconditional. As of
December 31, 2018
,
$0.8 million
and
$1.6 million
of the contract asset has been recorded within “Prepaid and other current assets” and “Other long-term assets,” respectively.
The Ironwood contract asset is discussed further below.
Collaboration and License Agreements
Ironwood Pharmaceuticals, Inc.
The future contingent milestones under the Ironwood Agreement are considered variable consideration and are estimated using the most likely method. As part of adopting ASC 606, the Company evaluated whether the future milestones under the Ironwood Agreement should have been included as part of the transaction price in periods before January 1, 2018. The Company concluded that because of development and regulatory risks at the time, it was probable that a significant revenue reversal could have occurred. Accordingly, the associated future contingent milestone values were not included in the transaction price for periods before January 1, 2018. At the end of each subsequent reporting period, the Company re-evaluates the probability or achievement of each such milestone and any related constraint, and if necessary, adjusts its estimates of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue in the period of adjustment. During the second and third quarter of 2018, the Company recognized and collected, respectively, a
$5.0 million
milestone payment related to the dosing of the first patient in a Phase 3 trial. There was
no
revenue recognized under this agreement for the year ended
December 31, 2017
.
PDL BioPharma, Inc.
In October 2013, the Company sold its interests in royalty and milestone payments under its license agreements relating to the Company’s Acuform technology in the Type 2 diabetes therapeutic area to PDL BioPharma, Inc. (PDL) for
$240.5 million
. On August 2, 2018 the Company sold its remaining interest in such payments to PDL for
$20.0 million
. The
$20.0 million
of revenue was recognized as royalty revenue in the third quarter of 2018.
ASC 606 Adoption
The Company considered the adoption of the new revenue standard, ASC 606, compared to what would have been recognized by the Company under the prior revenue standards, ASC 605. The adoption of ASC 606 did not have a material impact on the Company’s consolidated financial statements as of and for the year ended December 31, 2018.
NOTE 5. ACCOUNTS RECEIVABLES, NET
Accounts receivables, net, consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
December 31,
2018
|
|
December 31,
2017
|
|
|
Product sales, net
|
$
|
23,078
|
|
|
$
|
71,919
|
|
Receivables from Collegium
|
14,011
|
|
|
—
|
|
Other
|
122
|
|
|
563
|
|
Total accounts receivable, net
|
$
|
37,211
|
|
|
$
|
72,482
|
|
NOTE 6. INVENTORIES
Inventories consist of finished goods, raw materials and work in process and are stated at the lower of cost or net realizable value and consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
2018
|
|
2017
|
Raw materials
|
$
|
1,376
|
|
|
$
|
3,008
|
|
Work-in-process
|
732
|
|
|
204
|
|
Finished goods
|
1,288
|
|
|
9,830
|
|
Total
|
$
|
3,396
|
|
|
$
|
13,042
|
|
NOTE 7. PROPERTY AND EQUIPMENT
Property and equipment consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
2018
|
|
2017
|
Furniture and office equipment
|
$
|
2,237
|
|
|
$
|
5,986
|
|
Machinery and equipment
|
11,391
|
|
|
10,783
|
|
Laboratory equipment
|
351
|
|
|
3,335
|
|
Leasehold improvements
|
9,858
|
|
|
6,841
|
|
|
23,837
|
|
|
26,945
|
|
Less: Accumulated depreciation and amortization
|
(10,773
|
)
|
|
(13,921
|
)
|
Property and equipment, net
|
$
|
13,064
|
|
|
$
|
13,024
|
|
Depreciation expense was
$4.7 million
,
$2.0 million
and
$2.5 million
for the years ended
December 31, 2018
,
2017
and
2016
, respectively. Depreciation for the year ended December 31, 2018 includes
$2.7 million
of accelerated depreciation related of leasehold improvements in our former Newark, California headquarters in anticipation of our exit of that facility on September 30, 2018.
NOTE 8. INTANGIBLE ASSETS
The gross carrying amounts and net book values of the Company’s intangible assets were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2018
|
|
December 31, 2017
|
Product rights
|
|
Remaining
Useful Life
(In years)
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Net Book
Value
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Net Book
Value
|
NUCYNTA
|
|
7.0
|
|
$
|
1,019,978
|
|
|
$
|
(360,891
|
)
|
|
$
|
659,087
|
|
|
$
|
1,019,978
|
|
|
$
|
(266,590
|
)
|
|
$
|
753,388
|
|
CAMBIA
|
|
5.0
|
|
51,360
|
|
|
(25,891
|
)
|
|
25,469
|
|
|
51,360
|
|
|
(20,755
|
)
|
|
30,605
|
|
Zipsor
|
|
3.3
|
|
27,250
|
|
|
(19,707
|
)
|
|
7,543
|
|
|
27,250
|
|
|
(17,370
|
)
|
|
9,880
|
|
|
|
|
|
$
|
1,098,588
|
|
|
$
|
(406,489
|
)
|
|
$
|
692,099
|
|
|
$
|
1,098,588
|
|
|
$
|
(304,715
|
)
|
|
$
|
793,873
|
|
Future amortization expenses were estimated as follows (in thousands):
|
|
|
|
|
|
Year Ending December 31,
|
|
Estimated
Amortization
Expense
|
2019
|
|
$
|
101,774
|
|
2020
|
|
101,774
|
|
2021
|
|
101,774
|
|
2022
|
|
99,969
|
|
2023
|
|
99,227
|
|
Thereafter
|
|
187,581
|
|
Total
|
|
$
|
692,099
|
|
NOTE 9. ACCRUED LIABILITIES
Accrued liabilities consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
2018
|
|
2017
|
Accrued compensation
|
$
|
5,475
|
|
|
$
|
7,345
|
|
Accrued royalties
|
2,773
|
|
|
17,370
|
|
Accrued restructuring and one-time termination costs
|
1,578
|
|
|
9,483
|
|
Other accrued liabilities
|
21,535
|
|
|
26,298
|
|
Total accrued liabilities
|
$
|
31,361
|
|
|
$
|
60,496
|
|
NOTE 10. DEBT
Senior Notes
On April 2, 2015, the Company issued
$575.0 million
aggregate principal amount of senior secured notes (the Senior Notes) for aggregate gross proceeds of approximately
$562.0 million
pursuant to a Note Purchase Agreement dated March 12, 2015 (Note Purchase Agreement) among the Company and Deerfield Private Design Fund III, L.P., Deerfield Partners, L.P., Deerfield International Master Fund, L.P., Deerfield Special Situations Fund, L.P., Deerfield Private Design Fund II, L.P., Deerfield Private Design International II, L.P., BioPharma Secured Investments III Holdings Cayman LP, Inteligo Bank Ltd. and Phemus Corporation (collectively, the Purchasers) and Deerfield Private Design Fund III, L.P., as collateral agent. The Company used
$550.0 million
of the net proceeds received upon the sale of the Senior Notes to fund a portion of the Purchase Price paid to Janssen Pharma in connection with the NUCYNTA acquisition. The Company incurred debt issuance costs of
$0.5 million
for 2015.
The Senior Notes will mature on April 14, 2021 (unless earlier prepaid or repurchased), are secured by substantially all of the assets of the Company and any subsidiary guarantors, and bear interest at the rate equal to the lesser of (i)
9.75%
over the three month London Inter-Bank Offer Rate (LIBOR), subject to a floor of
1.0%
and (ii)
11.95%
(through the third anniversary of the purchase date) and
12.95%
(thereafter). The interest rate is determined at the first business day of each fiscal quarter, commencing with the first such date following April 2, 2015. The interest rate for the three months ended
December 31, 2018
and 2017 was
12.15%
and
11.09%
, respectively.
In April 2017, the Company prepaid and retired
$100.0 million
of the Senior Notes and paid a
$4.0 million
prepayment fee; and in November 2017, the Company prepaid and retired an additional
$10 million
of the Senior Notes and paid a
$0.4 million
prepayment fee. The Company recorded a net loss on prepayment of the Senior Notes of
$5.9 million
which represented the prepayment fees of
$4.4 million
and the immediate recognition of unamortized balances of debt discount and debt issuance costs of
$1.5 million
. This loss is recorded as a loss on prepayment of Senior Notes in the consolidated statements of operations for 2017.
The remaining
$282.5 million
of Senior Notes can be prepaid, at the Company’s option. The Company is required to repay the outstanding Senior Notes in full if the principal amount outstanding on its existing
2.50%
Convertible Senior Notes due 2021 as of March 31, 2021, is greater than
$100.0 million
. In addition, if the successor entity in a Major Transaction, as defined in the Note Purchase Agreement, does not satisfy specified qualification criteria, the Purchasers may require the Company to prepay the Senior Notes upon consummation of the Major Transaction in an amount equal to the principal amount of outstanding Senior Notes, accrued and unpaid interest and a prepayment premium in an amount equal to what the Company would have otherwise paid in an optional prepayment described in the following paragraph. The Company is required to make mandatory prepayments on the Senior Notes in an amount equal to the proceeds it receives in connection with asset dispositions in excess of
$10.0 million
, together with accrued and unpaid interest on the principal amount prepaid.
Pursuant to the Note Purchase Agreement, upon the consummation of the sale of the Senior Notes on April 2, 2015, the Company and Depo NF Sub, LLC entered into a Pledge and Security Agreement with the Deerfield Private Design Fund lll, L.P. (the Collateral Agent), pursuant to which the Company and Depo NF Sub each granted the Collateral Agent (on behalf of the Purchasers) a security interest in substantially all of their assets, other than specifically excluded assets.
On December 4, 2017, the Company and the Purchasers entered into an Amendment to the existing Note Purchase Agreement. The Amendment facilitated the Company’s entry into the Collegium Commercialization Agreement.
In connection with its entry into the Commercialization Agreement, the Purchasers (i) waived the requirement that some or all of the Asset Disposition Proceeds realized from the granting of the Exclusive License be used to prepay the
outstanding principal amount of the Notes pursuant to Section 2.7(b) of the Note Purchase Agreement and (ii) agreed to (a) replace the minimum net sales covenant in Section 6.7 of the Note Purchase Agreement with a minimum EBITDA covenant, and (b) made certain other amendments related to the amortization of the Notes. In addition, the prepayment premiums were amended to
4%
of the principal amount of the Notes to be prepaid, if such prepayment occurs after the second anniversary of the Purchase Date but on or prior to the fifth anniversary of the Purchase Date; and (iii)
zero
, if such prepayment occurs after the fifth anniversary of the Purchase Date. The Amendment also modifies the repayment schedule; and required the Company to prepaying and retiring
$10.0 million
of the Senior Notes and paying a
$0.4 million
prepayment fee. The Company paid a
$3.0 million
upfront non-refundable amendment fee which, pursuant to the terms of the modification, can be off-set dollar for dollar against any future prepayment fees. The Purchasers have also consented to terms and conditions of the Amendment to the Commercialization Agreement with Collegium described in Note 4 “Revenue”.
The Company accounted for the December 2017 amendment as a debt modification in accordance with the applicable accounting standards. Accordingly, the
$3.0 million
amendment fee paid to the Purchasers was capitalized and is being amortized over the remaining term of the Senior Notes.
The Senior Notes and related indenture contain customary covenants, including, among other things, and subject to certain qualifications and exceptions, covenants that restrict the Company’s ability and the ability of its subsidiaries to: incur or guarantee additional indebtedness; create or permit liens on assets; pay dividends on capital stock or redeem, repurchase or retire capital stock or subordinated indebtedness; make certain investments and other restricted payments; engage in mergers, acquisitions, consolidations and amalgamations; transfer and sell certain assets; and engage in transactions with affiliates.
The Company was in compliance with its covenants with respect to the Senior Notes as of December 31, 2018. See Note 18 - Subsequent Events for discussion of Amendment four to the Senior Notes which was entered into in January 2019.
The remaining principal amount of the Senior Notes repayable each year is as follows (in thousands):
|
|
|
|
|
2019
|
$
|
120,000
|
|
2020
|
80,000
|
|
2021
|
82,500
|
|
Total
|
$
|
282,500
|
|
The Company is scheduled to make the Senior Notes principal payments of
$120.0 million
prior to December 31, 2019 and has classified this portion of the Senior Notes within the current liabilities section of the consolidated balance sheet.
The following is a summary of the carrying value of the Senior Notes as of
December 31, 2018
and 2017 (in thousands):
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
2018
|
|
2017
|
Principal amount of the Senior Notes
|
$
|
282,500
|
|
|
$
|
365,000
|
|
Unamortized debt discount balance
|
(2,541
|
)
|
|
(4,717
|
)
|
Unamortized debt issuance costs
|
(1,650
|
)
|
|
(3,063
|
)
|
Total Senior Notes
|
$
|
278,309
|
|
|
$
|
357,220
|
|
The debt discount and debt issuance costs will be amortized as interest expense through April 2021. The following is a summary of Senior Notes interest expense (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
2018
|
|
2017
|
|
2016
|
Contractual interest expense
|
$
|
38,242
|
|
|
$
|
44,212
|
|
|
$
|
54,722
|
|
Amortization of debt discount and debt issuance costs
|
3,589
|
|
|
2,631
|
|
|
2,261
|
|
Total interest expense
|
$
|
41,831
|
|
|
$
|
46,843
|
|
|
$
|
56,983
|
|
Convertible Debt
On September 9, 2014, the Company issued
$345.0 million
aggregate principal amount of
2.50%
Convertible Senior Notes Due 2021 (the Convertible Notes) resulting in net proceeds to the Company of
$334.2 million
after deducting the underwriting discount and offering expenses of
$10.4 million
and
$0.4 million
, respectively.
The Convertible Notes were issued pursuant to an indenture, as supplemented by a supplemental indenture dated September 9, 2014, between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee (the Trustee), and mature on September 1, 2021, unless earlier converted, redeemed or repurchased. The Convertible Notes bear interest at the rate of
2.50%
per annum, payable semi-annually in arrears on March 1 and September 1 of each year, beginning March 1, 2015.
Prior to March 1, 2021, holders of the 2021 Convertible Notes can convert their securities, at their option: (i) during any calendar quarter commencing after December 31, 2015, if the last reported sale price of the common stock for at least
20
trading days (whether or not consecutive) during the period of
30
consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to
$25.01
(
130%
of the
$19.24
conversion price) on each applicable trading day (ii) during the
five
business day period after any
five
consecutive trading day period in which the trading price per
$1,000
principal amount of notes for each trading day of the measurement period was less than
98%
of the product of the last reported sale price of the Company’s common stock and the conversion rate on each such trading day; and (iii) at any time upon the occurrence of specified corporate transactions, to include a change of control (as defined in the Notes Indenture). On or after March 1, 2021 to the close of business on the second scheduled trading day immediately preceding the maturity date, the holders of the 2021 Convertible Notes may convert all or any portion of their notes, in multiples of
$1,000
principal amount, at the option of the holder regardless of the foregoing circumstances. The initial conversion rate of 51.9852 shares of common stock per
$1,000
principal amount of Convertible Notes is equivalent to a conversion price of approximately
$19.24
per share of common stock.
Upon conversion, the Company will pay or deliver, as the case may be, cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. If the conversion obligation is satisfied solely in cash or through payment and delivery of a combination of cash and shares, the amount of cash and shares, if any, due upon conversion will be based on a daily conversion value calculated on a proportionate basis for each trading day in a
40
trading day observation period.
The closing price of the Company’s common stock did not exceed
130%
of the
$19.24
conversion price, for the required period during the quarter ended
December 31, 2018
. As a result, the Convertible Notes are not convertible as of
December 31, 2018
.
The Convertible Notes were accounted for in accordance with ASC Subtopic 470-20,
Debt with Conversion and Other Options.
Pursuant to ASC Subtopic 470-20, since the Convertible Notes can be settled in cash, shares of common stock or a combination of cash and shares of common stock at the Company’s option, the Company is required to separately account for the liability (debt) and equity (conversion option) components of the instrument. The carrying amount of the liability component of any outstanding debt instrument is computed by estimating the fair value of a similar liability without the conversion option. The amount of the equity component is then calculated by deducting the fair value of the liability component from the principal amount of the convertible debt instrument. The effective interest rate used in determining the liability component of the Convertible Notes was
9.34%
. This resulted in the initial recognition of
$226.0 million
as the liability component net of a
$119.0 million
debt discount with a corresponding net of tax increase to paid-in capital of
$73.3 million
representing the equity component of the Convertible Notes. The underwriting discount of
$10.4 million
and offering expenses of
$0.4 million
were allocated between debt issuance costs and equity issuance costs in proportion to the allocation of the proceeds. Equity issuance costs of
$3.7 million
related to the convertible notes were recorded as an offset to additional paid-in capital.
The following is a summary of the liability component of the Convertible Notes as of
December 31, 2018
and
2017
(in thousands):
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
December 31,
|
|
2018
|
|
2017
|
Principal amount of the Convertible Notes
|
$
|
345,000
|
|
|
$
|
345,000
|
|
Unamortized discount of the liability component
|
(54,521
|
)
|
|
(71,799
|
)
|
Unamortized debt issuance costs
|
(2,681
|
)
|
|
(3,691
|
)
|
Total Convertible Notes
|
$
|
287,798
|
|
|
$
|
269,510
|
|
The debt discount and debt issuance costs will be amortized as interest expense through September 2021. The following is a summary of interest expense for
2018
,
2017
and
2016
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
2018
|
|
2017
|
|
2016
|
Stated coupon interest
|
|
$
|
8,624
|
|
|
$
|
8,625
|
|
|
$
|
8,625
|
|
Amortization of debt discount and debt issuance costs
|
|
18,288
|
|
|
16,784
|
|
|
15,412
|
|
Total interest expense
|
|
$
|
26,912
|
|
|
$
|
25,409
|
|
|
$
|
24,037
|
|
NOTE 11. RESTRUCTURING CHARGES
Restructuring and One-Time Termination Costs
In June 2017, the Company announced a limited reduction-in-force in order to streamline operations and achieve operating efficiencies, the activities related to that reduction-in-force were completed during the third quarter of 2017. In December 2017, the Company initiated a company-wide restructuring plan following the entry into the Commercialization Agreement with Collegium. Pursuant to this plan, in February 2018, the Company eliminated the pain sales force, consisting of approximately
230
sales representative and
25
manager positions. In addition, the Company reduced the staff at the headquarters office during the second quarter of 2018. In the third quarter of 2018, the corporate headquarters was relocated from Newark, California to Lake Forest, Illinois.
The following table summarizes the total expenses recorded related to the
2018
restructuring and one-time termination cost activities by type of activity and the locations recognized within the consolidated statements of operations as restructuring costs (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
2018
|
|
2017
|
|
2016
|
Employee compensation costs
|
$
|
16,852
|
|
|
$
|
13,247
|
|
|
$
|
—
|
|
Fixed Asset disposals and accelerated depreciation of leasehold improvements
|
3,511
|
|
|
—
|
|
|
—
|
|
Other exit costs
|
238
|
|
|
—
|
|
|
—
|
|
Total restructuring costs
|
$
|
20,601
|
|
|
$
|
13,247
|
|
|
$
|
—
|
|
Selected information relating to accrued restructuring, severance costs and one-time termination costs is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee separation costs
|
|
Other exit costs
|
|
Total
|
Net accruals
|
13,247
|
|
|
—
|
|
|
13,247
|
|
Non-cash additions/(reductions)
|
—
|
|
|
—
|
|
|
—
|
|
Cash paid
|
(3,764
|
)
|
|
—
|
|
|
(3,764
|
)
|
Balance at Balance at December 31, 2017
|
$
|
9,483
|
|
|
$
|
—
|
|
|
$
|
9,483
|
|
Net accruals
|
16,852
|
|
|
3,749
|
|
|
20,601
|
|
Non-cash additions/(reductions)
|
(2,146
|
)
|
|
(3,511
|
)
|
|
(5,657
|
)
|
Cash paid
|
(22,611
|
)
|
|
(238
|
)
|
|
(22,849
|
)
|
Balance at Balance at December 31, 2018
|
$
|
1,578
|
|
|
$
|
—
|
|
|
$
|
1,578
|
|
As of
December 31, 2018
, the full
$1.6 million
accrued restructuring liability balance was classified as a current liability in the Consolidated Balance Sheet. Non-cash charges related to stock based compensation and accelerated amortization of leasehold improvements at the Newark, CA headquarters. The Company expects costs related to the December 2017 restructuring plan, incurred in
2019
, to be insignificant.
NOTE 12. COMMITMENTS AND CONTINGENCIES
Leases
The Company has non-cancelable operating leases for its office and laboratory facilities and it is obligated to make payments under non-cancelable operating leases for automobiles used by its sales force. Future minimum lease payments under the Company’s non-cancelable operating leases at
December 31, 2018
were as follows (in thousands):
|
|
|
|
|
Year Ending December 31,
|
Lease Payments
|
2019
|
$
|
2,624
|
|
2020
|
2,526
|
|
2021
|
2,322
|
|
2022
|
2,188
|
|
2023
|
632
|
|
Thereafter
|
—
|
|
Total
|
$
|
10,292
|
|
In April 2012, the Company entered into an office and laboratory lease agreement to lease approximately
52,500
rentable square feet in Newark, California commencing on December 1, 2012. The Company leased approximately
8,000
additional rentable square feet commencing in July 2015. The Lease is due to expire on November 30, 2022.
The Company was allowed to control physical access to the premises upon signing the lease. Therefore, in accordance with the applicable accounting guidance, the lease term was deemed to have commenced in April 2012. Accordingly, the rent free periods and the escalating rent payments contained within the lease are being recognized on a straight‑line basis from April 2012.
The Company relocated its corporate headquarters from Newark, California to Lake Forest, Illinois in the third quarter of 2018. The Company has entered into
two
subleases,
one
in September 2018 and the second in February 2019, which, together, account for the entirety of the Newark facility. The value of these subleases is in excess of the Company's remaining costs under the Newark lease and therefore no cease use cost has been recognized.
Effective February 28, 2018, the Company entered into an Office Lease, in Lake Forest, Illinois (Lake Forest Lease) for its new corporate headquarters, where the Company leases approximately
31,000
rentable square feet of space. The initial tenant improvements in the space were completed in August 2018 and the Company began occupying the space at that time.
The Lake Forest Lease term is for five years and six months. The Company has the right to renew the term of the Lease
for
one
period of
five years
, provided that written notice is made to the Landlord no later than
twelve months
prior to the expiration of the initial term of the Lease.
The Lake Forest Lease initial annual base rent is
$18.00
per rentable square foot and will increase annually by
$0.50
per rentable square foot. The lease is a triple net lease, with the Company required to pay its pro rata share of real estate taxes and operating expenses. The Landlord will make available to the Company a tenant improvement allowance of
$28.00
per square rentable square foot, which the Company may use towards the initial build-out or apply to the payment of rent.
As of December 31, 2018, the aggregate rent payable over the remaining term of the lease agreements was approximately
$6.4 million
on the Newark Lease and
$3.0 million
on the Lake Forest Lease. Deferred rent was approximately
$1.6 million
as of December 31, 2018 and
$1.4 million
as of December 31, 2017. As of December 31, 2018, the Company had a liability of
$3.6 million
related to the deferred recognition of tenant improvement allowances. Rent expense relating to the Newark and Lake Forest lease agreements was
$0.6 million
,
$0.3 million
and
$0.6 million
for
2018
,
2017
and
2016
, respectively.
In December 2013, the Company entered into an operating lease agreement with Enterprise FM Trust (Enterprise) for the lease of vehicles to be used by the Company’s sales force. The Company began receiving vehicles in the second quarter of 2014, with the lease terms ranging from
18
to
36 months
. During the three months ended June 30, 2015, the Company entered into an additional lease with Enterprise, under the existing lease terms. The Company received the additional vehicles in the second half of 2015. As of
December 31, 2018
, the aggregate rent payable over the remaining term of the vehicle lease agreement was approximately
$0.8 million
. Rent expense relating to the lease of cars was
$0.8 million
,
$3.2 million
and
$3.2 million
for
2018
,
2017
and
2016
, respectively.
Legal Matters
Company v. NUCYNTA and NUCYNTA ER ANDA Filers
Actavis & Alkem: In July 2013, Janssen Pharma filed patent infringement lawsuits in the U.S. District Court for the District of New Jersey (D.N.J.) against Actavis Elizabeth LLC, Actavis Inc. and Actavis LLC (collectively, Actavis), as well as Alkem Laboratories Limited and Ascend Laboratories, LLC (collectively, Alkem). The patent infringement claims against Actavis and Alkem relate to their respective ANDAs seeking approval to market generic versions of NUCYNTA and NUCYNTA ER before the expiration of U.S. Reissue Patent No. 39,593 (the ’593 Patent), U.S. Patent No. 7,994,364 (the ’364 Patent) and, as to Actavis only, U.S. Patent No. 8,309,060 (the ’60 Patent). In December 2013, Janssen Pharma filed an additional complaint in the D.N.J. against Alkem asserting that newly issued U.S. Patent No. 8,536,130 (the ’130 Patent) was also infringed by Alkem’s ANDA seeking approval to market a generic version of NUCYNTA ER. In August 2014, Janssen Pharma amended the complaint against Alkem to add additional dosage strengths.
Sandoz & Roxane: In October 2013, Janssen Pharma received a Paragraph IV Notice from Sandoz, Inc. (Sandoz) with respect to NUCYNTA related to the ’364 Patent, and a Paragraph IV Notice from Roxane Laboratories, Inc. (Roxane) with respect to NUCYNTA related to the ’364 and ’593 Patents. In response to those notices, Janssen Pharma filed an additional complaint in the D.N.J. against Roxane and Sandoz asserting the ’364 Patent against Sandoz and the ’364 and ’593 Patents against Roxane. In April 2014, Janssen Pharma and Sandoz entered into a joint stipulation of dismissal of the case against Sandoz, based on Sandoz’s agreement not to market a generic version of NUCYNTA products prior to the expiration of the asserted patents. In June 2014, in response to a new Paragraph IV Notice from Roxane with respect to NUCYNTA ER, Janssen Pharma filed an additional complaint in the D.N.J. asserting the ’364, ’593, and ’130 Patents against Roxane.
Watson: In July 2014, in response to a Paragraph IV Notice from Watson Laboratories, Inc. (Watson) with respect to the NUCYNTA oral solution product and the ’364 and ’593 Patents, Janssen Pharma filed a lawsuit in the D.N.J. asserting the ’364 and ’593 Patents against Watson.
In each of the foregoing actions, the ANDA filers counterclaimed for declaratory relief of non-infringement and patent invalidity. At the time that the actions were commenced, Janssen Pharma was the exclusive U.S. licensee of the patents referred to above. On April 2, 2015, the Company acquired the U.S. rights to NUCYNTA ER and NUCYNTA from Janssen Pharma. As part of the acquisition, the Company became the exclusive U.S. licensee of the patents referred to above. The Company was added as a plaintiff to the pending cases and is actively litigating them.
In September 2015, the Company filed an additional complaint in the D.N.J. asserting the ’130 Patent against Actavis. The ’130 Patent issued in September 2013 and was timely listed in the Orange Book for NUCYNTA ER, but Actavis did not file a Paragraph IV Notice with respect to this patent. In its new lawsuit, the Company claimed that Actavis would infringe or induce infringement of the ’130 Patent if its proposed generic products were approved. In response, Actavis counterclaimed for
declaratory relief of non-infringement and patent invalidity, as well as an order requiring the Company to change the corrected use code listed in the Orange Book for the ’130 Patent.
In February 2016, Actavis, Actavis UT, Roxane and Alkem each stipulated to infringement of the ’593 and ’364 patents. On March 9, 2016, a two-week bench trial on the validity of the
three
asserted patents and infringement of the ’130 patent commenced. Closing arguments took place on April 27, 2016. On September 30, 2016, the Court issued its final decision. The Court found that the ’593, ’364 patent, and ’130 patents are all valid and enforceable, that Alkem will induce infringement of the ’130 patent, but that Roxane and Actavis will not infringe the ’130 patent.
On April 11, 2017, the Court entered final judgment in favor of the Company on the validity and enforceability of all
three
patents, on infringement of the ’593 and ’364 Patents by all defendants, and on infringement of the ’130 Patent against Alkem. The judgment includes an injunction enjoining all
three
defendants from engaging in certain activities with regard to tapentadol (the active ingredient in NUCYNTA), and ordering the effective date of any approval of Actavis, Actavis UT, and Roxane’s ANDAs, and Alkem’s ANDA for NUCYNTA IR to be no earlier than the expiry of the ’364 Patent (June 27, 2025), and the effective date of any approval of Alkem’s ANDA for NUCYNTA ER to be no early than the expiry of the ’130 Patent (September 22, 2028). The period of exclusivity with respect to all
four
defendants may in the future be extended with the award of pediatric exclusivity.
Notices of appeal were filed by defendants Alkem and Roxane concerning the validity of the ’364 and ’130 patents. The Company filed its own cross-appeal with regard to the Court’s finding that Roxane and Actavis will not infringe the claims of the ’130 Patent. The appeals have been consolidated at the Federal Circuit. Briefing concluded in March 2018 and oral arguments occurred on September 4, 2018. It is estimated that the Federal Circuit will issue a written decision in the first quarter of 2019. The ‘593 patent is not the subject of any appeals.
Company v. Purdue
The Company sued Purdue Pharma L.P (Purdue) for patent infringement in a lawsuit filed in January 2013 in the U.S. District Court for the District of New Jersey. The lawsuit arose from Purdue’s commercialization of reformulated OxyContin
®
(oxycodone hydrochloride controlled-release) in the U.S. and alleges infringement of U.S. Patent Nos. 6,340,475 (the ‘475 Patent) and 6,635,280 (the ‘280 Patent), which expired in September 2016.
On September 28, 2015, the district court stayed the Purdue lawsuit pending the decision of the U.S. Court of Appeals for the Federal Circuit (CAFC) in Purdue’s appeal of the PTAB’s Final Written Decisions described below. On June 30, 2016, the district court lifted the stay based on the CAFC’s opinion and judgment affirming the PTAB’s Final Written Decisions confirming the patentability of the patent claims of the ‘475 and ‘280 Patents Purdue had challenged. On June 10, 2016, the Company filed a motion for leave to file a second amended Complaint to plead willful infringement. On June 21, 2016, Purdue filed an opposition to the Company’s motion for leave to plead willful infringement. On January 31, 2017, the Court granted the Company’s motion for leave to plead willful infringement.
On February 1, 2017, the Company filed a Second Amended Complaint pleading willful infringement. On July 10, 2017, the case was reassigned to Judge Wolfson. On February 15, 2017, Purdue answered the Company’s Second Amended Complaint and pled counterclaims of non-infringement, invalidity, unenforceability and certain affirmative defenses. On September 26, 2017, the case was reassigned to Judge Martinotti. On December 22, 2017, the Court set the close of expert discovery for March 30, 2018. On January 5, 2018, the Court vacated the January 25, 2018 pretrial conference.
On July 9, 2018, the Court issued an order administratively terminating the case pending the outcome of settlement discussions between the parties. On August 28, 2018, the Company and each of Purdue, The P.F. Laboratories, Inc. a New Jersey corporation, and Purdue Pharmaceuticals L.P., a Delaware limited partnership (collectively, Purdue Companies), entered into a Settlement Agreement. Pursuant to the Settlement Agreement: (i) Purdue Companies paid the Company
$30 million
on August 28, 2018 and paid the Company an additional
$32 million
on January 30, 2019; (ii) each party covenanted not to the sue the other with regard to any alleged infringement of such party’s patents or patent rights as a result of the commercialization of the other party’s current product portfolio; (iii) each party covenanted not to challenge the other party’s patents or patent rights covering such other party’s current product portfolio; and (iv) each party agreed to a mutual release of claims relating to any claim or potential claim relating to the other party’s current product portfolio.
Securities Class Action Lawsuit and Related Matters
On August 23, 2017, the Company, its current chief executive officer and president, its former chief executive officer and president, and its former chief financial officer were named as defendants in a purported federal securities law class action filed in the United States District Court for the Northern District of California (
Huang v. Depomed et al.
, No. 3:17-cv-4830-JST, N.D. Cal.). The action alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 relating to certain prior disclosures of the Company about its business, compliance, and operational policies and practices concerning the sales and marketing of its opioid products and contends that the conduct supporting the alleged violations affected the value of Company common stock and is seeking damages and other relief. In an amended complaint filed on February 6, 2018, the lead plaintiff (referred to in its pleadings as the Depomed Investor Group), which seeks to represent a class consisting of all purchasers of Company common stock between July 29, 2015 and August 6, 2017, asserted the same claims arising out of the same and similar disclosures against the Company and the same individuals as were involved in the original complaint. The Company and the individuals filed a motion to dismiss the amended complaint on April 9, 2018. The lead plaintiff filed an opposition to the motion on June 8, 2018. The Company and the individuals filed a reply in support of their motion to dismiss on July 23, 2018. Oral arguments took place on December 13, 2018
.
The Company believes that the action is without merit and intends to contest it vigorously.
In addition,
five
shareholder derivative actions were filed on behalf of the Company against its officers and directors for breach of fiduciary duty, unjust enrichment, abuse of control, gross mismanagement, waste of corporate assets, and violations of the federal securities laws. The claims arise out of the same factual allegations as the class action. The first derivative action was filed in the Superior Court of California, Alameda County on September 29, 2017 (
Singh v. Higgins et al
., RG17877280). The second and third actions were filed in the Northern District of California on November 10, 2017 (
Solak v. Higgins et al
., No. 3:17-cv-6546-JST) and November 15, 2017 (
Ross v. Fogarty et al
., No. 3:17-cv-6592- JST). The fourth action was filed in the District of Delaware on December 21, 2018 (
Lutz v. Higgins et al
, No. 18-2044-CFC). The fifth derivative action was filed in the Superior Court of California, Alameda County on January 28, 2019 (
Youse v. Higgins et al
, No. HG19004409). On December 7, 2017, the plaintiffs in
Solak v. Higgins, et al.
voluntarily dismissed the first federal derivative action. The
Ross
,
Singh
, and
Lutz
actions were stayed on January 18, 2018, January 23, 2018, and January 11, 2019, respectively, pending the resolution of the motion to dismiss in the securities class action. The parties in the
Singh
and
Youse
actions are seeking to consolidate those cases and stay the consolidated matter pending the resolution of the motion to dismiss. The Company believes that these actions are without merit and intends to contest them vigorously.
Opioid-Related Request and Subpoenas
As a result of the greater public awareness of the public health issue of opioid abuse, there has been increased scrutiny of, and investigation into, the commercial practices of opioid manufacturers generally by federal, state, and local regulatory and governmental agencies. The Company received a letter from Senator Claire McCaskill (D-MO), the then-Ranking Member on the U.S. Senate Committee on Homeland Security and Governmental Affairs, requesting certain information from the Company regarding its historical commercialization of opioid products. The Company voluntarily furnished information responsive to Sen. McCaskill’s request. The Company has also received subpoenas or civil investigative demands focused on its historical promotion and sales of Lazanda, NUCYNTA, and NUCYNTA ER from various State Attorneys General seeking documents and information regarding the Company’s historical sales and marketing of opioid products. In addition, the State of California Department of Insurance (CDI) has issued a subpoena to the Company seeking information relating to its historical sales and marketing of Lazanda. The CDI subpoena also seeks information on Gralise, a non-opioid product in the Company’s portfolio. The Company has received subpoenas from the U.S. Department of Justice (DOJ) seeking documents and information regarding its historical sales and marketing of opioid products. The Company also from time to time receives and complies with subpoenas from governmental authorities related to investigations primarily directed at third parties, including health care practitioners, pursuant to which the Company’s records related to agreements with and payments made to those third parties, among other items, are produced. As a general matter, the Company is cooperating with all of the requests from and investigations by the regulators described above.
Multidistrict Opioid Litigation
A number of pharmaceutical manufacturers, distributors and other industry participants have been named in numerous lawsuits around the country brought by various groups of plaintiffs, including city and county governments, hospitals and others. In general, the lawsuits assert claims arising from defendants’ manufacturing, distributing, marketing and promoting of FDA-approved opioid drugs. The specific legal theories asserted vary from case to case, but most of the lawsuits include federal and state statutory claims as well as claims arising under state common law. Plaintiffs seek various forms of damages, injunctive and other relief and attorneys’ fees and costs.
For such cases filed in or removed to federal court, the Judicial Panel on Multi-District Litigation issued an order in December 2017, establishing a Multi-District Litigation court (MDL Court) in the Northern District of Ohio (In re National Prescription Opiate Litigation, Case No. 1:17-MD-2804). Since that time, more than
1,000
such cases that were originally filed in U.S. District Courts, or removed to federal court from state court, have been transferred to the MDL Court. The Company is currently involved in
19
lawsuits that have been transferred to the MDL Court and
one
additional federal lawsuit in the Eastern District of Missouri. Plaintiffs may file additional lawsuits in which the Company may be named. Plaintiffs in the federal cases include county and municipal governmental entities, employee benefit plans, health clinics and health insurance providers who assert federal and state statutory claims and state common law claims, such as conspiracy, nuisance, fraud, negligence or deceptive trade practices. In these cases, plaintiffs seek a variety of forms of relief, including actual damages to compensate for alleged past and future costs such as to provide care and services to persons with opioid-related addiction or related conditions, injunctive relief to prohibit alleged deceptive marketing practices and abate an alleged nuisance, establishment of a compensation fund, disgorgement of profits, punitive and statutory treble damages, and attorneys’ fees and costs. These lawsuits are in the earliest stages of proceedings, and the Company intends to defend itself vigorously in these matters.
State Opioid Litigation
Related to the cases in the MDL Court noted above, there have been hundreds of similar lawsuits filed in state courts around the country, in which various groups of plaintiffs assert opioid-drug related claims against similar groups of defendants. The Company is currently named in
20
such cases --
three
filed in Texas,
three
in Pennsylvania,
six
in Utah,
four
in Missouri,
two
in Nevada and
one
each in Arizona and Arkansas. Plaintiffs may file additional lawsuits in which the Company may be named. In these cases, plaintiffs are asserting state common law and statutory claims against the defendants similar in nature to the claims asserted in the MDL cases. Plaintiffs are seeking past and future damages, disgorgement of profits, injunctive relief, punitive and statutory treble damages, and attorneys’ fees and costs. These lawsuits are likewise in their earliest stages, and the Company intends to defend itself vigorously in these matters.
Insurance Litigation
On January 15, 2019, the Company was named as a defendant in a declaratory judgment action filed by Navigators Specialty Insurance Company (Navigators) in the United States District Court for the Northern District of California (Case No. 3:19-cv-255). Navigators is the Company’s primary product liability insurer. Navigators is seeking declaratory judgment that opioid litigation claims noticed by the Company (as further described above under “Multidistrict Opioid Litigation” and “State Opioid Litigation”) are not covered by the Company’s policies with Navigators. The Company filed a response to the complaint on February 28, 2019.
General
The Company cannot reasonably predict the outcome of the legal proceedings described above, nor can the Company estimate the amount of loss, range of loss or other adverse consequence, if any, that may result from these proceedings or the amount of any gain in the event the Company prevails in litigation involving a claim for damages. As such the Company is not currently able to estimate the impact of the above litigation on its financial position or results of operations.
The Company may from time to time become party to actions, claims, suits, investigations or proceedings arising from the ordinary course of its business, including actions with respect to intellectual property claims, breach of contract claims, labor and employment claims and other matters. The Company may also become party to further litigation in federal and state courts relating to opioid drugs. Although actions, claims, suits, investigations and proceedings are inherently uncertain and their results cannot be predicted with certainty, other than the matters set forth above, the Company is not currently involved in any matters that the Company believes may have a material adverse effect on its business, results of operations or financial condition. However, regardless of the outcome, litigation can have an adverse impact on the Company because of associated cost and diversion of management time.
NOTE 13. STOCK‑BASED COMPENSATION
The Company uses the Black‑Scholes option valuation model to determine the fair value of stock options and employee stock purchase plan (ESPP) shares. The determination of the fair value of stock‑based payment awards on the date of grant using an option valuation model is affected by the Company’s stock price as well as assumptions, which include the Company’s expected term of the award, the expected stock price volatility, risk‑free interest rate and expected dividends over the expected term of the award. The fair value of restricted stock units equals the market value of the underlying stock on the date of grant.
The Company uses historical option exercise data to estimate the expected term of the options. The Company estimates the volatility of its common stock price by using the historical volatility over the expected term of the options. The
Company bases the risk‑free interest rate on U.S. Treasury zero‑coupon issues with terms similar to the expected term of the options as of the date of grant. The Company does not anticipate paying any cash dividends in the foreseeable future and therefore uses an expected dividend yield of zero in the option valuation model.
The Company used the following assumptions to calculate the fair value of option grants for the years ended
December 31, 2018
,
2017
and
2016
.
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
2016
|
Employee and Director Stock Options
|
|
|
|
|
|
Risk-free interest rate
|
2.17%
|
|
1.65 - 1.93%
|
|
0.90 - 1.78%
|
Expected option term (in years)
|
4.34
|
|
4.24 - 4.30
|
|
4.23 - 4.31
|
Expected stock price volatility
|
61.94%
|
|
51.67 - 59.59%
|
|
48.39 - 50.96%
|
The Company used the following assumptions to calculate the fair value of stock purchase rights granted under the ESPP for the years ended
December 31, 2018
,
2017
and
2016
:
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
2016
|
Employee Stock Purchase Plan
|
|
|
|
|
|
Risk-free interest rate
|
2.05-2.50%
|
|
1.07 - 1.45%
|
|
0.49 - 0.60%
|
Expected option term (in years)
|
0.5
|
|
0.5
|
|
0.5
|
Expected stock price volatility
|
56.1-58.6%
|
|
52.2 - 82.0%
|
|
48.1 - 67.5%
|
The following table presents stock‑based compensation expense recognized for stock options, restricted stock units and the ESPP in the Company’s Statements of Operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
2016
|
Cost of sales
|
$
|
30
|
|
|
$
|
98
|
|
|
$
|
43
|
|
Research and development expense
|
446
|
|
|
710
|
|
|
496
|
|
Selling, general and administrative expense
|
9,963
|
|
|
12,157
|
|
|
16,633
|
|
Restructuring charges
|
2,146
|
|
|
51
|
|
|
—
|
|
Total
|
$
|
12,585
|
|
|
$
|
13,016
|
|
|
$
|
17,172
|
|
The weighted‑average grant date fair value of options granted during the years ended
December 31, 2018
,
2017
and
2016
was
$4.32
,
$5.55
and
$6.81
, respectively. The weighted‑average grant date fair value of stock purchase rights granted under the ESPP during the years ended
December 31, 2018
,
2017
and
2016
was
$1.73
,
$2.97
and
$6.09
, respectively. The total intrinsic value of options exercised during the years ended
December 31, 2018
,
2017
and
2016
was
$0.6 million
,
$5.0 million
and
$6.6 million
, respectively. The total grant date fair value of options that vested during the years ended
December 31, 2018
,
2017
and
2016
was
$2.3 million
,
$4.7 million
and
$9.3 million
, respectively. At
December 31, 2018
, the Company had
$14.0 million
of total unrecognized compensation expense, related to stock option grants and restricted stock units that will be recognized over an average vesting period of
2
years. Cash received from stock option exercises was
$1.5 million
,
$7.0 million
and
$6.7 million
for the years ended
December 31, 2018
,
2017
and
2016
, respectively. There is
no
stock‑based compensation recorded within inventory in any of the years presented. The recognized tax benefits on total stock-based compensation expense during the years ended
December 31, 2018
,
2017
and
2016
was
$0.7 million
,
$0.4 million
and
$0.6 million
, respectively.
2004 Equity Incentive Plan
The Company’s 2004 Equity Incentive Plan (2004 Plan) was adopted by the Board of Directors and approved by the shareholders in May 2004. The 2004 Plan provides for the grant to employees of the Company, including officers, of incentive stock options, and for the grant of non-statutory stock options to employees, directors and consultants of the Company. The number of shares authorized under the 2004 Plan was
14,450,000
shares and there were
no
more shares available for future issuance at
December 31, 2018
.
Generally, the exercise price of all incentive stock options and non-statutory stock options granted under the 2004 Plan must be at least
100%
and
85%
, respectively, of the fair value of the common stock of the Company on the grant date. The term of incentive and non-statutory stock options may not exceed
10
years from the date of grant. An option shall be exercisable on or after each vesting date in accordance with the terms set forth in the option agreement. The right to exercise an option generally vests over
four
years at the rate of at least
25%
by the end of the first year and then ratably in monthly installments over the remaining vesting period of the option.
The following tables summarize the activity for the year ended
December 31, 2018
under the 2004 Plan:
|
|
|
|
|
|
|
|
|
Shares
|
|
Weighted-
Average
Exercise
Price
|
Options outstanding at December 31, 2017
|
1,786,041
|
|
|
$
|
7.62
|
|
Options granted
|
—
|
|
|
—
|
|
Options exercised
|
(277,443
|
)
|
|
5.37
|
|
Options forfeited
|
(6,965
|
)
|
|
12.69
|
|
Options expired
|
(332,221
|
)
|
|
9.56
|
|
Options outstanding at December 31, 2018
|
1,169,412
|
|
|
$
|
7.57
|
|
Options vested and expected to vest at December 31, 2018
|
1,169,412
|
|
|
$
|
7.57
|
|
Options exercisable at December 31, 2018
|
1,169,412
|
|
|
$
|
7.57
|
|
|
|
|
|
|
|
|
|
Weighted-
Average
Remaining
Contractual
Term (years)
|
|
Aggregate
Intrinsic Value
(in thousands)
|
Options outstanding at December 31, 2018
|
1.78
|
|
$
|
29
|
|
Options vested and expected to vest at December 31, 2018
|
1.78
|
|
$
|
29
|
|
Options exercisable at December 31, 2018
|
1.78
|
|
$
|
29
|
|
There have been
no
restricted stock units granted under the 2004 Equity Incentive Plan.
Equity Match Program
On December 6, 2017, the Company Board of Directors approved a one-time incentive program (the Equity Match Program) for the Company’s Chief Executive Officer (the CEO). The Equity Match Program is intended to provide an incentive for the CEO to purchase shares of the Company’s common stock,
no
par value (the Common Stock), through open-market purchases between December 5, 2017 and February 3, 2018 (the Purchase Period). Under the terms of the Equity Match Program, for each
$100,000
of Common Stock purchased by the CEO during the Purchase Period (up to
$600,000
in total), the Company will grant the CEO an award of restricted stock units (the Matching Units) under the Company’s 2014 Omnibus Incentive Plan having a grant-date value equal to the purchase price of the Common Stock purchased by the CEO (rounded down to the nearest
$100,000
). The Matching Units will be granted on the first business day following the earlier of: (i) the CEO’s purchase of a total of
$600,000
of Common Stock, or (ii) the end of the Purchase Period. The Matching Units will vest in full on the third anniversary of the first day during the Purchase Period that the CEO purchased Common Stock in the open market, subject to the CEO’s continued employment through such date. Notwithstanding the foregoing, the Matching Units may vest in full upon a termination without cause or resignation for good reason (including following a change of control of the Company), or upon the CEO’s death or total and permanent disability. As of
December 31, 2018
,
75,000
shares of the Company Common Stock had been purchased by the CEO at an average price per share of
$8.16
and Matching Units of
73,529
shares were awarded, with a fair value of
$8.16
at the grant date.
2014 Omnibus Incentive Plan
The Company’s 2014 Omnibus Incentive Plan (2014 Plan) was adopted by the Board of Directors and approved by the shareholders in May 2014. The 2014 Plan provides for the grant of stock options, stock appreciation rights, stock awards, cash awards and performance award to the employees, non-employee directors and consultants of the Company. The number of
shares authorized under the 2014 Plan is
12,130,000
shares, of which
5,751,303
were available for future issuance at
December 31, 2018
.
Generally, the exercise price of all incentive stock options and non-statutory stock options granted under the 2014 Plan must be the fair value of the common stock of the Company on the grant date. The term of incentive and non-statutory stock options may not exceed
10
years from the date of grant. An option shall be exercisable on or after each vesting date in accordance with the terms set forth in the option agreement. The right to exercise an option generally vests over
four
years at the rate of at least
25%
by the end of the first year and then ratably in monthly installments over the remaining vesting period of the option.
The following table summarize the activity for the year ended
December 31, 2018
under the 2014 Plan:
|
|
|
|
|
|
|
|
|
Shares
|
|
Weighted
Average
Exercise
Price
|
Options outstanding at December 31, 2017
|
3,455,769
|
|
|
$
|
14.24
|
|
Options granted
|
75,304
|
|
|
8.55
|
|
Options exercised
|
—
|
|
|
—
|
|
Options forfeited
|
(1,270,762
|
)
|
|
13.20
|
|
Options expired
|
(798,842
|
)
|
|
17.83
|
|
Options outstanding at December 31, 2018
|
1,461,469
|
|
|
$
|
12.90
|
|
Options vested and expected to vest at December 31, 2018
|
1,461,469
|
|
|
$
|
12.90
|
|
Options exercisable at December 31, 2018
|
808,141
|
|
|
$
|
14.30
|
|
|
|
|
|
|
|
|
|
Weighted-
Average
Remaining
Contractual
Term (years)
|
|
Aggregate
Intrinsic Value
(in thousands)
|
Options outstanding at December 31, 2018
|
6.75
|
|
$
|
—
|
|
Options vested and expected to vest at December 31, 2018
|
6.75
|
|
$
|
—
|
|
Options exercisable at December 31, 2018
|
6.04
|
|
$
|
—
|
|
Restricted stock units generally vest over
three
or
four
years, with
33%
or
25%
of each award vesting annually, respectively.
|
|
|
|
|
|
|
|
|
|
|
Number of
Shares
|
|
Weighted
Average
Grant Date
Fair
Value
Per Share
|
|
Weighted
Average
Remaining
Contractual
Term
(in years)
|
Non-vested restricted stock units at December 31, 2017
|
1,166,046
|
|
|
$
|
10.69
|
|
|
|
Granted
|
1,897,661
|
|
|
6.84
|
|
|
|
Vested
|
(539,898
|
)
|
|
9.77
|
|
|
|
Forfeited
|
(585,021
|
)
|
|
9.05
|
|
|
|
Non-vested restricted stock units at December 31, 2018
|
1,938,788
|
|
|
$
|
6.94
|
|
|
1.24
|
The total fair value of restricted stock vested during
2018
was
$3.1 million
.
Performance-based Restricted Stock Units
During the
twelve
months ended
December 31, 2018
, the Company granted Performance Stock Units (PSUs) with an aggregate target award of
523,187
units and a weighted-average grant-date fair value of
$10.58
per unit. The PSUs vest in annual cliffs over a
three
year period based on the Relative Total Shareholder Return (TSR) of the Company’s common stock against the Russell 3000 Pharmaceuticals Total Return Index over the period. The ultimate award, which is determined at the end of the
three
-year cycle, can range from
zero
to
200%
of the target. The recipients of the PSU awards will have voting rights and the right to receive a dividend once the underlying shares have been issued. The grant-date fair value is based upon the Monte Carlo simulation method.
The following table summarizes the PSU activity for the year ended
December 31, 2018
under the 2014 Plan (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
Weighted
|
|
|
|
|
|
Average
|
|
Average
|
|
|
|
|
|
Grant Date
|
|
Remaining
|
|
|
|
|
|
Fair
|
|
Contractual
|
|
Aggregate
|
|
Number of
|
|
Value
|
|
Term
|
|
Intrinsic Value
|
|
Shares
|
|
Per Share
|
|
(in years)
|
|
(in 000s)
|
Non-vested performance-based restricted stock units at December 31, 2017
|
—
|
|
|
$
|
—
|
|
|
|
|
|
Granted
|
523,187
|
|
|
10.58
|
|
|
|
|
Vested
|
—
|
|
|
—
|
|
|
|
|
|
Forfeited
|
(148,363
|
)
|
|
11.68
|
|
|
|
|
Non-vested performance-based restricted stock units at December 31, 2018
|
374,824
|
|
|
$
|
10.14
|
|
|
2.09
|
|
1,353
|
As of
December 31, 2018
, total unrecognized compensation cost related to PSUs was
$2.8 million
which is expected to be recognized over the remaining weighted-average vesting period of
2.08
years.
NOTE 14. SHAREHOLDERS’ EQUITY
Reincorporation
On August 14, 2018, Depomed reincorporated from California to Delaware (the Reincorporation) and changed its name to Assertio Therapeutics, Inc. To effectuate the Reincorporation, Depomed merged with and into Assertio Therapeutics, Inc., a Delaware corporation and wholly owned subsidiary of Depomed prior to the effective time of the merger, with Assertio continuing as the surviving corporation. Pursuant to the merger, each share of Depomed common stock, no par value, was converted into one share of Assertio common stock,
$0.0001
par value, and all outstanding Depomed equity awards were assumed by Assertio. As a result of the Reincorporation and the related conversion of each share of Depomed-California common stock, no par value, into one share of Assertio-Delaware common stock,
$0.0001
par value, the Company has separated the par value of stock within Common Stock from additional-paid-in-capital on the Company's Consolidated Balance Sheets. The Company has elected to present this impact of the Reincorporation retrospectively. Accordingly, to conform to current year presentation, the Company reclassified $
264.5 million
from common stock to additional paid-in capital as of December 31, 2015 on the Company's Consolidated Balance Sheets.
Employee Stock Purchase Plan
In May 2004, the ESPP was approved by the shareholders. The ESPP is qualified under Section 423 of the Internal Revenue Code. The ESPP is designed to allow eligible employees to purchase shares of the Company’s common stock through periodic payroll deductions. The price of the common stock purchased under the ESPP must be equal to at least
85%
of the lower of the fair market value of the common stock on the commencement date of each offering period or the specified purchase date. The number of shares authorized for issuance under the ESPP as of
December 31, 2018
was
3,000,000
, of which
302,549
shares were available for future issuance.
In
2018
, the Company sold
106,500
shares of its common stock under the ESPP. The shares were purchased at a weighted‑average purchase price of
$4.95
with proceeds of approximately
$0.5 million
. In
2017
, the Company sold
261,569
shares of its common stock under the ESPP. The shares were purchased at a weighted‑average purchase price of
$7.49
with proceeds of approximately
$2.0 million
.
Option Exercises
Employees exercised options to purchase
278,000
shares of the Company’s common stock with net proceeds to the Company of approximately
$1.5 million
during
2018
. Employees exercised options to purchase
1,000,892
shares of the Company’s common stock with net proceeds to the Company of approximately
$7.0 million
during
2017
.
NOTE 15. NET INCOME (LOSS) PER SHARE
Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of shares of common stock outstanding during the period. Diluted net income (loss) per share is calculated by dividing the net income by the weighted-average number of shares of common stock outstanding during the period, plus potentially dilutive common shares, consisting of stock options and convertible debt. The Company uses the treasury-stock method to compute diluted earnings per share with respect to its stock options and equivalents. The Company uses the if-converted method to compute diluted earnings per share with respect to its convertible debt. For purposes of this calculation, options to purchase stock are considered to be potential common shares and are only included in the calculation of diluted net income (loss) per share when their effect is dilutive. Basic and diluted earnings per common share are calculated as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands, except for per share amounts)
|
|
2018
|
|
2017
|
|
2016
|
Basic and diluted net income (loss) per share
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
36,908
|
|
|
$
|
(102,496
|
)
|
|
$
|
(88,720
|
)
|
Denominator
|
|
63,794
|
|
|
62,702
|
|
|
61,297
|
|
Basic net income (loss) per share
|
|
$
|
0.58
|
|
|
$
|
(1.63
|
)
|
|
$
|
(1.45
|
)
|
|
|
|
|
|
|
|
Diluted net income (loss) per share
|
|
|
|
|
|
|
Numerator:
|
|
|
|
|
|
|
Net income (loss)
|
|
$
|
36,908
|
|
|
$
|
(102,496
|
)
|
|
$
|
(88,720
|
)
|
Denominator:
|
|
|
|
|
|
|
Denominator for basic income (loss) per share
|
|
63,794
|
|
|
62,702
|
|
|
61,297
|
|
Add effect of diluted securities:
|
|
|
|
|
|
|
Stock options and equivalents
|
|
414
|
|
|
—
|
|
|
—
|
|
Denominator for diluted income (loss) per share
|
|
$
|
64,208
|
|
|
$
|
62,702
|
|
|
$
|
61,297
|
|
Diluted net income (loss) per share
|
|
$
|
0.57
|
|
|
$
|
(1.63
|
)
|
|
$
|
(1.45
|
)
|
The following table sets forth outstanding potential shares of common stock that are not included in the computation of diluted net income (loss) per share because, to do so would be anti-dilutive:
|
|
|
|
|
|
|
|
|
|
|
(in thousands)
|
|
2018
|
|
2017
|
|
2016
|
Convertible debt
|
|
17,931
|
|
|
17,931
|
|
|
17,931
|
|
Stock options and equivalents
|
|
3,701
|
|
|
5,618
|
|
|
3,371
|
|
Total potentially dilutive common shares
|
|
21,632
|
|
|
23,549
|
|
|
21,302
|
|
NOTE 16. ACQUISITIONS AND DISPOSITIONS
On November 7, 2017, the Company entered into an agreement with Slán Medicinal Holdings Limited (Slán) under which it (i) acquired from Slán certain rights to market the specialty drug, long-acting cosyntropin in the United States and (ii) divested to Slán all of its rights to Lazanda® (fentanyl) nasal spray CII. The term of the License Agreement for long-acting cosyntropin runs from November 7, 2017, through the end of the
10
-year period following the first commercial sale of an
approved product (Licensed Product), but the Company may terminate the License Agreement if the FDA determines that a Licensed Product is not approvable in the U.S. Under the terms of the Agreement, Slán is responsible for clinical and regulatory expenses associated with long-acting cosyntropin prior to its first approval by the U.S. Food and Drug Administration. Upon approval, the Company will be responsible for marketing and selling long-acting cosyntropin for the first
seven years
following the first commercial sale of a Licensed Product in the U.S., and Slán will be responsible for selling the Licensed Product during the remaining
three years
of the
10
-year period.
The acquisition of exclusive rights to market long-acting cosyntropin in the United States was treated as an asset acquisition under the applicable guidance contained with U.S. GAAP. The fair value of the license to market long-acting cosyntropin was estimated to be approximately
$24.9 million
which, in accordance with the applicable accounting rules, was recorded as “acquired in process research and development” in the accompanying consolidated statements of operations as long-acting cosyntropin is still under development and the rights the Company acquired were deemed to have no alternative future use.
As consideration for this acquisition, the Company provided the seller all of the rights and obligations, as defined under the arrangement, associated with Lazanda and together with
$5.0 million
in cash to Slán. The divestiture of Lazanda was treated as a disposition of a business for accounting purposes and resulted in a gain of approximately
$17.1 million
which was recorded as “gain on divestiture of Lazanda” in the accompanying consolidated statements of operations. The Company determined that the divestiture of Lazanda does not qualify for reporting as discontinued operations as the divestiture does not constitute on its own a strategic shift that will have a major effect on the Company’s operations and financial results.
NOTE 17. INCOME TAXES
The (benefit) provision for income taxes consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Current:
|
2018
|
|
2017
|
|
2016
|
Federal
|
$
|
896
|
|
|
$
|
384
|
|
|
$
|
1,087
|
|
State
|
171
|
|
|
(1,813
|
)
|
|
140
|
|
|
$
|
1,067
|
|
|
$
|
(1,429
|
)
|
|
$
|
1,227
|
|
Deferred:
|
|
|
|
|
|
Federal
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
16,291
|
|
State
|
—
|
|
|
—
|
|
|
6,700
|
|
|
—
|
|
|
—
|
|
|
22,991
|
|
Total (benefit) provision for income taxes
|
$
|
1,067
|
|
|
$
|
(1,429
|
)
|
|
$
|
24,218
|
|
A reconciliation of income taxes at the statutory federal income tax rate to the actual tax rate included in the statements of operations is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2018
|
|
2017
|
|
2016
|
Tax at federal statutory rate
|
$
|
7,975
|
|
|
$
|
(36,374
|
)
|
|
$
|
(22,580
|
)
|
State tax, net of federal benefit
|
192
|
|
|
71
|
|
|
(748
|
)
|
Research credit
|
(41
|
)
|
|
(41
|
)
|
|
(902
|
)
|
Stock based compensation
|
1,259
|
|
|
159
|
|
|
1,435
|
|
Non-deductible meals and entertainment
|
223
|
|
|
973
|
|
|
955
|
|
Non-deductible other expense
|
308
|
|
|
6,508
|
|
|
1,426
|
|
Change in valuation allowance
|
(9,233
|
)
|
|
1,326
|
|
|
44,632
|
|
Uncertain tax provisions
|
384
|
|
|
(1,611
|
)
|
|
—
|
|
Tax rate changes
|
—
|
|
|
27,560
|
|
|
—
|
|
Total
|
$
|
1,067
|
|
|
$
|
(1,429
|
)
|
|
$
|
24,218
|
|
During
2018
, the Company recorded income tax expense of approximately
$1.1 million
principally due to the increase in book income from Purdue litigation settlement.
During
2017
, the Company recognized a tax benefit of approximately
$1.4 million
principally due to release of liability and accrued interest and penalties associated with uncertain tax
During 2016, the Company recorded income tax expense of approximately
$24.2 million
principally due to the recording of a full valuation allowance against its deferred tax assets.
On December 22, 2017, the U.S. government enacted the Tax Cuts and Jobs Act (the Tax Act). The Tax Act includes significant changes to the U.S. corporate income tax system including, but not limited to, a federal corporate rate reduction from 35% to 21% and limitations on the deductibility of interest expense and executive compensation. In order to calculate the effects of the new corporate tax rate on our deferred tax balances, ASC 740
Income Taxes
(ASC 740) required the re-measurement of our deferred tax balances as of the enactment date of the Tax Act, based on the rates at which the balances were expected to reverse in the future. Due to the Company’s full valuation allowance position, there is no change to the presentation of the deferred tax balances on the financial statements, except for the re-measurement of these deferred tax balances in the income tax footnote. The re-measurement resulted in a one-time reduction in federal & state deferred tax assets of approximately
$25.5 million
, which was fully offset by a corresponding change to the Company’s valuation allowance. In December 2017, the SEC staff issued Staff Accounting Bulletin No. 118
, Income Tax Accounting Implications of the Tax Cuts and Jobs Act
(SAB 118), which allows us to record provisional amounts during a measurement period not to extend beyond one year of the enactment date. As of December 31, 2018, we completed our accounting for all tax effects related to the Tax Act, and there were no material adjustments recorded during the year to the previously recorded provisional amounts reflected in our 2017 financial statements.
As of
December 31, 2018
, the Company had net operating loss carry forwards for federal income tax purposes of approximately
$4.9 million
, which begin to expire in 2021. Net operating loss carryforwards for state income tax purposes were approximately
$89.7 million
, which begin to expire in 2018. The Company had federal and California state research and development credit carryforwards of
$0.0 million
and
$2.6 million
, respectively. The California state research and development credit has no expiration.
Utilization of the Company’s net operating loss and credit carryforwards may be subject to a substantial annual limitation due to ownership change limitations provided by the Internal Revenue Code of 1986 and similar state provisions. The annual limitation may result in the expiration of net operating losses and credits before utilization.
Deferred income taxes reflect the temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
2018
|
|
2017
|
Deferred tax assets:
|
|
|
|
Net operating losses
|
$
|
6,618
|
|
|
$
|
16,391
|
|
Tax credit carryforwards
|
1,096
|
|
|
1,860
|
|
Intangibles
|
33,604
|
|
|
38,509
|
|
Stock-based compensation
|
2,286
|
|
|
1,505
|
|
Reserves and other accruals not currently deductible
|
10,706
|
|
|
12,094
|
|
Total deferred tax assets
|
54,310
|
|
|
70,359
|
|
Valuation allowance for deferred tax assets
|
(41,905
|
)
|
|
(54,224
|
)
|
|
$
|
12,405
|
|
|
$
|
16,135
|
|
Deferred tax liabilities
|
|
|
|
|
|
Convertible debt
|
$
|
(12,213
|
)
|
|
$
|
(16,135
|
)
|
Fixed Assets
|
(192
|
)
|
|
—
|
|
Net deferred tax asset (liability)
|
—
|
|
|
—
|
|
In
2018
, the Company recorded a valuation allowance of
$41.9 million
to offset, in full, the benefit related to its net deferred tax assets as of
December 31, 2018
because realization of the future benefits is uncertain. The Company reviewed both positive evidence such as, but not limited to, the projected availability of future taxable income and negative evidence such as the history of cumulative losses in recent years. The Company will continue to assess the realizability of its deferred tax assets on a quarterly basis, and assess whether an additional reserve or a release of the valuation allowance is required in future periods.
The valuation allowance decreased by
$12.3 million
, increased by
$9.0 million
, and increased by
$44.6 million
during the years ended
December 31, 2018
,
2017
and
2016
respectively.
The Company files income tax returns in the United States federal jurisdiction and in various states, and the tax returns filed for the years 1997 through 2017 and the applicable statutes of limitation have not expired with respect to those returns. Because of net operating losses and unutilized R&D credits, substantially all of the Company’s tax years remain open to examination.
Interest and penalties, if any, related to unrecognized tax benefits would be recognized as income tax expense by the Company. At
December 31, 2018
, the Company had approximately
$1.4 million
of accrued interest and penalties associated with any unrecognized tax benefits.
The following table summarizes the activity related to the Company’s unrecognized tax benefits for the three years ended
December 31, 2018
(in thousands):
|
|
|
|
|
Unrecognized tax benefits—January 1, 2016
|
$
|
5,686
|
|
Gross increases—current year tax positions
|
240
|
|
Gross increases—prior year tax positions
|
8,761
|
|
Unrecognized tax benefits—December 31, 2016
|
14,687
|
|
Gross increases—current year tax positions
|
3,423
|
|
Gross decreases—prior year tax positions
|
(966
|
)
|
Unrecognized tax benefits—December 31, 2017
|
17,144
|
|
Gross increases—current year tax positions
|
262
|
|
Gross decreases—prior year tax positions
|
(1,342
|
)
|
Unrecognized tax benefits—December 31, 2018
|
$
|
16,064
|
|
The total amount of unrecognized tax benefit that would affect the effective tax rate is approximately
$16.1 million
as of
December 31, 2018
and
$17.1 million
as of
December 31, 2017
. The Company has recorded an other asset of
$5.3 million
related to tax benefits that would be realized in 2018 if all uncertain tax positions were assessed.
The Company does not expect a significant change to its unrecognized tax benefits over the next twelve months. The unrecognized tax benefits may increase or change during the next year for items that arise in the ordinary course of business.
NOTE 18. SUBSEQUENT EVENTS
Amended Senior Note Agreement
In January 2019, the Company entered into a Fourth Amendment to Note Purchase Agreement (the “Amendment”) with respect to the Note Purchase Agreement, dated as of March 12, 2015, among the Company, the other credit parties party thereto, the purchasers party thereto and Deerfield. Pursuant to the Amendment, the minimum EBITDA covenant was replaced with a senior secured debt leverage ratio covenant and a minimum net sales covenant, the prepayment premium was adjusted to be
3%
of the principal amount of notes prepaid on or prior to April 14, 2020 and
1%
of the principal amount of notes prepaid thereafter, flexibility to sell certain royalty assets and/or modify the terms thereof was added, certain definitions were amended and certain other amendments were made. The Company paid a
$3.2 million
upfront non-refundable amendment fee.
NOTE 19. SELECTED QUARTERLY FINANCIAL DATA (UNAUDITED)
The following tables set forth certain unaudited quarterly financial data for each of the eight quarters beginning with the quarter ended March 31, 2017 through the quarter ended
December 31, 2018
(in thousands). This quarterly financial data is unaudited, but has been prepared on the same basis as the annual financial statements and, in the opinion of management, reflects all adjustments, consisting only of normal recurring adjustments necessary for a fair representation of the information for the periods presented. Operating results for any quarter are not necessarily indicative of results for any future period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2018 Quarter Ended
|
(in thousands)
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
Product sales
|
|
$
|
44,354
|
|
|
$
|
26,838
|
|
|
$
|
29,435
|
|
|
$
|
29,339
|
|
Total revenues
|
|
128,404
|
|
|
63,274
|
|
|
77,493
|
|
|
42,599
|
|
Gross margin on product sales
|
|
32,310
|
|
|
24,085
|
|
|
26,460
|
|
|
28,635
|
|
(Loss) income from operations
|
|
51,338
|
|
|
(4,225
|
)
|
|
9,628
|
|
|
(13,082
|
)
|
Net income (loss)
|
|
33,824
|
|
|
(21,048
|
)
|
|
48,270
|
|
|
(24,138
|
)
|
Basic net loss per share
|
|
$
|
0.53
|
|
|
$
|
(0.33
|
)
|
|
$
|
0.76
|
|
|
$
|
(0.38
|
)
|
Diluted net loss per share
|
|
$
|
0.48
|
|
|
$
|
(0.33
|
)
|
|
$
|
0.65
|
|
|
$
|
(0.38
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017 Quarter Ended
|
(in thousands)
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
Product sales
|
|
$
|
90,285
|
|
|
$
|
100,232
|
|
|
$
|
95,204
|
|
|
$
|
94,159
|
|
Total revenues
|
|
90,447
|
|
|
100,457
|
|
|
95,413
|
|
|
94,407
|
|
Gross margin on product sales
|
|
72,511
|
|
|
80,507
|
|
|
77,808
|
|
|
76,455
|
|
Loss from operations
|
|
(6,665
|
)
|
|
(4,068
|
)
|
|
1,238
|
|
|
(32,685
|
)
|
Net loss
|
|
(26,741
|
)
|
|
(26,659
|
)
|
|
(15,992
|
)
|
|
(33,104
|
)
|
Basic net loss per share
|
|
$
|
(0.43
|
)
|
|
$
|
(0.43
|
)
|
|
$
|
(0.25
|
)
|
|
$
|
(0.52
|
)
|
Diluted net loss per share
|
|
$
|
(0.43
|
)
|
|
$
|
(0.43
|
)
|
|
$
|
(0.25
|
)
|
|
$
|
(0.52
|
)
|