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(Mark one)
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ý
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934
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For the fiscal year ended December 31, 2018
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OR
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¨
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the transition period from: to
|
Delaware
(State or Other Jurisdiction of
Incorporation or Organization)
|
94‑3229046
(I.R.S. Employer
Identification No.)
|
100 South Saunders Road, Suite 300, Lake Forest, Illinois
(Address of Principal Executive Offices)
|
60045
(Zip Code)
|
Title of each class:
|
|
Name of each exchange on which registered:
|
Common Stock, $0.0001 par value
|
|
The NASDAQ Stock Market LLC
|
Large accelerated filer
¨
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Accelerated filer
ý
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Non‑accelerated filer
¨
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Smaller reporting company
¨
Emerging growth company
¨
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•
|
the commercial success and market acceptance of our products and product candidate, long-acting cosyntropin;
|
•
|
the success of Collegium Pharmaceutical, Inc. (Collegium) in commercializing NUCYNTA
®
ER and NUCYNTA
®
;
|
•
|
the reversal or any successful appeal of the court’s favorable ruling in our patent infringement litigation against the filers of Abbreviated New Drug Applications (each, an ANDA) to market generic versions of NUCYNTA ER and NUCYNTA in the United States (U.S.);
|
•
|
any additional patent infringement or other litigation, investigation or proceeding that may be instituted related to us or any of our products, product candidates or products we may acquire;
|
•
|
our ability to generate sufficient cash flow from our business to make payments on our indebtedness and our compliance with the terms and conditions of the agreements governing our indebtedness;
|
•
|
our and our collaborative partners’ compliance or non-compliance with legal and regulatory requirements related to the development or promotion of pharmaceutical products in the U.S.;
|
•
|
our plans to acquire, in-license or co-promote other products;
|
•
|
the results of our research and development efforts including clinical studies relating to our product candidates, including long-acting cosyntropin;
|
•
|
approval of regulatory filings, including filings for long-acting cosyntropin;
|
•
|
our ability to raise additional capital, if necessary;
|
•
|
our ability to successfully develop and execute our sales and marketing strategies;
|
•
|
variations in revenues obtained from commercialization and collaborative agreements, including contingent milestone payments, royalties, license fees and other contract revenues, including non-recurring revenues, and the accounting treatment with respect thereto;
|
•
|
our collaborative partners’ compliance or non-compliance with obligations under our collaboration agreements;
|
•
|
the outcome of both our opioid-related investigations, our opioid-related litigation brought by state and local governmental entities and private parties, and our insurance litigation, and the costs and expenses associated therewith;
|
•
|
the regulatory strategy for long-acting cosyntropin and both our and our collaborative partner’s ability to successfully develop and execute such strategy; and
|
•
|
our ability to attract and retain key executive leadership following our restructuring and office relocation.
|
•
|
Gralise
®
(gabapentin), a once daily product for the management of postherpetic neuralgia (PHN), that we launched in October 2011.
|
•
|
CAMBIA
®
(diclofenac potassium for oral solution), a non-steroidal anti-inflammatory drug for the acute treatment of migraine attacks, that we acquired in December 2013.
|
•
|
Zipsor
®
(diclofenac potassium liquid filled capsules), a non-steroidal anti-inflammatory drug for the treatment of mild to moderate acute pain, that we acquired in June 2012.
|
(1)
|
NUCYNTA ER and NUCYNTA product sales for 2018 reflect our sales of NUCYNTA between January 1 and January 8, 2018. See “Item 8. Financial Statements and Supplementary Data - Note 4. Revenue” for additional information.
|
(2)
|
NUCYNTA ER and NUCYNTA royalties from Collegium reflect royalties earned and inventory sold pursuant to the Commercialization Agreement after January 8, 2018. See “Item 8. Financial Statements and Supplementary Data - Note 4. Revenue” for additional information.
|
(3)
|
In November 2017, we entered into agreements with Slán Medicinal Holdings Limited and certain of its affiliates (Slán) pursuant to which Slán acquired our rights to Lazanda. Lazanda nasal spray is an intranasal fentanyl drug used to manage breakthrough pain in adults (18 years of age and older) who are already routinely taking other opioid pain medicines around‑the‑clock for cancer pain. We acquired Lazanda in July 2013 from Archimedes Pharma US Inc. and its affiliated companies.
|
|
Consolidated Revenue
|
|
Accounts Receivable related to product shipments
|
||||||||||||||
|
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
|
%
|
Product
|
|
U.S. Patent Nos. (Exp. Dates)
|
NUCYNTA
®
ER
|
|
8,536,130 (September 22, 2028)(1)(2)
|
|
|
7,994,364 (June 27, 2025)(1)(2)
|
|
|
RE39593 (August 5, 2022)(1)(2)
|
NUCYNTA
®
|
|
7,994,364 (June 27, 2025)(1)
|
|
|
RE39593 (August 5, 2022)(1)
|
Gralise
®
|
|
7,438,927 (February 26, 2024)
|
|
|
7,731,989 (October 25, 2022)
|
|
|
8,192,756 (October 25, 2022)
|
|
|
8,252,332 (October 25, 2022)
|
|
|
8,333,992 (October 25, 2022)
|
|
|
6,723,340 (October 25, 2021)
|
|
|
6,488,962 (June 20, 2020)
|
Zipsor
®
|
|
7,662,858 (February 24, 2029)
|
|
|
7,884,095 (February 24, 2029)
|
|
|
7,939,518 (February 24, 2029)
|
|
|
8,110,606 (February 24, 2029)
|
|
|
8,623,920 (February 24, 2029)
|
|
|
6,287,594 (January 15, 2019)
|
|
|
9,561,200 (February 24, 2029)
|
CAMBIA
®
|
|
7,759,394 (June 16, 2026) (1)
|
|
|
8,097,651 (June 16, 2026) (1)
|
|
|
8,927,604 (June 16, 2026) (1)
|
|
|
9,827,197 (June 16, 2026)
|
|
|
|
(1) Subject to six‑month pediatric patent term extension beyond scheduled expiration date.
(2) Patent rights are exclusively in‑licensed by us.
|
•
|
In Phase 1, we conduct clinical trials with a small number of subjects to determine a drug’s early safety profile and its pharmacokinetic pattern.
|
•
|
In Phase 2, we conduct limited clinical trials with groups of patients afflicted with a specific disease in order to determine preliminary efficacy, optimal dosages and further evidence of safety.
|
•
|
In Phase 3, we conduct large‑scale, multi‑center, comparative trials with patients afflicted with a target disease in order to provide enough data to statistically evaluate the efficacy and safety of the product candidate, as required by the FDA.
|
•
|
develop and execute its sales and marketing strategies for NUCYNTA and NUCYNTA ER;
|
•
|
achieve, maintain and grow market acceptance of, and demand for, NUCYNTA and NUCYNTA ER;
|
•
|
obtain and maintain adequate coverage, reimbursement and pricing from managed care, government and other third- party payers;
|
•
|
maintain and manage the necessary sales, marketing, manufacturing, managed markets, and other capabilities and infrastructure that are required to successfully integrate and commercialize NUCYNTA and NUCYNTA ER;
|
•
|
obtain adequate supply of NUCYNTA and NUCYNTA ER; and
|
•
|
comply with applicable legal and regulatory requirements.
|
•
|
Collegium may prioritize the commercialization of their other products, including Xtampza, over NUCYNTA and NUCYNTA ER;
|
•
|
Collegium may pursue higher-priority programs, or change the focus of its marketing programs;
|
•
|
Collegium may acquire or develop alternative products;
|
•
|
Collegium may in the future choose to devote fewer resources to NUCYNTA and NUCYNTA ER;
|
•
|
changes in laws and regulations applicable to, and scrutiny of, the pharmaceutical industry, including the opioid market;
|
•
|
market acceptance of NUCYNTA and NUCYNTA ER may fail to increase or may decrease;
|
•
|
the outcome of the appeal of the court’s ruling in our litigation against the Abbreviated New Drug Application (ANDA) filers seeking to prevent such ANDA filers from marketing a generic version of NUCYNTA and NUCYNTA ER in the U.S.;
|
•
|
Collegium may experience financial difficulties;
|
•
|
Collegium may fail to comply with its obligations under our commercialization and related agreements; or
|
•
|
Collegium’s involvement in governmental investigations and inquires or lawsuits and the disposition of such proceedings.
|
•
|
develop and execute our sales and marketing strategies for our products;
|
•
|
achieve, maintain and grow market acceptance of, and demand for, our products;
|
•
|
obtain and maintain adequate coverage, reimbursement and pricing from managed care, government and other third party payers;
|
•
|
maintain, manage or scale the necessary sales, marketing, manufacturing, managed markets, and other capabilities and infrastructure that are required to successfully integrate and commercialize our products;
|
•
|
obtain adequate supply of our products;
|
•
|
maintain and extend intellectual property protection for our products; and
|
•
|
comply with applicable legal and regulatory requirements.
|
•
|
any parallel development by a commercialization or collaborative partner of competitive technologies or products;
|
•
|
arrangements with commercialization or collaborative partners that limit or preclude us from developing products or technologies;
|
•
|
premature termination of a commercialization or collaboration agreement or the inability to renegotiate existing agreements on favorable terms; or
|
•
|
failure by a commercialization or collaborative partner to devote sufficient resources to the development and commercial sales of products using our current and potential future products and technologies.
|
•
|
government health administration authorities;
|
•
|
private health insurers;
|
•
|
health maintenance organizations;
|
•
|
managed care organizations;
|
•
|
pharmacy benefit management companies; and
|
•
|
other healthcare-related organizations.
|
•
|
negative or inconclusive results;
|
•
|
patient enrollment rates;
|
•
|
patient noncompliance with the protocol;
|
•
|
adverse medical events or side effects among patients during the clinical trials;
|
•
|
FDA inspections of our clinical operations;
|
•
|
failure to meet FDA preferred or recommended clinical trial design, end points or statistical power;
|
•
|
failure to comply with good clinical practices;
|
•
|
failure of our third party clinical trial vendors to comply with applicable regulatory laws and regulations;
|
•
|
compliance with applicable laws and regulations;
|
•
|
inability of our third party clinical trial vendors to satisfactorily perform their contractual obligations, comply with applicable laws and regulations or meet deadlines;
|
•
|
delays or failures in obtaining clinical materials and manufacturing sufficient quantities of the product candidate for use in our clinical trials
|
•
|
delays or failures in recruiting qualified patients to participate in our clinical trials; and
|
•
|
actual or perceived lack of efficacy or safety of the product candidate.
|
•
|
market acceptance;
|
•
|
a cost-effective commercial scale production; and
|
•
|
reimbursement under private or governmental health plans.
|
•
|
adversely affect our business, financial condition and results of operations;
|
•
|
result in reputational harm and reduced market acceptance and demand for our products;
|
•
|
harm our and our commercial partner’s ability to market our products;
|
•
|
cause us to incur significant liabilities, costs and expenses; and
|
•
|
cause our senior management to be distracted from execution of our business strategy.
|
•
|
we may be unable to maintain product liability insurance on acceptable terms;
|
•
|
we may be unable to obtain product liability insurance for future trials;
|
•
|
we may be unable to obtain product liability insurance for future products; or
|
•
|
our insurance may not provide adequate protection against potential liabilities (including pending and future claims relating to opioid litigation), or may provide no protection at all.
|
•
|
make it more difficult for us to meet our payment and other obligations under the Convertible Notes, the Senior Secured Notes or our other indebtedness;
|
•
|
result in other events of default under our Convertible Notes, Senior Secured Notes or our other indebtedness, which events of default could result in all of our debt becoming immediately due and payable;
|
•
|
make us more vulnerable to adverse changes in general economic, industry and competitive conditions and adverse changes in government regulation;
|
•
|
limit our ability to borrow additional amounts for working capital and other general corporate purposes, including funding possible acquisitions of, or investments in, new and complementary businesses, products and technologies which is a key element of our corporate strategy;
|
•
|
subject us to the risk of increased sensitivity to interest rate increases on our indebtedness with variable interest rates, including the Senior Notes;
|
•
|
require the dedication of a substantial portion of our cash flow from operations to service our indebtedness, thereby reducing the amount of our cash flow available for other purposes, including working capital, clinical trials, research and development, business development activities, capital expenditures and other general corporate purposes;
|
•
|
prevent us from raising funds necessary to repurchase the Convertible Notes in the event we are required to do so following a “fundamental change,” as specified in the indenture governing the Convertible Notes, to repurchase the Senior Notes in the event we are required to do so following a “major transaction” or as required in the event that the principal amount outstanding under the Convertible Notes as of March 31, 2021 is greater than $100.0 million, as specified in the Note Purchase Agreement or to settle conversions of the Convertible Notes in cash;
|
•
|
result in dilution to our existing shareholders as a result of the conversion of the Convertible Notes into shares of common stock;
|
•
|
limit our flexibility in planning for, or reacting to, changes in our business and our industry; and
|
•
|
put us at a disadvantage compared to our competitors who have less debt.
|
•
|
minimize the disruption and distraction of our management and other employees, including our sales force, in connection with the integration of any acquired business, product or technology;
|
•
|
maintain and increase sales of our existing products;
|
•
|
establish or manage the transition of the manufacture and supply of any acquired product, including the necessary active pharmaceutical ingredients, excipients and components;
|
•
|
identify and add the necessary sales, marketing, manufacturing, regulatory and other related personnel, capabilities and infrastructure that are required to successfully integrate any acquired business, product or technology;
|
•
|
manage the transition and migration of all commercial, financial, legal, clinical, regulatory and other pertinent information relating to any acquired business, product or technology;
|
•
|
comply with legal, regulatory and contractual requirements applicable to any acquired business, product or technology;
|
•
|
obtain and maintain adequate coverage, reimbursement and pricing from managed care, government and other third- party payers with respect to any acquired product; and
|
•
|
maintain and extend intellectual property protection for any acquired product or technology.
|
•
|
the degree of commercial success and market acceptance of NUCYNTA and NUCYNTA ER achieved by Collegium;
|
•
|
the degree of commercial success and market acceptance of Gralise, CAMBIA and Zipsor achieved;
|
•
|
the current and future market conditions for short-acting and long-acting opioids;
|
•
|
filings and other regulatory or governmental actions, investigations or proceedings related to our products and product candidate and those of our commercialization and collaborative partners;
|
•
|
the outcome of the appeal of the court’s favorable ruling in our patent infringement litigation against the filers of ANDAs for NUCYNTA and NUCYNTA ER;
|
•
|
the regulatory strategy for long-acting cosyntropin and our and our collaborative partner’s ability to successfully develop and execute such strategy;
|
•
|
our ability to successfully commercialize long-acting cosyntropin if regulatory approval is obtained;
|
•
|
developments concerning proprietary rights, including patents, infringement allegations, inter party review proceedings and litigation matters;
|
•
|
legal and regulatory developments in the U.S.;
|
•
|
actions taken by industry stakeholders affecting the market for our products;
|
•
|
our ability to generate sufficient cash flow from our business to make payments on our indebtedness;
|
•
|
our and our commercialization and collaborative partners’ compliance or non-compliance with legal and regulatory requirements and with obligations under our collaborative agreements;
|
•
|
our ability to successfully develop and execute our sales and marketing strategies;
|
•
|
our plans to acquire, in-license or co-promote other products, compounds or acquire or combine with other companies, and our degree of success in realizing the intended advantages of, and mitigating any risks associated with, any such transaction;
|
•
|
adverse events related to our products, including recalls;
|
•
|
interruptions of manufacturing or supply, or other manufacture or supply difficulties;
|
•
|
variations in revenues obtained from commercialization and collaborative agreements, including contingent milestone payments, royalties, license fees and other contract revenues, including non-recurring revenues, and the accounting treatment with respect thereto;
|
•
|
adverse events or circumstances related to our peer companies or our industry or the markets for our products;
|
•
|
adoption of new technologies by us or our competitors;
|
•
|
the outcome of our opioid-related investigations and litigation;
|
•
|
the outcome and impact of a proxy contest initiated by an activist shareholder;
|
•
|
our compliance with the terms and conditions of the agreements governing our indebtedness;
|
•
|
decisions by collaborative partners to proceed or not to proceed with subsequent phases of a collaboration or program;
|
•
|
our ability to generate additional revenues from our intellectual property rights;
|
•
|
sales of large blocks of our common stock or the dilutive effect of our Convertible Notes; and
|
•
|
variations in our operating results, earnings per share, cash flows from operating activities, deferred revenue, and other financial metrics and non-financial metrics, and how those results are measured, presented and compare to analyst expectations.
|
•
|
responding to proxy contests and other actions by activist stockholders can be costly and time-consuming, disrupting our operations and diverting the attention of management and our employees;
|
•
|
perceived uncertainties as to our future direction may result in the loss of potential business opportunities and may make it more difficult to attract and retain qualified personnel, business partners, customers and others important to our success, any of which could negatively affect our business and our results of operations and financial condition; and
|
•
|
if nominees advanced by activist shareholders are elected or appointed to our Board of Directors with a specific agenda, it may adversely affect our ability to effectively and timely implement our strategic plans or to realize long-term value from our assets, and this could in turn have an adverse effect on our business and on our results of operations and financial condition.
|
|
12/31/2013
|
|
12/31/2014
|
|
12/31/2015
|
|
12/31/2016
|
|
12/31/2017
|
|
12/31/2018
|
|
||||||
Assertio Therapeutics, Inc.
|
$
|
100
|
|
$
|
152
|
|
$
|
171
|
|
$
|
170
|
|
$
|
76
|
|
$
|
34
|
|
NASDAQ Composite Index
|
$
|
100
|
|
$
|
113
|
|
$
|
120
|
|
$
|
129
|
|
$
|
165
|
|
$
|
159
|
|
NASDAQ Pharmaceutical Index
|
$
|
100
|
|
$
|
114
|
|
$
|
116
|
|
$
|
103
|
|
$
|
116
|
|
$
|
122
|
|
Consolidated Statement of Operations Data (in thousands, except per share amounts)
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
Revenues:
|
|
|
|
|
|
|
|
|
|
||||||||||
Product sales, net
|
129,966
|
|
|
$
|
379,880
|
|
|
$
|
455,066
|
|
|
$
|
341,750
|
|
|
$
|
114,219
|
|
|
Royalties and milestones
|
26,061
|
|
|
844
|
|
|
831
|
|
|
985
|
|
|
1,821
|
|
|||||
Commercialization Agreement and other revenue
(1)
|
155,743
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
31,515
|
|
|||||
Non-cash PDL royalty revenue
(1)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
242,808
|
|
|||||
Total revenues
|
311,770
|
|
|
380,724
|
|
|
455,897
|
|
|
342,735
|
|
|
390,363
|
|
|||||
Total costs and expenses
|
268,111
|
|
|
422,904
|
|
|
431,388
|
|
|
393,135
|
|
|
153,549
|
|
|||||
Income (loss) from operations
|
43,659
|
|
|
(42,180
|
)
|
|
24,509
|
|
|
(50,400
|
)
|
|
236,814
|
|
|||||
Net income (loss) before income taxes
|
37,975
|
|
|
(103,925
|
)
|
|
(64,502
|
)
|
|
(123,237
|
)
|
|
213,108
|
|
|||||
Benefit from (provision for) income taxes
|
(1,067
|
)
|
|
1,429
|
|
|
(24,218
|
)
|
|
47,499
|
|
|
(81,346
|
)
|
|||||
Net income (loss)
|
36,908
|
|
|
$
|
(102,496
|
)
|
|
$
|
(88,720
|
)
|
|
$
|
(75,738
|
)
|
|
$
|
131,762
|
|
|
Basic net income (loss) per share
|
$
|
0.58
|
|
|
$
|
(1.63
|
)
|
|
$
|
(1.45
|
)
|
|
$
|
(1.26
|
)
|
|
$
|
2.26
|
|
Diluted net income (loss) per share
|
$
|
0.57
|
|
|
$
|
(1.63
|
)
|
|
$
|
(1.45
|
)
|
|
$
|
(1.26
|
)
|
|
$
|
2.05
|
|
Shares used in computing basic net income (loss) per share
|
63,794
|
|
|
62,702
|
|
|
61,297
|
|
|
60,117
|
|
|
58,293
|
|
|||||
Shares used in computing diluted net income (loss) per share
|
64,208
|
|
|
62,702
|
|
|
61,297
|
|
|
60,117
|
|
|
66,307
|
|
|
2018
|
|
2017
|
|
2016
|
|
2015
|
|
2014
|
||||||||||
Consolidated Balance Sheet Data (in thousands)
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents and short term investments
(3)
|
$
|
110,949
|
|
|
$
|
128,089
|
|
|
$
|
177,420
|
|
|
$
|
209,768
|
|
|
$
|
566,402
|
|
Total assets
|
932,866
|
|
|
1,038,617
|
|
|
1,225,337
|
|
|
1,357,249
|
|
|
711,065
|
|
|||||
Total current liabilities
(1)(2)
|
246,036
|
|
|
310,580
|
|
|
227,242
|
|
|
219,632
|
|
|
57,499
|
|
|||||
Contingent consideration liability, non-current
|
1,038
|
|
|
1,457
|
|
|
10,247
|
|
|
11,653
|
|
|
14,252
|
|
|||||
Senior Notes
(3)
|
158,309
|
|
|
274,720
|
|
|
466,051
|
|
|
563,012
|
|
|
—
|
|
|||||
Convertible Notes
|
287,798
|
|
|
269,510
|
|
|
252,725
|
|
|
237,313
|
|
|
223,150
|
|
|||||
Other long-term liabilities
|
19,350
|
|
|
12,842
|
|
|
18,284
|
|
|
10,584
|
|
|
12,387
|
|
|||||
Accumulated (deficit) earnings
|
(182,600
|
)
|
|
(219,508
|
)
|
|
(116,744
|
)
|
|
(28,024
|
)
|
|
47,717
|
|
|||||
Total shareholders’ equity
|
220,335
|
|
|
169,508
|
|
|
250,788
|
|
|
315,055
|
|
|
364,447
|
|
|
(1)
|
Effective January 8, 2018, the Company entered into a Commercialization Agreement to sub-license NUCYNTA, which results in royalty income. The Company recognized the entire remaining balance of the liability related to sale of future royalties and milestones of approximately $147.0 million as non‑cash PDL royalty revenue during 2014.
|
(2)
|
The increase in current liabilities as of December 31, 2017, is primarily due to the reclassification of principal payments due on our Senior Notes in 2018. The increase in total current liabilities as of December 31, 2015 is primarily due to the acquisition of NUCYNTA in April 2015.
|
(3)
|
The Company made principal payments of $82.5 million in 2018. The Company prepaid $114.4 million and $105.0 million of its Senior Notes, including prepayment premiums of $4.4 million and $5.0 million in 2017 and 2016, respectively.
|
•
|
Gralise
®
(gabapentin), a once daily product for the management of postherpetic neuralgia (PHN), that we launched in October 2011.
|
•
|
CAMBIA
®
(diclofenac potassium for oral solution), a non-steroidal anti-inflammatory drug for the acute treatment of migraine attacks, that we acquired in December 2013.
|
•
|
Zipsor
®
(diclofenac potassium liquid filled capsules), a non-steroidal anti-inflammatory drug for the treatment of mild to moderate acute pain, that we acquired in June 2012.
|
(in thousands)
|
|
Contract Sales
Discounts (1)(2)
|
|
Product Returns (2)
|
|
Cash
Discounts (2)
|
|
Total
|
||||||||
Balance at December 31, 2015
|
|
$
|
103,031
|
|
|
$
|
18,027
|
|
|
$
|
1,458
|
|
|
$
|
122,516
|
|
Revenue Allowances:
|
|
|
|
|
|
|
|
|
||||||||
Provision related to current period sales
|
|
314,611
|
|
|
9,997
|
|
|
15,898
|
|
|
340,506
|
|
||||
Changes in estimates related to sales made in prior years
|
|
549
|
|
|
(1,961
|
)
|
|
—
|
|
|
(1,412
|
)
|
||||
Payments and credits related to sales made in current period
|
|
(206,684
|
)
|
|
—
|
|
|
(13,789
|
)
|
|
(220,473
|
)
|
||||
Payments and credits related to sales made in prior periods
|
|
(103,580
|
)
|
|
(2,454
|
)
|
|
(1,457
|
)
|
|
(107,491
|
)
|
||||
Balance at December 31, 2016
|
|
$
|
107,927
|
|
|
$
|
23,609
|
|
|
$
|
2,110
|
|
|
$
|
133,646
|
|
Revenue Allowances:
|
|
|
|
|
|
|
|
|
||||||||
Provision related to current period sales
|
|
325,489
|
|
|
13,555
|
|
|
14,858
|
|
|
353,902
|
|
||||
Changes in estimates related to sales made in prior years
|
|
1,483
|
|
|
7,875
|
|
|
—
|
|
|
9,358
|
|
||||
Payments and credits related to sales made in current period
|
|
(224,002
|
)
|
|
—
|
|
|
(13,358
|
)
|
|
(237,360
|
)
|
||||
Payments and credits related to sales made in prior periods
|
|
(104,751
|
)
|
|
(15,357
|
)
|
|
(2,110
|
)
|
|
(122,218
|
)
|
||||
Balance at December 31, 2017
|
|
$
|
106,146
|
|
|
$
|
29,682
|
|
|
$
|
1,500
|
|
|
$
|
137,328
|
|
Revenue Allowances:
|
|
|
|
|
|
|
|
|
||||||||
Provision related to current period sales
|
|
123,623
|
|
|
5,716
|
|
|
5,024
|
|
|
134,363
|
|
||||
Changes in estimates related to sales made in prior years
|
|
(19,210
|
)
|
|
7,327
|
|
|
—
|
|
|
(11,883
|
)
|
||||
Payments and credits related to sales made in current period
|
|
(75,380
|
)
|
|
—
|
|
|
(4,605
|
)
|
|
(79,985
|
)
|
||||
Payments and credits related to sales made in prior periods
|
|
(86,936
|
)
|
|
(14,986
|
)
|
|
(1,500
|
)
|
|
(103,422
|
)
|
||||
Balance at December 31, 2018
|
|
$
|
48,243
|
|
|
$
|
27,739
|
|
|
$
|
419
|
|
|
$
|
76,401
|
|
|
(1)
|
Includes wholesaler fees and retail discounts, patient support programs, managed care rebates, and government chargebacks and rebates.
|
(2)
|
In November 2017 we divested the rights to Lazanda to Slán. In January 2018, we entered into an agreement which granted commercialization rights of NUCYNTA to Collegium. NUCYNTA was acquired from Janssen Pharma in April 2015.
|
(in thousands)
|
|
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
(1)
|
|
18,944
|
|
|
239,539
|
|
|
281,261
|
|
|||
Lazanda
(2)
|
|
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
|
|
(1)
|
NUCYNTA product sales for the year ended December 31, 2018 reflect our sales of NUCYNTA between January 1 and January 8, 2018. During the year ended December 31, 2018, we recognized sales reserve estimate adjustments related to sales recognized for NUCYNTA and Lazanda in prior periods. During the first quarter of 2018, in connection with the Collegium transaction, we recognized 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.
|
(2)
|
We divested Lazanda in November 2017. Product sales for the year ended December 31, 2018 relate to sales reserve estimate adjustments.
|
(in thousands)
|
|
2018
|
|
2017
|
|
2016
|
||||||
Cost of Sales
|
|
$
|
18,476
|
|
|
$
|
72,598
|
|
|
$
|
87,414
|
|
Dollar change from prior year
|
|
(54,122
|
)
|
|
(14,816
|
)
|
|
19,516
|
|
|||
Percentage change from prior year
|
|
-74.6
|
%
|
|
-16.9
|
%
|
|
28.7
|
%
|
(in thousands)
|
|
2018
|
|
2017
|
|
2016
|
||||||
Research and development expenses
|
|
$
|
8,042
|
|
|
$
|
13,718
|
|
|
$
|
32,631
|
|
Dollar change from prior year
|
|
(5,676
|
)
|
|
(18,913
|
)
|
|
15,090
|
|
|||
Percentage change from prior year
|
|
-41.4
|
%
|
|
-58.0
|
%
|
|
86.0
|
%
|
|||
Acquired in-process research and development
|
|
$
|
—
|
|
|
24,900
|
|
|
$
|
—
|
|
(in thousands)
|
|
2018
|
|
2017
|
|
2016
|
||||||
Selling, general and administrative expenses
|
|
$
|
119,218
|
|
|
$
|
195,696
|
|
|
$
|
204,498
|
|
Dollar change from prior year
|
|
(76,478
|
)
|
|
(8,802
|
)
|
|
5,146
|
|
|||
Percentage change from prior year
|
|
-39.1
|
%
|
|
-4.3
|
%
|
|
2.6
|
%
|
(in thousands)
|
|
2018
|
|
2017
|
|
2016
|
||||||
Amortization of intangible assets—NUCYNTA
|
|
$
|
94,301
|
|
|
$
|
94,302
|
|
|
$
|
98,207
|
|
Amortization of intangible assets—CAMBIA
|
|
5,136
|
|
|
5,136
|
|
|
5,136
|
|
|||
Amortization of intangible assets—Zipsor
|
|
2,337
|
|
|
2,337
|
|
|
2,337
|
|
|||
Amortization of intangible assets—Lazanda
|
|
—
|
|
|
970
|
|
|
1,165
|
|
|||
Total amortization of intangible assets
|
|
$
|
101,774
|
|
|
$
|
102,745
|
|
|
$
|
106,845
|
|
(in thousands)
|
|
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
|
|
|
$
|
—
|
|
(in thousands)
|
|
2018
|
|
2017
|
|
2016
|
||||||
Litigation settlement
|
|
$
|
62,000
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Gain on divestiture of Lazanda
|
|
—
|
|
|
17,064
|
|
|
—
|
|
|||
Interest and other income
|
|
1,197
|
|
|
681
|
|
|
485
|
|
|||
Loss on prepayment of Senior Notes
|
|
—
|
|
|
(5,938
|
)
|
|
(5,777
|
)
|
|||
Interest expense
|
|
$
|
(68,881
|
)
|
|
$
|
(73,552
|
)
|
|
$
|
(83,719
|
)
|
|
|
$
|
(5,684
|
)
|
|
$
|
(61,745
|
)
|
|
$
|
(89,011
|
)
|
|
|
As of December 31,
|
||||||
(in thousands)
|
|
2018
|
|
2017
|
||||
Cash, cash equivalents and short-term investments
|
|
$
|
110,949
|
|
|
$
|
128,089
|
|
•
|
payments from Collegium pursuant to our Commercialization Agreement;
|
•
|
acquisitions or licenses of complementary businesses, products, technologies or companies;
|
•
|
sales of our marketed products;
|
•
|
expenditures related to our commercialization of Gralise, CAMBIA, and Zipsor;
|
•
|
expenditures related to our product candidates;
|
•
|
milestone and royalty revenue we receive under our collaborative development arrangements;
|
•
|
interest and principal payments on our current and future indebtedness;
|
•
|
financial terms of definitive license agreements or other commercial agreements we may enter into; and
|
•
|
changes in the focus and direction of our business strategy and/or research and development programs.
|
|
|
Year ended December 31,
|
||||||||||
(in thousands)
|
|
2018
|
|
2017
|
|
2016
|
||||||
Cash provided by operating activities
|
|
$
|
72,497
|
|
|
$
|
62,167
|
|
|
71,263
|
|
|
Cash (used in) provided by investing activities
|
|
(7,082
|
)
|
|
57,894
|
|
|
45,536
|
|
|||
Cash (used in) financing activities
|
|
(81,350
|
)
|
|
(110,886
|
)
|
|
(100,174
|
)
|
|||
Net (decrease) increase in cash and cash equivalents
|
|
$
|
(15,935
|
)
|
|
$
|
9,175
|
|
|
$
|
16,625
|
|
|
|
|
|
|
|
|
|
More than
|
|
|
||||||||||
(in thousands)
|
|
1 Year
|
|
2 - 3 Years
|
|
4 - 5 Years
|
|
5 Years
|
|
Total
|
||||||||||
Senior Notes—principal
|
|
$
|
120,000
|
|
|
162,500
|
|
|
—
|
|
|
—
|
|
|
$
|
282,500
|
|
|||
Senior Notes—interest
|
|
26,125
|
|
|
16,993
|
|
|
—
|
|
|
—
|
|
|
43,118
|
|
|||||
Convertible Debt—principal
|
|
—
|
|
|
345,000
|
|
|
|
|
|
—
|
|
|
345,000
|
|
|||||
Convertible Debt—interest
|
|
8,625
|
|
|
17,250
|
|
|
—
|
|
|
—
|
|
|
25,875
|
|
|||||
Operating leases
(1)
|
|
2,624
|
|
|
4,848
|
|
|
2,820
|
|
|
—
|
|
|
10,292
|
|
|||||
Purchase commitments
|
|
3,000
|
|
|
3,000
|
|
|
—
|
|
|
—
|
|
|
6,000
|
|
|||||
Total
|
|
$
|
160,374
|
|
|
$
|
549,591
|
|
|
$
|
2,820
|
|
|
$
|
—
|
|
|
$
|
712,785
|
|
|
(1)
|
Amounts represent payments under a non‑cancelable office and laboratory lease and under an operating lease for vehicles used by our sales force.
|
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
110,949
|
|
|
$
|
126,884
|
|
Short-term investments
|
—
|
|
|
1,205
|
|
||
Accounts receivable, net
|
37,211
|
|
|
72,482
|
|
||
Inventories, net
|
3,396
|
|
|
13,042
|
|
||
Prepaid and other current assets
|
56,551
|
|
|
17,238
|
|
||
Total current assets
|
208,107
|
|
|
230,851
|
|
||
Property and equipment, net
|
13,064
|
|
|
13,024
|
|
||
Intangible assets, net
|
692,099
|
|
|
793,873
|
|
||
Investments
|
11,784
|
|
|
—
|
|
||
Other long-term assets
|
7,812
|
|
|
869
|
|
||
Total assets
|
$
|
932,866
|
|
|
$
|
1,038,617
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
6,138
|
|
|
$
|
14,732
|
|
Accrued rebates, returns and discounts
|
75,759
|
|
|
135,828
|
|
||
Accrued liabilities
|
31,361
|
|
|
60,496
|
|
||
Income taxes payable
|
—
|
|
|
126
|
|
||
Current portion of Senior Notes
|
120,000
|
|
|
82,500
|
|
||
Contingent consideration liability, current portion
|
—
|
|
|
156
|
|
||
Interest payable
|
11,645
|
|
|
13,220
|
|
||
Other current liabilities
|
1,133
|
|
|
3,522
|
|
||
Total current liabilities
|
246,036
|
|
|
310,580
|
|
||
Contingent consideration liability, long-term portion
|
1,038
|
|
|
1,457
|
|
||
Senior Notes
|
158,309
|
|
|
274,720
|
|
||
Convertible Notes
|
287,798
|
|
|
269,510
|
|
||
Other long-term liabilities
|
19,350
|
|
|
12,842
|
|
||
Total liabilities
|
712,531
|
|
|
869,109
|
|
||
Commitments and contingencies
|
|
|
|
||||
Shareholders’ equity:
|
|
|
|
||||
Common stock, $0.0001 par value, 200,000,000 shares authorized; 64,185,224 and 63,400,348 shares issued and outstanding at December 31, 2018 and
December 31, 2017, respectively |
6
|
|
|
6
|
|
||
Additional paid-in capital
|
402,934
|
|
|
389,015
|
|
||
Accumulated deficit
|
(182,600
|
)
|
|
(219,508
|
)
|
||
Accumulated other comprehensive loss
|
(5
|
)
|
|
(5
|
)
|
||
Total shareholders’ equity
|
220,335
|
|
|
169,508
|
|
||
Total liabilities and shareholders' equity
|
$
|
932,866
|
|
|
$
|
1,038,617
|
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Revenues:
|
|
|
|
|
|
||||||
Product sales, net
|
$
|
129,966
|
|
|
$
|
379,880
|
|
|
$
|
455,066
|
|
Commercialization agreement, net
|
155,743
|
|
|
—
|
|
|
—
|
|
|||
Royalties and milestones
|
26,061
|
|
|
844
|
|
|
831
|
|
|||
Total revenues
|
311,770
|
|
|
380,724
|
|
|
455,897
|
|
|||
Costs and expenses:
|
|
|
|
|
|
||||||
Cost of sales (excluding amortization of intangible assets)
|
18,476
|
|
|
72,598
|
|
|
87,414
|
|
|||
Research and development expenses
|
8,042
|
|
|
13,718
|
|
|
32,631
|
|
|||
Acquired in-process research and development
|
—
|
|
|
24,900
|
|
|
—
|
|
|||
Selling, general and administrative expenses
|
119,218
|
|
|
195,696
|
|
|
204,498
|
|
|||
Amortization of intangible assets
|
101,774
|
|
|
102,745
|
|
|
106,845
|
|
|||
Restructuring charges
|
20,601
|
|
|
13,247
|
|
|
—
|
|
|||
Total costs and expenses
|
268,111
|
|
|
422,904
|
|
|
431,388
|
|
|||
Income (loss) from operations
|
43,659
|
|
|
(42,180
|
)
|
|
24,509
|
|
|||
Other income (expense):
|
|
|
|
|
|
||||||
Litigation settlement
|
62,000
|
|
|
—
|
|
|
—
|
|
|||
Gain on divestiture of Lazanda
|
—
|
|
|
17,064
|
|
|
—
|
|
|||
Interest and other income
|
1,197
|
|
|
681
|
|
|
485
|
|
|||
Loss on prepayment of Senior Notes
|
—
|
|
|
(5,938
|
)
|
|
(5,777
|
)
|
|||
Interest expense
|
(68,881
|
)
|
|
(73,552
|
)
|
|
(83,719
|
)
|
|||
Income (loss) before income taxes
|
37,975
|
|
|
(103,925
|
)
|
|
(64,502
|
)
|
|||
Income tax (expense) benefit
|
(1,067
|
)
|
|
1,429
|
|
|
(24,218
|
)
|
|||
Net income (loss)
|
$
|
36,908
|
|
|
$
|
(102,496
|
)
|
|
$
|
(88,720
|
)
|
Basic net income (loss) per share
|
$
|
0.58
|
|
|
$
|
(1.63
|
)
|
|
$
|
(1.45
|
)
|
Diluted net income (loss) per share
|
$
|
0.57
|
|
|
$
|
(1.63
|
)
|
|
$
|
(1.45
|
)
|
Shares used in computing basic net income (loss) per share
|
63,794
|
|
|
62,702
|
|
|
61,297
|
|
|||
Shares used in computing diluted net income (loss) per share
|
64,208
|
|
|
62,702
|
|
|
61,297
|
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Net income (loss)
|
$
|
36,908
|
|
|
$
|
(102,496
|
)
|
|
$
|
(88,720
|
)
|
Unrealized gain on available-for-sale securities, net of tax
|
—
|
|
|
14
|
|
|
35
|
|
|||
Comprehensive income (loss)
|
$
|
36,908
|
|
|
$
|
(102,482
|
)
|
|
$
|
(88,685
|
)
|
|
Common Stock
|
|
Additional
Paid-In
Capital
|
|
Accumulated
Earnings
(Deficit)
|
|
Accumulated
Other
Comprehensive
Loss
|
|
Shareholders’
Equity
|
|||||||||||||
|
Shares
|
|
Amount
|
|
|
|
|
|||||||||||||||
Balances at December 31, 2015
|
60,787
|
|
|
$
|
264,511
|
|
|
$
|
78,622
|
|
|
$
|
(28,024
|
)
|
|
$
|
(54
|
)
|
|
$
|
315,055
|
|
Reclassification due to reincorporation
|
|
|
(264,505
|
)
|
|
264,505
|
|
|
|
|
|
|
|
|||||||||
Balances at December 31, 2015
|
60,787
|
|
|
6
|
|
|
343,127
|
|
|
(28,024
|
)
|
|
(54
|
)
|
|
315,055
|
|
|||||
Issuance of common stock upon exercise of options
|
716
|
|
|
—
|
|
|
6,693
|
|
|
—
|
|
|
—
|
|
|
6,693
|
|
|||||
Issuance of common stock under employee stock purchase plan
|
201
|
|
|
—
|
|
|
3,258
|
|
|
—
|
|
|
—
|
|
|
3,258
|
|
|||||
Issuance of common stock in conjunction with vesting of restricted stock units
|
262
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
17,172
|
|
|
—
|
|
|
—
|
|
|
17,172
|
|
|||||
Shares withheld for payment of employee's withholding tax liability
|
—
|
|
|
—
|
|
|
(3,342
|
)
|
|
—
|
|
|
—
|
|
|
(3,342
|
)
|
|||||
Windfall tax benefit
|
—
|
|
|
—
|
|
|
637
|
|
|
—
|
|
|
—
|
|
|
637
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(88,720
|
)
|
|
—
|
|
|
(88,720
|
)
|
|||||
Unrealized gain on available-for-sale securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
35
|
|
|
35
|
|
|||||
Balances at December 31, 2016
|
61,966
|
|
|
$
|
6
|
|
|
$
|
367,545
|
|
|
$
|
(116,744
|
)
|
|
$
|
(19
|
)
|
|
$
|
250,788
|
|
Issuance of common stock upon exercise of options
|
1,001
|
|
|
—
|
|
|
6,979
|
|
|
—
|
|
|
—
|
|
|
6,979
|
|
|||||
Issuance of common stock under employee stock purchase plan
|
262
|
|
|
—
|
|
|
1,960
|
|
|
—
|
|
|
—
|
|
|
1,960
|
|
|||||
Issuance of common stock in conjunction with vesting of restricted stock units
|
171
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
13,016
|
|
|
—
|
|
|
—
|
|
|
13,016
|
|
|||||
Cumulative effect adjustment from adoption of ASU No. 2016-09
|
—
|
|
|
—
|
|
|
268
|
|
|
(268
|
)
|
|
—
|
|
|
—
|
|
|||||
Shares withheld for payment of employee's withholding tax liability
|
—
|
|
|
—
|
|
|
(753
|
)
|
|
—
|
|
|
—
|
|
|
(753
|
)
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(102,496
|
)
|
|
—
|
|
|
(102,496
|
)
|
|||||
Unrealized gain on available-for-sale securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
14
|
|
|
14
|
|
|||||
Balances at December 31, 2017
|
63,400
|
|
|
$
|
6
|
|
|
$
|
389,015
|
|
|
$
|
(219,508
|
)
|
|
$
|
(5
|
)
|
|
$
|
169,508
|
|
Issuance of common stock upon exercise of options
|
278
|
|
|
—
|
|
|
1,493
|
|
|
—
|
|
|
—
|
|
|
1,493
|
|
|||||
Issuance of common stock under employee stock purchase plan
|
107
|
|
|
—
|
|
|
527
|
|
|
—
|
|
|
—
|
|
|
527
|
|
|||||
Issuance of common stock in conjunction with vesting of restricted stock units
|
400
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
12,585
|
|
|
—
|
|
|
—
|
|
|
12,585
|
|
|||||
Shares withheld for payment of employee's withholding tax liability
|
—
|
|
|
—
|
|
|
(686
|
)
|
|
—
|
|
|
—
|
|
|
(686
|
)
|
|||||
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
36,908
|
|
|
—
|
|
|
36,908
|
|
|||||
Balances at December 31, 2018
|
64,185
|
|
|
$
|
6
|
|
|
$
|
402,934
|
|
|
$
|
(182,600
|
)
|
|
$
|
(5
|
)
|
|
$
|
220,335
|
|
|
Year Ended December 31,
|
||||||||||
|
2018
|
|
2017
|
|
2016
|
||||||
Operating Activities
|
|
|
|
|
|
||||||
Net income (loss)
|
$
|
36,908
|
|
|
$
|
(102,496
|
)
|
|
$
|
(88,720
|
)
|
Adjustments for non-cash items:
|
|
|
|
|
|
||||||
Depreciation and amortization
|
106,426
|
|
|
105,502
|
|
|
109,375
|
|
|||
Accretion of debt discount and debt issuance costs
|
21,877
|
|
|
19,415
|
|
|
17,673
|
|
|||
Loss on prepayment of Senior Notes
|
—
|
|
|
5,938
|
|
|
5,777
|
|
|||
Provision for inventory obsolescence
|
598
|
|
|
2,673
|
|
|
1,179
|
|
|||
(Gain) loss on disposal of property and equipment
|
669
|
|
|
(271
|
)
|
|
—
|
|
|||
Stock-based compensation
|
12,585
|
|
|
13,016
|
|
|
17,172
|
|
|||
Change in fair value of contingent consideration
|
(391
|
)
|
|
(8,024
|
)
|
|
1,637
|
|
|||
Deferred income taxes
|
—
|
|
|
—
|
|
|
23,632
|
|
|||
Gain on divestiture of Lazanda
|
—
|
|
|
(17,064
|
)
|
|
—
|
|
|||
Acquired in-process research and development
|
—
|
|
|
24,900
|
|
|
—
|
|
|||
Other
|
1,023
|
|
|
240
|
|
|
611
|
|
|||
Changes in assets and liabilities:
|
|
|
|
|
|
||||||
Accounts receivable
|
35,271
|
|
|
30,107
|
|
|
(30,902
|
)
|
|||
Inventories
|
9,048
|
|
|
(1,873
|
)
|
|
(3,718
|
)
|
|||
Prepaid and other assets
|
(56,136
|
)
|
|
(5,114
|
)
|
|
(2,464
|
)
|
|||
Income taxes receivable
|
—
|
|
|
—
|
|
|
6,359
|
|
|||
Accounts payable and other accrued liabilities
|
(33,610
|
)
|
|
(6,436
|
)
|
|
5,862
|
|
|||
Accrued rebates, returns and discounts
|
(60,069
|
)
|
|
4,292
|
|
|
10,478
|
|
|||
Interest payable
|
(1,576
|
)
|
|
(2,705
|
)
|
|
(2,747
|
)
|
|||
Income taxes payable
|
(126
|
)
|
|
67
|
|
|
59
|
|
|||
Net cash provided by operating activities
|
72,497
|
|
|
62,167
|
|
|
71,263
|
|
|||
Investing Activities
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(5,507
|
)
|
|
(666
|
)
|
|
(2,860
|
)
|
|||
Investment in convertible instrument
|
(3,000
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from disposal of property and equipment
|
145
|
|
|
280
|
|
|
—
|
|
|||
Purchases of marketable securities
|
—
|
|
|
(8,277
|
)
|
|
(68,818
|
)
|
|||
Proceeds from sale of other assets
|
80
|
|
|
66,557
|
|
|
115,207
|
|
|||
Sales of marketable securities
|
1,200
|
|
|
—
|
|
|
2,007
|
|
|||
Net cash provided (used in) by investing activities
|
(7,082
|
)
|
|
57,894
|
|
|
45,536
|
|
|||
Financing Activities
|
|
|
|
|
|
||||||
Payment of contingent consideration liability
|
(184
|
)
|
|
(1,673
|
)
|
|
(1,783
|
)
|
|||
Repayment of Senior Notes
|
(82,500
|
)
|
|
(110,000
|
)
|
|
(100,000
|
)
|
|||
Fees for early repayment and modifications of Senior Notes
|
—
|
|
|
(7,400
|
)
|
|
(5,000
|
)
|
|||
Proceeds from issuance of common stock
|
2,020
|
|
|
8,940
|
|
|
9,951
|
|
|||
Shares withheld for payment of employee's withholding tax liability
|
(686
|
)
|
|
(753
|
)
|
|
(3,342
|
)
|
|||
Net cash (used in) financing activities
|
(81,350
|
)
|
|
(110,886
|
)
|
|
(100,174
|
)
|
|||
Net increase (decrease) in cash and cash equivalents
|
(15,935
|
)
|
|
9,175
|
|
|
16,625
|
|
|||
Cash and cash equivalents at beginning of year
|
126,884
|
|
|
117,709
|
|
|
101,084
|
|
|||
Cash and cash equivalents at end of period
|
$
|
110,949
|
|
|
$
|
126,884
|
|
|
$
|
117,709
|
|
Supplemental Disclosure of Cash Flow Information
|
|
|
|
|
|
||||||
Net cash paid (received) for income taxes
|
$
|
6,472
|
|
|
$
|
121
|
|
|
$
|
(14,425
|
)
|
Cash paid for interest
|
$
|
48,440
|
|
|
$
|
55,542
|
|
|
$
|
71,093
|
|
Non-cash consideration for in-process research and development
|
$
|
—
|
|
|
$
|
19,900
|
|
|
$
|
—
|
|
Accrued research and development
|
$
|
—
|
|
|
$
|
5,000
|
|
|
$
|
—
|
|
Capital expenditures incurred but not yet paid
|
$
|
212
|
|
|
$
|
—
|
|
|
$
|
402
|
|
•
|
Gralise
®
(gabapentin), a once daily product for the management of postherpetic neuralgia (PHN), that was launched in October 2011.
|
•
|
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.
|
•
|
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.
|
Furniture and office equipment
|
|
3 - 5 years
|
Machinery and equipment
|
|
5 - 7 years
|
Laboratory equipment
|
|
3 - 5 years
|
Leasehold improvements
|
|
Shorter of estimated useful life or lease term
|
|
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
|
%
|
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
|
|
|
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
|
)
|
•
|
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.
|
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
|
|
|
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
|
|
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
|
|
|
|
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
|
|
•
|
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.
|
|
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
|
|
|
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
|
|
|
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
|
|
|
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
|
|
|
|
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
|
|
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
|
|
|
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
|
|
2019
|
$
|
120,000
|
|
2020
|
80,000
|
|
|
2021
|
82,500
|
|
|
Total
|
$
|
282,500
|
|
|
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
|
|
|
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
|
|
|
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
|
|
|
|
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
|
|
|
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
|
|
|
$
|
—
|
|
|
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
|
|
Year Ending December 31,
|
Lease Payments
|
||
2019
|
$
|
2,624
|
|
2020
|
2,526
|
|
|
2021
|
2,322
|
|
|
2022
|
2,188
|
|
|
2023
|
632
|
|
|
Thereafter
|
—
|
|
|
Total
|
$
|
10,292
|
|
|
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%
|
|
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
|
|
|
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
|
|
|
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
|
|
$
|
—
|
|
|
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
|
|
|
|
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
|
(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
|
)
|
(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
|
|
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
|
|
|
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
|
|
|
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)
|
—
|
|
|
—
|
|
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
|
|
|
|
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
|
)
|
|
|
|
|
Additions
|
|
|
|
|
||||||||||||
Description
|
|
Balance at
Beginning of
Year
|
|
Charged as a
Reduction to
Revenue
|
|
Change in
Deferred
Revenue
|
|
Deductions
(1)
|
|
Balance at
End of
Year
|
||||||||||
Sales & return allowances, discounts, chargebacks and rebates:
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Year ended December 31, 2018
|
|
$
|
137,328
|
|
|
$
|
122,481
|
|
|
$
|
—
|
|
|
$
|
(183,408
|
)
|
|
$
|
76,401
|
|
Year ended December 31, 2017
|
|
$
|
133,646
|
|
|
$
|
363,260
|
|
|
$
|
—
|
|
|
$
|
(359,578
|
)
|
|
$
|
137,328
|
|
Year ended December 31, 2016
|
|
$
|
122,516
|
|
|
$
|
339,094
|
|
|
$
|
—
|
|
|
$
|
(327,964
|
)
|
|
$
|
133,646
|
|
|
|
|
|
Additions
|
|
|
|
|
||||||||||||
Description
|
|
Balance at
Beginning of
Year
|
|
Charged as a
Reduction to
Revenue
|
|
Change in
Deferred
Revenue
|
|
Deductions(1)
|
|
Balance at
End of
Year
|
||||||||||
Deferred tax asset valuation allowance:
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Year ended December 31, 2018(4)
|
|
$
|
54,224
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(12,319
|
)
|
|
$
|
41,905
|
|
Year ended December 31, 2017(3)
|
|
$
|
45,206
|
|
|
$
|
9,018
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
54,224
|
|
Year ended December 31, 2016(2)
|
|
$
|
573
|
|
|
$
|
44,633
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
45,206
|
|
|
(1)
|
Deductions to sales discounts and allowances relate to discounts or allowances actually taken or paid.
|
(2)
|
The Company recorded a valuation allowance of
$44.6 million
during
2016
.
|
(3)
|
The Company recorded a valuation allowance of
$9.0 million
during
2017
.
|
(4)
|
The Company reversed a valuation allowance of
$12.3 million
during
2018
.
|
ITEM 12.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREHOLDER MATTERS
|
(1)
|
Financial Statements
|
(2)
|
Financial Statement Schedules
|
Exhibit Number
|
Description of Document
|
|
2.1
|
|
|
3.1
|
|
|
3.2
|
|
|
3.3
|
|
|
3.4
|
|
|
4.1
|
|
|
4.2
|
|
|
4.3
|
|
|
10.1*
|
|
|
10.2*
|
|
|
10.3*
|
|
|
10.4*
|
|
|
10.5*
|
|
|
10.6*
|
|
10.7*
|
|
|
10.8*
|
|
|
10.9*
|
|
|
10.10*
|
|
|
10.11*
|
|
|
10.12*
|
|
|
10.13*
|
|
|
10.14*
|
|
|
†10.15
|
|
|
†10.16
|
|
|
10.17
|
|
|
†10.18
|
|
|
†10.19
|
|
|
†10.20
|
|
|
†10.21
|
|
|
†10.22
|
|
10.23
|
|
|
†10.24
|
|
|
†10.25
|
|
|
10.26
|
|
|
10.27
|
|
|
10.28
|
|
|
†10.29
|
|
|
†10.30
|
|
|
†10.31
|
|
|
10.32
|
|
|
10.33
|
|
|
10.34
|
|
|
10.35
|
|
|
10.36
|
|
|
10.37
|
|
10.38
|
|
|
†10.39
|
|
|
10.40
|
|
|
10.41
|
|
|
21.1
|
|
|
23.1
|
|
|
24.1
|
|
|
31.1
|
|
|
31.2
|
|
|
32.1**
|
|
|
32.2**
|
|
|
101.INS
|
|
XBRL Instance Document
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
Assertio Therapeutics, Inc.
|
|
|
|
|
|
Date:
|
March 11, 2019
|
By
|
/s/ Arthur J. Higgins
|
|
|
|
Arthur J. Higgins
|
|
|
|
President and Chief Executive Officer
|
|
|
|
|
/s/ ARTHUR J. HIGGINS
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
March 11, 2019
|
Arthur J. Higgins
|
|
||
|
|
|
|
/s/ DANIEL A. PEISERT
|
|
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)
|
March 11, 2019
|
Daniel A. Peisert
|
|
||
|
|
|
|
/s/ JAMES P. FOGARTY
|
|
Chairman of the Board of Directors
|
March 11, 2019
|
James P. Fogarty
|
|
||
|
|
|
|
/s/ KAREN A. DAWES
|
|
Director
|
March 11, 2019
|
Karen A. Dawes
|
|
||
|
|
|
|
/s/ LOUIS J. LAVIGNE JR.
|
|
Director
|
March 11, 2019
|
Louis J. Lavigne Jr.
|
|
||
|
|
|
|
|
|
Director
|
March 11, 2019
|
Heather L. Mason
|
|
||
|
|
|
|
/s/ WILLIAM T. MCKEE
|
|
Director
|
March 11, 2019
|
William T. McKee
|
|
||
|
|
|
|
/s/ PETER D. STAPLE
|
|
Director
|
March 11, 2019
|
Peter D. Staple
|
|
|
|
|
|
|
|
/s/ JAMES L. TYREE
|
|
Director
|
March 11, 2019
|
James L. Tyree
|
|
|
Name of Subsidiary
|
|
State of Jurisdiction or Organization
|
|
Depo DR Sub, LLC
|
|
Delaware
|
|
Depo NF Sub, LLC
|
|
Delaware
|
|
Depomed Bermuda Ltd
|
|
Bermuda
|
|
1)
|
Registration Statements (Forms S-3 No. 333-53486, No. 333-66688, No. 333-86542, No. 333-104956, No. 333-197433 and No. 333-223420) and related Prospectuses of Assertio Therapeutics, Inc.,
|
2)
|
Registration Statements (Forms S-8 No. 333-116697, No. 333-145291, No. 333-156538, No. 333-167015, No. 333-181710, No. 333-196263, No. 333-211642, No. 333-211643, No. 333-224924, and No. 333-228290) pertaining to the 2004 Equity Incentive Plan, the Second and Amended and Restated 2004 Employee Stock Purchase Plan, the Amended and Restated 2014 Omnibus Incentive Plan of Assertio Therapeutics, Inc. and the Assertio Therapeutics, Inc. Inducement Award Program.
|
1.
|
I have reviewed this Annual Report on Form 10-K of Assertio Therapeutics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: March 11, 2019
|
By:
|
/s/ Arthur J. Higgins
|
|
|
Arthur J. Higgins
|
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
1.
|
I have reviewed this Annual Report on Form 10-K of Assertio Therapeutics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a)
|
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b)
|
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c)
|
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d)
|
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a)
|
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
(b)
|
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date: March 11, 2019
|
By:
|
/s/ Daniel A. Peisert
|
|
|
Daniel A. Peisert
|
|
|
Senior Vice President and Chief Financial Officer
(Principal Financial Officer)
|
(1)
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: March 11, 2019
|
|
/s/ Arthur J. Higgins
|
|
|
Arthur J. Higgins
|
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
(1)
|
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: March 11, 2019
|
|
/s/ Daniel A. Peisert
|
|
|
Daniel A. Peisert
|
|
|
Senior Vice President and Chief Financial Officer
(Principal Financial Officer)
|