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Fourth-Quarter 2018 | Full-Year 2018 | |||
(in millions, except earnings per share) | GAAP | Non-GAAP (3) | GAAP | Non-GAAP (3) |
Total Revenues (1) (2) | 42.6 | 62.8 | 311.8 | 278.0 |
Net Income/(Loss) | (24.1) | 23.1 | 36.9 | 93.2 |
Earnings/(Loss) Per Share | $(0.38) | $0.30 | $0.57 | $1.22 |
Adjusted EBITDA | — | 41.0 | — | 155.3 |
• | FDA Accepted Filing of 505(b)(2) NDA Filing for Cosyntropin: On February 19, 2019, the Company received notification of acceptance for filing from the U.S. Food and Drug Administration for its 505(b)(2) New Drug Application for its injectable formulation of long-acting cosyntropin (synthetic adrenocorticotropic hormone, or ACTH). The Company, together with its partner West Therapeutic Development, LLC, seeks approval for the use of long-acting cosyntropin as a diagnostic drug in the screening of patients presumed to have adrenocortical insufficiency. The PDUFA date is October 19, 2019. |
• | Strong Cash Generation and Debt Reduction: In 2018, the Company secured $97.0 million in non-dilutive cash through strategic transactions, of which approximately $65.0 million was received in 2018; the balance of $32 million was received on January 30, 2019. These cash inflows, as well as the Company’s own cash-flow generation, reduced total secured debt by $82.5 million from $365.0 million as of December 31, 2017 to $282.5 million as of December 31, 2018. As of December 31, 2018, the Company had cash and cash equivalents of $110.9 million. |
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Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were removed , added and changed by Assertio Therapeutics, Inc.
Assertio Therapeutics, Inc's Definitive Proxy Statement (Form DEF 14A) filed after their 2019 10-K Annual Report includes:
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Cost of sales consists of costs of the active pharmaceutical ingredient, contract manufacturing and packaging costs, royalties payable to third parties, inventory write downs, amortization of inventory write-ups associated with business acquisitions, product quality testing, internal employee costs related to the manufacturing process, distribution costs and shipping costs related to our product sales.
Due to our valuation allowance position and deferred tax liabilities, 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 which were fully offset by a corresponding change to our valuation allowance.
The increase in Cash provided by operating activities in 2018 compared to 2017 is due to increased net income from the settlement of the Purdue Litigation, the sale of royalties to PDL and the milestone payment from Ironwood.
The decrease in NUCYNTA product sales for the year ended December 31, 2017 compared to 2016 was primarily the result of lower unit demand for NUCYNTA attributable to declines in both the long-acting and short-acting opioid prescription markets.
The loss on prepayment of Senior Notes in 2017 and 2016 represents the prepayment fees paid to the lender as well as the acceleration of the unamortized balances of the debt discount and debt issuance costs associated with these prepayments of our debt.
Research and development expenses in...Read more
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Effective January 8, 2018, the...Read more
A contract liability is recorded...Read more
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Cost of sales excludes the...Read more
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The related divestiture of Lazanda...Read more
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The decrease in Gralise product...Read more
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Total selling, general and administrative...Read more
We recognize a contract asset...Read more
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Financial Statements, Disclosures and Schedules
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Assertio Therapeutics, Inc provided additional information to their SEC Filing as exhibits
Ticker: ASRT
CIK: 1005201
Form Type: 10-K Annual Report
Accession Number: 0001005201-19-000040
Submitted to the SEC: Mon Mar 11 2019 4:00:47 AM EST
Accepted by the SEC: Mon Mar 11 2019
Period: Monday, December 31, 2018
Industry: Pharmaceutical Preparations