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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. |
• | Amended Senior Secured Credit Facility: On January 8, 2019, the Company amended its Senior Secured Credit Facility, replacing the previous fixed adjusted EBITDA covenant with a trailing 12-month debt-to-adjusted EBITDA ratio that declines over time. The amendment gives the Company greater flexibility to continue to pay down debt and invest in the core business, including potential business development transactions. |
• | Strengthened NUCYNTA Collaboration with Collegium - Extends Minimum Term; Annual Royalty Payments Through 2021: On November 8, 2018, the Company announced an amendment to the Commercialization Agreement with Collegium Pharmaceutical, Inc. relating to the NUCYNTA® franchise. The amendment strengthens the collaboration and further aligns the parties’ mutual interest in growing the franchise. The amendment secures a minimum term of the Commercialization Agreement through at least December 31, 2021, prior to which Collegium may not terminate. |
• | Completed Previously Announced Corporate Restructuring and HQ Relocation: In 2018, the Company completed its reincorporation from California to Delaware and changed its name from “Depomed, Inc.” to “Assertio Therapeutics, Inc.” In connection with the reincorporation and name change, the Company’s common stock began trading under a new ticker symbol “ASRT” and a new CUSIP number, 04545L 107, on August 15, 2018. |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Product sales, net: | |||||||||||||||
Gralise | $ | 14,805 | $ | 20,208 | $ | 58,077 | $ | 77,034 | |||||||
CAMBIA | 10,933 | 7,749 | 35,803 | 31,597 | |||||||||||
Zipsor | 3,212 | 4,415 | 16,387 | 16,700 | |||||||||||
Total neurology product sales, net | 28,950 | 32,372 | 110,267 | 125,331 | |||||||||||
Nucynta products (1) | 162 | 60,018 | 18,944 | 239,539 | |||||||||||
Lazanda (2) | 227 | 1,770 | 755 | 15,010 | |||||||||||
Total product sales, net | 29,339 | 94,160 | 129,966 | 379,880 | |||||||||||
Commercialization agreement: (3) | |||||||||||||||
Commercialization rights and facilitation services, net | 12,983 | — | 100,038 | — | |||||||||||
Revenue from transfer of inventory | — | — | 55,705 | — | |||||||||||
Royalties and milestone revenue | 277 | 248 | 26,061 | 844 | |||||||||||
Total revenues | $ | 42,599 | $ | 94,408 | $ | 311,770 | $ | 380,724 |
(1) | The Company transitioned the commercial rights to sell NUCYNTA to Collegium on January 9, 2018. NUCYNTA product sales for the three months ended December 31, 2018 relate to sales reserve estimate adjustments. NUCYNTA product sales for the twelve months ended December 31, 2018 reflect the Company's sales of NUCYNTA during a stub period between January 1st and January 8th, and also includes a $12.5 million benefit related to the release of sales reserves for which the Company is no longer financially responsible. |
(2) | The Company divested Lazanda in November 2017. Product sales for the three and twelve months ended December 31, 2018 relate to sales reserve estimate adjustments. |
(3) | The Commercialization Agreement revenues for the twelve months ended December 31, 2018 includes $100.0 million related to the commercialization rights and facilitation services provided to Collegium and $55.7 million related to the fair value of inventory transferred to Collegium. During the fourth quarter of 2018, the Company amended the Commercialization Agreement and agreed upon a variable revenue stream to take the place of the existing fixed revenue stream. As such, as of the date of the amendment, on November 8, 2018, the Company ceased recognition of fixed revenues and will begin recognition of variable revenues when they become due beginning in January 2019. Cash collected during the fourth quarter remained in-line with the pre-modification agreement amount of $33.8 million. |
2019 Guidance | |
Neurology Franchise Net Sales | Low-to Mid-Single Digit Growth |
GAAP Net (Loss)/Income(1) | ($71) to ($61) million |
Non-GAAP Adjusted EBITDA(1) | $115 to $125 million |
• | From the Assertio website: http://investor.assertiotx.com. Please access the website 15 minutes prior to the start of the call to download and install any necessary audio software. |
• | By telephone: Participants can access the call by dialing (877) 550-3745 (United States) or (281) 973-6277 (International) referencing Conference ID 3784827. |
• | By replay: A replay of the webcast will be located under the Investor Relations section of Assertio's website approximately two hours after the conclusion of the live call. |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
(unaudited) | (unaudited) | ||||||||||||||
Revenues: | |||||||||||||||
Product sales, net | $ | 29,339 | $ | 94,160 | $ | 129,966 | $ | 379,880 | |||||||
Commercialization agreement, net | 12,983 | — | 155,743 | — | |||||||||||
Royalties and milestones | 277 | 248 | 26,061 | 844 | |||||||||||
Total revenues | 42,599 | 94,408 | 311,770 | 380,724 | |||||||||||
Costs and expenses: | |||||||||||||||
Cost of sales (excluding amortization of intangible assets) | 704 | 17,704 | 18,476 | 72,598 | |||||||||||
Research and development expenses | 2,207 | 1,259 | 8,042 | 13,718 | |||||||||||
Acquired in-process research and development | — | 24,900 | — | 24,900 | |||||||||||
Selling, general and administrative expenses | 25,468 | 48,318 | 119,218 | 195,696 | |||||||||||
Amortization of intangible assets | 25,443 | 25,541 | 101,774 | 102,745 | |||||||||||
Restructuring charges | 1,859 | 9,372 | 20,601 | 13,247 | |||||||||||
Total costs and expenses | 55,681 | 127,094 | 268,111 | 422,904 | |||||||||||
Income/(loss) from operations | (13,082 | ) | (32,685 | ) | 43,659 | (42,180 | ) | ||||||||
Litigation settlement | — | — | 62,000 | — | |||||||||||
Gain on divestiture of Lazanda | — | 17,064 | — | 17,064 | |||||||||||
Interest and other income | 224 | 77 | 1,197 | 681 | |||||||||||
Loss on prepayment of Senior Notes | — | (573 | ) | — | (5,938 | ) | |||||||||
Interest expense | (16,613 | ) | (17,857 | ) | (68,881 | ) | (73,552 | ) | |||||||
Income tax (expense) benefit | 5,333 | 870 | (1,067 | ) | 1,429 | ||||||||||
Net income/(loss) | $ | (24,138 | ) | $ | (33,104 | ) | $ | 36,908 | $ | (102,496 | ) | ||||
Basic net (loss) income per share | $ | (0.38 | ) | $ | (0.52 | ) | $ | 0.58 | $ | (1.63 | ) | ||||
Diluted net income (loss) per share | $ | (0.38 | ) | $ | (0.52 | ) | $ | 0.57 | $ | (1.63 | ) | ||||
Basic shares used in calculation | 64,004 | 63,137 | 63,794 | 62,702 | |||||||||||
Diluted shares used in calculation | 64,004 | 63,137 | 64,208 | 62,702 |
December 31, 2018 | December 31, 2017 | ||||||
Cash, cash equivalents and marketable securities | $ | 110,949 | $ | 128,089 | |||
Accounts receivable, net | 37,211 | 72,482 | |||||
Inventories | 3,396 | 13,042 | |||||
Property and equipment, net | 13,064 | 13,024 | |||||
Intangible assets, net | 692,099 | 793,873 | |||||
Investments | 11,784 | — | |||||
Prepaid and other assets | 64,363 | 18,107 | |||||
Total assets | $ | 932,866 | $ | 1,038,617 | |||
Accounts payable | $ | 6,138 | $ | 14,732 | |||
Income tax payable | — | 126 | |||||
Interest payable | 11,645 | 13,220 | |||||
Accrued liabilities | 31,361 | 60,496 | |||||
Accrued rebates, returns and discounts | 75,759 | 135,828 | |||||
Senior notes | 278,309 | 357,220 | |||||
Convertible notes | 287,798 | 269,510 | |||||
Contingent consideration liability | 1,038 | 1,613 | |||||
Other liabilities | 20,483 | 16,364 | |||||
Shareholders’ equity | 220,335 | 169,508 | |||||
Total liabilities and shareholders’ equity | $ | 932,866 | $ | 1,038,617 |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
(unaudited) | (unaudited) | ||||||||||||||
GAAP net income/(loss) | $ | (24,138 | ) | $ | (33,104 | ) | $ | 36,908 | $ | (102,496 | ) | ||||
Commercialization agreement revenues (1) | 21,262 | — | (25,164 | ) | — | ||||||||||
Commercialization agreement cost of sales (2) | — | — | 6,200 | — | |||||||||||
Nucynta sales reserve (3) | — | — | (10,711 | ) | — | ||||||||||
Nucynta and Lazanda revenue reserves (4) | (1,024 | ) | — | (1,562 | ) | — | |||||||||
Expenses for opioid-related litigation, investigations and regulations (5) | 3,537 | — | 7,897 | — | |||||||||||
Intangible amortization related to product acquisitions | 25,443 | 25,541 | 101,774 | 102,745 | |||||||||||
Contingent consideration related to product acquisitions | 143 | (104 | ) | (515 | ) | (6,629 | ) | ||||||||
Stock-based compensation | 2,549 | 3,095 | 10,439 | 12,965 | |||||||||||
Purdue litigation settlement | — | — | (62,000 | ) | — | ||||||||||
Interest and other income | (224 | ) | (77 | ) | (1,197 | ) | (410 | ) | |||||||
Interest expense | 16,613 | 18,361 | 68,881 | 78,190 | |||||||||||
Depreciation | 254 | 918 | 1,931 | 2,757 | |||||||||||
Provision for (benefit from) income taxes | (5,333 | ) | (870 | ) | 1,067 | (1,429 | ) | ||||||||
Restructuring and related costs (6) | 1,881 | 9,817 | 21,264 | 16,834 | |||||||||||
Acquired in process research and development | — | 24,900 | — | 24,900 | |||||||||||
Gain on divestiture of Lazanda | — | (17,064 | ) | — | (17,064 | ) | |||||||||
Managed care dispute reserve | — | — | — | 4,742 | |||||||||||
Transaction and other costs | — | 1,435 | 123 | 1,435 | |||||||||||
Non-GAAP adjusted EBITDA | $ | 40,963 | $ | 32,848 | $ | 155,335 | $ | 116,540 |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
(unaudited) | (unaudited) | ||||||||||||||
GAAP net income/(loss) | $ | (24,138 | ) | $ | (33,104 | ) | $ | 36,908 | $ | (102,496 | ) | ||||
Commercialization agreement revenues (1) | 21,262 | — | (25,164 | ) | — | ||||||||||
Commercialization agreement cost of sales (2) | — | — | 6,200 | — | |||||||||||
Nucynta sales reserve (3) | — | — | (10,711 | ) | — | ||||||||||
Nucynta and Lazanda revenue reserves (4) | (1,024 | ) | — | (1,562 | ) | — | |||||||||
Expenses for opioid-related litigation, investigations and regulations (5) | 3,537 | — | 7,897 | — | |||||||||||
Intangible amortization related to product acquisitions | 25,443 | 25,541 | 101,774 | 102,745 | |||||||||||
Contingent consideration related to product acquisitions | 143 | (104 | ) | (515 | ) | (6,629 | ) | ||||||||
Stock-based compensation | 2,549 | 3,095 | 10,439 | 12,965 | |||||||||||
Restructuring and related costs (6) | 1,881 | 9,817 | 21,264 | 16,834 | |||||||||||
Acquired in process research and development | — | 24,900 | — | 24,900 | |||||||||||
Gain on divestiture of Lazanda | — | (17,064 | ) | — | (17,064 | ) | |||||||||
Purdue litigation settlement | — | — | (62,000 | ) | — | ||||||||||
Non-cash interest expense on debt | 5,579 | 5,340 | 21,877 | 20,953 | |||||||||||
Managed care dispute reserve | — | — | — | 4,742 | |||||||||||
Valuation allowance on deferred tax assets | — | 11,017 | — | 30,291 | |||||||||||
Other costs | — | — | 123 | — | |||||||||||
Income tax effect of non-GAAP adjustments (7) | (12,147 | ) | (18,626 | ) | (13,305 | ) | (56,875 | ) | |||||||
Non-GAAP adjusted earnings | $ | 23,085 | $ | 10,813 | $ | 93,225 | $ | 30,366 | |||||||
Add interest expense of convertible debt, net of tax (8) | 1,704 | 1,348 | 6,814 | 5,390 | |||||||||||
Numerator | $ | 24,789 | $ | 12,160 | $ | 100,039 | $ | 35,756 | |||||||
Shares used in calculation (8) | 81,935 | 81,360 | 82,139 | 81,619 | |||||||||||
Non-GAAP adjusted earnings per share | $ | 0.30 | $ | 0.15 | $ | 1.22 | $ | 0.44 |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||
GAAP net income/(loss) per share | (0.38 | ) | (0.52 | ) | 0.57 | (1.63 | ) | ||||
Conversion from basic shares to diluted shares | 0.09 | 0.12 | (0.13 | ) | 0.38 | ||||||
Commercialization agreement revenues | 0.26 | — | (0.30 | ) | — | ||||||
Commercialization agreement cost of sales | — | — | 0.08 | — | |||||||
Nucynta sales reserve | — | — | (0.13 | ) | — | ||||||
Non-cash interest expense on debt | 0.07 | 0.07 | 0.27 | 0.26 | |||||||
Nucynta and Lazanda revenue reserves | — | — | (0.01 | ) | — | ||||||
Managed care dispute reserve | — | — | — | 0.06 | |||||||
Expenses for opioid-related litigation, investigations and regulations | 0.04 | — | 0.09 | — | |||||||
Purdue litigation settlement | — | — | (0.75 | ) | — | ||||||
Intangible amortization related to product acquisitions | 0.31 | 0.31 | 1.23 | 1.25 | |||||||
Contingent consideration related to product acquisitions | (0.01 | ) | — | (0.01 | ) | (0.08 | ) | ||||
Stock based compensation | 0.03 | 0.04 | 0.13 | 0.16 | |||||||
Restructuring and related costs | 0.03 | 0.12 | 0.26 | 0.21 | |||||||
Acquired in process research and development | — | 0.30 | — | 0.30 | |||||||
Gain on divestiture of Lazanda | — | (0.21 | ) | — | (0.21 | ) | |||||
Valuation allowance on deferred tax assets | — | 0.14 | — | 0.37 | |||||||
Income tax effect of non-GAAP adjustments | (0.16 | ) | (0.23 | ) | (0.16 | ) | (0.70 | ) | |||
Add interest expense of convertible debt, net of tax | 0.02 | 0.02 | 0.08 | 0.07 | |||||||
Non-GAAP adjusted diluted earnings per share | 0.30 | 0.15 | 1.22 | 0.44 |
Commercialization agreement revenues | Product Sales | Royalties and milestones | Total Revenue | Cost of sales | Research and development expense | Selling, general and administrative expense | ||||||||||||||||||||||
GAAP as reported | $ | 12,983 | $ | 29,339 | $ | 277 | $ | 42,599 | $ | 704 | $ | 2,207 | $ | 25,468 | ||||||||||||||
Commercialization agreement revenues and cost of sales | 21,262 | — | — | 21,262 | — | — | — | |||||||||||||||||||||
Nucynta sales reserve | — | — | — | — | — | — | — | |||||||||||||||||||||
Third party royalties | (82 | ) | — | — | (82 | ) | 82 | — | — | |||||||||||||||||||
Nucynta and Lazanda revenue reserves | — | (1,024 | ) | — | (1,024 | ) | — | — | — | |||||||||||||||||||
Expenses for opioid-related litigation, investigations and regulations | — | — | — | — | — | — | (3,537 | ) | ||||||||||||||||||||
Contingent consideration related to product acquisitions | — | — | — | — | — | — | (143 | ) | ||||||||||||||||||||
Stock based compensation | — | — | — | — | — | (109 | ) | (2,440 | ) | |||||||||||||||||||
Restructuring and other costs | — | — | — | — | — | — | (22 | ) | ||||||||||||||||||||
Non-GAAP adjusted EBITDA | $ | 34,163 | $ | 28,315 | $ | 277 | $ | 62,755 | $ | 786 | $ | 2,098 | $ | 19,326 |
Commercialization agreement revenues | Product Sales | Royalties and milestones | Total Revenue | Cost of sales | Research and development expense | Selling, general and administrative expense | ||||||||||||||||||||||
GAAP as reported | $ | 155,743 | $ | 129,966 | $ | 26,061 | $ | 311,770 | $ | 18,476 | $ | 8,042 | $ | 119,218 | ||||||||||||||
Commercialization agreement revenues and cost of sales | (25,164 | ) | — | — | (25,164 | ) | — | — | — | |||||||||||||||||||
Nucynta sales reserve | — | (10,711 | ) | — | (10,711 | ) | — | — | — | |||||||||||||||||||
Third party royalties | 3,659 | — | — | 3,659 | (3,659 | ) | — | — | ||||||||||||||||||||
Nucynta and Lazanda revenue reserves | — | (1,562 | ) | — | (1,562 | ) | — | — | — | |||||||||||||||||||
Expenses for opioid-related litigation, investigations and regulations | — | — | — | — | — | — | (7,897 | ) | ||||||||||||||||||||
Contingent consideration related to product acquisitions | — | — | — | — | — | — | 515 | |||||||||||||||||||||
Stock based compensation | — | — | — | — | (30 | ) | (446 | ) | (9,963 | ) | ||||||||||||||||||
Restructuring and other costs | — | — | — | — | — | — | (661 | ) | ||||||||||||||||||||
Other costs | — | — | — | — | — | — | (123 | ) | ||||||||||||||||||||
Non-GAAP adjusted EBITDA | $ | 134,238 | $ | 117,693 | $ | 26,061 | $ | 277,992 | $ | 14,787 | $ | 7,596 | $ | 101,089 |
Earnings(1) | ||||||||||||
Low End | High End | |||||||||||
GAAP | ($71) | ($61) | ||||||||||
Specified Items(2) | $ | 186 | $ | 186 | ||||||||
Non-GAAP | $ | 115 | $ | 125 |
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Ticker: ASRTEvents:
CIK: 1005201
Form Type: 8-K Corporate News
Accession Number: 0001005201-19-000038
Submitted to the SEC: Wed Mar 06 2019 4:05:01 PM EST
Accepted by the SEC: Wed Mar 06 2019
Period: Wednesday, March 6, 2019
Industry: Pharmaceutical Preparations