Ireland (State or Other Jurisdiction of Incorporation) | 000-28508 (Commission File Number) | 98-1341933 (I.R.S. Employer Identification No.) | ||||
Block 10-1 Blanchardstown Corporate Park, Ballycoolin Dublin 15, Ireland (Address of Principal Executive Offices) | Not Applicable (Zip Code) |
99.1 | Press release dated May 2, 2018, issued by Avadel Pharmaceuticals plc * | ||
99.2 | Presentation materials dated May 2, 2018, issued by Avadel Pharmaceuticals plc* | ||
99.3 | Press release dated May 1, 2018, issued by Avadel Pharmaceuticals plc* |
• | On January 10, 2018 the U.S. Food and Drug Administration granted Orphan Drug Designation to FT 218 for the treatment of narcolepsy. |
• | Divested pediatric products in February to Cerecor, Inc. and increased strategic focus on urology, hospital and CNS / sleep markets. |
• | Completed a convertible debt offering with net proceeds of $138.4 million. |
• | Launched NOCTIVA to the trade four weeks ahead of schedule. |
• | Total revenues for the first quarter 2018 were $33.3 million, compared to $34.8 million in the fourth quarter 2017 and $52.5 million in the first quarter 2017. |
• | GAAP net loss for the first quarter 2018 was $(12.2) million, or $(0.32) per diluted share, compared to GAAP net loss of $(8.2) million, or $(0.21) per diluted share, in the fourth quarter 2017 and a GAAP net income of $25.9 million, or $0.61 per diluted share, in the first quarter 2017. |
• | Adjusted net loss for the first quarter 2018 was $(13.0) million, or $(0.34) per diluted share, compared to an adjusted net loss of $(10.0) million, or $(0.25) per diluted share, in the fourth quarter 2017 and an adjusted net income of $11.8 million, or $0.28 per diluted share, in the first quarter 2017. (1) |
• | Cash and marketable securities at March 31, 2018 were $198.2 million, up from $94.1 million at December 31, 2017. |
Contacts: | Michael F. Kanan |
Chief Financial Officer | |
Phone: (636) 449-1844 | |
Email: mkanan@avadel.com | |
Lauren Stival | |
Sr. Director, Investor Relations & Corporate Communications | |
Phone: (636) 449-5866 | |
Email: lstival@avadel.com |
Three Months Ended March 31, | ||||||||
2018 | 2017 | |||||||
Revenues: | ||||||||
Product sales | $ | 33,161 | $ | 51,757 | ||||
License revenue | 132 | 750 | ||||||
Total revenues | 33,293 | 52,507 | ||||||
Operating expenses: | ||||||||
Cost of products | 6,592 | 3,902 | ||||||
Research and development expenses | 9,951 | 7,206 | ||||||
Selling, general and administrative expenses | 24,487 | 11,812 | ||||||
Intangible asset amortization | 1,767 | 564 | ||||||
Loss (gain) - changes in fair value of related party contingent consideration | 2,968 | (6,971 | ) | |||||
Restructuring costs | 153 | 2,653 | ||||||
Total operating expenses | 45,918 | 19,166 | ||||||
Operating (loss) income | (12,625 | ) | 33,341 | |||||
Investment income and other income (expense), net | 54 | 821 | ||||||
Interest expense, net | (1,597 | ) | (263 | ) | ||||
Other (expense) income - changes in fair value of related party payable | (395 | ) | 550 | |||||
(Loss) income before income taxes | (14,563 | ) | 34,449 | |||||
Income tax (benefit) provision | (2,327 | ) | 8,539 | |||||
Net (loss) income | $ | (12,236 | ) | $ | 25,910 | |||
Net (loss) income per share - basic | $ | (0.32 | ) | $ | 0.63 | |||
Net (loss) income per share - diluted | (0.32 | ) | 0.61 | |||||
Weighted average number of shares outstanding - basic | 38,559 | 41,374 | ||||||
Weighted average number of shares outstanding - diluted | 38,559 | 42,810 |
March 31, 2018 | December 31, 2017 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 40,911 | $ | 16,564 | ||||
Marketable securities | 157,269 | 77,511 | ||||||
Accounts receivable | 16,677 | 14,785 | ||||||
Inventories | 5,948 | 6,157 | ||||||
Prepaid expenses and other current assets | 11,128 | 8,958 | ||||||
Total current assets | 231,933 | 123,975 | ||||||
Property and equipment, net | 2,722 | 3,001 | ||||||
Goodwill | 18,491 | 18,491 | ||||||
Intangible assets, net | 72,571 | 92,289 | ||||||
Research and development tax credit receivable | 5,903 | 5,272 | ||||||
Other non-current assets | 20,241 | 10,249 | ||||||
Total assets | $ | 351,861 | $ | 253,277 | ||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Current portion of long-term debt | $ | 114 | $ | 111 | ||||
Current portion of long-term related party payable | 21,121 | 25,007 | ||||||
Accounts payable | 15,906 | 7,477 | ||||||
Deferred revenue | 1,884 | 2,007 | ||||||
Accrued expenses | 45,948 | 50,926 | ||||||
Other current liabilities | 2,212 | 1,011 | ||||||
Total current liabilities | 87,185 | 86,539 | ||||||
Long-term debt, less current portion | 111,724 | 156 | ||||||
Long-term related party payable, less current portion | 51,646 | 73,918 | ||||||
Other non-current liabilities | 14,252 | 7,084 | ||||||
Total liabilities | 264,807 | 167,697 | ||||||
Shareholders’ equity: | ||||||||
Preferred shares, $0.01 nominal value; 50,000 shares authorized at March 31, 2018 and December 31, 2017, respectively; none issued or outstanding at March 31, 2018 and December 31, 2017, respectively | — | — | ||||||
Ordinary shares, nominal value of $0.01; 500,000 shares authorized; 42,066 issued and 37,642 outstanding at March 31, 2018 and 41,463 issued and 39,346 outstanding at December 31, 2017 | 420 | 414 | ||||||
Treasury shares, at cost, 4,424 and 2,117 shares held at March 31, 2018 and December 31, 2017, respectively | (42,573 | ) | (22,361 | ) | ||||
Additional paid-in capital | 427,383 | 393,478 | ||||||
Accumulated deficit | (274,921 | ) | (262,685 | ) | ||||
Accumulated other comprehensive loss | (23,255 | ) | (23,266 | ) | ||||
Total shareholders’ equity | 87,054 | 85,580 | ||||||
Total liabilities and shareholders’ equity | $ | 351,861 | $ | 253,277 |
Three Months Ended March 31, | ||||||||
2018 | 2017 | |||||||
Cash flows from operating activities: | ||||||||
Net (loss) income | $ | (12,236 | ) | $ | 25,910 | |||
Adjustments to reconcile net (loss) income to net cash provided by operating activities: | ||||||||
Depreciation and amortization | 1,985 | 837 | ||||||
Loss (gain) on sale of marketable securities | 662 | (287 | ) | |||||
Foreign exchange loss | (167 | ) | — | |||||
Remeasurement of related party acquisition-related contingent consideration | 2,968 | (6,971 | ) | |||||
Remeasurement of related party financing-related contingent consideration | 395 | (550 | ) | |||||
Amortization of debt discount and debt issuance costs | 657 | — | ||||||
Change in deferred tax and income tax deferred charge | (2,851 | ) | — | |||||
Stock-based compensation expense | 2,134 | 2,047 | ||||||
Other adjustments | 162 | — | ||||||
Net changes in assets and liabilities | ||||||||
Accounts receivable | (1,891 | ) | 4,376 | |||||
Inventories | (466 | ) | (2,148 | ) | ||||
Prepaid expenses and other current assets | (2,285 | ) | (1,354 | ) | ||||
Research and development tax credit receivable | (494 | ) | (716 | ) | ||||
Accounts payable & other current liabilities | 6,374 | 1,456 | ||||||
Deferred revenue | (123 | ) | (606 | ) | ||||
Accrued expenses | (5,854 | ) | 2,714 | |||||
Accrued income taxes | 32 | 8,538 | ||||||
Earn-out payments for related party contingent consideration in excess of acquisition-date fair value | (5,790 | ) | (7,166 | ) | ||||
Royalty payments for related party payable in excess of original fair value | (825 | ) | (1,003 | ) | ||||
Other non-current assets and liabilities | (395 | ) | 231 | |||||
Net cash (used in) provided by operating activities | (18,008 | ) | 25,308 | |||||
Cash flows from investing activities: | ||||||||
Purchases of property and equipment | (41 | ) | (334 | ) | ||||
Proceeds from sales of marketable securities | 194,400 | 14,419 | ||||||
Purchases of marketable securities | (275,098 | ) | (46,074 | ) | ||||
Net cash used in investing activities | (80,739 | ) | (31,989 | ) | ||||
Cash flows from financing activities: | ||||||||
Earn-out payments for related party contingent consideration | (402 | ) | (444 | ) | ||||
Proceeds from debt issuance | 143,750 | — | ||||||
Payments for debt issuance costs | (5,391 | ) | — | |||||
Reimbursement of conditional R&D grants | (39 | ) | — | |||||
Proceeds from loans or conditional R&D grants | 86 | — | ||||||
Share repurchases | (18,000 | ) | — | |||||
Exercise of warrants | 2,911 | — | ||||||
Cash proceeds from issuance of ordinary shares and warrants | — | 38 | ||||||
Net cash provided by (used in) financing activities | 122,915 | (406 | ) | |||||
Effect of foreign currency exchange rate changes on cash and cash equivalents | 179 | 108 | ||||||
Net change in cash and cash equivalents | 24,347 | (6,979 | ) | |||||
Cash and cash equivalents at January 1, | 16,564 | 39,215 | ||||||
Cash and cash equivalents at March 31, | $ | 40,911 | $ | 32,236 |
Three Months Ended March 31, | ||||||||
Revenues by Product: | 2018 | 2017 | ||||||
Bloxiverz | $ | 7,491 | $ | 13,902 | ||||
Vazculep | 12,961 | 10,179 | ||||||
Akovaz | 10,217 | 25,638 | ||||||
Noctiva | 666 | — | ||||||
Other | 1,826 | 2,038 | ||||||
Total product sales | 33,161 | 51,757 | ||||||
License revenue | 132 | 750 | ||||||
Total revenues | $ | 33,293 | $ | 52,507 |
GAAP to Non-GAAP adjustments for the three-months ended March 31, 2018 | ||||||||||||||||||||||||||||||||||||||||
Exclude | Include | |||||||||||||||||||||||||||||||||||||||
GAAP | Intangible asset amortization | Foreign exchange (gain)/loss | Restructuring impacts | Equity securities unrealized (gain)/loss impact | Exchangeable Notes interest payments | Contingent related party payable fair value remeasurements | Contingent related party payable paid/accrued | Total adjustments | Adjusted GAAP | |||||||||||||||||||||||||||||||
Revenues: | ||||||||||||||||||||||||||||||||||||||||
Product sales | $ | 33,161 | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 33,161 | ||||||||||||||||||||
License revenue | 132 | — | — | — | — | — | — | — | — | 132 | ||||||||||||||||||||||||||||||
Total revenues | 33,293 | — | — | — | — | — | — | — | — | 33,293 | ||||||||||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||||||||||||||||
Cost of products | 6,592 | — | — | — | — | — | — | — | — | 6,592 | ||||||||||||||||||||||||||||||
Research and development expenses | 9,951 | — | — | — | — | — | — | — | — | 9,951 | ||||||||||||||||||||||||||||||
Selling, general and administrative expenses | 24,487 | — | — | — | — | — | — | — | — | 24,487 | ||||||||||||||||||||||||||||||
Intangible asset amortization | 1,767 | (1,767 | ) | — | — | — | — | — | — | (1,767 | ) | — | ||||||||||||||||||||||||||||
Loss (gain) - changes in fair value of related party contingent consideration | 2,968 | — | — | — | — | — | (2,968 | ) | 5,790 | 2,822 | 5,790 | |||||||||||||||||||||||||||||
Restructuring costs | 153 | — | — | (153 | ) | — | — | — | — | (153 | ) | — | ||||||||||||||||||||||||||||
Total operating expenses | 45,918 | (1,767 | ) | — | (153 | ) | — | — | (2,968 | ) | 5,790 | 902 | 46,820 | |||||||||||||||||||||||||||
Operating (loss) income | (12,625 | ) | 1,767 | — | 153 | — | — | 2,968 | (5,790 | ) | (902 | ) | (13,527 | ) | ||||||||||||||||||||||||||
Investment income and other income (expense), net | 54 | — | (167 | ) | — | 298 | — | — | — | 131 | 185 | |||||||||||||||||||||||||||||
Interest expense, net | (1,597 | ) | — | — | — | — | 656 | — | — | 656 | (941 | ) | ||||||||||||||||||||||||||||
Other (expense) income - changes in fair value of related party payable | (395 | ) | — | — | — | — | — | 395 | (797 | ) | (402 | ) | (797 | ) | ||||||||||||||||||||||||||
(Loss) income before income taxes | (14,563 | ) | 1,767 | (167 | ) | 153 | 298 | 656 | 3,363 | (6,587 | ) | (517 | ) | (15,080 | ) | |||||||||||||||||||||||||
Income tax (benefit) provision | (2,327 | ) | 371 | — | — | (3 | ) | — | 123 | (246 | ) | 245 | (2,082 | ) | ||||||||||||||||||||||||||
Net (loss) income | $ | (12,236 | ) | $ | 1,396 | $ | (167 | ) | $ | 153 | $ | 301 | $ | 656 | $ | 3,240 | $ | (6,341 | ) | $ | (762 | ) | $ | (12,998 | ) | |||||||||||||||
Net income (loss) per share - diluted(1) | $ | (0.32 | ) | $ | 0.04 | $ | — | $ | — | $ | 0.01 | $ | 0.02 | $ | 0.08 | $ | (0.16 | ) | $ | (0.02 | ) | $ | (0.34 | ) | ||||||||||||||||
Weighted average number of shares outstanding - diluted | 38,559 | 38,559 | 38,559 | 38,559 | 38,559 | 38,559 | 38,559 | 38,559 | 38,559 | 38,559 |
GAAP to Non-GAAP adjustments for the three-months ended December 31, 2017 | ||||||||||||||||||||||||||||||||||||||||
Exclude | Include | |||||||||||||||||||||||||||||||||||||||
GAAP | Intangible asset amortization | Foreign exchange (loss) gain | Restructuring impacts | License revenue adjustment | US tax reform impact | Contingent related party payable fair value remeasurements | Contingent related party payable paid/accrued | Total adjustments | Adjusted GAAP | |||||||||||||||||||||||||||||||
Revenues: | ||||||||||||||||||||||||||||||||||||||||
Product sales and services | $ | 34,832 | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 34,832 | ||||||||||||||||||||
License revenue | (80 | ) | — | — | — | 342 | — | — | — | 342 | 262 | |||||||||||||||||||||||||||||
Total revenue | 34,752 | — | — | — | 342 | — | — | — | 342 | 35,094 | ||||||||||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||||||||||||||||
Cost of products and services sold | 4,048 | — | — | — | — | — | — | — | — | 4,048 | ||||||||||||||||||||||||||||||
Research and development expenses | 11,325 | — | — | — | — | — | — | — | — | 11,325 | ||||||||||||||||||||||||||||||
Selling, general and administrative expenses | 23,056 | — | — | — | — | — | — | — | — | 23,056 | ||||||||||||||||||||||||||||||
Intangible asset amortization | 1,967 | (1,967 | ) | — | — | — | — | — | — | (1,967 | ) | — | ||||||||||||||||||||||||||||
(Gain) loss - changes in fair value of related party contingent consideration | (933 | ) | — | — | — | — | — | 933 | 6,067 | 7,000 | 6,067 | |||||||||||||||||||||||||||||
Restructuring costs | (631 | ) | — | — | 631 | — | — | — | — | 631 | — | |||||||||||||||||||||||||||||
Total operating expenses | 38,832 | (1,967 | ) | — | 631 | — | — | 933 | 6,067 | 5,664 | 44,496 | |||||||||||||||||||||||||||||
Operating income (loss) | (4,080 | ) | 1,967 | — | (631 | ) | 342 | — | (933 | ) | (6,067 | ) | (5,322 | ) | (9,402 | ) | ||||||||||||||||||||||||
Investment income and other income (expense), net | (426 | ) | — | 587 | — | — | — | — | — | 587 | 161 | |||||||||||||||||||||||||||||
Interest expense, net | (263 | ) | — | — | — | — | — | — | — | — | (263 | ) | ||||||||||||||||||||||||||||
Other income (expense) - changes in fair value of related party payable | (917 | ) | — | — | — | — | — | 917 | (832 | ) | 85 | (832 | ) | |||||||||||||||||||||||||||
Income (loss) before income taxes | (5,686 | ) | 1,967 | 587 | (631 | ) | 342 | — | (16 | ) | (6,899 | ) | (4,650 | ) | (10,336 | ) | ||||||||||||||||||||||||
Income tax (benefit) provision | 2,559 | 706 | — | — | — | (3,513 | ) | 307 | (440 | ) | (2,940 | ) | (381 | ) | ||||||||||||||||||||||||||
Net income (loss) | $ | (8,245 | ) | $ | 1,261 | $ | 587 | $ | (631 | ) | $ | 342 | $ | 3,513 | $ | (323 | ) | $ | (6,459 | ) | $ | (1,710 | ) | $ | (9,955 | ) | ||||||||||||||
Net income (loss) per share - diluted(1) | $ | (0.21 | ) | $ | 0.03 | $ | 0.01 | $ | (0.02 | ) | $ | 0.01 | $ | 0.09 | $ | (0.01 | ) | $ | (0.16 | ) | $ | (0.04 | ) | $ | (0.25 | ) | ||||||||||||||
Weighted average number of shares outstanding - diluted | 39,350 | 39,350 | 39,350 | 39,350 | 39,350 | 39,350 | 39,350 | 39,350 | 39,350 | 39,350 |
GAAP to Non-GAAP adjustments for the three-months ended March 31, 2017 | ||||||||||||||||||||||||||||||||||||
Exclude | Include | |||||||||||||||||||||||||||||||||||
GAAP | Intangible asset amortization | Foreign exchange (gain)/loss | Restructuring impacts | Purchase accounting adjustments - FSC | Contingent related party payable fair value remeasurements | Contingent related party payable paid/accrued | Total adjustments | Adjusted GAAP | ||||||||||||||||||||||||||||
Revenues: | ||||||||||||||||||||||||||||||||||||
Product sales | $ | 51,757 | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 51,757 | ||||||||||||||||||
License revenue | 750 | — | — | — | — | — | — | — | 750 | |||||||||||||||||||||||||||
Total revenues | 52,507 | — | — | — | — | — | — | — | 52,507 | |||||||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||||||||||||||
Cost of products | 3,902 | — | — | — | (46 | ) | — | — | (46 | ) | 3,856 | |||||||||||||||||||||||||
Research and development expenses | 7,206 | — | — | — | — | — | — | — | 7,206 | |||||||||||||||||||||||||||
Selling, general and administrative expenses | 11,812 | — | — | — | — | — | — | — | 11,812 | |||||||||||||||||||||||||||
Intangible asset amortization | 564 | (564 | ) | — | — | — | — | — | (564 | ) | — | |||||||||||||||||||||||||
Loss (gain) - changes in fair value of related party contingent consideration | (6,971 | ) | — | — | — | — | 6,971 | 9,616 | 16,587 | 9,616 | ||||||||||||||||||||||||||
Restructuring costs | 2,653 | — | — | (2,653 | ) | — | — | — | (2,653 | ) | — | |||||||||||||||||||||||||
Total operating expenses | 19,166 | (564 | ) | — | (2,653 | ) | (46 | ) | 6,971 | 9,616 | 13,324 | 32,490 | ||||||||||||||||||||||||
Operating (loss) income | 33,341 | 564 | — | 2,653 | 46 | (6,971 | ) | (9,616 | ) | (13,324 | ) | 20,017 | ||||||||||||||||||||||||
Investment income and other income (expense), net | 821 | — | 231 | — | — | — | — | 231 | 1,052 | |||||||||||||||||||||||||||
Interest expense, net | (263 | ) | — | — | — | — | — | — | — | (263 | ) | |||||||||||||||||||||||||
Other (expense) income - changes in fair value of related party payable | 550 | — | — | — | — | (550 | ) | (1,299 | ) | (1,849 | ) | (1,299 | ) | |||||||||||||||||||||||
(Loss) income before income taxes | 34,449 | 564 | 231 | 2,653 | 46 | (7,521 | ) | (10,915 | ) | (14,942 | ) | 19,507 | ||||||||||||||||||||||||
Income tax (benefit) provision | 8,539 | 201 | — | — | 17 | (360 | ) | (691 | ) | (833 | ) | 7,706 | ||||||||||||||||||||||||
Net (loss) income | $ | 25,910 | $ | 363 | $ | 231 | $ | 2,653 | $ | 29 | $ | (7,161 | ) | $ | (10,224 | ) | $ | (14,109 | ) | $ | 11,801 | |||||||||||||||
Net income (loss) per share - diluted(1) | $ | 0.61 | $ | 0.01 | $ | 0.01 | $ | 0.06 | $ | — | $ | (0.17 | ) | $ | (0.24 | ) | $ | (0.33 | ) | $ | 0.28 | |||||||||||||||
Weighted average number of shares outstanding - diluted | 42,810 | 42,810 | 42,810 | 42,810 | 42,810 | 42,810 | 42,810 | 42,810 | 42,810 |
E6C
M55TR(=33J:.I-.J308:*4TE "44M% "4444 +2444 )2TE+2&%%%% "4M)2T
M !I*6FDA023@#DT 8'B&X8NELK':.7&>M8?;A>A]:FNYC G
M2M)93'NC3)7'0UGVFIV.FWTL%W*KFT,N74\X\,J(]1NE Z7+D
M 5V%O*9W5VQE8W4USN@6H36KTF5&7>\N]3D8KH=.N[:]2&:S.^$JP) []ZUK
M6YK(B@GRW9!X=40:=*IP2)3UKJ=,$:W?"@,PQ6!H<$=QJ4]HWK/D^8P[BJE351
M6DR:=>5&JG!:GM=I?VVH0^;;2+(%.& /0U8K@/"6JFU10]FT2/P<]_>N]1Q*
M@=""IZ$5X5>DZ4K+8^MPF(]M3O+<6BBBLF=CW"BBBD(*2EI* "BBB@!11244
M#"EI** !F"J6/0#)KB+B8W-S)(PR&+ZEN2(*P,)IW**Z?&1H8TZCHE]X. #6D-BA!(F]1!&$
M9X,C?VQ$'8FT=<@CK_753>PWC->^^!:&LE/7WB6F*J/CU N2LKHSW6&_43J1
M[Z-]1O7V4(KUNP0 N#0D=BA!8C_7%"T\=F+?&&H?:BNHD]&9'^\