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Avadel Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full Year 2020 Financial Results
- New Drug Application (NDA) for once-nightly FT218 to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy accepted for filing by the FDA; assigned a Prescription Drug User Fee Act (PDUFA) target date of
October 15, 2021 - Completed key appointments for Commercial, Clinical and Medical Affairs functions to lead launch planning and readiness to capitalize on significant market opportunity
- Presenting new data highlighting the overall clinical value proposition of FT218 at upcoming medical congresses and key publications
- Management to host a conference call today at
8:30 a.m. ET
“We are pleased with the significant and rapid progress we have made on a number of fronts with our once nightly FT218 program including clinical research, market opportunity assessment, launch preparation, and our regulatory filing strategy. In less than 10 months, we have delivered exceptional top line results, an NDA submission and now formal FDA acceptance for review of our once-nightly FT218 NDA,” said
Fourth quarter and recent company highlights
- The NDA for FT218 was accepted for filing by the FDA and assigned a PDUFA target action date of
October 15, 2021 - Appointed
Richard Kim as Chief Commercial Officer to lead the commercial strategy and launch of FT218, if approved - Appointed Dr.
Jennifer Gudeman as Vice President, Medical and Clinical Affairs, leading the Company’s medical and clinical affairs activities - Scheduled to present data from our REST-ON trial at the
American Academy of Neurology inApril 2021 and at SLEEP inJune 2021 , including all three primary endpoints, as well as a number of secondary endpoints and post-hoc analyses - To highlight the novel technology and predictable PK profile of FT218, four of the clinically relevant Phase 1 PK studies were recently described in a Clinical Therapeutics publication, “Pharmacokinetics of FT218, a Once-Nightly Sodium Oxybate Formulation in Healthy Adults”
- Ongoing analysis of an internal comprehensive market assessment has provided key insights about the narcolepsy market and once nightly therapy, including:
- Once-nightly FT218, if approved, is expected to be the preferred oxybate of choice based on results from large quantitative HCP and patient research projects
- Oxybate eligible patients ranked a once-nightly therapy as being the most important driver of treatment preference
- A once-nightly therapy was characterized by patients as increasing the likelihood of compliance and reducing stress and anxiety associated with the middle of the night dosing
- Oxybate market expansion potential could benefit once-nightly FT218 due to patients and HCPs reported dosing challenges associated with the twice nightly treatment regimen of currently available oxybate products
- Continued the expansion and enrollment of the RESTORE open-label extension/switch study of FT218 designed to generate long-term safety, tolerability, and efficacy data, as well as data on switching from twice-nightly sodium oxybate and patient preference
Overview of Fourth Quarter Results
As a result of the sale of the sterile injectable products to
R&D expenses were $5.3 million in the fourth quarter of 2020, compared to
SG&A expenses were
Net loss for the fourth quarter of 2020 was
Cash, cash equivalents and marketable securities were
Conference Call:
A conference call to discuss these results has been scheduled for
About FT218
FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel’s MicroPump™ controlled-release (CR) technology. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. In
About
Cautionary Disclosure Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, the FDA’s review of the NDA for FT218, the sufficiency of data supporting the NDA for FT218, the commercial launch of FT218 (if approved), and the market acceptance of FT218 (if approved). In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions, and the negatives thereof (if applicable).
Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risk that the NDA for FT218 is not approved by the FDA or such approval is delayed, the risk that FT218 (if approved) may not receive a 7-year Orphan Drug Exclusivity, the risk that the RESTORE study may be delayed or may not be completed at all, the risk that commercial launch of FT218 (if approved) is delayed, the risk that the potential market performance for FT218 (if approved) may differ materially from projections, and the risk that the impact of the current COVID-19 pandemic on our financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended
Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.
Contacts:
Investor Contacts
Chief Financial Officer
Phone: (636) 449-1843
Email: tmchugh@avadel.com
Phone: (212) 915.2564
Email: tim@lifesciadvisors.com
Media Contact
Phone: (646) 970-4688
Email: pbursey@lifescicomms.com
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF (LOSS) INCOME
(In thousands, except per share data)
Three Months Ended |
Twelve Months Ended |
||||||||||||||
2020 | 2019 | 2020 | 2019 | ||||||||||||
Product sales | $ | — | $ | 10,995 | $ | 22,334 | $ | 59,215 | |||||||
Operating expenses: | |||||||||||||||
Cost of products | — | 2,414 | 5,742 | 12,125 | |||||||||||
Research and development expenses | 5,286 | 7,757 | 20,442 | 32,917 | |||||||||||
Selling, general and administrative expenses | 8,974 | 7,663 | 32,405 | 30,183 | |||||||||||
Intangible asset amortization | — | 206 | 406 | 816 | |||||||||||
Changes in fair value of contingent consideration | — | (1,539 | ) | 3,327 | 845 | ||||||||||
Gain on sale of Hospital Products | — | — | (45,760 | ) | — | ||||||||||
Restructuring costs (income) | — | 1,841 | (43 | ) | 6,441 | ||||||||||
Total operating expenses | 14,260 | 18,342 | 16,519 | 83,327 | |||||||||||
Operating (loss) income | (14,260 | ) | (7,347 | ) | 5,815 | (24,112 | ) | ||||||||
Investment and other income (expense), net | 74 | (1,479 | ) | (832 | ) | 1,069 | |||||||||
Interest expense | (3,308 | ) | (3,190 | ) | (12,994 | ) | (12,483 | ) | |||||||
Gain from release of certain liabilities | 3,364 | — | 3,364 | — | |||||||||||
Gain (loss) on deconsolidation of subsidiary | — | 162 | — | (2,678 | ) | ||||||||||
Other income (expense) - changes in fair value of contingent consideration payable | — | 118 | (435 | ) | (378 | ) | |||||||||
Loss before income taxes | (14,130 | ) | (11,736 | ) | (5,082 | ) | (38,582 | ) | |||||||
Income tax benefit | (2,852 | ) | (8,997 | ) | (12,110 | ) | (5,356 | ) | |||||||
Net (loss) income | $ | (11,278 | ) | $ | (2,739 | ) | $ | 7,028 | $ | (33,226 | ) | ||||
Net loss (income) per share - basic | $ | (0.19 | ) | $ | (0.07 | ) | $ | 0.13 | $ | (0.89 | ) | ||||
Net loss (income) per share - diluted | (0.19 | ) | (0.07 | ) | 0.13 | (0.89 | ) | ||||||||
Weighted average number of shares outstanding - basic | 58,325 | 37,465 | 52,996 | 37,403 | |||||||||||
Weighted average number of shares outstanding - diluted | 58,325 | 37,465 | 54,941 | 37,403 | |||||||||||
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 71,722 | $ | 9,774 | |||
Marketable securities | 149,680 | 54,384 | |||||
Accounts receivable | — | 8,281 | |||||
Inventories, net | — | 3,570 | |||||
Research and development tax credit receivable | 3,326 | 2,107 | |||||
Prepaid expenses and other current assets | 38,726 | 4,264 | |||||
Total current assets | 263,454 | 82,380 | |||||
Property and equipment, net | 359 | 544 | |||||
Operating lease right-of-use assets | 2,604 | 3,612 | |||||
16,836 | 18,491 | ||||||
Intangible assets, net | — | 813 | |||||
Research and development tax credit receivable | 3,445 | 6,322 | |||||
Other non-current assets | 24,939 | 39,274 | |||||
Total assets | $ | 311,637 | $ | 151,436 | |||
LIABILITIES AND SHAREHOLDERS’ EQUITY (DEFICIT) | |||||||
Current liabilities: | |||||||
Current portion of long-term contingent consideration payable | $ | — | $ | 5,554 | |||
Current portion of operating lease liability | 474 | 645 | |||||
Accounts payable | 2,934 | 6,100 | |||||
Accrued expenses | 6,501 | 19,810 | |||||
Other current liabilities | 5,200 | 3,875 | |||||
Total current liabilities | 15,109 | 35,984 | |||||
Long-term debt | 128,210 | 121,686 | |||||
Long-term contingent consideration payable, less current portion | — | 11,773 | |||||
Long-term operating lease liability | 1,840 | 2,319 | |||||
Other non-current liabilities | 4,212 | 8,873 | |||||
Total liabilities | 149,371 | 180,635 | |||||
Shareholders’ equity (deficit): | |||||||
Preferred shares, nominal value of |
5 | — | |||||
Ordinary shares, nominal value of |
583 | 429 | |||||
— | (49,998 | ) | |||||
Additional paid-in capital | 566,916 | 434,391 | |||||
Accumulated deficit | (384,187 | ) | (391,215 | ) | |||
Accumulated other comprehensive loss | (21,051 | ) | (22,806 | ) | |||
Total shareholders’ equity (deficit) | 162,266 | (29,199 | ) | ||||
Total liabilities and shareholders’ equity (deficit) | $ | 311,637 | $ | 151,436 | |||
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Twelve Months Ended |
|||||||
2020 | 2019 | ||||||
Cash flows from operating activities: | |||||||
Net income (loss) | $ | 7,028 | $ | (33,226 | ) | ||
Adjustments to reconcile net income (loss) to net cash used in operating activities: | |||||||
Depreciation and amortization | 1,690 | 2,486 | |||||
Remeasurement of acquisition-related contingent consideration | 3,327 | 845 | |||||
Remeasurement of financing-related contingent consideration | 435 | 378 | |||||
Amortization of debt discount and debt issuance costs | 6,524 | 5,995 | |||||
Changes in deferred tax | (7,431 | ) | (6,334 | ) | |||
Share-based compensation expense | 2,999 | 519 | |||||
Gain on the disposition of the Hospital Products | (45,760 | ) | — | ||||
Loss on deconsolidation of subsidiary | — | 1,750 | |||||
Gain from the release of certain liabilities | (3,364 | ) | — | ||||
Other adjustments | 142 | (254 | ) | ||||
Net changes in assets and liabilities | |||||||
Accounts receivable | 8,281 | 2,471 | |||||
Inventories, net | (1,352 | ) | 1,155 | ||||
Prepaid expenses and other current assets | 1,863 | (1,187 | ) | ||||
Research and development tax credit receivable | 2,213 | (1,014 | ) | ||||
Accounts payable & other current liabilities | (2,788 | ) | 4,641 | ||||
Deferred revenue | — | (114 | ) | ||||
Accrued expenses | (13,226 | ) | 357 | ||||
Earn-out payments for contingent consideration in excess of acquisition-date fair value | (5,323 | ) | (10,988 | ) | |||
Royalty payments for contingent consideration payable in excess of original fair value | (866 | ) | (1,748 | ) | |||
Other assets and liabilities | (3,126 | ) | (4,057 | ) | |||
Net cash used in operating activities | (48,734 | ) | (38,325 | ) | |||
Cash flows from investing activities: | |||||||
Purchases of property and equipment | (98 | ) | (29 | ) | |||
Proceeds from disposal of property and equipment | — | 154 | |||||
Proceeds from the disposition of the Hospital Products | 25,500 | — | |||||
Proceeds from sales of marketable securities | 36,284 | 63,246 | |||||
Purchases of marketable securities | (131,407 | ) | (24,648 | ) | |||
Net cash (used in) provided by investing activities | (69,721 | ) | 38,723 | ||||
Cash flows from financing activities: | |||||||
Proceeds from the |
60,570 | — | |||||
Proceeds from the |
116,924 | — | |||||
Proceeds from issuance of ordinary shares | 2,189 | 118 | |||||
Other financing activities, net | — | (145 | ) | ||||
Net cash provided by (used in) financing activities | 179,683 | (27 | ) | ||||
Effect of foreign currency exchange rate changes on cash and cash equivalents | 720 | 78 | |||||
Net change in cash and cash equivalents | 61,948 | 449 | |||||
Cash and cash equivalents at |
9,774 | 9,325 | |||||
Cash and cash equivalents at |
$ | 71,722 | $ | 9,774 | |||
UNAUDITED SUPPLEMENTAL INFORMATION
(In thousands, except per share data)
Three Months Ended |
Twelve Months Ended |
|||||||||||||||
Revenues by Product: | 2020 | 2019 | 2020 | 2019 | ||||||||||||
Bloxiverz | $ | — | $ | 1,087 | $ | 2,201 | $ | 7,479 | ||||||||
Vazculep | — | 5,483 | 10,429 | 33,152 | ||||||||||||
Akovaz | — | 4,696 | 9,545 | 18,642 | ||||||||||||
Other | — | (271 | ) | 159 | (58 | ) | ||||||||||
Product sales | $ | — | $ | 10,995 | $ | 22,334 | $ | 59,215 |
Source: Avadel Pharmaceuticals plc