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Avadel Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Update on FT218 Development Program
- NDA for once-nightly FT218 is on track for FDA submission by end of December 2020
- New market assessment data identifies a significant potential market expansion opportunity for once-nightly FT218 beyond existing twice-nightly sodium oxybate patients
- Management to host a conference call today at
8:30 a.m. ET
“Over the past several months, the Avadel clinical and regulatory teams have made substantial progress in advancing FT218 toward its anticipated FDA approval for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The Company remains on track to submit the filing to the FDA by the end of December. We are pleased with the progress we have made despite the challenges of a global pandemic and look forward to updating our shareholders on this upcoming regulatory milestone for the FT218 program,” said
“We recently gained even greater insight into this evolving therapeutic area including the significant and growing opportunity for FT218. Specifically, we completed a comprehensive market assessment, which provided current and critical prescriber and patient insights. A key finding is that six out of ten sodium oxybate-eligible patients are not going on therapy today, with twice-nightly dosing being the primary reason cited. This finding suggests there could be a significantly larger potential sodium oxybate-eligible market beyond those currently being treated with twice-nightly therapy. These insights, coupled with patient discontinuation rates of nearly 50% within the first 12 months of initiating twice-nightly therapy, underscore the unmet patient need and opportunity once-nightly FT218 may have in addition to the nearly
Third quarter and recent company highlights
• FT218 NDA is on track and expected to be filed with the FDA by the end of December.
• Completed a new comprehensive market assessment that included a review of over five years of twice-nightly sodium oxybate utilization and interviews with over 500 critical stakeholders. Key findings from the market assessment include:
- Insights from over 150 sodium oxybate prescribing physicians show that 60% of sodium oxybate-eligible patients are not receiving sodium oxybate treatment today, with the primary reason being twice-nightly dosing-related challenges.
- In a survey of current sodium oxybate-treated patients, once-nightly dosing ranked as the most important driver of their treatment preference, placing it higher in importance than efficacy and side effect profile.
- Analysis of longitudinal patient claims analysis demonstrates nearly 50% of all newly treated twice-nightly sodium oxybate patients discontinued their treatment within 12 months of initiation, including about half of that group discontinuing within the first 30 days.
• Supported a recently published article in the peer-reviewed journal Sleep Medicine highlighting the lack of evidence linking the sodium content of sodium oxybate with increased cardiovascular risk in patients with narcolepsy. (https://doi.org/10.1016/j.sleep.2020.09.017)
• Additional subgroup analysis of the REST-ON study demonstrated comparable, robust results for FT218 in narcolepsy patients both with and without cataplexy as well as those on concomitant wake-promoting agents compared to those not on wake-promoting agents. In addition, results of responder analyses for the Maintenance of Wakefulness Test and mean weekly cataplexy attacks further supported the potential clinical benefits of FT218.
• Continued progress of the RESTORE trial, an open-label extension/switch study of FT218 as a potential treatment for excessive daytime sleepiness and cataplexy in patients with narcolepsy.
- 29 patients have been enrolled and initiated treatment or are pending treatment initiation.
- The majority of these patients switched from twice-nightly sodium oxybate, many of which also completed the REST-ON study, and nearly all are on the same or lower stable dose of FT218 compared to their prior twice-nightly treatment.
• U.S. Patent & Trademark Office issued the second
Overview of Third Quarter Results
As a result of the sale of the sterile injectable products to
R&D expenses were $5.6 million in the third quarter of 2020, compared to
SG&A expenses were
Net loss for the third 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 Micropump™ controlled-release (CR) sodium oxybate. 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. FT218 has been granted Orphan Drug Designation from the
About
Footnote: 1. Annualized Xyrem revenues from the Jazz Pharmaceuticals third quarter and year to date results reported in their press release dated
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 planned submission of the FT218 NDA to the FDA and commercial launch 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 we do not file the NDA for FT218 on a timely basis or at all, the risk that the FDA does accept such NDA, the risk that such NDA is not approved by the FDA or such approval is delayed, 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)
(Unaudited)
Three Months Ended |
Nine Months Ended |
|||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
Product sales | $ | — | $ | 14,229 | $ | 22,334 | $ | 48,220 | ||||||||
Operating expenses: | ||||||||||||||||
Cost of products | — | 2,823 | 5,742 | 9,711 | ||||||||||||
Research and development expenses | 5,569 | 7,539 | 15,156 | 25,160 | ||||||||||||
Selling, general and administrative expenses | 8,423 | 5,316 | 23,431 | 22,520 | ||||||||||||
Intangible asset amortization | — | 205 | 406 | 610 | ||||||||||||
Changes in fair value of contingent consideration | (69 | ) | 627 | 3,327 | 2,384 | |||||||||||
Gain on sale of Hospital Products | — | — | (45,760 | ) | — | |||||||||||
Restructuring (income) costs | (226 | ) | 1,866 | (43 | ) | 4,600 | ||||||||||
Total operating expense | 13,697 | 18,376 | 2,259 | 64,985 | ||||||||||||
Operating (loss) income | (13,697 | ) | (4,147 | ) | 20,075 | (16,765 | ) | |||||||||
Investment and other income (expense), net | 213 | 781 | (906 | ) | 2,548 | |||||||||||
Interest expense | (3,259 | ) | (3,125 | ) | (9,686 | ) | (9,293 | ) | ||||||||
Loss on deconsolidation of subsidiary | — | — | — | (2,840 | ) | |||||||||||
Other expense - changes in fair value of contingent consideration payable | — | (139 | ) | (435 | ) | (496 | ) | |||||||||
(Loss) income before income taxes | (16,743 | ) | (6,630 | ) | 9,048 | (26,846 | ) | |||||||||
Income tax (benefit) provision | (5,040 | ) | 2,234 | (9,258 | ) | 3,641 | ||||||||||
Net (loss) income | $ | (11,703 | ) | $ | (8,864 | ) | $ | 18,306 | $ | (30,487 | ) | |||||
Net (loss) income per share - basic | $ | (0.20 | ) | $ | (0.24 | ) | $ | 0.36 | $ | (0.82 | ) | |||||
Net (loss) income per share - diluted | (0.20 | ) | (0.24 | ) | 0.35 | (0.82 | ) | |||||||||
Weighted average number of shares outstanding - basic | 58,213 | 37,436 | 51,206 | 37,382 | ||||||||||||
Weighted average number of shares outstanding - diluted | 58,213 | 37,436 | 52,849 | 37,382 |
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
(unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 83,109 | $ | 9,774 | ||||
Marketable securities | 148,467 | 54,384 | ||||||
Accounts receivable | — | 8,281 | ||||||
Inventories | — | 3,570 | ||||||
Research and development tax credit receivable | 3,058 | 2,107 | ||||||
Prepaid expenses and other current assets | 47,054 | 4,264 | ||||||
Total current assets | 281,688 | 82,380 | ||||||
Property and equipment, net | 373 | 544 | ||||||
Operating lease right-of-use assets | 2,866 | 3,612 | ||||||
16,836 | 18,491 | |||||||
Intangible assets, net | — | 813 | ||||||
Research and development tax credit receivable | 3,608 | 6,322 | ||||||
Other non-current assets | 22,264 | 39,274 | ||||||
Total assets | $ | 327,635 | $ | 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 | 520 | 645 | ||||||
Accounts payable | 2,660 | 6,100 | ||||||
Accrued expenses | 16,398 | 19,810 | ||||||
Other current liabilities | 3,431 | 3,875 | ||||||
Total current liabilities | 23,009 | 35,984 | ||||||
Long-term debt | 126,520 | 121,686 | ||||||
Long-term contingent consideration payable, less current portion | — | 11,773 | ||||||
Long-term operating lease liability | 1,968 | 2,319 | ||||||
Other non-current liabilities | 4,938 | 8,873 | ||||||
Total liabilities | 156,435 | 180,635 | ||||||
Shareholders’ equity (deficit): | ||||||||
Preferred shares, nominal value of |
5 | — | ||||||
Ordinary shares, nominal value of |
582 | 429 | ||||||
— | (49,998 | ) | ||||||
Additional paid-in capital | 565,440 | 434,391 | ||||||
Accumulated deficit | (372,909 | ) | (391,215 | ) | ||||
Accumulated other comprehensive loss | (21,918 | ) | (22,806 | ) | ||||
Total shareholders’ equity (deficit) | 171,200 | (29,199 | ) | |||||
Total liabilities and shareholders’ equity (deficit) | $ | 327,635 | $ | 151,436 |
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Nine Months Ended |
||||||||
2020 | 2019 | |||||||
Cash flows from operating activities: | ||||||||
Net income (loss) | $ | 18,306 | $ | (30,487 | ) | |||
Adjustments to reconcile net income (loss) to net cash provided by operating activities: | ||||||||
Depreciation and amortization | 1,297 | 1,690 | ||||||
Loss on disposal of property and equipment | — | 478 | ||||||
Remeasurement of acquisition-related contingent consideration | 3,327 | 2,384 | ||||||
Remeasurement of financing-related contingent consideration | 435 | 496 | ||||||
Amortization of debt discount and debt issuance costs | 4,835 | 4,424 | ||||||
Change in deferred tax and income tax deferred charge | (4,582 | ) | 1,333 | |||||
Stock-based compensation expense | 1,705 | 177 | ||||||
Gain on the disposition of the hospital products | (45,760 | ) | — | |||||
Loss on deconsolidation of subsidiary | — | 1,750 | ||||||
Other adjustments | 306 | (667 | ) | |||||
Net changes in assets and liabilities | ||||||||
Accounts receivable | 8,281 | 2,026 | ||||||
Inventories | (1,352 | ) | 2,465 | |||||
Prepaid expenses and other current assets | 1,759 | (1,859 | ) | |||||
Research and development tax credit receivable | 2,036 | (749 | ) | |||||
Accounts payable & other current liabilities | (4,051 | ) | 259 | |||||
Accrued expenses | (6,625 | ) | (2,379 | ) | ||||
Earn-out payments for contingent consideration in excess of acquisition-date fair value | (5,323 | ) | (8,640 | ) | ||||
Royalty payments for contingent consideration payable in excess of original fair value | (866 | ) | (1,374 | ) | ||||
Other assets and liabilities | (3,337 | ) | (1,399 | ) | ||||
Net cash used in operating activities | (29,609 | ) | (30,072 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchases of property and equipment | (33 | ) | (29 | ) | ||||
Proceeds from the disposal of property and equipment | — | 154 | ||||||
Proceeds from the disposition of the hospital products | 17,250 | — | ||||||
Proceeds from sales of marketable securities | 30,075 | 57,242 | ||||||
Purchases of marketable securities | (124,254 | ) | (23,814 | ) | ||||
Net cash (used in) provided by investing activities | (76,962 | ) | 33,553 | |||||
Cash flows from financing activities: | ||||||||
Proceeds from the |
60,570 | — | ||||||
Proceeds from the |
116,924 | — | ||||||
Proceeds from stock option exercises and ESPP | 2,006 | 123 | ||||||
Other financing activities, net | — | (109 | ) | |||||
Net cash provided by financing activities | 179,500 | 14 | ||||||
Effect of foreign currency exchange rate changes on cash and cash equivalents | 406 | 47 | ||||||
Net change in cash and cash equivalents | 73,335 | 3,542 | ||||||
Cash and cash equivalents at |
9,774 | 9,325 | ||||||
Cash and cash equivalents at |
$ | 83,109 | $ | 12,867 |
UNAUDITED SUPPLEMENTAL INFORMATION
(In thousands, except per share data)
(Unaudited)
Three Months Ended |
Nine Months Ended |
|||||||||||||||
Revenues by Product: | 2020 | 2019 | 2020 | 2019 | ||||||||||||
Bloxiverz | $ | — | $ | 1,466 | $ | 2,201 | $ | 6,392 | ||||||||
Vazculep | — | 8,786 | 10,429 | 27,669 | ||||||||||||
Akovaz | — | 4,208 | 9,545 | 13,946 | ||||||||||||
Other | — | (231 | ) | 159 | 213 | |||||||||||
Total product sales | $ | — | $ | 14,229 | $ | 22,334 | $ | 48,220 |
Source: Avadel Pharmaceuticals plc