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Avadel Pharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Company Update
- Better-than-expected Hospital Product revenue improves liquidity position
- Restructuring and other cost reduction actions on track to realize
$80 to $90 million in annualized cost savings
- REST-ON 69% enrolled; 81 patients remain to be enrolled
“During the second quarter, we made meaningful progress against our key strategic objectives,” said
“I am pleased to announce that the benefits from our restructuring initiatives are being realized, as evidenced by approximately
Second quarter and recent company highlights
- The REST-ON clinical trial has enrolled 183 patients, which is 69% of the total 264 target enrollment for the study; based on current trends, the Company remains on-track to complete enrollment in the second half of 2020;
- Data were presented in two posters at the SLEEP 2019 conference, highlighting the pharmacokinetic (PK) profile of FT218, including a head-to-head comparison to twice-nightly sodium oxybate and a dose proportionality study demonstrating linearity across three doses;
Gregory J. Divis was appointed Chief Executive Officer;
- The Company has significantly strengthened its scientific, clinical and regulatory capabilities with the appointments of
Jordan Dubow , M.D., as Chief Medical Officer;Courtney Wells as Vice President, Clinical Operations, andDavid Seiden , M.D., as Senior Medical Director;
The U.S. Food and Drug Administration accepted the New Drug Application for AV001, the Company’s fourth hospital product with an updated Prescription Drug User Fee Act (PDUFA) target action date ofDecember 15, 2019 ;
- Cost reductions and restructuring actions to date have resulted in approximately
$40 million of lower SG&A and R&D spending; the Company is on track to realize the full$80 to $90 million of cost reductions beforeDecember 31, 2019 , as previously announced;
- Cash and cash equivalents as of
June 30, 2019 totaled$79.3 million compared to$79.9 million as ofMarch 31, 2019 , and compared to$99.9 million as ofDecember 31, 2018 and;
- Reported revenues of
$17.6 million in the second quarter of 2019; annual revenue is now expected to be in excess of$45 million for 2019.
Overview of second quarter 2019 financial results
Revenues for the second quarter of 2019 were $17.6 million, compared to $29.2 million in the second quarter of 2018. The decline on a year-over-year basis was primarily attributed to lower net selling prices across all of the Company’s hospital products as a result of increased market competition.
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
Revenues by Product: | 2019 | 2018 | 2019 | 2018 | ||||||||||||
Bloxiverz | $ | 2,358 | $ | 5,544 | $ | 4,926 | $ | 13,035 | ||||||||
Vazculep | 9,410 | 11,377 | 18,883 | 24,338 | ||||||||||||
Akovaz | 5,946 | 11,875 | 9,738 | 22,092 | ||||||||||||
Other | (160 | ) | 320 | 444 | 2,812 | |||||||||||
Total product sales | 17,554 | 29,116 | 33,991 | 62,277 | ||||||||||||
License revenue | — | 114 | — | 246 | ||||||||||||
Total revenues | $ | 17,554 | $ | 29,230 | $ | 33,991 | $ | 62,523 | ||||||||
Research and development (R&D) expenses were $10.3 million in the second quarter of 2019 compared to
Selling, general and administrative (SG&A) expenses were
Net loss for the second quarter of 2019 was
Cash, cash equivalents and marketable securities were
2019 Guidance:
Based on recent hospital products sales performance and continuing to factor in increased competition from products launched and products expected to be launched in 2019, and possible market price actions, which have not yet occurred, hospital product revenue for 2019 is now expected to be in excess of
Conference Call:
A conference call to discuss these results has been scheduled for
About Avadel Pharmaceuticals plc:
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. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “believe,” “expect,” “look forward,” “guidance,” “anticipate,” “estimate,” “project” 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 of our research, development and commercialization activities 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:
(a) | risks relating to our recent net losses and restructuring plan, including risks relating to the following: | ||||
• | due to a decrease in our available liquid assets, our business strategy has been refocused and is now substantially dependent upon a single product, FT218; | ||||
• | our recent restructuring plan may not be as effective as we anticipate and may have unintended negative impacts; | ||||
• | further restructuring actions, if needed, may require third-party consents (including consents under the indenture governing our convertible debt) and such consents may not be granted; | ||||
• | the Chapter 11 bankruptcy filing by our subsidiary Avadel Specialty Pharmaceuticals LLC may have unexpected adverse results; and | ||||
• | Patient enrollment for our FT 218 clinical trial is not expected to be complete until the second half of 2020. As a result, we do not expect to submit an application for FDA approval of FT218 until sometime during 2021, Our financial resources are currently anticipated to be sufficient to finance our operations into 2021. Accordingly, it may be necessary for us to seek additional financial resources to continue our operations, and such financial resources may not be available to us on reasonable terms, or at all. | ||||
(b) | risks relating to the following: | ||||
• | our three products Bloxiverz®, Vazculep® and Akovaz®, which are not patent protected, and have a small number of customers, currently produce substantially all of our revenues, and could face further competition resulting in a further loss of market share and/or forcing us to further reduce our prices for those products; | ||||
• | our current “unapproved marketed drug” (UMD) product candidate, AV001, could fail to achieve FDA approval; or we could fail to develop future potential UMD product candidates, or competitors could develop such products and market such products with FDA approval before us; | ||||
• | we could experience failure or further delay in completing the Phase III clinical trial for FT218, and if the FDA ultimately approves such product, the approval may not include any period of market exclusivity; | ||||
• | we may not have sufficient cash or the ability to raise sufficient cash to service our $143.75 million Exchangeable Senior Notes due 2023, including cash necessary to repay such Notes at maturity, to settle exchanges of such Notes in cash or to repurchase such Notes as required following a “fundamental change” event described in the indenture governing such Notes; | ||||
• | we depend on one or a limited number of third parties to manufacture certain of our products and to provide certain raw materials used in our products; | ||||
• | our competitors may develop and market technologies or products that are more effective or safer than ours, or obtain regulatory approval and market such technologies or products before we do; | ||||
• | we face challenges in protecting intellectual property underlying our products and drug delivery technologies; and | ||||
• | we depend on key personnel to execute our business plan. | ||||
(c) | the other 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 December 31, 2018 which we filed with the Securities and Exchange Commission on March 15, 2019. | ||||
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 the forward-looking statements contained in this Annual Report.
Contacts: | Michael F. Kanan | |
Chief Financial Officer | ||
Phone: (636) 449-1844 | ||
Email: mkanan@avadel.com | ||
Lee Roth | ||
Burns McClellan | ||
Phone: (212) 213-0006 | ||
Email: lroth@burnsmc.com |
AVADEL PHARMACEUTICALS PLC | ||||||||||||||||
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS | ||||||||||||||||
(In thousands, except per share data, Unaudited) | ||||||||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Revenues: | ||||||||||||||||
Product sales | $ | 17,554 | $ | 29,116 | $ | 33,991 | $ | 62,277 | ||||||||
License revenue | — | 114 | — | 246 | ||||||||||||
Total revenues | 17,554 | 29,230 | 33,991 | 62,523 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of products | 3,622 | 3,512 | 6,888 | 10,104 | ||||||||||||
Research and development expenses | 10,292 | 11,890 | 17,621 | 21,841 | ||||||||||||
Selling, general and administrative expenses | 6,758 | 27,843 | 17,204 | 52,330 | ||||||||||||
Intangible asset amortization | 204 | 1,609 | 405 | 3,376 | ||||||||||||
Changes in fair value of related party contingent consideration | (377 | ) | (12,889 | ) | 1,757 | (9,921 | ) | |||||||||
Restructuring costs | 1,506 | 50 | 2,734 | 203 | ||||||||||||
Total operating expenses | 22,005 | 32,015 | 46,609 | 77,933 | ||||||||||||
Operating loss | (4,451 | ) | (2,785 | ) | (12,618 | ) | (15,410 | ) | ||||||||
Investment and other income, net | 950 | 583 | 1,767 | 637 | ||||||||||||
Interest expense | (3,106 | ) | (2,980 | ) | (6,168 | ) | (4,577 | ) | ||||||||
Loss on deconsolidation of subsidiary | (167 | ) | — | (2,840 | ) | — | ||||||||||
Other (expense) income - changes in fair value of related party payable | (50 | ) | 1,402 | (357 | ) | 1,007 | ||||||||||
Loss before income taxes | (6,824 | ) | (3,780 | ) | (20,216 | ) | (18,343 | ) | ||||||||
Income tax provision (benefit) | 1,781 | (342 | ) | 1,407 | (2,669 | ) | ||||||||||
Net loss | $ | (8,605 | ) | $ | (3,438 | ) | $ | (21,623 | ) | $ | (15,674 | ) | ||||
Net loss per share - basic | $ | (0.23 | ) | $ | (0.09 | ) | $ | (0.58 | ) | $ | (0.42 | ) | ||||
Net loss per share - diluted | (0.23 | ) | (0.09 | ) | (0.58 | ) | (0.42 | ) | ||||||||
Weighted average number of shares outstanding - basic | 37,356 | 36,772 | 37,355 | 37,666 | ||||||||||||
Weighted average number of shares outstanding - diluted | 37,356 | 36,772 | 37,355 | 37,666 |
AVADEL PHARMACEUTICALS PLC | ||||||||
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(In thousands, except per share data) | ||||||||
June 30, 2019 | December 31, 2018 | |||||||
(unaudited) | ||||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 17,111 | $ | 9,325 | ||||
Marketable securities | 62,151 | 90,590 | ||||||
Accounts receivable | 10,172 | 11,330 | ||||||
Inventories | 2,601 | 4,770 | ||||||
Prepaid expenses and other current assets | 5,165 | 8,836 | ||||||
Total current assets | 97,200 | 124,851 | ||||||
Property and equipment, net | 934 | 1,911 | ||||||
Operating lease right-of-use assets | 5,454 | — | ||||||
Goodwill | 18,491 | 18,491 | ||||||
Intangible assets, net | 1,224 | 1,629 | ||||||
Research and development tax credit receivable | 7,833 | 7,272 | ||||||
Other non-current assets | 34,573 | 36,146 | ||||||
Total assets | $ | 165,709 | $ | 190,300 | ||||
LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY | ||||||||
Current liabilities: | ||||||||
Current portion of long-term debt | $ | 105 | $ | 106 | ||||
Current portion of long-term related party payable | 8,264 | 9,439 | ||||||
Current portion of operating lease liability | 999 | — | ||||||
Accounts payable | 4,798 | 3,503 | ||||||
Accrued expenses | 15,737 | 21,695 | ||||||
Other current liabilities | 3,677 | 3,640 | ||||||
Total current liabilities | 33,580 | 38,383 | ||||||
Long-term debt, less current portion | 118,631 | 115,734 | ||||||
Long-term related party payable, less current portion | 15,983 | 19,401 | ||||||
Long-term operating lease liability | 3,617 | — | ||||||
Other non-current liabilities | 11,675 | 14,002 | ||||||
Total liabilities | 183,486 | 187,520 | ||||||
Shareholders’ (deficit) equity: | ||||||||
Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; none issued or outstanding at June 30, 2019 and December 31, 2018, respectively | — | — | ||||||
Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 42,763 issued and 37,356 outstanding at June 30, 2019 and 42,720 issued and 37,313 outstanding at December 31, 2018 | 427 | 427 | ||||||
Treasury shares, at cost, 5,407 shares held at June 30, 2019 and December 31, 2018, respectively | (49,998 | ) | (49,998 | ) | ||||
Additional paid-in capital | 434,254 | 433,756 | ||||||
Accumulated deficit | (379,612 | ) | (357,989 | ) | ||||
Accumulated other comprehensive loss | (22,848 | ) | (23,416 | ) | ||||
Total shareholders’ (deficit) equity | (17,777 | ) | 2,780 | |||||
Total liabilities and shareholders’ (deficit) equity | $ | 165,709 | $ | 190,300 |
AVADEL PHARMACEUTICALS PLC | ||||||||
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
(In thousands, (Unaudited) | ||||||||
Six Months Ended June 30, | ||||||||
2019 | 2018 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (21,623 | ) | $ | (15,674 | ) | ||
Adjustments to reconcile net loss to net cash provided by operating activities: | ||||||||
Depreciation and amortization | 1,064 | 3,810 | ||||||
Loss on disposal of property and equipment | 478 | — | ||||||
Amortization of premiums on marketable securities | 17 | 1,693 | ||||||
Remeasurement of related party acquisition-related contingent consideration | 1,757 | (9,921 | ) | |||||
Remeasurement of related party financing-related contingent consideration | 357 | (1,007 | ) | |||||
Amortization of debt discount and debt issuance costs | 2,918 | 2,019 | ||||||
Change in deferred tax and income tax deferred charge | 1,900 | (3,247 | ) | |||||
Stock-based compensation expense | 406 | 4,358 | ||||||
Loss on deconsolidation of subsidiary | 1,750 | — | ||||||
Other adjustments | (1,012 | ) | 91 | |||||
Net changes in assets and liabilities | ||||||||
Accounts receivable | 579 | (157 | ) | |||||
Inventories | 2,124 | (242 | ) | |||||
Prepaid expenses and other current assets | (1,829 | ) | 1,587 | |||||
Research and development tax credit receivable | (593 | ) | (1,003 | ) | ||||
Accounts payable & other current liabilities | 3,127 | 5,206 | ||||||
Accrued expenses | (3,737 | ) | (9,831 | ) | ||||
Earn-out payments for related party contingent consideration in excess of acquisition-date fair value | (5,790 | ) | (11,113 | ) | ||||
Royalty payments for related party payable in excess of original fair value | (917 | ) | (1,618 | ) | ||||
Other assets and liabilities | (3,629 | ) | (2,893 | ) | ||||
Net cash used in operating activities | (22,653 | ) | (37,942 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchases of property and equipment | (29 | ) | (99 | ) | ||||
Proceeds from the disposal of property and equipment | 154 | — | ||||||
Purchase of intangible asset | — | (20,000 | ) | |||||
Proceeds from sales of marketable securities | 52,202 | 253,525 | ||||||
Purchases of marketable securities | (21,991 | ) | (312,638 | ) | ||||
Net cash provided by (used in) investing activities | 30,336 | (79,212 | ) | |||||
Cash flows from financing activities: | ||||||||
Earn-out payments for related party contingent consideration | — | (645 | ) | |||||
Proceeds from debt issuance | — | 143,750 | ||||||
Payments for debt issuance costs | — | (5,760 | ) | |||||
Share repurchases | — | (27,637 | ) | |||||
Proceeds from issuance of ordinary shares and warrants | 92 | 3,446 | ||||||
Other financing activities, net | (37 | ) | 6 | |||||
Net cash provided by financing activities | 55 | 113,160 | ||||||
Effect of foreign currency exchange rate changes on cash and cash equivalents | 48 | (93 | ) | |||||
Net change in cash and cash equivalents | 7,786 | (4,087 | ) | |||||
Cash and cash equivalents at January 1, | 9,325 | 16,564 | ||||||
Cash and cash equivalents at June 30, | $ | 17,111 | $ | 12,477 | ||||
Source: Avadel Pharmaceuticals plc