UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or Section 15(d)
of the Securities Exchange Act of 1934
Date of Report
(Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction | (Commission | (IRS Employer |
| of incorporation) | File Number) | Identification No.) |
Not Applicable | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including
area code: +
Not applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|
|
|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 2.02 | Results of Operations and Financial Condition |
On May 8, 2024, Avadel Pharmaceuticals plc announced its financial results for the quarter ended March 31, 2024. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01. | Exhibits |
(d) Exhibits
| 99.1 | Press release issued by Avadel Pharmaceuticals plc on May 8, 2024, furnished herewith. |
| 104 | Cover Page Interactive Data File (embedded with the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AVADEL PHARMACEUTICALS PLC | |||
| By: | /s/ Jerad G. Seurer | ||
| Date: May 8, 2024 | Name: | Jerad G. Seurer | |
| Title: | General Counsel & Corporate Secretary | ||
Exhibit 99.1
Avadel Pharmaceuticals Provides Corporate Update and Reports First Quarter 2024 Financial Results
-- Generated $27.2 million in net revenue from sales of LUMRYZ™ --
-- Through March 31, greater than 2,800 patients enrolled in Avadel’s RYZUP patient support services and more than 1,700 patients initiated therapy --
-- Pursuing expansion opportunities for LUMRYZ with sNDA in pediatric narcolepsy; on track to enroll first patient in a Phase 3 pivotal idiopathic hypersomnia trial in the second half of 2024 --
-- Management to host a conference call today at 8:30 a.m. ET --
DUBLIN, Ireland, May 8, 2024 - Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a corporate update and announced its financial results for the quarter ended March 31, 2024.
“We are pleased to report another strong quarter of launch performance from LUMRYZ as we continue to serve the narcolepsy patient community. The continued positive feedback we hear daily from patients, prescribers and caregivers builds on the strong commercial foundation we established early into the launch,” said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. “Over the course of 2024, we will be laser focused on the continued market growth of LUMRYZ for the treatment of narcolepsy as well as potentially expanding to the pediatric population and initiating our Phase 3 pivotal trial in idiopathic hypersomnia in the second half of the year.”
First Quarter and Recent Company Highlights
LUMRYZ Commercial Updates:
| · | Greater than 1,700 patients initiated therapy as of March 31, representing an increase of greater than 70% from December 31. |
| o | More than 2,800 patients enrolled in Avadel’s RYZUP patient support services, an increase of approximately 50% since December 31. | |
| o | The majority of RYZUP enrollments and patients currently being treated with LUMRYZ are patients who switched from first generation oxybates, with the balance made up of patients who previously tried and discontinued a first generation oxybate and patients who are new to oxybate treatment. |
Pipeline Updates:
| · | U.S. Food and Drug Administration (FDA) accepted the Supplemental New Drug Application (sNDA) for LUMRYZ for treatment of cataplexy or EDS in the pediatric narcolepsy population. The FDA has assigned a target action date of September 7, 2024. |
| o | With potential approval in the pediatric population, LUMRYZ could alleviate the burden placed on families and caregivers of children with narcolepsy who are responsible for waking up in the middle of the night to administer a second dose. | |
| o | Pediatric patients currently represent approximately 5% of all oxybate treated narcolepsy patients. |
| · | On track to enroll the first patient in a Phase 3 pivotal trial for the use of LUMRYZ to treat idiopathic hypersomnia in the second half of 2024. |
Overview of First Quarter Financial Results
Recognized $27.2 million in net product revenue and gross profit of $25.7 million for the quarter ended March 31, 2024. Net product revenue consists of LUMRYZ product sales, which was launched in the U.S. on June 5, 2023.
R&D expenses were $3.1 million in the quarter ended March 31, 2024, compared to $3.8 million for the same period in 2023. The decrease was driven primarily by lower pre-commercial LUMRYZ related costs that were capitalized into inventory beginning in May 2023 upon FDA approval of LUMRYZ.
SG&A expenses were $48.6 million in the quarter ended March 31, 2024, compared to $24.5 million for the same period in 2023. This increase was driven primarily by higher costs associated with the commercial launch of LUMRYZ, higher compensation costs due to increased headcount, higher selling and marketing activities, and higher legal fees.
Net loss for the quarter ended March 31, 2024 was $27.3 million, or ($0.30) per diluted share, compared to net loss of $30.8 million, or ($0.48) per diluted share, for the same period in 2023.
Cash, cash equivalents and marketable securities were $88.8 million as of March 31, 2024.
Conference Call Details:
To access the conference call, investors are invited to dial +1 (800) 715-9871 (U.S. and Canada) or +1 (646) 307-1963 (International) and use the conference ID 2270373. A live audio webcast of the call be accessed by visiting the investor relations section of the Company’s website, www.avadel.com. A replay of the webcast will be archived on Avadel’s website for 90 days following the event.
About LUMRYZ™ (sodium oxybate) for extended-release oral suspension
LUMRYZ, is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
The FDA approval of LUMRYZ was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS, clinicians’ overall assessment of patients’ functioning (CGI-I) and cataplexy attacks, for all three evaluated doses when compared to placebo.
With its approval, the FDA also granted seven years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.
About Avadel Pharmaceuticals plc
Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. For more information, please visit www.avadel.com.
IMPORTANT SAFETY INFORMATION
|
WARNING: Taking LUMRYZ™ (sodium oxybate) with other central nervous system (CNS) depressants, such as medicines used to make you fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope) and death.
The active ingredient of LUMRYZ (sodium oxybate) is a form of gamma hydroxybutyrate (GHB), a controlled substance. Abuse or misuse of illegal GHB alone or with other CNS depressants (drugs that cause changes in alertness or consciousness) have caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma and death. Call your doctor right away if you have any of these serious side effects.
Because of these risks, LUMRYZ is available only by prescription and filled through certified pharmacies in the LUMRYZ REMS. You must be enrolled in the LUMRYZ REMS to receive LUMRYZ. Further information is available at www.LUMRYZREMS.com or by calling 1-877-453-1029. |
INDICATIONS
LUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in adults with narcolepsy:
| · | sudden onset of weak or paralyzed muscles (cataplexy) | |
| · | excessive daytime sleepiness (EDS) |
It is not known if LUMRYZ is safe and effective in people less than 18 years of age.
Do not take LUMRYZ if you take other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol or have a rare problem called succinic semialdehyde dehydrogenase deficiency.
Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling or giving away LUMRYZ may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Anyone who takes LUMRYZ should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery or flying an airplane, for at least six (6) hours after taking LUMRYZ. Those activities should not be done until you know how LUMRYZ affects you.
Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized.
LUMRYZ can cause serious side effects, including the following:
| · | Breathing problems, including slower breathing, trouble breathing and/or short periods of not breathing while sleeping (e.g., sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take LUMRYZ. | |
| · | Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness and difficulty concentrating. Tell your doctor if you have or had depression or have tried to harm yourself. Call your doctor right away if you have symptoms of mental health problems or a change in weight or appetite. | |
| · | Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you start sleepwalking. |
Tell your doctor if you are on a salt-restricted diet or if you have high blood pressure, heart failure or kidney problems. LUMRYZ contains a lot of sodium (salt) and may not be right for you.
The most common side effects of LUMRYZ in adults include nausea, dizziness, bedwetting, headache and vomiting. Your side effects may increase when you take higher doses of LUMRYZ. LUMRYZ can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of LUMRYZ.
For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full Prescribing Information, including BOXED Warning.
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, expectations regarding the potential therapeutic benefit of LUMRYZ; the success of the commercialization of LUMRYZ; the anticipated market availability, demand and sales opportunity of LUMRYZ; the potential expansion of LUMRYZ into the pediatric narcolepsy population including FDA’s review of the sNDA for such population and timing related thereto; the Company’s plans to initiate a Phase 3 pivotal trial for LUMRYZ in idiopathic hypersomnia and timing related thereto; the Company’s anticipated financial condition, expenses, uses of capital and other future financial results. In some cases, forward-looking statements can be identified by 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).
The Company’s 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, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s 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 the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission.
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. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.
Investor Contact:
Courtney Mogerley
Stern Investor Relations, Inc.
Courtney.Mogerley@sternir.com
(212) 698-8687
Media Contact:
Lesley Stanley
Real Chemistry
lestanley@realchemistry.com
(609) 273-3162
AVADEL PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF LOSS
(In thousands, except per share data)
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Net product revenue | $ | 27,178 | $ | — | ||||
| Cost of products sold | 1,522 | — | ||||||
| Gross profit | 25,656 | — | ||||||
| Operating expenses: | ||||||||
| Research and development expenses | 3,068 | 3,830 | ||||||
| Selling, general and administrative expenses | 48,623 | 24,468 | ||||||
| Total operating expense | 51,691 | 28,298 | ||||||
| Operating loss | (26,035 | ) | (28,298 | ) | ||||
| Investment and other income, net | 1,378 | 193 | ||||||
| Interest expense | (2,592 | ) | (3,259 | ) | ||||
| Loss before income taxes | (27,249 | ) | (31,364 | ) | ||||
| Income tax provision (benefit) | 93 | (580 | ) | |||||
| Net loss | $ | (27,342 | ) | $ | (30,784 | ) | ||
| Net loss per share - basic | $ | (0.30 | ) | $ | (0.48 | ) | ||
| Net loss per share - diluted | (0.30 | ) | (0.48 | ) | ||||
| Weighted average number of shares outstanding - basic | 91,693 | 63,886 | ||||||
| Weighted average number of shares outstanding - diluted | 91,693 | 63,886 | ||||||
AVADEL PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
| March 31, 2024 | December 31, 2023 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 35,794 | $ | 31,167 | ||||
| Marketable securities | 52,995 | 73,944 | ||||||
| Accounts receivable, net | 22,692 | 12,103 | ||||||
| Inventories | 11,928 | 10,380 | ||||||
| Research and development tax credit receivable | 1,293 | 1,322 | ||||||
| Prepaid expenses and other current assets | 11,333 | 5,286 | ||||||
| Total current assets | 136,035 | 134,202 | ||||||
| Property and equipment, net | 526 | 585 | ||||||
| Operating lease right-of-use assets | 2,374 | 2,591 | ||||||
| Goodwill | 16,836 | 16,836 | ||||||
| Research and development tax credit receivable | 360 | 332 | ||||||
| Other non-current assets | 11,768 | 10,152 | ||||||
| Total assets | $ | 167,899 | $ | 164,698 | ||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Current portion of operating lease liability | $ | 953 | $ | 934 | ||||
| Accounts payable | 18,961 | 11,433 | ||||||
| Accrued expenses | 27,642 | 24,227 | ||||||
| Other current liabilities | 252 | 261 | ||||||
| Total current liabilities | 47,808 | 36,855 | ||||||
| Long-term operating lease liability | 1,449 | 1,690 | ||||||
| Royalty financing obligation | 34,333 | 32,760 | ||||||
| Other non-current liabilities | 5,925 | 5,654 | ||||||
| Total liabilities | 89,515 | 76,959 | ||||||
| Shareholders’ equity: | ||||||||
| Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; zero issued and outstanding at March 31, 2024 and 5,194 issued and outstanding at December 31, 2023 | — | 52 | ||||||
| Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 96,097 issued and outstanding at March 31, 2024 and 89,825 issued and outstanding at December 31, 2023 | 960 | 898 | ||||||
| Additional paid-in capital | 874,018 | 855,452 | ||||||
| Accumulated deficit | (772,838 | ) | (745,496 | ) | ||||
| Accumulated other comprehensive loss | (23,756 | ) | (23,167 | ) | ||||
| Total shareholders’ equity | 78,384 | 87,739 | ||||||
| Total liabilities and shareholders’ equity | $ | 167,899 | $ | 164,698 | ||||
AVADEL PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2024 | 2023 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (27,342 | ) | $ | (30,784 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | 541 | 588 | ||||||
| Amortization of debt discount and debt issuance costs | — | 1,873 | ||||||
| Share-based compensation expense | 5,389 | 1,522 | ||||||
| Other adjustments | (719 | ) | (1 | ) | ||||
| Net changes in assets and liabilities | ||||||||
| Accounts receivable | (10,589 | ) | — | |||||
| Inventories | (1,260 | ) | — | |||||
| Prepaid expenses and other current assets | (6,093 | ) | (4,131 | ) | ||||
| Research and development tax credit receivable | (17 | ) | — | |||||
| Accounts payable & other current liabilities | 7,528 | 468 | ||||||
| Accrued expenses | 3,415 | 348 | ||||||
| Other assets and liabilities | (557 | ) | (116 | ) | ||||
| Net cash used in operating activities | (29,704 | ) | (30,233 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Proceeds from sales of marketable securities | 119,066 | 15,295 | ||||||
| Purchases of marketable securities | (97,679 | ) | (10,229 | ) | ||||
| Net cash provided by investing activities | 21,387 | 5,066 | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds received in advance of Series B Preferred Shares Issuance | — | 40,000 | ||||||
| Payments for February 2023 Notes | — | (17,500 | ) | |||||
| Proceeds from issuance of shares off the at-the-market offering program | 9,250 | 11,913 | ||||||
| Proceeds from stock option exercises and employee share purchase plan | 3,940 | 29 | ||||||
| Net cash provided by financing activities | 13,190 | 34,442 | ||||||
| Effect of foreign currency exchange rate changes on cash and cash equivalents | (246 | ) | 135 | |||||
| Net change in cash and cash equivalents | 4,627 | 9,410 | ||||||
| Cash and cash equivalents at January 1, | 31,167 | 73,981 | ||||||
| Cash and cash equivalents at March 31, | $ | 35,794 | $ | 83,391 | ||||
Cover |
May 08, 2024 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | May 08, 2024 |
| Entity File Number | 001-37977 |
| Entity Registrant Name | AVADEL PHARMACEUTICALS PLC |
| Entity Central Index Key | 0001012477 |
| Entity Tax Identification Number | 98-1341933 |
| Entity Incorporation, State or Country Code | L2 |
| Entity Address, Address Line One | 10 Earlsfort Terrace |
| Entity Address, City or Town | Dublin 2 |
| Entity Address, Country | IE |
| Entity Address, Postal Zip Code | D02 T380 |
| City Area Code | 353 |
| Local Phone Number | 1 901 5201 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Ordinary Shares, nominal value $0.01 per share |
| Trading Symbol | AVDL |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |