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Commercial launch for Noctiva™ on target for second quarter 2018
NDA filing for FT218 expected by year-end 2018
Total revenues expected to range from
For 2018, the Company has set forth the following expectations:
- Implement a full-scale commercial launch for Noctiva during the second quarter
- File the NDA for FT218 by the end of 2018
- File the NDA for AV001, its fourth UMD product
- Maintain market leading position across its portfolio of hospital products and improve the effectiveness and efficiency of its pediatric operations
- Enhance portfolio development through selective M&A and advancement of internal pipeline
- Generate total revenues between
$110 - $130 million
Mr. Anderson continued, “We not only expect to successfully complete our Phase III REST-ON trial of FT218 for excessive daytime sleepiness and cataplexy, and subsequently file our NDA by year end, but we are also gearing up for a strong commercial launch for Noctiva™ in the second quarter. Both FT218 and Noctiva are proprietary products with enormous market potential. They will expand our commercial footprint into new therapeutic categories and create meaningful long-term value for shareholders.”
Avadel is progressing in enrolling patients for its REST-ON Phase III clinical trial. REST-ON is a double-blind, randomized, placebo controlled study of 264 patients to assess the efficacy and safety of FT218, a once nightly formulation of sodium oxybate for extended-release oral suspension for the treatment of excessive daytime sleepiness (
“Filing the NDA for FT218 by the end of 2018 is still our target, and strategies to drive enrollment through social media, clinical site incentive goals and identification of additional clinical sites have aided us in maintaining this objective. We recognize that enrollment is the most difficult aspect of this trial given the limited population of narcolepsy patients and the strict exclusion criteria agreed upon in our Special Protocol Assessment with
Mr. Anderson continued, “We maintain that FT218 is our most important clinical project in 2018. The opportunity to enter a possible blockbuster market with a potentially superior product is incredibly meaningful for our company. The current approved product to treat the condition generates well over
In addition to FT218, Avadel is also working to file an NDA for a fourth sterile injectable product, AV001, which is currently being marketed by another company without
The Company estimates that peak revenues for Noctiva could be as high as
Avadel’s three sterile injectable products, Akovaz® (ephedrine sulfate), Bloxiverz® (neostigmine methylsulfate) and Vazculep® (phenylephrine hydrochloride), ended 2017 as market share leaders for each of their respective categories. Akovaz and Bloxiverz were both subject to additional generic competitors late in the second half of 2017, and the Company expects increased pressure on both share and price as a result in 2018. Avadel remains committed to maintaining market leadership across its hospital products during 2018.
Mr. Divis said, “These hospital products were developed to provide the company with cash flow and they have exceeded our expectations. Despite the increasingly competitive environment for these generics, we have continued to maintain market leadership and strong gross margins across our portfolio, and we fully anticipate that these products will continue to be valuable assets to our company.”
Avadel’s pediatric products showed good growth during 2017 with Karbinal ER showing especially robust growth. Recent weekly prescription trends for Karbinal ER average approximately 1,800 TRxs per week, representing greater than 200% growth over 2016. In July, Flexichamber was launched and continues to grow slowly but steadily. The company’s original plan for the pediatric business was to include additional products to add to those acquired from FSC Pediatrics. To date, the company continues to look for proprietary meaningfully differentiated products with growth potential to add into the portfolio.
The Company is reaffirming its 2017 revenue guidance to be in the range of
2018 Financial Guidance
Due to the generic nature of its hospital business and recent increased competition, the Company expects revenues to decline on a year-over-year basis and anticipates generating between
Noctiva is the first and only formulation of desmopressin acetate, a vasopressin analog, approved by the
Important Safety Information and Indication for Noctiva (desmopressin acetate)
- NOCTIVA can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death.
- NOCTIVA is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids.
- Ensure serum sodium concentrations are normal before starting or resuming NOCTIVA. Measure serum sodium within seven days and approximately one month after initiating therapy or increasing the dose, and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia.
- If hyponatremia occurs, NOCTIVA may need to be temporarily or permanently discontinued.
Safe Harbor: This press release may include 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. The words “will,” “may,” “believe,” “expect,” “anticipate,” “estimate,” “project” and similar expressions, and the negatives thereof, identify forward-looking statements, each of which speaks only as of the date the statement is made. Although we believe that our forward-looking statements are based on reasonable assumptions within the bounds of our knowledge of our business and operations, our business is subject to significant risks and as a result there can be no assurance that actual results of our research, development and commercialization activities and our results of operations will not differ materially from the results contemplated in such forward-looking statements. These risks include: (i) risks relating to our license agreement with
Non-GAAP Disclosures and Adjustments
Avadel discloses certain non-GAAP financial measures, including adjusted net income and loss and adjusted net income and loss per diluted share, as management believes that a comparison of its current and historical results would be difficult if the disclosures were limited to financial measures prepared only in accordance with generally accepted accounting principles (GAAP) in the U.S. In addition to reporting its financial results in accordance with GAAP, Avadel reports certain non-GAAP results that exclude, if any, fair value remeasurements of its contingent consideration, impairment of intangible assets, amortization of intangible assets, restructuring costs, foreign exchange gains and losses on assets and liabilities denominated in foreign currencies, but includes the operating cash flows plus any unpaid accrued amounts associated with the contingent consideration, in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance. The Company's management uses these non-GAAP measures internally for forecasting, budgeting and measuring its operating performance. Investors and other readers should review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most closely applicable GAAP measure set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. The table provided within the following “Supplemental Information” section reconciles GAAP net income and loss and diluted earnings or loss per share to the corresponding adjusted amounts.
|Contacts:||Michael F. Kanan|
|Chief Financial Officer|
|Phone: (636) 449-1844|
|Sr. Director, Investor Relations & Corporate Communications|
|Phone: (636) 449-5866|
1 Data on file.
2 Sources: (1) US census data 2016 estimates (2) Lee, L. K., et al. "Potential benefits of diagnosis and treatment…” International journal of clinical practice 70.1 (2016): 66-81.