=Avadel Pharmaceuticals (AVDL) issues corporate outlook

• Headquarters: Republic of Ireland
• avadel.com

Avadel Pharmaceuticals reaffirms FY17 guidance ranges, but sees FY17 EPS near top end of range; sees FY18 revs below consensus

• Co reaffirms guidance for FY17 (Dec), sees EPS of near top end of $0.25-0.35 vs. $0.30 Capital IQ Consensus Estimate; sees FY17 (Dec) revs of $165-175 mln vs. $171.36 mln Capital IQ Consensus Estimate.
• Co issues downside guidance for FY18 (Dec), sees FY18 (Dec) revs of $110-130 mln vs. $139.05 mln Capital IQ Consensus Estimate.
• 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.
• 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 FDA approval.During the formulation and development work for AV001, the Company uncovered what it believes is a meaningful improvement to the product's safety profile. AV001 is expected to compete in an estimated market size of approximately $30 - $40 mln per year once launched in 2019.
• In preparation to reach its 2018 strategic objectives, the Company expects to invest heavily in both Research & Development and Sales & Marketing. R&D costs are expected to range from $40 - $50 mln, the majority of which will be incurred by the REST-ON trial and subsequent NDA filing.Selling, General & Administrative expense is expected to be in the range of $85 - $95 mln. Included in SG&A is approximately $50 - $55 mln of Selling & Marketing costs for Noctiva. Excluding these launch costs, SG&A is expected to be in the range of $35 -- $40 mln, down slightly from 2017. Given the revenue, R&D and SG&A spending expectations and a $20 mln Noctiva launch milestone payment due by June 30, 2018, the Company expects negative cash flow in 2018.