Melinta meldet Zahlen für Q1/19
- Umsatz 14 Mio. $
- Verlust 27 Mio. $
- Cash 117 Mio. $
- MK 42 Mio. $
2019 Guidance In light of the first quarter results, and to provide the Company with additional time to evaluate the impact of its new strategic commercial initiatives, the Company will update 2019 financial guidance as part of its second quarter 2019 earnings communications. Previous revenue guidance should no longer be relied upon.
Portfolio Updates - sNDA submission to FDA for Baxdela for treatment of CABP in adult patients in April 2019; awaiting official acceptance and PDUFA date from the FDA
- Clinical study for a new formulation of Orbactiv scheduled to commence in the second half of 2019, targeted to reduce infusion time from three hours to one hour
- Presentation of portfolio data, including results from real-world registry studies of Vabomere, Orbactiv and Minocin for Injection at the Making a Difference in Infectious Diseases (MAD-ID) 2019 Annual Meeting held from May 8-11, 2019 in Orlando, Florida
Business Highlights - Recent execution of several new strategic commercial initiatives, including the engagement of a contract sales organization to sell Baxdela in the retail setting
- Implementation of operating cost-reduction initiatives, delivering significant cost savings in 2019
Upcoming Potential Catalysts - European Commission approval decision for delafloxacin (to be marketed under the brand name Quofenix) for acute bacterial skin and skin structure infections (ABSSSI)
- Country approvals for Baxdela in South America and Central America
- Latin America commercialization agreement execution for Vabomere, Orbactiv and Minocin for Injection
- FDA approval for Baxdela for the treatment of CABP in adults
http://ir.melinta.com/news-releases/...s-first-quarter-2019-financial
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