Achaogen (AKAO) Misses Q2 EPS by 28c

Achaogen (NASDAQ: AKAO) reported Q2 EPS of ($1.20), $0.28 worse than the analyst estimate of ($0.92). Revenue for the quarter came in at $2.6 million versus the consensus estimate of $1.36 million.

Recent Highlights and Upcoming Milestones

• ZEMDRI Launch: On July 20, 2018, ZEMDRI was made available for use in the United States. Achaogen has deployed a team of experienced sales and medical professionals to communicate the proper use, efficacy and safety of ZEMDRI, including its once-daily, 30-minute dosing regimen. Greater than 75% of high priority accounts have been engaged in the first two weeks.
• ZEMDRI U.S. Approval: On June 25, 2018, the U.S. Food and Drug Administration (FDA) approved ZEMDRI (plazomicin) for adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options.
• ZEMDRI New Technology Add-On Payment (NTAP) Approval: On August 2, 2018, ZEMDRI received approval from Centers for Medicare & Medicaid Services (CMS) for NTAP, a special designation for new technologies that demonstrate substantial clinical improvement over current treatments. The NTAP payment will provide hospitals with a payment, in addition to the standard-of-care Diagnostic Related Group (DRG) reimbursement, of up to 50% of the cost of ZEMDRI for a period of two to three years, starting on October 1, 2018.
• European Marketing Authorization Application (MAA): Achaogen plans to submit a MAA to the European Medicines Agency for plazomicin in the second half of 2018.

For earnings history and earnings-related data on Achaogen (AKAO) click here.

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