The Waltham, Mass.-based company posted a net loss of -$11.3 million, or -46¢ per share, for the 3 months ended Dec. 31, for bottom-line loss of -34.5% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were -46¢, missing the -37¢ consensus put forth by analysts on The Street.
Kala Pharmaceuticals posted a net loss of -$42.2 million, or -$6.11 per share, for the full year. The company’s losses grew 27.1% compared to 2016.
“This last year included significant accomplishments for Kala, marked by a successful initial public offering, and the acceptance of a New Drug Application for Inveltys (KPI-121 1%) for the treatment of inflammation and pain following ocular surgery with a PDUFA target action date of August 24, 2018,” chairman & CEO Mark Iwicki said in prepared remarks.
“Additionally, in January 2018, we reported topline results from two Phase 3 clinical trials of KPI-121 0.25%, Stride 1 and Stride 2, in patients with dry eye disease. Since January, we have been conducting additional analyses of the data from these two Phase III trials and the Phase II study. These analyses are being done to better understand the results and to prepare for discussions with the Food and Drug Administration. We expect to meet with the FDA to develop our path forward and will provide further updates following that meeting,” he added.
KALA shares closed yesterday at $14.73 apiece, down -13.8%.
Steve MacMillan took over as CEO of Hologic in 2013, drawing on his experience at medtech titans like Stryker and Johnson & Johnson. Since then, Hologic has grown into a $3 billion business.
At DeviceTalks Boston, MacMillan will provide exclusive insights into the Massachusetts-based company and its evolving definition of women's healthcare. You don't want to miss it!
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