Dermira, Inc. announced consolidated earnings results for the third quarter and first nine months ended September 30, 2017. For the quarter, the company announced collaboration and license revenue was $1,066,000 compared to $119,000 for the same period a year ago. Loss from operations was $178,031,000 compared to $25,941,000 for the same period a year ago. Net loss was $179,174,000 compared to $25,510,000 for the same period a year ago. Net loss per share, basic and diluted was $4.30 compared to $0.72 for the same period a year ago.

For the first nine months, the company announced collaboration and license revenue was $3,198,000 compared to $119,000 for the same period a year ago. Loss from operations was $246,650,000 compared to $82,737,000 for the same period a year ago. Net loss was $247,249,000 compared to $81,701,000 for the same period a year ago. Net loss per share, basic and diluted was $6.15 compared to $2.54 for the same period a year ago.

The company is updating its financial guidance for full year 2017 primarily to reflect the impact of the licensing agreement with Roche, including the acquired in-process research and development expenses associated with the payments to Roche. Management now expects collaboration and license revenue of approximately $4.3 million, research and development and general and administrative expenses totaling $170.0 million to $180.0 million, which includes estimated stock-based compensation expense of approximately $20.0 million, and acquired in-process research and development expenses of $128.6 million.

The company also announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for glycopyrronium tosylate (formerly DRM04). The formal notification indicates that the FDA has completed its filing review and the NDA for glycopyrronium tosylate is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act target date for the completion of the FDA's review of the NDA is June 30, 2018. Glycopyrronium tosylate is an investigational topical therapy for potential use in adult and adolescent patients who suffer from primary axillary hyperhidrosis (excessive underarm sweating), a medical condition that results in sweating beyond what is needed for normal body temperature regulation. If approved, glycopyrronium tosylate would be the first FDA-approved topical wipe medication specifically indicated to treat patients with primary axillary hyperhidrosis.