Endo Removes Qwo from Market Due to Concerns About Injection Site Bruising, Skin Discoloration

This decision is expected to result in annualized pre-tax cash savings of approximately $50 million to $60 million and a reduction to Endo's global workforce of approximately 90 full-time positions.

Endo International plc is ceasing the production and sale of Endo Aesthetics' Qwo (collagenase clostridium histolyticum-aaes) in light of market concerns about the extent and variability of bruising following initial treatment as well as the potential for prolonged skin discoloration.

For more than a year, Endo worked to address those concerns, including launching an open-label study in June 2022, APHRODITE, to test different interventions and whether they might mitigate bruising. Although certain APHRODITE study cohorts' results reflected a modest reduction of bruising area and severity, none achieved a consistent level of reduced bruising following initial treatment to adequately alleviate the market's concerns.

"After careful consideration, we have determined that QWO does not represent a viable commercial opportunity for Endo," says Blaise Coleman, President and CEO of Endo, in a news release. "This difficult decision unfortunately results in a workforce reduction. We are grateful for the dedication and hard work of all team members who supported QWO and our Endo Aesthetics business, and we are committed to providing support and assistance to our impacted team members."

This decision is expected to result in annualized pre-tax cash savings of approximately $50 million to $60 million and a reduction to Endo's global workforce of approximately 90 full-time positions. In connection with ceasing QWO production and sales, the Company expects to incur pre-tax cash restructuring charges of approximately $15 million to $20 million and record a total pre-tax restructuring charge of approximately $235 million to $250 million in the fourth quarter 2022. The Company will seek any necessary approvals from the United States Bankruptcy Court for the Southern District of New York in connection with this decision.

QWO remains an FDA-approved product with clinically proven results and an established safety profile, so practices may continue to use unexpired QWO that they have in stock, as well as order additional supply. Alternatively, practitioners can return unused QWO purchased prior to this announcement for a refund. Practices will be notified about these options.