Endo Health Solutions (NSDQ:ENDP) saw shares drop 20% today after announcing plans to close its Astora Women’s Health biz in March due to concerns over future product liability related to mesh implants, despite posting a solid earnings beat for Q4 and the full year 2015.
The company, along with other medical device makers, have been hit with series of lawsuits related to transvaginal meshes, intended to treat pelvic organ prolapse. Last July, Endo settled a batch of product liability lawsuits brought against subsidiary American Medical Systems Holdings over its pelvic mesh implants.
Last October the company agreed to put some 20,000 of the lawsuits to rest, saying it would increase the amount of money it had set aside to cover the claims from $1.2 billion to approximately $1.6 billion. In April 2014, Endo announced it reached agreements to settle up to approximately 21,700 additional mesh claims with separate plaintiffs’ law firms. In June 2013, it settled an undisclosed number of cases for $54.5 million.
The FDA, prompted by a significant increase in complaints about a type of surgical mesh used to treat pelvic organ prolapse in women, put the products under its most stringent level of review, Class III, in January.
Endo said it sought to divest itself of the Astora Women’s Health unit last year, but did not manage to sell the biz, and will now being winding down the business with a closure targeted at March 31.
“In 2015, the Company divested its AMS Men’s Health business and launched a strategic process for AMS Women’s Health – now Astora Women’s Health. While that process resulted in formal bids for Astora, Endo determined in the 1st quarter 2016 that it will wind down Astora business operations in order to reduce the potential for product liability related to future mesh implants. Endo will conduct a wind down process and work efficiently to support physicians in transitioning to alternative products. The company will cease business operations for Astora by March 31, 2016,” the company wrote in an SEC filing for its yearly earnings release.
Endo reported losses of $118.5 million, or 53¢ per share, on sales of $1.07 billion for the 3 months ended December 31. That amounts to a 121% growth in losses as sales stepped up 62% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were $1.36, a solid 9¢ above the $1.27 analysts on Wall Street were looking for in the quarter.
For the full year, Endo reported losses of $1.5 billion, or $7.59 per share, on sales of $3.3 billion for the 12 months ended December 31. The company saw losses grow over 200% as sales only grew 37.3% compared with the last business year.
Adjusted to exclude 1-time items, earnings per share were $4.87, a solid 29¢ higher than analysts on the Street were expecting.
Despite beating the street in revenue and profits, the company has seen shares drop 20.7% as of 2:36 p.m. EST to trade at $42.00.
“Endo delivered solid financial results this quarter and was further strengthened by our first full quarter of revenues from the acquisition of Par Pharmaceutical Holdings, Inc. As we enter 2016, we believe our business is diversified and positioned for double-digit underlying growth over the mid- to long-term. Moving forward, we are focused on operational execution – especially on the integration of Par and on supporting growth for priority branded products such as Xiaflex and Belbuca – and continuing to create value for Endo shareholders,” CEO Rajiv De Silva said in an SEC filing.
News of the shuttering comes only days after the FDA scheduled a panel date to discuss the premarket approval submission from Astora Women’s Health for its Topas incontinence device. The company and federal watchdog were slated to meet in late February to consider the company’s sling mesh device.
The Topas is designed to be implanted around the puborectalis muscle for treating women with fecal incontinence who’ve failed more conservative therapies.
