• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
    • Cardiovascular
    • Orthopedics
  • Wall Street Beat
    • Funding Roundup
    • Mergers & Acquisitions
  • Podcasts & Webinars
    • Podcasts
    • Webinars
  • Resources
    • About MassDevice
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Whitepapers
  • DeviceTalks Tuesdays
  • Coronavirus: Live updates
Home » Endo tumbles on plans to shutter Astora biz

Endo tumbles on plans to shutter Astora biz

February 29, 2016 By Fink Densford

Endo, Astora Women's HealthEndo 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.

Filed Under: Business/Financial News, Women's Health Tagged With: Astora Women's Health, Endo Health

In case you missed it

  • EchoNous partners with Samsung on AI-guided ultrasound
  • RefleXion expands footprint through multi-system contract with Select Healthcare
  • Report: 3M faces losses of $100B in earplug lawsuits
  • Caregility, Eko partner to bring smart stethoscope to telehealth platform
  • Henry Schein makes $400M increase to share repurchase plan
  • Tandem Diabetes Care delivers 1 million insulin boluses using t:connect mobile app
  • CathVision closes $7.2M financing round for electrophysiology recording tech
  • Verily’s Onduo, Sword Health collaborate on virtual care
  • FDA clears expanded labeling for Preceptis Medical’s ear tube system
  • KeyCare raises $24M for virtual care platform
  • FDA says 44 more deaths have been reported in Philips ventilator recall
  • Paragonix reaches milestone of 2,000 organs preserved, transported for transplantation
  • Axonics expands IP portfolio with new patents
  • BD, Accelerate Diagnostics partner on rapid antibiotic testing
  • FDA clears VySpine’s VyPlate anterior cervical plate system
  • Technical Brief – “Understanding the Extensive OEM Benefits of Total Linear Motion Solutions.”
  • Exactech launches total hip arthroplasty system

RSS From Medical Design & Outsourcing

  • MIT engineers fabricate chip-free, wireless e-skin
    MIT engineers have developed a new wireless, wearable sensor without semiconductors or batteries in what they say is a first step toward chip-free wireless sensors. This electronic skin — or e-skin — is a flexible, semiconducting film that MIT describes as a sort of electronic Scotch tape. The device has an ultrathin gallium nitride film… […]
  • Owens & Minor and Allina Health partner on supply chain resiliency
    Owens & Minor (NYSE: OMI) and Minneapolis-based Allina Health are partnering on what they call a “unique integrated service model for supply chain resiliency.” An Owens & Minor distribution center that has been in operation for more than 25 years in Moundsview, Minnesota will serve as the integrated service center powering the model, the companies… […]
  • Chronic pain researchers say sound and electrical stimulation has treatment potential
    University of Minnesota researchers are using sound and electrical stimulation to treat chronic pain and other sensory disorders without pharmaceutical drugs. The combination of sound and stimulation activates the brain’s somatosensory cortex, according to a study on guinea pigs published in the Journal of Neural Engineering. Also known as the tactile cortex, the somatosensory cortex is… […]
  • What Laura Mauri learned from a ‘firestorm’ in her first months at Medtronic
    Dr. Laura Mauri faced a monumental moment with former Medtronic CEO Omar Ishrak shortly after she joined the company as VP of global clinical research and analytics. It was late 2018, and Mauri — who’s now an SVP and the chief scientific, medical and regulatory officer at Medtronic (NYSE: MDT) — was in a meeting… […]
  • Senators seek post-market FDA study of pulse oximeters and skin color
    Democratic U.S. senators are prodding the FDA to launch a post-market study of pulse oximeters due to unreliable performance for patients with dark skin. Pulse oximeters estimate blood oxygen levels (SpO2) and pulse rates in patients using infrared light — usually on a fingertip — at home or in clinical settings. Blood oxygenation is one… […]
  • TE Connectivity opens global medical device prototyping center in Ireland
    TE Connectivity (NYSE:TEL) today announced it opened its global Propelus Prototype Center for medical devices in Galway, Ireland. The $5 million rapid prototyping center was built into its existing manufacturing site in Galway and directly connects TE engineers with customers to reduce development time and increase speed to market for lifesaving and life-improving medical devices. Propelus… […]
  • Contract manufacturer Minnetronix Medical launches its first in-house product, MindsEye
    Minnetronix Medical has launched MindsEye, making it the first medical device that the contract developer and manufacturer has conceived and commercialized. St. Paul-based Minnetronix Medical’s MindsEye is the first expandable brain access port on the market. The FDA cleared the device under the 510(k) pathway in August 2020. The minimally invasive device gives neurosurgeons deep… […]
  • What’s next for Jennifer Fried after leaving Explorer Surgical?
    Explorer Surgical co-founder Jennifer Fried has resigned from the company after selling it to Global Healthcare Exchange in October. Fried announced her departure last week on LinkedIn, saying she’s preparing for her next professional chapter. “It’s bittersweet — I’m so proud of everything our team has built and accomplished,” Fried wrote. “The time has flown… […]
  • The 24 best medical device innovations of 2022
    The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards. There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021. The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.… […]
  • FDA issues new COVID-19 testing guidance to avoid false negatives
    COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers. The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies… […]
  • Confluent Medical expands Costa Rica manufacturing footprint for nitinol, complex catheter production
    Confluent Medical Technologies this week announced the opening of its new addition to its Costa Rica manufacturing facility. The expansion adds 66,000 sq. ft to its large-scale manufacturing center of excellence in Alajuela, Costa Rica to expand Confluent’s capacity for nitinol component processing and complex catheter manufacturing. “Confluent has experienced consistent and strong growth in… […]

Primary Sidebar

DeviceTalks Weekly

August 12, 2022
DTW – Medtronic’s Mauri brings years of patient care to top clinical, regulatory, scientific post
See More >

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Medtech news in a minute?
We Deliver!

MassDevice Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us
Add us on Facebook Follow us on Twitter Connect with us on LinkedIn Follow us on YouTube

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy