Recent Bans of Textured Implants & Polynovo to Stop BIA ALCL?, page-15

Q1 2019 results released by Establishment Labs this week suggest that the company hasn’t been negatively impacted by rising safety concerns about breast implants. Last December France recalled Allergan implants and tissue expanders and then followed with a ban on all brands of textured breast implants last month. To date, Canada has followed suit.

Establishment Labs announced Q1 2019 revenues of $20.8 million, a 40.2% year-over-year increase. Meanwhile, Allergan reported a roughly 75% year-over-year decline in sales of breast implants in Q1 2019 ($104.8 down to $72.4 m), following a previous drop in Q4 2018 resulting from its E.U. market withdrawal of textured implants and tissue expanders.

Establishment Labs issued guidance for 2019 revenues of $80 - $84 million. This compares with 2018 ($61.2 m), 2017 ($34.7 m) and 2016 ($19.8 m). Cash balance as of 31/03/19 was $43.1 million.

The company has continued to expand its geographic footprint, with Motiva Implants now commercially available in more than 70 countries worldwide (but not yet including the United States). A direct sales force strategy is being employed in Brazil, UK, France, Sweden, Denmark, Norway and Austria.

Establishment Lab’s global sales team was also expanded by more than 20% during Q1 2019 from 67 to 83 dedicated sales team members and contractors.

The company has also submitted  a flexible form breast implant as well as a tissue expander product (used in breast reconstruction) for CE Mark approval.

PolyNovo has said that it expects to produce testable polymer breast devices by September/October. Establishment Labs will then be responsible for undertaking all non-clinical and clinical trials and regulatory submissions as well as global marketing and sales expenses.

https://www.********/earnings/call-...ent-labs-holdings-inc-esta-q1-2019-earni.aspx
https://www.globenewswire.com/news-...ter-and-Full-Year-2018-Financial-Results.html
https://www.allergan.com/news/assets/agn-q1-2019-earnings-press-release.aspx
https://www.medtechdive.com/news/allergan-breast-implant-sales-drop-more-than-30-in-q1/554252/