FDA Approves Conceptus' Essure Data - Analyst Blog
April 16 2012 - 7:00AM
Zacks
The manufacturer of Essure
permanent birth control system, Conceptus (CPTS)
recently received the US Food and Drug Administration (FDA) nod for
including 10-year data on effectiveness of Essure in the Essure
procedure US Instructions for Use (IFU) and Patient Information
Booklet (PIB). On top of that, FDA also allowed the company to
include full five-year clinical study results and effectiveness
rate of 99.83% in the IFU and PIB. With this approval, the clinical
trial for Essure, which was initiated in 1998 and showed zero
pregnancies over five years will close.
Amidst several recent headwinds,
especially related to the tough competitive landscape and difficult
macroeconomic conditions, this latest FDA approval came as a relief
for Conceptus. Earlier, in January 2012, the company received an
unfavorable ruling in a lawsuit related to its request to prohibit
its competitor Hologic(HOLX) from selling its
permanent birth control product Adiana system in the US. Moreover,
with such a verdict, Hologic will no longer be required to pay any
royalty to Conceptus on future sales of Adiana.
Moreover, Conceptus remains
challenged with limited revenue and earnings visibility arising
from tough macroeconomic conditions including high unemployment
rates that hampered the market for non-urgent procedures like
Essure. During the fourth quarter of fiscal 2011, domestic sales of
Essure plunged 5.6% year over year. International sales also
declined 18.8% on a year-over-year basis.
Apart from these setbacks,
Conceptus declared a 15% drop in its US field sales organization,
which resulted from its decision to discontinue its Gynecare
Thermachoice Uterine Balloon Therapy System’s promotion in the US.
This decision was primarily based on the company’s intention to
focus on driving sales of its key product Essure. Also the company
is presently working on new product development which may
supplement Essure procedure going ahead.
Besides, OB/GYN office visits
slowed down leading to soft growth in the trans-cervical
sterilization market. Moreover, Conceptus is facing severe
challenges as Hologic’s Adiana, which is a direct competitor of
Essure, is being trialed by many physicians. This has become a real
concern for Conceptus as it lacks the resource to re-educate
existing customers on the efficacy of Essure.
We are concerned about the
penetration of Hologic’s Adiana in the US, which has increasingly
cannibalized Conceptus’ market share. Although Conceptus is
undertaking several initiatives to recapture market share, the
outcome remains unimpressive as growth in the hysteroscopic
sterilization market has been decelerating for three consecutive
quarters. We also believe that the current hindrances will further
deteriorate the already gloomy situation. However, the recent FDA
approval to include 10-year data is expected to act in favor of
Conceptus’ regaining its position in a still underpenetrated US
hysteroscopicsterilization market.
Presently, Conceptus retains a
Zacks #3 (short-term ‘Hold’ Rank), which also corresponds to our
long-term ‘Underperform’ recommendation on the stock.
CONCEPTUS INC (CPTS): Free Stock Analysis Report
HOLOGIC INC (HOLX): Free Stock Analysis Report
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