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Biotech / Medical : Conceptus (CPTS) -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (88)5/18/2010 4:39:41 PM
From: tuck  Respond to of 96
 
Improved labeling for 3rd generation device is a plus . . .

Press Release Source: Conceptus Inc. On Tuesday May 18, 2010, 4:18 pm

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Conceptus Inc. (NASDAQ: CPTS - News), developer of the Essure(R) procedure, the first and proven non-surgical permanent birth control method, announced today that the third generation (ESS305) of the Essure procedure has received FDA-approval for an improved bilateral placement rate of 96.9%. Improvement in the hysteroscopic time of 9 minutes is an additional benefit.

The bilateral placement rate, at first attempt, has increased from 94.6% to 96.9%; and the hysteroscopic time decreased from thirteen to nine minutes based on a clinical study in a commercial setting with 94 physicians treating 612 patients. The post-approval study was designed to evaluate bilateral placement rate and ease-of-use of the ESS305 after its July 2007 introduction. This improved labeling offers patients and physicians with even more security of placing the micro-inserts properly the first time and ease of performing the procedure.

“The announcement of an increased bilateral placement rate and faster procedure time illustrates the continued commitment of Conceptus to improve an already simple procedure for both the benefit of physicians and patients,” said Dr. Mark Levie, an OB/GYN based in New York City. “In my opinion, Essure continues to be the choice for physicians and women seeking a permanent birth control solution.”

During the procedure, a physician places two soft, flexible micro-inserts into each fallopian tube through the cervix without incisions. Essure is 99.74% effective based on five years of follow up with zero pregnancies reported in clinical trials, making it the most effective form of permanent birth control on the market.

Mark Sieczkarek, president and chief executive officer of Conceptus Inc. states, “The improvements to our product were a direct response to customer input. The objective to provide an even simpler and faster procedure was met as shown by FDA approval of our updated labeling. Conceptus continues to be dedicated to providing ‘best in class’ innovative solutions in women’s healthcare.”

About the Essure Procedure:

The Essure procedure, FDA approved since 2002, is a permanent birth control method that can be performed in the comfort of a physician’s office in about 9 minutes (average hysteroscopic time) without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Small, flexible micro-inserts are placed in a woman’s fallopian tubes through the cervix without incisions. Over the next three months, the body forms a natural barrier around the micro-inserts to prevent sperm from reaching the egg. Essure is 99.74% effective based on five years of follow up with zero pregnancies reported in clinical trials, making it the most effective form of permanent birth control on the market. The procedure is covered by most insurance plans, and when it is performed in a doctor’s office the cost may be as low as a simple co-pay.

Three months after the Essure procedure, a doctor performs an Essure Confirmation Test to confirm that the fallopian tubes are fully blocked, and that the patient can rely on Essure for permanent birth control. Essure has been proven and trusted by physicians since 2002, with more than 400,000 women worldwide having undergone the Essure procedure.

Essure and Conceptus are registered trademarks of Conceptus Inc. (NASDAQ:CPTS)<<

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Cheers, Tuck



To: tuck who wrote (88)7/8/2010 4:51:26 PM
From: tuck  Read Replies (1) | Respond to of 96
 
>>The macro environment -- i.e. the crappy economy -- is about a wash. The desire to spend less on elective procedures is offset by the desire not to have children when you can't afford them. Long term use of condoms might actually be more expensive for the patient, and of course, less fun. This is in the context of insurance paying for most of the procedure. No indication that will change under ObamaCare.<<

Evidently, it's not a wash. CPTS cut guidance for the quarter and year citing macro concerns, and the stock is off about 25% after hours:

>>Conceptus® Updates Second Quarter and Full Year 2010 Financial Guidance
Company to Hold Second Quarter Financial Results Conference Call on August 5, 2010

Press Release Source: Conceptus, Inc. On Thursday July 8, 2010, 4:05 pm
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Conceptus, Inc. (Nasdaq: CPTS - News), developer of the Essure® procedure, the first proven non-surgical permanent birth control method available, today updated second quarter and full year 2010 financial guidance that was previously issued on April 20, 2010.

Based upon preliminary financial results from the just completed second quarter, the Company expects the following:

Updated Second Quarter 2010 Guidance:

Net sales are expected to be in a range of $36.8 million to $36.9 million. The Company’s previous net sales guidance range was $39.5 million to $41.0 million. Net sales in the second quarter of 2009 were $33.0 million.

GAAP diluted EPS loss is expected to be in a range of ($0.02) to ($0.01). The Company’s previous GAAP diluted EPS guidance range was $0.00 to $0.03. The Company’s GAAP diluted EPS loss in the second quarter of 2009 was ($0.02).

Non-GAAP diluted EPS is expected to be in a range of $0.10 to $0.11. The Company’s previous non-GAAP diluted EPS guidance range was $0.12 to $0.15. The Company’s non-GAAP diluted EPS in the second quarter of 2009 was $0.08.

Updated Full Year 2010 Guidance:

Net sales are expected to be in a range of $143.0 million to $145.0 million. The Company’s previous net sales guidance range was $160.0 million to $165.0 million. Net sales in 2009 were $131.4 million.
GAAP diluted EPS is expected to be in a range of $0.21 to $0.26. The Company’s previous GAAP diluted EPS guidance range was $0.50 to $0.55. The Company’s GAAP diluted EPS in 2009 was $0.25.

Non-GAAP diluted EPS is expected to be in a range of $0.70 to $0.75. The Company’s previous non-GAAP diluted EPS guidance range was $0.99 to $1.04. The Company’s non-GAAP diluted EPS in 2009 was $0.65.

The Company has lowered net sales guidance for the second quarter and full year 2010 due to domestic macroeconomic factors that are causing a reduction in physician office visits, and, to a lesser extent, a stronger U.S. dollar and Company initiatives related to competitive trialing. Based on third-party research combined with Company projections, domestic physician office visits in general during 2010 are expected to remain depressed over prior-year levels by 5% to 10% due to continued high unemployment rates. In addition, the Company estimates that currency exchange will negatively impact 2010 net sales by approximately $4.0 million and GAAP diluted EPS by approximately $0.09, compared with the Company’s previous expectations.

“2010 has developed into a challenging year for us, with the weak domestic economy and strong U.S. dollar impacting our results more than we had anticipated,” said Mark Sieczkarek, president and chief executive officer of Conceptus. “To proactively address competitive trialing, we have been re-educating physicians on the superior clinical results of the Essure procedure, which has temporarily lessened our focus on physician metrics. Even with these factors, we are projecting overall net sales growth of 9% to 10% for the year, which includes international unit volume growth of 30%.”

“We remain optimistic about our long-term growth prospects. Permanent birth control is a multi-billion dollar market with more than one million procedures performed annually in the U.S. alone. The Essure procedure is faster, safer, less expensive and more effective than competing procedures,” said Sieczkarek. “Our team is dedicated to establishing the Essure procedure as the industry’s standard of care.”

Conference Call on August 5, 2010

The Company will release second quarter 2010 financial results on August 5, 2010 after the close of market. Management will host an investment community conference call beginning at 4:30 p.m. Eastern time to discuss results and answer questions. Conference call dial-in information is as follows:

U.S. callers: (888) 803-8296
International callers: (706) 634-1250
Individuals interested in listening to the live conference call via the Internet may do so by logging on to the Company's website, www.conceptus.com.

A telephone replay will be available from 6:30 p.m. Eastern time August 5, 2010 through 11:59 p.m. Eastern time on August 9, 2010. Replay dial-in information is as follows:

U.S. callers: (800) 642-1687 (domestic)
International callers: (706) 645-9291 (international)
Conference ID number (U.S. and international): 87124264
The replay will also be available at www.conceptus.com <<

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Cheers, Tuck



To: tuck who wrote (88)5/1/2012 9:40:16 AM
From: tuck  Respond to of 96
 
Conceptus settles with Hologic, giving back ~18 million, while Hologic withdraws Adiana from the market:

>>Conceptus ( CPTS) announced that it has reached an agreement with Hologic ( HOLX) to settle the ongoing patent infringement litigation related to Hologic's Adiana Permanent Contraception System. The settlement agreement resolves all outstanding litigation between Conceptus and Hologic. Under the terms of the settlement agreement, Hologic has agreed to remove its Adiana system from the worldwide permanent birth control market by May 18. In addition, Conceptus has relieved Hologic of the $18.8M payment for monetary damages awarded to Conceptus as part of the October 17, 2011 jury verdict. Both companies have agreed to withdraw their respective appeals. In February, Conceptus had filed an appeal to overturn the court's ruling denying its motion for permanent injunction against the sale of Hologic's Adiana system, and Hologic had filed an appeal of the jury's finding of patent validity and infringement. Hologic has also agreed to withdraw its False Patent Marking claims filed in 2009 in the United States District Court for Massachusetts. Furthermore, both parties will file with the United States District Court for Northern California appropriate motions seeking a consent judgment to the voluntary injunction of Hologic's sale of the Adiana product within the next 30 days. Lastly, Conceptus will receive non-exclusive licensing rights to the technology related to Hologic's Adiana system, limited to use in the field of permanent birth control. While Conceptus has been granted these rights, it does not intend to market the Adiana system.<<

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No longer have a position.

Cheers, Tuck