0001193125-12-185987.txt : 20120426 0001193125-12-185987.hdr.sgml : 20120426 20120426161704 ACCESSION NUMBER: 0001193125-12-185987 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20120426 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20120426 DATE AS OF CHANGE: 20120426 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CONCEPTUS INC CENTRAL INDEX KEY: 0000896778 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 973170244 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-27596 FILM NUMBER: 12783716 BUSINESS ADDRESS: STREET 1: 334 E EVELYN AVE CITY: MOUNTAIN VIEW STATE: CA ZIP: 94041 BUSINESS PHONE: 650 962 4000 MAIL ADDRESS: STREET 1: 334 E EVELYN AVE CITY: MOUNTAIN VIEW STATE: CA ZIP: 94041 8-K 1 d341043d8k.htm FORM 8-K Form 8-K

 

 

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): April 26, 2012

 

 

CONCEPTUS, INC.

(Exact name of registrant as specified in charter)

 

 

 

Delaware   000-27596   94-3170244

(State or other jurisdiction of

incorporation or organization)

 

(Commission

file number)

 

(I.R.S. employer

identification no.)

331 East Evelyn Avenue

Mountain View, CA 94041

(Address of principal executive offices) (Zip code)

Registrant’s telephone number, including area code: (650) 962-4000

 

 

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


ITEM 2.02. RESULTS OF OPERATIONS AND FINANCIAL CONDITION.

On April 26, 2012, the Registrant publicly disseminated a press release announcing certain financial results for the three months ended March 31, 2012. The foregoing description is qualified in its entirety by reference to the Registrant’s Press Release dated April 26, 2012, a copy of which is attached hereto as Exhibit 99.1.

Forward-Looking Statements. This report includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements relate to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of those terms and other comparable terminology. These statements reflect only management’s current expectations. Important factors that could cause actual results to differ materially from the forward-looking statements we make or incorporate by reference in this report are set forth under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as may be updated from time to time by our future filings under the Securities Exchange Act. If one or more of these risks or uncertainties materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.

 

ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.

 

  (d) Exhibits

 

Exhibit No.

  

Description

99.1    Press Release dated April 26, 2012.

 

2


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  CONCEPTUS, INC.
  (Registrant)
  By:  

/s/ Gregory E. Lichtwardt

          Gregory E. Lichtwardt
          Executive Vice President, Operations
          and Chief Financial Officer
Dated: April 26, 2012    

 

3

EX-99.1 2 d341043dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

LOGO

Investor and Public Relations Contact:

Cindy Klimstra

(650) 962-4032

cindy_klimstra@conceptus.com

Conceptus® Reports First Quarter Financial Results

Domestic Net Sales Return to Solid Growth of 15%

MOUNTAIN VIEW, Calif., April 26, 2012 – Conceptus, Inc. (Nasdaq: CPTS), developer of the Essure® procedure, the leading non-surgical permanent birth control method, today reported financial results for the three months ended March 31, 2012 and revised financial guidance for 2012.

Net sales for the first quarter of 2012 were $29.0 million, an increase of 9.3% compared with net sales for the first quarter of 2011 of $26.6 million.

The net loss for the first quarter of 2012 was $2.8 million, or ($0.09) per share. This compares with a net loss for the first quarter of 2011 of $2.9 million, or ($0.09) per share.

Adjusted earnings before interest, taxes, depreciation, amortization and stock-based compensation (“adjusted EBITDA”) for the first quarter of 2012 was essentially breakeven. This compares with adjusted EBITDA for the first quarter of 2011 of $0.07 million.

“We are pleased with our financial results for the first quarter, particularly the growth of our domestic business. While some portion of this domestic growth is attributable to the comparative weakness of the first quarter of 2011, we are nonetheless encouraged by more favorable U.S. macro-environmental trends and the early effects of our programs to restore growth,” said D. Keith Grossman, president and chief executive officer of Conceptus. “We also believe that the U.S. hysteroscopic permanent birth control market had positive year-over-year growth for the first time in four quarters. We remain optimistic about the future growth opportunity for Conceptus and our ability to increase share of the permanent birth control market.”

First Quarter Highlights

Domestic sales were $21.7 million for the first quarter of 2012, compared with $18.9 million for the first quarter of 2011, representing an increase of $2.9 million or 15.1%.

In the first quarter of 2012, the Company expanded U.S. physician penetration by entering approximately 476 physicians into preceptorship, certifying approximately 225 physicians and transitioning approximately 96 physicians to performing Essure procedures in the office setting. To date, there are approximately 14,800 active U.S. physicians who have performed an Essure procedure.

International sales were $7.3 million for the first quarter of 2012, compared with $7.7 million for the first quarter of 2011. The 5.2% decrease is due to lower sales to the Company’s distributor in Spain where the overall economic conditions continue to be quite weak. The remainder of the Company’s international sales grew 5.6% in the first quarter compared to last year.


Gross profit was $23.9 million or 82.2% of net sales for the first quarter of 2012, compared with $21.4 million or 80.4% of net sales for the first quarter of 2011. The year-over-year increase in gross profit margin was primarily due to continued reductions in manufacturing costs, higher international average selling prices and channel mix.

Total operating expenses were $27.7 million for the first quarter of 2012, compared with $25.1 million for the first quarter of 2011. This year-over-year increase is primarily attributable to the Company’s direct to consumer (“DTC”) advertising campaign, costs related to product development of the next-generation Essure device and clinical trials for the Essure Transvaginal Ultrasound confirmation study.

In the first quarter of 2012, the Company recorded a net income tax benefit of $2.5 million due to a pre-tax loss of $5.3 million. This provision reflects a tax rate of approximately 46.6%.

Cash, cash equivalents and investments were $60.1 million as of March 31, 2012, a decrease of $43.3 million from December 31, 2011 and a decrease of $31.6 million from March 31, 2011. The Company’s cash usage from operations in the first quarter of 2012 was $6.4 million, due primarily to an increase in working capital. On February 15, 2012, the Company redeemed its 2027 senior convertible notes for cash including full principal and accrued interest of $36.6 million. In December 2011 $50.0 million of the original 2027 notes were refinanced and are now due in 2031.

2012 Financial Guidance

Conceptus revised its 2012 financial guidance as follows:

 

   

Net sales: the Company expects 2012 net sales to be in the range of $135 million to $139 million, compared with previous guidance of $134 million to $138 million and 2011 net sales of $127 million.

 

   

Adjusted EBITDA: the Company expects 2012 adjusted EBITDA to be in the range of $23 million to $25 million, compared with previous guidance of $22 million to $24 million and 2011 adjusted EBITDA of $14.1 million.

“The strength of our first quarter was encouraging to the extent that it reflected continuing improvements in domestic OB/GYN physician office visits, recent sales force productivity enhancements and possibly a favorable impact from our DTC campaign. However, for the remainder of the year we expect growth rates to be on track with our original guidance provided in February,” said Mr. Grossman. “We continue to focus exclusively on initiatives that will restore long-term growth and profitability of the business and remain confident in our direction based on these early signs.”

Conference Call

Conceptus will host an investment community conference call beginning at 4:30 p.m. Eastern time today 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 on April 26, 2012, through 11:59 p.m. Eastern time on April 30, 2012. Replay dial-in information is as follows:

 

   

U.S. callers: (855) 859-2056

 

   

International callers: (404) 537-3406

 

   

Conference ID number (U.S. and international): 69218699

 

   

The replay will also be available at www.conceptus.com

Use of Non-GAAP Financial Measures

The Company has supplemented its GAAP net income/loss with a non-GAAP measure of adjusted EBITDA. Management believes that this non-GAAP financial measure provides useful supplemental information to management and investors regarding the performance of the Company, facilitates a more meaningful comparison of results for current periods with previous operating results, and assists management in analyzing future trends, making strategic and business decisions and establishing internal budgets and forecasts. A reconciliation of non-GAAP adjusted EBITDA to GAAP net income/loss in the most directly comparable GAAP measure is provided in the schedule below.

There are limitations in using this non-GAAP financial measure because it is not prepared in accordance with GAAP and may be different from non-GAAP financial measures used by other companies. This non-GAAP financial measure should not be considered in isolation or as a substitute for GAAP financial measures. Investors and potential investors should consider non-GAAP financial measures only in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP and the reconciliations of the non-GAAP financial measure provided in the schedule below.

About the Essure® Procedure

The Essure procedure, FDA approved since 2002, is the first permanent birth control method that can be performed in the comfort of a physician’s office in less than 10 minutes (average hysteroscopic time) without hormones, cutting, burning or the risks associated with general anesthesia or tubal ligation. Soft, flexible 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 and through the inserts to prevent sperm from reaching the egg. Three months after the Essure procedure, a doctor is able to perform an Essure Confirmation Test to confirm that the inserts are properly placed and that the fallopian tubes are fully blocked, allowing the patient to rely upon Essure for permanent birth control.

The Essure procedure is 99.83% 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. Essure’s 10-year commercial data tracks closely with its five-year clinical results, and Essure has been proven and trusted by physicians since 2002. The Essure procedure is covered in the U.S. by most public and private insurance plans and more than 625,000 women worldwide have undergone the procedure.

About Conceptus®, Inc.

Conceptus, Inc. is a leader in the design, development and marketing of innovative solutions in women’s healthcare. The Company manufactures and markets the Essure procedure. The Essure procedure is available in the United States, Europe, Australia, New Zealand, Canada, Mexico, Central and South America and the Middle East.


Please visit www.essure.com for more information on the Essure procedure. Patients may call the Essure Information Center at 1-877-ESSURE-1 with questions or to find a physician in their area.

Forward Looking Statements

Except for the historical information contained herein, the matters discussed in this press release include forward-looking statements, the accuracy of which is subject to known and unknown risks and uncertainties. These forward-looking statements include, without limitation, discussions regarding projected net sales and adjusted earnings before interest, taxes, depreciation, amortization and stock-based compensation (“adjusted EBITDA”) for the full year 2012, the expected impact of macro-environmental trends and U.S. OB/GYN office visits on our growth in 2012, our ability to expand physician market penetration and utilization, our ability to improve sales force productivity, our ability to market effectively to physicians and prospective patients, our ability to secure government reimbursement in foreign countries, and make the Essure procedure the standard of care in permanent birth control. These discussions and other forward-looking statements included herein may differ significantly from actual results. Such differences may be based upon factors such as changes in strategic planning decisions by management, re-allocation of internal resources, changes in the impact of domestic and global macroeconomic pressures, reimbursement decisions by insurance companies and domestic and foreign governments, scientific advances by third parties, litigation risks, and attempts to amend or repeal all or part of the Patient Protection and Affordable Care Act of 2010 as amended, as well as those factors set forth in the Company’s most recent Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q, and other filings with the Securities and Exchange Commission. These forward-looking statements speak only as to the date on which the statements were made. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise.


Conceptus, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except per share amounts)

 

     Three Months Ended
March 31
 
     2012      2011  

Net sales

   $  29,029       $  26,570   

Cost of goods sold

     5,178         5,201   
  

 

 

    

 

 

 

Gross profit

     23,851         21,369   
  

 

 

    

 

 

 

Operating expenses:

     

Research and development

     2,503         1,762   

Selling, general and administrative

     25,219         23,291   
  

 

 

    

 

 

 

Total operating expenses

     27,722         25,053   

Operating loss

     (3,871)         (3,684)   

Interest and other income (expense), net

     (1,440)         (1,548)   
  

 

 

    

 

 

 

Loss before benefit for income taxes

     (5,311)         (5,232)   

Benefit for income taxes

     (2,473)         (2,304)   
  

 

 

    

 

 

 

Net loss

   $  (2,838)       $  (2,928)   
  

 

 

    

 

 

 

Basic and diluted net loss per share

   $ (0.09)       $ (0.09)   
  

 

 

    

 

 

 

Weighted-average shares used in

     

computing basic and diluted net loss per share

     31,305         31,144   


Conceptus, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands)

 

     March 31,
2012
    December 31,
2011
 

Cash and cash equivalents

   $ 11,575      $ 42,237   

Short-term investments

     48,546        59,203   

Accounts receivable, net

     16,003        17,321   

Inventories, net

     4,885        4,187   

Short-term deferred tax asset

     4,737        4,735   

Other current assets

     7,783        6,655   
  

 

 

   

 

 

 

Total current assets

     93,529        134,338   

Property and equipment, net

     8,824        9,465   

Intangible assets, net

     22,326        23,092   

Long-term investments

     —          2,000   

Goodwill

     17,069        16,570   

Long-term deferred tax asset

     78,356        75,877   

Other assets

     2,085        2,242   
  

 

 

   

 

 

 

Total assets

   $ 222,189      $ 263,584   
  

 

 

   

 

 

 

Total liabilities

     68,135        109,458   
  

 

 

   

 

 

 

Common stock and additional paid in capital

     319,490        317,675   

Other comprehensive loss

     (2,313     (3,264

Accumulated deficit

     (163,123     (160,285
  

 

 

   

 

 

 

Total stockholders’ equity

     154,054        154,126   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 222,189      $ 263,584   
  

 

 

   

 

 

 


Conceptus, Inc.

Reconciliation of Net Loss to Adjusted Earnings Before Interest, Taxes,

Depreciation, Amortization and Stock-Based Compensation (Adjusted EBITDA)

(Unaudited)

(In thousands)

 

     Three Months Ended
March 31,
 
     2012      2011  

Net loss, as reported

   $  (2,838)       $  (2,928)   

Adjustments to net loss:

     

Interest and other income (expense), net (a)

     1,440         1,548   

Provision (benefit) for income taxes

     (2,473)         (2,304)   

Amortization of intangibles (b)

     903         813   

Stock-based compensation (c)

     1,695         1,695   

Depreciation expense (d)

     1,278         1,242   
  

 

 

    

 

 

 

Adjustments to net loss

     2,843         2,994   

Adjusted EBITDA

   $ 5       $ 66   
  

 

 

    

 

 

 

 

(a) Consists of interest from available-for-sale securities, interest expense associated with our convertible debt and foreign exchange currency transactions
(b) Consists of amortization of intangible assets, primarily licenses and customer relationships
(c) Consists of stock-based compensation in accordance with ASC 718
(d) Consists of depreciation, primarily on property, plant and equipment

Conceptus, Inc.

Reconciliation of Forward-Looking Guidance For Non-GAAP Financial Measures

To Projected GAAP Net Income

(Unaudited)

 

     Twelve Months Ending
December 31, 2012
 
     From      To  

Net Income Guidance

   $ 1,377       $ 2,476   

Adjustments to net income:

     

Interest and other income (expense), net (a)

     4,440         4,440   

Provision for income taxes

     1,124         2,025   

Amortization of intangibles (b)

     3,631         3,631   

Stock-based compensation (c)

     6,925         6,925   

Depreciation expense (d)

     5,503         5,503   
  

 

 

    

 

 

 

Adjustments to net income

     21,623         22,524   

Adjusted EBITDA

   $  23,000       $  25,000   
  

 

 

    

 

 

 

 

(a) Consists of interest from available-for-sale securities, interest expense associated with our convertible debt and foreign exchange currency transactions
(b) Consists of amortization of intangible assets, primarily licenses and customer relationships
(c) Consists of stock-based compensation in accordance with ASC 718
(d) Consists of depreciation, primarily on property, plant and equipment

© 2012 Conceptus, Inc. – All rights reserved. Conceptus and Essure are trademarks or registered trademarks of Conceptus, Inc.

CC-3114 25APR12F

###

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