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HOLX > SEC Filings for HOLX > Form 10-Q on 7-Feb-2013All Recent SEC Filings

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Form 10-Q for HOLOGIC INC


7-Feb-2013

Quarterly Report


Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations

CAUTIONARY STATEMENT

Some of the statements contained in this report are 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 involve known and unknown risks, uncertainties and other factors which may cause our or our industry's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding:

• the effect of the continuing worldwide macroeconomic uncertainty on our business and results of operation;

• the coverage and reimbursement decisions of third-party payors relating to the use of our products and treatments;

• the uncertainty of the impact of cost containment efforts and federal healthcare reform legislation on our business and results of operation;

• the anticipated impact of the U.S. excise tax on the sale of most medical devices, which is effective on January 1, 2013, on our business and results of operations;

• the impact and anticipated benefits of the acquisition of Gen-Probe and the challenges associated with successfully integrating and operating the Gen-Probe business;

• the impact and anticipated benefits of other recently completed acquisitions and acquisitions we may complete in the future;

• the ability to consolidate certain of our manufacturing and other operations on a timely basis and within budget, without disrupting our business and to achieve anticipated cost synergies in connection therewith;

• our goal of expanding our market positions;

• the development of new competitive technologies and products;

• regulatory approval and clearances for our products;

• production schedules for our products;

• the anticipated development of our markets and the success of our products in these markets;

• the anticipated performance and benefits of our products;

• business strategies;

• estimated asset and liability values;

• the impact and costs and expenses of any litigation we may be subject to now or in the future;

• our compliance with covenants contained in our indebtedness;

• anticipated trends relating to our financial condition or results of operations; and

• our capital resources and the adequacy thereof.

In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "potential" and similar expressions intended to identify forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by such forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this report. Except as otherwise required by law, we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained in this offering circular to reflect any change in our expectations or any change in events, conditions or circumstances on which any of our forward-looking statements are based. Factors that could cause or contribute to differences in our future financial results include the cautionary statements set forth herein and in our filings with the Securities and Exchange Commission, including those set forth under "Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 29, 2012. We qualify all of our forward-looking statements by these cautionary statements.

OVERVIEW

We are a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products with an emphasis on serving the healthcare needs of women. Our core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. On August 1, 2012, we completed our acquisition of Gen-Probe. Gen-Probe is a leader in molecular diagnostics products and services that are used primarily to diagnose human diseases and screen donated human blood. Gen-Probe is part of our Diagnostics business segment.


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Our breast health products include a broad portfolio of breast imaging and related products and accessories, including digital and film-based mammography systems, MRI breast coils, CAD for mammography and minimally invasive breast biopsy devices, breast biopsy site markers, breast biopsy guidance systems, breast imaging comfort pads, and breast brachytherapy products. Our most advanced breast imaging platform, Dimensions, utilizes a new technology called tomosynthesis to produce 3D images, as well as conventional 2D full field digital mammography images.

We offer a wide range of diagnostic products which are used primarily to aid in the diagnosis of human diseases and screen donated human blood. Our molecular diagnostics products include our APTIMA family of assays, our Proprietary Invader and TMA chemistries and advanced instrumentation (PANTHER, TIGRIS and HTA). The APTIMA family of assays is used to detect the common STDs chlamydia and gonorrhea, certain high-risk strains of HPV, and Trichomonas vaginalis, the parasite that causes trichomoniasis. Our Invader chemistry comprises molecular diagnostic reagents used for a variety of DNA and RNA analysis applications, including Cervista HPV HR, and Cervista HPV 16/18 products to assist in the diagnosis of HPV, as well as other products to diagnose cystic fibrosis, cardiovascular risk and other diseases. In fiscal 2012, we received FDA approval of assays to run on our Panther instrument including APTIMA CT/GC and Trichomonas. We are also applying for approval of APTIMA HPV and Genotyping, anticipated for later this year. Our diagnostics products also include the ThinPrep System, which is primarily used in cytology applications such as cervical cancer screening, and the Rapid Fetal Fibronectin Test, which assists physicians in assessing the risk of pre-term birth. In blood screening, we develop and manufacture the PROCLEIX family of assays, which are used to detect HIV, HCV, HBV, WNV, HAV and Parvovirus in donated human blood. These blood screening products are marketed worldwide by our blood screening collaborator, Novartis, under Novartis' trademarks.

Our GYN surgical products include our NovaSure system and MyoSure system. The NovaSure system involves a trans-cervical procedure for the treatment of heavy menstrual bleeding. The MyoSure system is a tissue removal device that is designed to provide incision-less removal of fibroids and polyps within the uterus. At the end of the second quarter of fiscal 2012, we decided to cease manufacturing, marketing and selling our Adiana permanent contraception system determining that the product was not financially viable and would not become so in the foreseeable future.

Our skeletal health products include dual-energy X-ray bone densitometry systems, an ultrasound-based osteoporosis assessment product, and our Fluoroscan mini C-arm imaging products.

Unless the context otherwise requires, references to we, us, Hologic or our company refer to Hologic, Inc. and each of its consolidated subsidiaries.

Trademark Notice

Hologic is a trademark of Hologic, Inc. Other trademarks, logos, and slogans registered or used by Hologic and its divisions and subsidiaries in the United States and other countries include, but are not limited to, the following:

Adiana, Affirm, APTIMA, APTIMA COMBO 2, Aquilex, ATEC, Celero, Cervista, C-View, Dimensions, Eviva, Fluoroscan, Gen-Probe, Healthcome, Interlace, Invader, LIFECODES, LORAD, MammoPad, MammoSite, MultiCare, MyoSure, NovaSure, PANTHER, PROCLEIX, PreservCyt, QDR, Rapid fFN, Sahara, SecurView, Selenia, Sentinelle, Serenity, StereoLoc, Suresound, TCT, ThinPrep, THA, THS, TIGRIS, TLI IQ, and Trident.

RECENT DEVELOPMENTS

On August 1, 2012, we completed our acquisition of Gen-Probe. Such acquisition, and the significant indebtedness we incurred to fund that acquisition, subject us to risks and uncertainties described herein and under the caption "Risk Factors" in Part I, Item 1A of our Annual Report on Form 10-K for our year ended September 29, 2012.

Market acceptance of our medical products in the United States and other countries is dependent upon the purchasing and procurement practices of our customers, patient demand for our products and procedures and the reimbursement of patients' medical expenses by government healthcare programs, private insurers or other healthcare payors. In the United States, the Centers for Medicare & Medicaid Services, known as CMS, establish coverage and reimbursement policies for healthcare providers treating Medicare and Medicaid beneficiaries. Under current CMS policies, varying reimbursement levels have been established for our products and treatments. Coverage and reimbursement policies and rates applicable to patients with private insurance are dependent upon individual private payor decisions which may not follow the policies and rates established by CMS. The use of our products and treatments outside the United States is similarly affected by coverage and reimbursement policies adopted by foreign governments and private insurance carriers. CMS has not adopted a reimbursement rate for the use of 3D tomosynthesis. We are working with governmental authorities, healthcare providers, insurance companies and other third-party payors in our efforts to secure


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reimbursement for the use of 3D tomosynthesis. However, we cannot assure that these efforts will be successful. Failure to obtain or delays in obtaining adequate reimbursement for the use of 3D tomosynthesis could adversely affect sales of our Dimensions 3D systems.

The continuing uncertainty surrounding worldwide financial markets and macroeconomic conditions has caused and may continue to cause the purchasers of medical equipment to decrease or delay their medical equipment purchasing and procurement activities. Additionally, volatility in world credit markets has caused and continues to cause our customers to experience difficulty securing the financing necessary to purchase certain of our products. Economic uncertainty and unemployment have and may continue to result in cost-conscious consumers focusing on acute care rather than wellness, which has and may continue to adversely affect demand for our products and procedures. Furthermore, governments and other third-party payors around the world facing tightening budgets could move to further reduce the reimbursement rates or the scope of coverage offered, which could adversely affect sales of our products. If the current adverse macroeconomic conditions continue, our business and prospects may be negatively impacted.

In March 2010, significant reforms to the healthcare system were adopted as law in the United States. The law includes provisions that, among other things, reduce and/or limit Medicare reimbursement, require all individuals to have health insurance (with limited exceptions) and imposes new and/or increased taxes. Specifically, the law requires the medical device industry to subsidize healthcare reform in the form of a 2.3% excise tax on United States sales of certain medical devices effective January 1, 2013. We expect that the majority of our products will fall under the government classification requiring the excise tax. Product sales in the United States represented 70% and 73% of our worldwide net product sales for the three months ended December 29, 2012 and year ended September 29, 2012, respectively.

We operate in a highly regulated industry and other governmental actions may adversely affect our business, operations or financial condition, including, without limitation: new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to healthcare availability, methods of delivery and payment for health care products and services; changes in the FDA and foreign regulatory approval processes that may delay or prevent the approval of new products and result in lost market opportunity; changes in FDA and foreign regulations that may require additional safety monitoring, labeling changes, restrictions on product distribution or use, or other measures after the introduction of our products to market, which could increase our costs of doing business, adversely affect the future permitted uses of approved products, or otherwise adversely affect the market for our products and treatments; new laws, regulations and judicial decisions affecting pricing or marketing practices; and changes in the tax laws relating to our operations, including those associated with the recently adopted healthcare reform law discussed above.

Professional societies, government agencies, practice management groups, private health/science foundations, and organizations involved in healthcare issues may publish guidelines, recommendations or studies to the healthcare and patient communities from time to time. Recommendations of government agencies or these other groups/organizations may relate to such matters as usage, cost-effectiveness, and use of related preventative services and treatments/therapies. Recommendations, guidelines or studies that are followed by patients and healthcare providers could result in decreased use of our products. For example, in November 2012, the American Congress of Obstetrics and Gynecologists, known as the ACOG, released updates in which they have recommended less frequent cervical cancer screening similar to guidelines released by ACOG in November 2009 and guidelines released in March 2012 by the U.S. Preventative Services Task Force, known as the USPSTF, and the American Cancer Society. However, the USPSTF recommendations now also include HPV co-testing for certain patient populations, an update from their draft guidelines in October 2011.

Over the last few years, there have been periodic significant fluctuations in foreign currencies relative to the U.S. dollar. The ongoing fluctuations of the value of the U.S. dollar, including the recent strengthening of the U.S. dollar against the Euro, may cause our products to be less competitive in international markets and may impact sales and profitability over time. Historically, a majority of our capital equipment sales to international dealers were denominated in U.S. dollars. However, more sales are now denominated in the Euro compared to the U.S. dollar for our Euro zone dealers. In addition, we have international sales, principally in our Diagnostics segment, that are denominated in foreign currencies. The value of these sales is also impacted by fluctuations in the value of the U.S. dollar. Given the uncertainty in the worldwide financial markets, foreign currency fluctuations may be significant in the future, and if the U.S. dollar continues to strengthen, we may experience a material adverse effect on our international revenues and operating results.

Acquisition of Gen-Probe Incorporated

On August 1, 2012, we completed the acquisition of Gen-Probe and acquired all of the outstanding shares of Gen-Probe. The total purchase price was $3.97 billion, which was funded through available cash and financing consisting of senior secured credit facilities and senior notes resulting in aggregate proceeds of $3.48 billion, net of discounts.

Gen-Probe, headquartered in San Diego, California, is a leader in molecular diagnostics products and services that are used primarily to diagnose human diseases and screen donated human blood. We expect this acquisition to enhance our molecular diagnostics franchise and to complement our existing portfolio of diagnostics products. Gen-Probe's results of operations are reported within our Diagnostics reporting segment from the date of acquisition.


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The preliminary allocation of the purchase price is based on estimates of the fair value of assets acquired and liabilities assumed as of August 1, 2012. We are continuing to obtain information to finalize fair values of the acquired assets and liabilities, including tax assets and liabilities. Certain of Gen-Probe's assets have been designated as assets held-for-sale and recorded at fair value less the estimated cost to sell such assets. These represent non-core assets to our business plan and are expected to be sold within one year of the acquisition. In the first quarter of fiscal 2013, we completed the sale of one of these asset groups for $2.2 million. On January 3, 2013, we entered into a definitive agreement to sell our LIFECODES business to Immucor for $85.0 million in cash, subject to adjustment, plus contingent payments of up to an additional $10.0 million based on future revenue results. LIFECODES sells molecular and antibody-based assays in the markers of transplant diagnostics, specialty coagulation and transfusion medicine. The transaction is subject to customary closing conditions, including expiration of the applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and an international regulatory review and is expected to close in the first half of fiscal 2013.

The Company recorded $227.0 million of in-process research and development projects related to six projects. One project, valued at $7.0 million, received FDA approval in October 2012, and another project, valued at $27.0 million received FDA approval in January 2013. The other projects are expected to be completed within the next 6 months to 42 months with a total estimated cost of approximately $51 million to complete such projects. Given the uncertainties inherent with product development and introduction, we cannot assure that any of our product development efforts will be successful, completed on a timely basis or within budget, if at all.

RESULTS OF OPERATIONS

All dollar amounts in tables are presented in thousands.

Product Sales



                                                                        Three Months Ended
                                            December 29, 2012                December 24, 2011                 Change
                                                           % of                             % of
                                                           Total                            Total
                                          Amount          Revenue          Amount          Revenue        Amount         %
Product Sales
Diagnostics                            $     296,538            47 %    $     152,195            32 %    $ 144,343        95 %
Breast Health                                141,277            22 %          144,454            31 %       (3,177 )      (2 )%
GYN Surgical                                  80,556            13 %           78,149            16 %        2,407         3 %
Skeletal Health                               16,831             3 %           17,298             4 %         (467 )      (3 )%

                                       $     535,202            85 %    $     392,096            83 %    $ 143,106        36 %

Diagnostics product sales increased 95% in the current quarter compared to the corresponding period in the prior year primarily due to the inclusion of Gen-Probe's product sales (acquired in the fourth quarter of fiscal 2012), which contributed $140.4 million in revenue, and an increase of $4.4 million from our legacy molecular diagnostics products, which includes our HPV products, as we continue to gain new customer accounts and unit sales to existing customers and increase our international sales through TCT. The inclusion of Gen-Probe's results is partially impacted by the Novartis collaboration. Pursuant to the collaboration, a portion of Gen-Probe's revenue is contingent on donations testing revenue earned by Novartis, however, Gen-Probe recognizes the full product cost upon shipment. As a result, amounts to be received for this contingent revenue related to inventory on hand and not yet utilized by Novartis' customers as of the acquisition date were recorded as unbilled accounts receivable on the balance sheet in purchase accounting and are not recorded as revenue in our results of operations. In the current quarter, this contingent revenue of $17.1 million was not recognized in our results of operations. In addition, we experienced an increase in international sales of ThinPrep, principally from an increase in the sales price and higher volumes of ThinPrep in China, partially offset by a slight decline in domestic units sold.

Breast Health product sales decreased 2% in the current quarter compared to the corresponding period in the prior year. In the current three month period, our digital mammography systems revenue decreased $1.5 million compared to the corresponding period in the prior year due to a decrease in the number of Selenia systems sold, primarily in the United States, a slight deterioration of average selling prices, and a continued shift in Selenia product mix and configuration differences. We have experienced the trend of selling more Selenia Performance models, which have fewer features than our base Selenia model and carry lower average selling prices than our full-featured Selenia models. In addition, we sold more Selenia systems internationally as a percentage of total Selenia systems, and average selling prices are lower in our international markets compared to the domestic market. Partially offsetting the Selenia decrease, we sold more units of our 3D Dimensions product, which have higher average selling prices than our Selenia models, in the current quarter compared to the corresponding period in the prior year. Also, we experienced a decline in sales of related components and workstations of $2.7 million in the current quarter compared to the corresponding period in the prior year. Partially offsetting the decrease in digital mammography product sales, our breast biopsy products revenue increased $1.9 million in the current quarter compared to the corresponding period in the prior year due to the increase in the number of Eviva biopsy devices sold in the United States, partially offset by a decline of ATEC devices sold worldwide.


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GYN Surgical product sales increased 3% in the current quarter compared to the corresponding period in the prior year primarily due to an increase in MyoSure system sales, including our new Aquilex fluid management system used with our MyoSure devices, of $8.1 million, partially offset by the discontinuance of Adiana system sales of $5.1 million and a decline in sales of NovaSure devices of $1.0 million. The MyoSure system was FDA approved shortly before we acquired Interlace in January 2011 and the product continues to gain strong market acceptance. The reduction in Adiana system revenues was due to our decision to cease manufacturing, marketing and selling the product as of the end of the second quarter of fiscal 2012, determining it was not financially viable and would not become so in the foreseeable future. We experienced a decrease in the number of NovaSure devices sold in the United States, which we primarily attribute to the continuing effect of unemployment and economic uncertainty, which has resulted in patients delaying surgery or opting for lower cost and generally less effective alternatives.

Skeletal Health product sales decreased 3% in the current quarter compared to the corresponding period in the prior year primarily due to a decline of $2.0 million in our osteoporosis assessment product sales worldwide. Partially offsetting this decrease was an increase in mini C-arm sales of $1.6 million primarily due to the introduction of our new Insight FD product.

Product sales by geography as a percentage of total product sales were as follows:

                                         Three Months Ended
                            December 29, 2012           December 24, 2011
           United States                    70 %                        73 %
           Europe                           15 %                        13 %
           Asia                             10 %                         8 %
           All others                        5 %                         6 %

                                           100 %                       100 %

The increase in European product sales as a percent of consolidated product sales is primarily due to a higher percentage of Selenia system unit sales to total sales in Europe as well as the inclusion of Gen-Probe product sales in this region. The increase in Asian product sales as a percentage of consolidated product sales is driven by an increase in ThinPrep sales in China year over year.

Service and Other Revenues



                                                                         Three Months Ended
                                              December 29, 2012                December 24, 2011                Change
                                                             % of                             % of
                                                             Total                            Total
                                            Amount          Revenue          Amount          Revenue        Amount       %
Service and Other Revenues               $     96,160             15 %    $     80,615             17 %    $ 15,545       19 %

Service and other revenues are primarily comprised of revenue generated from our field service organization to provide ongoing service, installation and repair of our products. Service and other revenues increased 19% in the current quarter compared to the corresponding period in the prior year primarily in our Breast Health business due to an increase in the number of service contracts driven by an increase in our installed base of our digital mammography systems, and spare parts sales. In addition, the inclusion of Gen-Probe contributed $7.7 million in the current quarter compared to the corresponding period in the prior year.

Cost of Product Sales



                                                                        Three Months Ended
                                            December 29, 2012                December 24, 2011                 Change
                                                           % of                             % of
                                                          Product                          Product
                                          Amount          Revenue          Amount          Revenue        Amount        %
Cost of Product Sales                  $     223,493            42 %    $     131,944            33 %    $  91,549       69 %
Cost of Product Sales - Amortization
of Intangible Assets                          75,287            14 %           46,171            12 %       29,116       63 %


                                       $     298,780            56 %    $     178,115            45 %    $ 120,665       68 %

Product sales gross margin decreased to 44% in the current quarter compared to 55% in the corresponding period in the prior year.

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