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8-K - FORM 8-K - MYRIAD GENETICS INCd344108d8k.htm

Exhibit 99.1

Contact:

Rebecca Chambers

Director, Investor Relations and Corporate Communications

(801) 584-1143

rchambers@myriad.com

NOT FOR IMMEDIATE RELEASE

MYRIAD GENETICS REPORTS RECORD THIRD FISCAL QUARTER 2012 RESULTS

Company Raises Guidance for Fiscal Year 2012

Salt Lake City, May 1, 2012 – Myriad Genetics, Inc. (NASDAQ: MYGN) today announced results for its third fiscal quarter and nine months ending March 31, 2012. Revenue for the third fiscal quarter was $129.8 million, an increase of 27 percent over the $102.4 million reported in the third fiscal quarter of 2011. Earnings per diluted share were $0.34, an increase of 10 percent over the same period of the prior year.

“Myriad continues to generate very strong top and bottom line results and therefore we are raising our expectations for fiscal 2012 performance,” said Peter D. Meldrum, President and Chief Executive Officer of Myriad Genetics, Inc. “We are committed to continuing down this path of strong performance and these results reflect the success of our strategic directives: to grow existing tests and markets, to expand internationally and to launch new tests, including companion diagnostics, across a diverse set of major disease indications.”

Analysis of Third Fiscal Quarter 2012 Results

 

   

Molecular diagnostic testing revenue in the third fiscal quarter equaled $123.3 million, an increase of 20 percent compared to the prior year period. Revenue from the Oncology segment equaled $86.6 million, an increase of 19 percent over the third fiscal quarter of 2011. Women’s Health revenue totaled $36.7 million, an increase of 25 percent over the same period in the prior year.

 

   

Revenue from the BRACAnalysis® test, which represented 81 percent of total revenue in the third quarter, was $105.9 million, a 17 percent increase over the same period of the prior year.

 

   

Revenue from the COLARIS® and COLARIS AP® tests, which represented 9 percent of total revenue during the quarter, was $11.2 million, an increase of 51 percent compared to the same fiscal quarter of the prior year.

 

   

Myriad’s other molecular diagnostic tests contributed $6.2 million to third quarter revenue, or 5 percent of total revenue, an increase of 34 percent over the same period in the prior year.

 

   

Companion diagnostic service revenue in the third fiscal quarter equaled $6.5 million and represented 5 percent of total company revenue. There was no prior year revenue, as the Company acquired this business in May 2011.

 

   

Operating income was $46.1 million, an increase of 10 percent from the prior year period. This level of operating income included the impact of investment in research &


 

development to support the Company’s existing molecular diagnostic tests and future products, and in the Company’s international expansion to support the European launch of BRACAnalysis and COLARIS, as well as investments in Myriad RBM.

 

   

Net income for the third fiscal quarter was $29.6 million, an increase of 6 percent over the $27.9 million reported in same period of the prior year.

 

   

The Company repurchased 502,008 shares of its common stock during the quarter under its previously announced stock repurchase program. Diluted weighted average shares outstanding were 86.5 million in the third fiscal quarter as compared to 90.1 million in the same period of the prior year.

 

   

The Company ended the quarter with $466.7 million in cash, cash equivalents and marketable investment securities, a 3 percent increase over the $451.5 million reported in the same period of the prior year.

 

   

Days sales outstanding for Myriad’s accounts receivable improved to 36 days, compared with 41 days in the same period of the prior year and bad debt expense was 5.3 percent of revenue.

Analysis of Year to Date 2012 Results

 

   

Total revenue for the first nine months of fiscal 2012 was $363.0 million, an increase of 23 percent over $294.7 million reported for the first nine months of fiscal 2011.

 

   

Operating income for the first nine months of fiscal 2012 was $133.0 million, an increase of 15 percent year-over-year.

 

   

Net income for the first nine months of fiscal 2012 equaled $83.0 million, compared to $74.7 million for the first nine months of the prior year.

 

   

In the first nine months of fiscal 2012, diluted earnings per share increased 19 percent to $0.96 from $0.80 for the same period of the prior year.

Business Highlights during the Third Fiscal Quarter 2012

 

   

Entered into a Companion Diagnostic Agreement with Cephalon Inc., a subsidiary of Teva Pharmaceutical Industries Ltd., to conduct BRCA1 and BRCA2 mutation testing on patients to be enrolled in a Phase I/II clinical trial.

 

   

Published a study in the British Journal of Cancer which highlighted the ability of the Company’s Prolaris® test to significantly predict prostate cancer aggressiveness and consequent death from the disease.

 

   

Presented a study at the 2012 Genitourinary Cancers Symposium which concluded that the Company’s Prolaris test demonstrated significant and unique prognostic ability in men who had undergone radical prostatectomy, and accurately predicted their elevated risk for prostate cancer recurrence.

 

   

Presented a Prolaris biochemical recurrence study and won the Best Poster Honor at the 27th Annual EAU Congress in Paris, France.

 

   

Acquired an exclusive license to intellectual property covering the analysis of the RAD51C gene for risk of hereditary breast and ovarian cancer.

 

   

Presented a study at the 2012 American College of Medical Genetics and Genomics Meeting which showed that cancer causing mutations in the PMS2 gene constituted 14 percent of all mutations in patients who had personal and family histories suggestive of a Lynch syndrome, a hereditary form of colon cancer.


Fiscal Year 2012 Outlook

The Company has increased its expectations for fiscal year 2012 financial performance. Total revenue is now expected to be $492 million to $496 million, an increase from the original fiscal 2012 guidance of $445 million to $465 million. This level of revenue is expected to result in fully diluted earnings per share of $1.29 to $1.31, up from the original guidance of $1.20 to $1.25. Molecular diagnostic revenue is now expected to range between $467 million and $471 million and companion diagnostic service revenue continues to be expected to range between $24 million and $26 million. These projections are forward looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further detail on its business outlook during the conference call it is holding today to discuss its fiscal results for the third fiscal quarter and first nine months of fiscal 2012.

Conference Call and Webcast

A conference call will be held on Tuesday, May 1, 2012, at 4:30 p.m. Eastern Time to discuss Myriad’s financial results for the third fiscal quarter and first nine months of 2012 as well as the Company’s fiscal year 2012 outlook. The dial-in number for domestic callers is (800) 616-4021. International callers may dial (303) 223-4399. All callers will be asked to reference reservation number 21586629. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call will also be available through a live Webcast at www.myriad.com.

About Myriad Genetics

Myriad Genetics, Inc. is a leading molecular diagnostic company dedicated to making a difference in patients’ lives through the discovery and commercialization of transformative tests to assess a person’s risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad’s portfolio of nine molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a focus on improving an individual’s decision making process for monitoring and treating disease. With fiscal year 2011 annual revenue of over $400 million and more than 1,000 employees, Myriad is working on strategic directives, including new product introductions, companion diagnostics, and international expansion, to take advantage of significant growth opportunities. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com.

Myriad, the Myriad logo, BRACAnalysis, Colaris, Colaris AP, Melaris, TheraGuide, Prezeon, OnDose, Panexia and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-F, MYGN-G

Safe Harbor Statement

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Company’s raising of its expectations for fiscal 2012 performance; the Company’s commitment to its continuing strong performance and its strategic directives; the Company’s increased guidance for fiscal year 2012 under the caption “Fiscal Year 2012 Outlook;”and the Company’s strategic directives under the caption “About Myriad Genetics”. These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and


companion diagnostic services may decline or will not continue to increase at historical rates; the risk that we may be unable to expand into new markets outside of the United States; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and companion diagnostic services and any future products are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with manufacturing our products or operating our laboratory testing facilities; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of healthcare payment systems; risks related to our ability to obtain new corporate collaborations and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we acquire; the development of competing tests and services; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our tests; the risk of patent-infringement and invalidity claims or challenges of our patents; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading “Risk Factors” contained in Item 1A in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.


MYRIAD GENETICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED INCOME STATEMENTS (Unaudited)

 

(in thousands, except per share amounts)    Three Months Ended     Nine Months Ended  
   Mar. 31, 2012      Mar. 31, 2011     Mar. 31, 2012     Mar. 31, 2011  

Molecular diagnostic testing

   $ 123,312      $ 102,374     $ 344,891      $ 294,672  

Companion diagnostic services

     6,465        —          18,149        —     
  

 

 

    

 

 

   

 

 

   

 

 

 

Total revenue

     129,777        102,374       363,040        294,672  

Costs and expenses:

         

Cost of molecular diagnostic testing

     13,465        11,133       37,580        34,191  

Cost of companion diagnostic services

     3,763        —          10,127        —     

Research and development expense

     11,753        6,667       30,502        18,520  

Selling, general, and administrative expense

     54,700        42,750       151,799        125,960  
  

 

 

    

 

 

   

 

 

   

 

 

 

Total costs and expenses

     83,681        60,550       230,008        178,671  
  

 

 

    

 

 

   

 

 

   

 

 

 

Operating income

     46,096        41,824       133,032        116,001  

Other income (expense):

         

Interest income

     1,379        547       3,235        1,816  

Other

     6        (59     (199     (273
  

 

 

    

 

 

   

 

 

   

 

 

 

Total other income

     1,385        488       3,036        1,543  

Income before income taxes

     47,481        42,312       136,068        117,544  

Income tax provision (benefit)

     17,866        14,372       53,059        42,874  
  

 

 

    

 

 

   

 

 

   

 

 

 

Net income

   $ 29,615      $ 27,940       83,009        74,670  
  

 

 

    

 

 

   

 

 

   

 

 

 

Earnings per share:

         

Basic

   $ 0.35       $ 0.32      $ 0.98      $ 0.82   

Diluted

   $ 0.34       $ 0.31      $ 0.96      $ 0.80   

Weighted average shares outstanding

         

Basic

     84,403         88,206        84,715        91,019   

Diluted

     86,462         90,127        86,537        92,846   

Condensed Consolidated Balance Sheets (Unaudited)

 

(In thousands)    Mar. 31, 2012      Jun. 30, 2011  

Cash, cash equivalents, and marketable investment securities

   $ 466,710       $ 417,314  

Trade receivables, net

     50,948         50,272  

Other receivables

     1,501         575  

Prepaid taxes

     10,633         —     

Inventory

     10,383         8,218  

Prepaid expenses

     2,154         2,949  

Equipment and leasehold improvements, net

     24,101         23,080  

Note receivable

     18,333         —     

Other assets

     8,000         —     

Intangibles, net

     15,990         16,715  

Goodwill

     56,850         56,051  

Deferred tax assets

     33,650         35,653  
  

 

 

    

 

 

 

Total assets

   $ 699,253       $ 610,827  

Accounts payable and accrued liabilities

   $ 35,665       $ 33,040  

Deferred revenue

     1,387         1,347  

Uncertain tax benefits

     10,008         9,648  

Stockholders’ equity

     652,193         566,792  
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 699,253       $ 610,827