0001193125-15-031519.txt : 20150203 0001193125-15-031519.hdr.sgml : 20150203 20150203161635 ACCESSION NUMBER: 0001193125-15-031519 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20150130 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150203 DATE AS OF CHANGE: 20150203 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MYRIAD GENETICS INC CENTRAL INDEX KEY: 0000899923 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 870494517 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26642 FILM NUMBER: 15571318 BUSINESS ADDRESS: STREET 1: 320 WAKARA WAY CITY: SALT LAKE CITY STATE: UT ZIP: 84108 MAIL ADDRESS: STREET 1: 320 WAKARA WAY CITY: SALT LAKE CITY STATE: UT ZIP: 84108 8-K 1 d864170d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

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): January 30, 2015

 

 

MYRIAD GENETICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   0-26642   87-0494517

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

320 Wakara Way

Salt Lake City, Utah 84108

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (801) 584-3600

Not Applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 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 1.01 ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT.

The disclosure provided under Item 5.02(c) below is incorporated herein by reference.

ITEM 2.02 RESULTS OF OPERATIONS AND FINANCIAL CONDITION.

On February 3, 2015, Myriad Genetics, Inc. (“Myriad” or the “Company”) announced its financial results for the three and six months ended December 31, 2014. The earnings release is attached hereto as an exhibit to this Current Report on Form 8-K and incorporated herein by reference, and is being furnished pursuant to this Item 2.02 as Exhibit 99.1 to this Current Report on Form 8-K.

ITEM 5.02 DEPARTURE OF DIRECTORS OR PRINCIPAL OFFICERS; ELECTION OF DIRECTORS; APPOINTMENT OF PRINCIPAL OFFICERS.

 

(a) Not applicable.

 

(b) On February 3, 2015, the Company announced that Peter D. Meldrum, President and Chief Executive Officer, has notified the Company of his decision to retire at the conclusion of the fiscal year on June 30, 2015. Effective as of that date, Mr. Meldrum will also retire from his position as a member of the Company’s Board of Directors. The disclosure provided under Item 5.02(c) below is incorporated herein by reference. The press release is attached hereto as an exhibit to this Current Report on Form 8-K and incorporated herein by reference, and is being filed pursuant to this Item 5.02 as Exhibit 99.2 to this Current Report on Form 8-K.

 

(c) On February 3, 2015, the Company announced that Mark C. Capone, President of the Company’s largest wholly-owned subsidiary, Myriad Genetic Laboratories, Inc., will succeed Mr. Meldrum as President and Chief Executive Officer of Myriad Genetics, Inc., effective as of July 1, 2015. Effective as of that date, Mr. Capone will also be appointed as a member of the Company’s Board of Directors. The press release is attached hereto as an exhibit to this Current Report on Form 8-K and incorporated herein by reference, and is being filed pursuant to this Item 5.02 as Exhibit 99.2 to this Current Report on Form 8-K.

Resignation Agreement with Mr. Meldrum

On January 30, 2015, the Company entered into a Resignation Agreement with Mr. Meldrum. Pursuant to the Resignation Agreement, Mr. Meldrum will hold the title of President and Chief Executive Officer and Director until June 30, 2015 and maintain employment on a full-time basis until June 30, 2015, at which point he will retire as an employee and Director of the Company. Upon his retirement, Myriad has agreed to pay Mr. Meldrum $1,287,500, less all applicable taxes and withholding amounts, and accelerate the vesting of all of his stock options and performance stock units that are due to vest on or before September 30, 2016 (subject to the achievement of any applicable performance targets set forth in such performance stock units) in order to (i) retain Mr. Meldrum as a non-employee consultant to provide certain consulting services to the Company through December 31, 2015, and (ii) provide Mr. Meldrum payment for his accomplishments and contributions to the success of the Company during his 24 years of service to Myriad. The


Resignation Agreement also provides for the release of all claims by Mr. Meldrum against the Company, subject to specific exceptions, and the release of all claims by the Company against Mr. Meldrum. Additionally, as part of the Company’s regular year-end compensation determinations, the Company will pay Mr. Meldrum his annual cash incentive bonus for fiscal 2015 and his three-year cash incentive bonus awarded in fiscal 2012, each as determined by the Compensation Committee of the Board of Directors, as described under the headings “Executive Compensation – Fiscal Year 2014 Named Executive Officer Compensation—Annual Cash Incentive Bonus” and “Executive Compensation — Narrative Disclosure to Summary Compensation Table and 2014 Fiscal Year Grants of Plan-Based Awards Table” in the Company’s definitive proxy statement for its 2014 annual meeting of stockholders filed with the Securities and Exchange Commission on October 14, 2014 (the “Proxy Statement”).

The foregoing description of the Resignation Agreement does not purport to be complete and is qualified in its entirety by reference to such agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 5.02.

Employment Arrangements with Mr. Capone

Mr. Capone, age 52, has spent 13 years at Myriad, holding various senior management positions, most recently president of Myriad’s largest wholly-owned subsidiary, Myriad Genetic Laboratories. Previously, he served for 17 years at Eli Lilly and Company where he held positions as product development manager, manufacturing plant manager and area sales director. Mr. Capone received his B.S. degree in chemical engineering from Penn State University, graduating with highest distinction, and both his M.S. degree in chemical engineering and M.S. degree in management from the Massachusetts Institute of Technology.

Upon assuming the role of President and Chief Executive Officer, Mr. Capone will receive an annual base salary of $800,000 per year, and will be eligible to receive an annual cash incentive bonus of up to 100% of his base salary, with the actual amount to be determined by the Compensation Committee under the Company’s compensation programs, as described under the heading “Executive Compensation – Compensation Discussion and Analysis – Elements of Our Compensation Program” in the Proxy Statement.

Mr. Capone has previously entered into the Company’s standard form of employment agreement and executive retention agreement, as described under the headings “Executive Compensation — Narrative Disclosure to Summary Compensation Table and 2014 Fiscal Year Grants of Plan-Based Awards Table” and “Executive Compensation — Potential Payments Upon Termination or Change-in-Control” in the Proxy Statement. Mr. Capone’s employment agreement and retention agreement have been filed as Exhibit 10.21 and Exhibit 10.24, respectively, to the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2014, File No. 0-26642, and are incorporated by reference into this Item 5.02.

Mr. Capone has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.

 

(d) The disclosure provided under Item 5.02(c) above is incorporated herein by reference.

 

(e) The disclosure provided under Item 5.02(c) above is incorporated herein by reference.

 

(f) Not applicable.


ITEM 9.01 FINANCIAL STATEMENT AND EXHIBITS.

(d)

 

Exhibit

Number

  

Description

10.1    Resignation Agreement between Myriad Genetics, Inc. and Peter D. Meldrum dated January 30, 2015.
99.1    Earnings release dated February 3, 2015 for the three and six months ended December 31, 2014.
99.2    Press release dated February 3, 2015.

The press releases may contain hypertext links to information on our website or other parties’ websites. The information on our website and other parties’ websites is not incorporated by reference into this Current Report on Form 8-K and does not constitute a part of this Form 8-K.

In accordance with General Instruction B-2 of Form 8-K, the information set forth in Item 2.02 and in Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.


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.

 

MYRIAD GENETICS, INC.
Date: February 3, 2015 By:

/s/ Peter D. Meldrum

Peter D. Meldrum
President and Chief Executive Officer


EXHIBIT INDEX

 

Exhibit

Number

  

Description

10.1    Resignation Agreement between Myriad Genetics, Inc. and Peter Meldrum dated January 30, 2015.
99.1    Earnings release dated February 3, 2015 for the three and six months ended December 31, 2014.
99.2    Press release dated February 3, 2015.
EX-10.1 2 d864170dex101.htm EX-10.1 EX-10.1

Exhibit 10.1

RESIGNATION AGREEMENT

This Resignation Agreement (“Agreement”) is entered into by and between Myriad Genetics, Inc., a Delaware corporation, with its principal office at 320 Wakara Way, Salt Lake City, Utah 84108 (hereinafter referred to as “Myriad” or the “Company”) and Peter D. Meldrum (hereinafter referred to as “Meldrum”).

RECITALS

A. Meldrum has been employed by Myriad since May 1991, currently holds the offices of President and Chief Executive Officer and Director of the Myriad Board of Directors, and has expressed his intention of resigning from such offices.

B. In order to facilitate a smooth transition for the new President and Chief Executive Officer, Myriad desires to retain Meldrum as a full-time employee through June 30, 2015, and thereafter for the period of time set forth herein as a non-employee consultant to provide certain consulting services to the Company, and Meldrum is willing to provide these services to the Company.

C. Myriad desires to provide Meldrum compensation for his accomplishments and contributions to the success of the Company from his 24 years of service to Myriad.

D. Myriad desires to provide compensation to Meldrum in consideration for Meldrum’s commitment to, and the anticipated provision of, consulting services to be rendered to the Company.

E. Myriad and Meldrum desire to resolve any and all disputes that may exist, if any, whether known or unknown, between them, including, but not limited to, disputes relating to Meldrum’s employment with Myriad, service on the Company’s Board of Directors, and the termination of that employment relationship.

F. Myriad is willing to provide the consideration provided for herein to Meldrum in return for the commitments, releases and agreements set forth herein.

AGREEMENT

NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements set forth herein, the parties mutually agree as follows:

1. Effective Date. This Agreement is effective on the eighth day following Meldrum’s execution of this Agreement, provided that Meldrum does not revoke his execution of this Agreement as provided in Paragraph 22 below.

2. Resignation. Meldrum resigns his positions with Myriad as President and Chief Executive Officer and as a Director of the Myriad Board of Directors, and resigns his employment with Myriad, effective June 30, 2015.


3. Benefits. In reliance on the agreements and releases set forth herein and following the expiration of the revocation period described in Paragraph 22 below and the unrevoked signing of this Agreement by Meldrum, and subject to the further terms and conditions of this Agreement, Myriad shall provide the following benefits to Meldrum:

a. Position: Meldrum will hold the title of “President and Chief Executive Officer” and “Director” until June 30, 2015 and will continue his employment with Myriad on a full-time basis through June 30, 2015 at which time all employment responsibilities with the Company will cease. Meldrum may not represent to third parties that he is an employee of Myriad after June 30, 2015.

b. Payment: Myriad will pay Meldrum the sum of $1,287,500, less applicable employment tax withholding amounts, promptly after June 30, 2015, and may make such payment through Myriad’s next payroll cycle along with any final wages due Meldrum.

c. Stock Options: All unvested stock options issued and outstanding to Meldrum which would otherwise vest on or before September 30, 2016, shall vest as of June 30, 2015, and shall be exercisable in accordance with the terms of the respective underlying stock option grant.

d. Restricted Stock Unit Award. All unvested performance stock units granted on September 17, 2014, issued and outstanding to Meldrum which, following any applicable adjustment, would otherwise vest on or before September 30, 2016, shall vest as of June 30, 2015, in accordance with the terms of the performance stock unit award, but subject to the achievement and certification of any applicable revenue performance targets provided for such performance stock unit award.

4. Consulting Services. As consideration, in part, of the compensation provided to Meldrum hereunder, Meldrum agrees to provide up to 40 hours per month of consulting services to Myriad through December 31, 2015.

5. Receipt of this Agreement. Meldrum understands and acknowledges that on January 30, 2015, he received a copy of this Agreement, and that he has 21 days from receipt of this Agreement in which to consider and consult with an attorney regarding this Agreement. Meldrum acknowledges that he has an adequate amount of time in which to consult with any person of his choice with respect to the contents of this Agreement prior to signing.

 

/s/ Peter D. Meldrum January 30, 2015
Peter D. Meldrum Date

6. Release of Claims by Meldrum. Meldrum, for himself and for all persons claiming by, thorough, or under him, hereby completely and unconditionally releases and discharges Myriad and each of Myriad’s parents, subsidiaries, affiliates, successors, assigns, agents, directors, officers, employees, representatives, attorneys and all persons acting by,

 

2


through, under or in concert with any of them (hereinafter collectively referred to as “Releasees”) from any and all claims, demands, charges, grievances, damages, debts, liabilities, accounts, costs, attorney’s fees, expenses, liens and causes of action of every kind and nature whatsoever (hereinafter collectively referred to as “Claims”). The Claims from which Meldrum is releasing Releasees herein include without limitation, breach of implied or express contract, breach of implied covenant of good faith and fair dealing, libel, slander, misrepresentation, fraud, wrongful discharge, discrimination claims under the Age Discrimination in Employment Act, the Older Workers Benefit Protection Act, Title VII of the Civil Rights Act of 1964, the Utah Antidiscrimination Act, and any other laws prohibiting age, race, religion, sex, national origin, disability and other forms of discrimination, and any tort or other claim arising in any way out of the employment relationship or termination of that relationship between Myriad and Meldrum whether now known or unknown, suspected or unsuspected, accrued or unaccrued. Meldrum specifically waives any and all claims for back pay, front pay, or any other form of compensation for services, except as set forth herein. This release and waiver of claims by Meldrum releases and waives all claims against Myriad which may accrue as of June 30, 2015.

Meldrum hereby waives any right to recover damages, costs, attorneys’ fees, and any other relief in any proceeding or action brought against Myriad by any other party, including without limitation the Equal Employment Opportunity Commission and the Utah Antidiscrimination and Labor Division, on Meldrum’s behalf asserting any claim, charge, demand, grievance, or cause of action released by Meldrum as stated above.

Notwithstanding the foregoing, Meldrum does not waive rights, if any Meldrum may have, to unemployment insurance benefits or workers’ compensation benefits. Myriad agrees that if Meldrum is unable to find employment before his severance runs out and he applies for unemployment benefits, Myriad will not oppose that application. Nothing in this paragraph prohibits Meldrum from paying COBRA premiums to maintain Meldrum’s participation, if any, in Myriad’s group health plan to the extent allowed by the terms, conditions, and limitations of the health plan.

In addition, notwithstanding this release language, Meldrum is not waiving any rights and interests he has in the Myriad 401(k) retirement plan, and Meldrum’s individual account balance in such plan is and remains fully vested in Meldrum. Meldrum will be sent the necessary paperwork to allow him to withdraw his money from those retirement accounts.

7. Release of Claims by Myriad. Myriad, for itself, its heirs, assigns and representatives, hereby releases and waives all claims it has or may have, whether known, unknown, actual, potential or contingent, against Meldrum, including any of his agents and representatives, in any way arising out of or relating to Meldrum’s employment with Myriad and/or the termination of Meldrum’s employment with Myriad. This release and waiver of claims by Myriad covers, but is not limited to, all claims for misrepresentation, fraud, breach of implied or express contract, breach of implied covenant of good faith and fair dealing, defamation, and interference with economic relations. This release and waiver of claims by Myriad releases and waives all claims against Meldrum which may accrue as of June 30, 2015.

 

3


8. Amendment. This Agreement may not be supplemented, amended, or modified except through a new written agreement signed by both parties.

9. No Assignment of Claims. Meldrum represents and warrants that he has not previously assigned or transferred, or attempted to assign or transfer, to any third party, any of the Claims waived and released herein.

10. No Claim Filed. Meldrum represents that he has not filed any claim, complaint, charge or lawsuit against Myriad or any other Releasee with any governmental agency or any state or federal court, and covenants not to file any lawsuit at any time hereafter for any matter, claim or incident known or unknown which occurred or arose out of occurrences prior to the date hereof.

11. Additional Consideration. Meldrum agrees and acknowledges that the payment and benefits provided pursuant to this Agreement are in addition to any payments or benefits to which Meldrum would be entitled without signing this Agreement.

12. Confidential Information. As a further material inducement to Myriad to enter into this Agreement, Meldrum agrees that he will not divulge the following information or types of information to anyone without the prior written consent of Myriad which will not be unreasonably withheld: trade secrets, salaries, financial information, franchise information, marketing information, pricing, products, product lists, product information, sales information, personal employee information, or any other information of a similar confidential, sensitive or competitive nature. Meldrum acknowledges that he has previously signed a confidentiality agreement with Myriad that remains in effect and under which he continues to be obliged to not disclose or make use of confidential or proprietary company information.

13. Company Property. Meldrum hereby represents and warrants that he has returned to Myriad all documents, property and records owned by, belonging to or created by Myriad or other Releasees, including, but not limited to all copies thereof (hereinafter referred to as “Properties”), except as permitted by Myriad. For the purposes of this Agreement, “Properties” includes but is not limited to keys, small wares, complete and partial documents, correspondence, reports, memoranda, laboratory records of any kind, notes, software, computer disks, manuals, computerized information and reports.

14. Meldrum Personal Property. Myriad hereby represents and warrants that it will return to Meldrum all documents, property and records owned by, belonging to or created by Meldrum prior to his employment at Myriad. “Properties” include but are not limited to personal effects currently stored in his former office, complete and partial documents, correspondence, reports, memoranda, laboratory records of any kind, notes, software, computer disks, manuals, computerized information and reports, except to the extent that any of the foregoing constitutes property of Myriad. Meldrum will not be prevented from creating electronic copies of all personal computer files that are stored on his former computer at Myriad.

15. Nondisparagement. Meldrum agrees not to damage, disparage or criticize, orally or in writing, Myriad, its officers, executives, management or operations to any third person or entity. Myriad agrees, through its executives and officers, not to damage, disparage or criticize Meldrum to any third person or entity.

 

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16. Entire Agreement. This Agreement contains the entire agreement and understanding of Myriad and Meldrum concerning the subject matter hereof and this Agreement supersedes and replaces all prior negotiations, proposed agreements, agreements or representations whether written or oral. Myriad and Meldrum agree and acknowledge that neither Myriad nor Meldrum, including any agent or attorney of either, has made any representation, guarantee or promise whatsoever not contained in this Agreement to induce the other to execute this Agreement, and neither party is relying on any representations, guarantee, or promise not contained in this Agreement in entering into this Agreement.

17. Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Utah, without giving effect to Utah’s choice of law rules.

18. Submission to Jurisdiction. Meldrum and Myriad each submits to the jurisdiction of any state or federal court sitting in the State of Utah in any action or proceeding arising out of or relating to this Agreement, and each party agrees that all claims of whatever type relating to or arising out of this Agreement may be heard and determined only in a state or federal court sitting in the State of Utah. Meldrum and Myriad each waives any defense of inconvenient forum to the maintenance of any action or proceeding so brought, and waives any bond, surety, or other security that might be required of any other party with respect thereto. Meldrum and Myriad each agrees that if any action or proceeding relating to or arising out of this Agreement is brought in any other court or forum other than a state or federal court sitting in the State of Utah, the action or proceeding shall be dismissed with prejudice and the party bringing the action or proceeding shall pay the other party’s legal fees and costs.

19. Consultation with Attorney. Meldrum understands and acknowledges that Myriad has advised Meldrum to consult with an attorney of Meldrum’s choice prior to signing this Agreement.

20. Voluntary and Knowing Signing. Meldrum acknowledges that he has read this Agreement carefully and fully understands this Agreement. Meldrum acknowledges that he executes this Agreement voluntarily and of his own free will, and that he is knowingly and voluntarily releasing and waiving all Claims he may have against Releasees, including Myriad.

21. Breach of Agreement. Breach of any terms of this agreement by Meldrum including any obligation of nondisparagement, failure of any representation or warranty, and any obligation not to divulge confidential information, shall be grounds for termination of any or all of the separation benefits, including vested stock options.

 

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22. Revocation Period. Meldrum has seven (7) days from the date on which he signs this Agreement to revoke this Agreement by providing written notice of his revocation to:

Jayne Hart

Executive Vice President of Human Resources

Myriad Genetics, Inc.

320 Wakara Way

Salt Lake City, Utah 84108

Meldrum’s revocation, to be effective, must be received by the above-named person by the end of the seventh day after Meldrum signs this Agreement. This Agreement becomes effective on the eighth day after Meldrum signs this Agreement, providing that Meldrum has not revoked this Agreement as provided above.

23. Indemnification. Nothing herein shall be construed to diminish any rights of Meldrum, or obligations of Myriad, to indemnify Meldrum to the extent provided for under the By-Laws of the Company and Delaware General Corporation Law as a result of any claim arising from or relating to the fact that Meldrum was an officer and a Director of Myriad.

IN WITNESS WHEREOF, the parties have executed this Agreement on the dates indicated to be effective for all purposes as of the Effective Date indicated above.

 

MYRIAD GENETICS, INC. PETER D. MELDRUM
/s/ John Henderson, M.D. /s/ Peter D. Meldrum

By: John Henderson, M.D.

Its: Chairman of the Board of Directors

Date: January 16, 2015

Date: January 30, 2015

 

6

EX-99.1 3 d864170dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

News Release

Media Contact:

Ron Rogers

(801) 584-3065

rrogers@myriad.com

Investor Contact:

Scott Gleason

(801) 584-1143

sgleason@myriad.com

Myriad Genetics Reports Fiscal Second-Quarter 2015 Financial Results

 

    Revenues of $184.4 Million

 

    Adjusted Diluted EPS of $0.40, and Diluted EPS of $0.32

 

    myRisk™ Hereditary Cancer Revenues of $85.1 Million

 

    BRACAnalysis CDx™ Approved by the FDA

 

    Tumor BRACAnalysis CDx™ Granted European CE Marking Approval

 

    Company Revises Fiscal Year 2015 Financial Guidance; Provides Fiscal 3Q15 Financial Guidance

SALT LAKE CITY, UTAH, February 3, 2015 – Myriad Genetics, Inc. (NASDAQ: MYGN) today announced financial results for its fiscal second-quarter and six months ended December 31, 2014, provided an update on recent business highlights, provided fiscal Q3 financial guidance and revised its financial guidance for the fiscal year ending June 30, 2015.

“Myriad delivered strong financial results in its second fiscal quarter with revenues increasing nine percent over its first fiscal quarter. In particular, the transition from single cancer testing to the myRisk cancer panel has proceeded exceptionally well with myRisk revenue up 60 percent sequentially,” said Peter D. Meldrum, president and chief executive officer of Myriad. “While delays for some of our new products reimbursement have caused us to revise guidance for this year, we remain very encouraged by our progress and believe we will exit this year on an excellent trajectory for long-term future growth.”


Fiscal Second-Quarter 2015 Financial Highlights

 

    Total revenues for the fiscal second quarter was $184.4 million compared to $204.1 million in the same period of the prior year, a decrease of 10 percent. The year-over-year decline in revenues was primarily attributable to the one-time revenue benefit from celebrity publicity in the second quarter of the prior year. The following tables display Myriad’s product revenues by segment and product:

 

     Three months
ended December 31,
 

($ in millions)

   2014      2013  

Molecular diagnostic testing revenue:

     

Oncology

   $ 83.7       $ 101.6   

Preventive Care

     84.6         94.6   

Rheumatology

     10.8         —     
  

 

 

    

 

 

 

Total molecular diagnostic testing revenue

$ 179.1    $ 196.2   
  

 

 

    

 

 

 

 

     Three months
ended December 31,
 

($ in millions)

   2014      2013  

Hereditary Cancer Testing

     165.0         193.0   

Vectra® DA

     10.8         —     

Other Tests

     3.4         3.2   
  

 

 

    

 

 

 

Total molecular diagnostic testing revenue

  179.1      196.2   
  

 

 

    

 

 

 

Pharmaceutical and clinical service revenue

  5.2      7.9   
  

 

 

    

 

 

 

Total Revenue

$ 184.4    $ 204.1   
  

 

 

    

 

 

 

 

    myRisk Hereditary Cancer revenue increased 640 percent to $85.1 million in the second quarter of fiscal 2015 from $11.5 million in the second quarter of the prior year. In the second quarter of this year, a large percentage of Integrated BRACAnalysis tests were transitioned to myRisk, resulting in Integrated BRACAnalysis revenue of $72.5 million in this quarter compared to $165.9 million in the same quarter of the prior year. The Company also transitioned approximately one half of its COLARIS and COLARIS AP tests to myRisk, resulting in COLARIS and COLARIS AP revenue of $7.4 million compared to $15.6 million in the same period of the previous year.

 

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    Operating income was $36.3 million in the second quarter and excluding certain non-cash amortization charges, adjusted operating income was $43.8 million. Adjusted operating income declined 47 percent year-over-year primarily due to the positive impact of celebrity publicity on operating income in the second quarter of the prior year, dilution from the Crescendo acquisition, lower gross margins associated with the transition to myRisk, and product launch expenses.

 

    Excluding certain non-cash amortization charges and one-time severance expenses, second- quarter adjusted net income was $29.9 million compared to $50.6 million in the same period of the previous year and adjusted earnings per share was $0.40 compared to $0.66 in the same period of the prior year. Net income was $24.0 million and diluted earnings per share were $0.32.

 

    During the quarter, the Company repurchased 1.7 million shares, or $58 million, of common stock under its share repurchase program. As of December 31, 2014, $62 million of share repurchase authorization remained under the board authorized share repurchase program. Fiscal second-quarter diluted weighted average shares outstanding were 75.4 million compared to 76.8 million in the same period last year.

Business Highlights

 

    Myriad received FDA approval for its BRACAnalysis CDx test to identify ovarian cancer patients who may benefit from the PARP inhibitor Lynparza™ (olaparib). The approval of BRACAnalysis CDx represents the first and only complex sequencing based laboratory developed test approved by the FDA.

 

    The Company was granted European CE Marking approval for its Tumor BRACAnalysis CDx test. Tumor BRACAnalysis CDx is the only tumor-based BRCA test with CE Marking, and in clinical studies has shown that it identifies up to 44 percent more potential responders to PARP inhibitors such as Lynparza when compared to germline testing.

 

    Myriad and TESARO announced an expanded companion diagnostic agreement during the second quarter to use Myriad’s myChoice HRD™ test in clinical studies in support of niraparib, TESARO’s novel PARP inhibitor.

 

    At the San Antonio Breast Cancer Symposium (SABCS), Myriad presented data from a study of 17,142 patients demonstrating that the myRisk Hereditary Cancer test detected 105 percent more patients with mutations when compared to standard single cancer syndrome tests.

 

    The Company also presented data at the SABCS demonstrating that its myChoice HRD test successfully predicted neoadjuvant response to platinum-based therapies in triple negative breast cancer patients. In the study, 52 percent of patients with a high HRD score responded to platinum compared to only 10 percent of patients with a low HRD score.

 

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    At the American Society for Dermatopathology annual meeting, Myriad presented data from its first clinical utility study on myPath™ Melanoma. The study demonstrated that myPath Melanoma led to a 49 percent change in physicians’ treatment recommendations for patients.

 

    At the American College of Rheumatology meeting, Crescendo Bioscience presented data highlighting Vectra® DA as a better predictor of radiographic progression (joint damage) when compared to other tests such as C-reactive protein and DAS28.

 

    At the Society of Urological Oncology annual meeting, Myriad presented a health economic study on its Prolaris® test. The study demonstrated that Prolaris could save the healthcare system $6 billion over 10 years.

Fiscal Year 2015 Financial Guidance

The Company is revising its fiscal year 2015 financial guidance and now expects total revenues of $730 to $740 million and adjusted diluted earnings per share of $1.50 to $1.55 (diluted EPS of $1.16 to $1.21). The primary reasons for this guidance change are a lag in obtaining private reimbursement coverage for Vectra DA, a delay in Medicare reimbursement for Prolaris, an increase in work-in-process, and the timing of certain contracts in the pharmaceutical and clinical services segment. The Company is projecting total revenues for the fiscal third quarter of 2015 of $180 to $185 million and adjusted diluted earnings per share of $0.38 to $0.40 (diluted EPS of $0.28 to $0.30). 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 details on its business outlook during the conference call it is holding today to discuss its fiscal second quarter 2015 financial results.

Conference Call and Webcast

A conference call will be held today, Tuesday, February 3, 2015, at 4:30 p.m. Eastern Time to discuss Myriad’s financial results for the fiscal second quarter of 2015, business developments and financial guidance. The dial-in number for domestic callers is (800) 408-6335. International callers may dial (303) 223-2680. All callers will be asked to reference reservation number 21759233. 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 also will be available through a live Webcast at www.myriad.com.

 

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About Myriad Genetics

Myriad Genetics 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 is focused on strategic directives to grow existing markets, diversify through the introduction of new products, including companion diagnostics, as well as to expand internationally. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan Lung Cancer, BRACAnalysis CDx, Tumor BRACAnalysis CDx, HRD, Vectra and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G

Lynparza is a trademark of AstraZeneca PLC.

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 our strong financial results in our second fiscal quarter with revenues increasing nine percent over our first fiscal quarter; the transition of our testing to our myRisk cancer panel proceeding exceptional well; reimbursement delays for some of our newer products; our encouragement on our progress and our belief that we will exit this year on an excellent trajectory for long-term future growth; the Company’s revised fiscal year 2015 financial guidance, including the primary reasons stated for the guidance change, and the fiscal Q3 2015 financial guidance under the caption “Fiscal Year 2015 Financial Guidance”; 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 molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing single cancer tests to our new cancer panel test, including unexpected costs and delays; risks related to decisions or changes in the governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate

 

5


revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with 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 the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses 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 license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries; 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.

 

6


MYRIAD GENETICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED INCOME STATEMENTS (Unaudited)

 

(in thousands, except per share amounts)

   Three Months Ended      Six Months Ended  
     Dec. 31,
2014
     Dec. 31,
2013
     Dec. 31,
2014
     Dec. 31,
2013
 

Molecular diagnostic testing

   $ 179,149       $ 196,158       $ 343,656       $ 389,144   

Pharmaceutical and clinical services

     5,244         7,902         9,574         17,383   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total Revenue

  184,393      204,060      353,230      406,527   

Costs and expenses:

Cost of molecular diagnostic testing

  35,050      22,755      67,847      44,194   

Cost of pharmaceutical and clinical services

  2,802      3,376      4,870      7,418   

Research and development expense

  17,504      17,090      40,116      33,893   

Selling, general, and administrative expense

  92,695      77,840      178,135      155,119   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total costs and expenses

  148,051      121,061      290,968      240,624   
  

 

 

    

 

 

    

 

 

    

 

 

 

Operating income

  36,342      82,999      62,262      165,903   

Other income (expense):

Interest income

  85      1,330      140      2,691   

Other

  1,513      (185   1,416      (623
  

 

 

    

 

 

    

 

 

    

 

 

 

Total other income

  1,598      1,145      1,556      2,068   

Income before income taxes

  37,940      84,144      63,818      167,971   

Income tax provision

  13,909      33,784      23,805      62,146   
  

 

 

    

 

 

    

 

 

    

 

 

 

Net income

$ 24,031    $ 50,360      40,013      105,825   
  

 

 

    

 

 

    

 

 

    

 

 

 

Earnings per share:

Basic

$ 0.33    $ 0.67    $ 0.55    $ 1.37   

Diluted

$ 0.32    $ 0.66    $ 0.53    $ 1.33   

Weighted average shares outstanding

Basic

  72,467      75,070      72,615      77,323   

Diluted

  75,401      76,825      75,755      79,312   

Condensed Consolidated Balance Sheets (Unaudited)

 

     Dec. 31,
2014
     Jun. 30,
2014
 
(In thousands)              

Cash, cash equivalents, and marketable investment securities

   $ 207,415       $ 270,586   

Restricted cash

     22,138         —     

Trade receivables, net

     81,222         81,297   

Other receivables

     5,331         3,770   

Prepaid expenses

     7,694         6,921   

Inventory

     20,173         23,919   

Prepaid taxes

     5,602         13,609   

Equipment and leasehold improvements, net

     46,458         34,594   

Other assets

     5,000         5,000   

Intangibles, net

     198,827         205,312   

Goodwill

     169,181         169,181   

Deferred tax assets

     12,813         9,625   
  

 

 

    

 

 

 

Total assets

$ 781,854    $ 823,814   

Accounts payable and accrued liabilities

$ 58,013    $ 79,488   

Deferred revenue

  1,824      1,090   

Deferred tax liabilities

  2,450      —     

Uncertain tax benefits

  25,326      24,238   

Stockholders’ equity

  694,241      718,998   
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

$ 781,854    $ 823,814   

 

7


Statement regarding use of non-GAAP financial measures

In this press release, the Company’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. Management believes that presentation of operating results using non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. Management also uses non-GAAP financial measures to establish budgets and to manage the Company’s business. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached financial statements.

Following is a description of the adjustments made to GAAP measures:

 

    Acquisition — amortization of intangible assets: Represents recurring amortization charges resulting from the acquisition of intangible assets including developed technology and database rights.

 

    Severance — executive severance: Represents one-time severance expenses associated with the departure of executive officers of Myriad Genetics, Inc.

The Company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Non-GAAP results are reported in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.

 

8


Reconciliation of GAAP to Non-GAAP Financial Measures

for the Three and Six Months ended December 31, 2014 and 2013

(Unaudited data in thousands, except per share amount)

 

     Three Months Ended     Six Months Ended  
     Dec. 31,
2014
    Dec. 31,
2013
    Dec. 31,
2014
    Dec. 31,
2013
 

GAAP Cost of molecular diagnostic testing

   $ 35,050      $ 22,755      $ 67,847      $ 44,194   

GAAP Cost of pharmaceutical and clinical services

     2,802        3,376        4,870        7,418   

Acquisition – amortization of intangible assets

     —          —          —          —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP COGS

$ 37,852    $ 26,131    $ 72,717    $ 51,612   

Non-GAAP Gross Margin

  79   87   79   87

GAAP Research and Development

$ 17,504    $ 17,090    $ 40,116    $ 33,893   

Acquisition – amortization of intangible assets

  (78   (78   (156   (156
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP R&D

$ 17,426    $ 17,012    $ 39,960    $ 33,737   

GAAP Selling, General and Administrative

$ 92,695    $ 77,840    $ 178,135    $ 155,119   

Severance – executive severance

  (4,312   —        (4,312   —     

Acquisition – amortization of intangible assets

  (3,057   (167   (6,114   (334
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP SG&A

$ 85,326    $ 77,673    $ 167,709    $ 154,785   

GAAP Operating Income

$ 36,342    $ 82,999    $ 62,262    $ 165,903   

Severance – executive severance

  4,312      —      $ 4,312      —     

Acquisition – amortization of intangible assets

  3,135      245    $ 6,270      490   
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Operating Income

$ 43,789    $ 83,244    $ 72,844    $ 166,393   

Non-GAAP Operating Margin

  24   41   21   41

GAAP Net Income

$ 24,031    $ 50,360    $ 40,013    $ 105,825   

Severance – executive severance

  4,312      —        4,312      —     

Acquisition – amortization of intangible assets

  3,135      245      6,270      490   

Tax expense associated with non-GAAP adjustments

  (1,581   —        (1,581   —     
  

 

 

   

 

 

   

 

 

   

 

 

 

Non-GAAP Net Income

$ 29,897    $ 50,605    $ 49,014    $ 106,315   

GAAP Diluted EPS

$ 0.32    $ 0.66    $ 0.53    $ 1.33   

Non-GAAP Diluted EPS

$ 0.40    $ 0.66    $ 0.65    $ 1.34   

Diluted shares outstanding

  75,401      76,825      75,755      79,312   

Free Cash Flow Reconciliation

(Unaudited data in thousands)

 

     Three Months Ended      Six Months Ended  
     Dec. 31,
2014
     Dec. 31,
2013
     Dec. 31,
2014
     Dec. 31,
2013
 

GAAP cash flow from operations

   $ 52,597       $ 47,549       $ 59,578       $ 138,031   

Capital expenditures

     (5,946      (2,833      (17,448      (8,098
  

 

 

    

 

 

    

 

 

    

 

 

 

Free cash flow

$ 46,651    $ 44,716    $ 42,130    $ 129,933   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

9


Reconciliation of GAAP to Non-GAAP for Fiscal Year 2015 and Third Quarter Fiscal Year 2015 Financial Guidance

The Company’s future performance and financial results are subject to risks and uncertainties, and actual results could differ materially from guidance set forth below. Some of the factors that could affect the Company’s financial results are stated in the safe harbor statement of this press release. More information on potential factors that could affect the Company’s financial results are included under the heading “Risk Factors” contained in Item 1A in the Company’s 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 the Company’s Quarterly Reports on Form 10-Q or Current Reports on Form 8-K.

 

     Fiscal Year
2015
 

Diluted net income per share

  

GAAP diluted net income per share

   $ 1.16 - $1.21   

Acquisition – amortization of intangible assets

     0.16   

Severance – executive severance

     0.18   
  

 

 

 

Non-GAAP diluted net income per share

$ 1.50 - $1.55   
  

 

 

 
     Fiscal Third
Quarter 2015
 

Diluted net income per share

  

GAAP diluted net income per share

   $ 0.28 - $0.30   

Acquisition – amortization of intangible assets

     0.04   

Severance – executive severance

     0.06   
  

 

 

 

Non-GAAP diluted net income per share

$ 0.38 - $0.40   

 

10

EX-99.2 4 d864170dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

News Release

Media Contact:

Ron Rogers

(801) 584-3065

rrogers@myriad.com

Investor Contact:

Scott Gleason

(801) 584-1143

sgleason@myriad.com

Myriad Announces Retirement of Peter D. Meldrum, President and CEO

Company Appoints Mark C. Capone as New President and CEO Effective July 1, 2015

SALT LAKE CITY, Utah, Feb. 3, 2015 – Myriad Genetics, Inc. (Nasdaq: MYGN) today announced that Peter D. Meldrum, president and chief executive officer, has notified the company of his decision to retire at the conclusion of the fiscal year on June 30, 2015. Pursuant to the company’s succession plan, the board of directors has unanimously elected Mark C. Capone, currently president of Myriad Genetic Laboratories, Inc., as Mr. Meldrum’s successor. Mr. Capone, a 13-year veteran of the company, has worked closely with Mr. Meldrum and the board in charting the strategic direction and managing the overall business of the company, as well as regularly interfacing with our institutional shareholders.

“Pete has led Myriad for the past 24 years, since the founding of the company and has been the key architect in developing Myriad into one of the world leaders in molecular diagnostics,” said John Henderson, chairman of the board of directors of Myriad. “We are incredibly thankful for Pete’s years of extraordinary contributions to the company, and we wish him a long, healthy and fulfilling retirement.”

“I want to thank Myriad’s board of directors for their wisdom and guidance over the years, and in particular, I have enjoyed my partnership with our chairman, John Henderson. Most importantly, I will genuinely miss each and every one of the wonderful Myriad employees who make the company such a unique and special place to work,” said Mr. Meldrum. “I know I will leave Myriad in exceptionally capable hands with Mark Capone at the helm. I can’t think of anyone with better leadership skills than Mark Capone to guide Myriad into the future and wish him well as the new president and CEO.”

During Mr. Capone’s 13 years at Myriad, he has held various senior management positions, most recently as president of Myriad’s largest wholly-owned subsidiary, Myriad Genetic Laboratories. During his tenure at Myriad Genetic Laboratories, Mr. Capone has been responsible for growing the annual molecular diagnostic revenues from $14 million to over $700 million. In addition, over the past five years, Mr. Capone has been instrumental in developing and leading the strategic initiative to diversify the company’s molecular diagnostic test portfolio through internal development and acquisition. This has resulted in a twenty-fold increase in scientific publications and ten new products addressing a global market potential in excess of $15 billion dollars. Mr. Capone received his B.S. degree, with


highest distinction, in chemical engineering from Penn State University, an M.S. degree in chemical engineering from Massachusetts Institute of Technology, and an M.S. degree in management from the Sloan School of Management at MIT. In total, Mr. Capone has almost 30 years of experience in the life science industry, having spent 17 years at Eli Lilly in various positions in sales and marketing, research and development, and manufacturing.

“Pete has been an outstanding and insightful mentor over the years,” commented Mr. Capone. “I feel honored to have worked closely with him, and I look forward to leading Myriad as the company continues the exciting journey to enrich the lives of our patients through pioneering science.”

About Myriad Genetics

Myriad Genetics 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 is focused on strategic initiatives to grow existing markets, diversify through the introduction of new products, including companion diagnostics, and expand internationally. For more information on how Myriad is making a difference, please visit the company’s website: www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan Lung Cancer, BRACAnalysis CDx, HRD, Vectra 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 related to the retirement of Peter D. Meldrum as the Company’s president and CEO; the election of Mark C. Capone as successor to Mr. Meldrum; the growth of our annual molecular diagnostic revenues; the development or our strategic initiatives to diversify the company’s molecular diagnostic test portfolio; and the Company’s strategic initiatives under the caption “About Myriad Genetics.” These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing single cancer tests to our new cancer panel tests, including unexpected costs and delays; risks related to decisions or changes in the governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk

 

2


that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical 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 pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our 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 the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses 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 license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services or covering patents or enforcement in the United States and foreign countries generally; 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 of our Annual Report on Form 10-K for the fiscal year ended June 30, 2014, which has been 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.

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