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 6, 2017

 

 

Keryx Biopharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   000-30929   13-4087132

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

One Marina Park Drive, 12 th Floor

Boston, Massachusetts 02210

(Address of Principal Executive Offices)

(617) 466-3500

(Registrant’s telephone number, including area code)

 

 

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:

 

  Written communications pursuant to Rule 425 under the Securities Act.

 

  Soliciting material pursuant to Rule 14a-12 under the Exchange Act.

 

  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

 

  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On January 8, 2017, Keryx Biopharmaceuticals, Inc. (“Keryx”) issued a press release announcing business progress and certain preliminary unaudited financial data for the quarter and year ended December 31, 2016. Keryx also announced that on January 11, 2017 at 2:30 p.m. PST (5:30 p.m. EST), it will webcast its corporate presentation and breakout session at the 35 th Annual J.P. Morgan Healthcare Conference. A copy of such press release is being furnished as Exhibit 99.1 to this report and is incorporated herein by reference. A copy of the investor presentation to be used on the webcast is being furnished as Exhibit 99.2 to this report and is incorporated herein by reference.

The information set forth in Exhibits 99.1 and 99.2 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.

 

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

(c) On January 6, 2017, Keryx entered into an employment agreement with Christine A. Carberry (the “Employment Agreement”) to serve as Keryx’s Chief Operating Officer. Ms. Carberry is expected to start with Keryx on or about January 16, 2017 and her employment with Keryx under the Employment Agreement will be on an “at will” basis.

Ms. Carberry, age 56 years, brings to Keryx approximately 30 years of biotech and pharmaceutical leadership, including most recently as an executive team member and Senior Vice President, Quality, Technical Operations, Program and Alliance Management at Forum Pharmaceuticals Inc. Prior to Forum, Ms. Carberry spent 25 years at Biogen Inc. and held roles of increasing responsibility, culminating as Vice President, Program and Alliance Management.

Under the Employment Agreement, Ms. Carberry’s base salary will be equal to $385,000 per year, subject to increases by the Compensation Committee of Keryx’s Board of Directors (the “Committee”) at any time in its sole discretion. Ms. Carberry is also eligible to receive an annual discretionary bonus, not to exceed 40% of her base salary, if certain performance goals are met in the discretion of the Committee.

Under the Employment Agreement, Ms. Carberry is also entitled to 85,000 shares of restricted common stock (the “Stock Grant”) and options to purchase an additional 170,000 shares of common stock (the “Option Grant”), all issuable upon commencement of employment with Keryx. The Stock Grant and the Option Grant will vest over three years with the first one-third of the shares under each grant vesting on the first anniversary of Ms. Carberry’s start date with Keryx and thereafter the remaining two-thirds of the shares under each grant will vest in equal quarterly installments through the third anniversary of Ms. Carberry’s start date with Keryx, in each case conditioned upon Ms. Carberry’s continued employment with Keryx.

Under the Employment Agreement, Ms. Carberry will be entitled to cash severance payments if Keryx terminates her employment without cause (as defined in the Employment Agreement) or if Ms. Carberry resigns her employment for good reason (as defined in the Employment Agreement).

In connection with the execution of the Employment Agreement, Ms. Carberry agreed to maintain Keryx’s confidential information and trade secrets (as defined in the Employment Agreement) and also to adhere to certain covenants of non-competition.

The foregoing summary of the Employment Agreement is qualified in its entirety by the copy of such agreement filed as Exhibit 10.1 hereto and incorporated by reference.

No family relationships exist between Ms. Carberry and any of our directors or other executive officers. There are no arrangements or understandings between Ms. Carberry and any other person pursuant to which Ms. Carberry was selected as an officer, nor are there any transactions to which Keryx is or was a participant and in which Ms. Carberry has a material interest subject to disclosure under Item 404(a) of Regulation S-K.

 

Item 8.01. Other Events.

Auryxia ® (ferric citrate) Commercial Progress

On January 8, 2017, Keryx reported prescription demand for Auryxia for the fourth quarter of 2016 was approximately 8,700 prescriptions, which included 4,500 prescriptions for the month of December, the first full month of sales post resupply of Auryxia following the previously announced supply interruption. This compares to approximately 5,000 prescriptions for the month of July 2016, the last full month of sales prior to the interruption.

Keryx also announced that the U.S. Food and Drug Administration (“FDA”) has approved Patheon’s manufacturing facility in France to manufacturer supply of Auryxia for the United States. The approval of this site provides Keryx with a third manufacturing site for finished Auryxia drug product.


Submission of Supplemental New Drug Application

On January 8, 2017, Keryx also announced that it submitted a supplemental new drug application to the FDA seeking to expand the label of ferric citrate to include the treatment of iron deficiency anemia in adults with stage 3-5 non-dialysis dependent chronic kidney disease.

Preliminary Unaudited Financial Data

On January 8, 2017, Keryx announced the following preliminary unaudited financial data for the quarter and year ended December 31, 2016:

Total revenues for the quarter ended December 31, 2016 are expected to be approximately $9.5 million, compared with $5.8 million during the same period in 2015. Total revenue expectations for the fourth quarter of 2016 consist of approximately $8.2 million in ex-factory Auryxia net U.S. product sales, compared to $4.8 million in the fourth quarter of 2015, which were recorded based on actual prescriptions written during the period. Total expected revenues for the fourth quarter of 2016 also include $1.3 million in license revenues as compared to $1.0 million during the same period in 2015.

For the year ended 2016, total revenues are expected to be approximately $31.9 million as compared to $13.7 million in 2015. Total expected revenues for 2016 include $27.1 million of Auryxia net U.S. product sales and $4.8 million in license revenues as compared to $10.1 million and $3.5 million, respectively, in 2015.

Cost of goods sold for the quarter ended December 31, 2016 are expected to be approximately $13.3 million, compared with $1.1 million during the same period in 2015. Expected cost of goods sold for the fourth quarter of 2016 include an approximately $11.8 million write-off of work-in-process inventory that was determined to no longer be suitable for commercial manufacture. For the year ended 2016, total cost of goods sold are expected to be approximately $37.7 million, as compared to $4.5 million in 2015. Total expected 2016 cost of goods sold includes approximately $25.6 million in write-offs of work-in-process inventory that was determined to no longer be suitable for commercial manufacture and approximately $2.6 million related to manufacturing charges incurred as a result of not fully utilizing planned production at the company’s third-party drug product manufacturers. Total 2015 cost of goods sold included $2.6 million related to manufacturing charges incurred as a result of not fully utilizing planned production at the company’s third-party drug product manufacturers.

Cash and cash equivalents as of December 31, 2016 totaled approximately $112.1 million.

The preliminary unaudited financial data for the quarter and the year ended December 31, 2016 set forth above is derived from preliminary internal financial reports. Keryx has not yet finalized its complete results of operations for the year ended December 31, 2016. In connection with the finalization of its year-end closing and reporting processes, the completion of its financial statements for the year ended December 31, 2016 and the completion of the audit of its financial statements for the year ended December 31, 2016, Keryx and its auditors may identify items that would require Keryx to make adjustments, some of which could be material, to the preliminary unaudited financial data set forth above.

 

Item 9.01. Financial Statements And Exhibits.

 

(d) Exhibits.

 

10.1    Employment Agreement with Christine A. Carberry dated January 6, 2017.
99.1    Press release issued by Keryx Biopharmaceuticals, Inc. dated January 8, 2017.
99.2    Investor presentation of Keryx Biopharmaceuticals, Inc. dated January 2017.


SIGNATURE

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.

 

    Keryx Biopharmaceuticals, Inc.
    (Registrant)
Date: January 9, 2017    
    By:  

/s/ Brian Adams

      Brian Adams
      General Counsel and Corporate Secretary


INDEX TO EXHIBITS

 

Exhibit

Number

  

Description

10.1    Employment Agreement with Christine A. Carberry dated January 6, 2017.
99.1    Press release issued by Keryx Biopharmaceuticals, Inc. dated January 8, 2017.
99.2    Investor presentation of Keryx Biopharmaceuticals, Inc. dated January 2017.

Exhibit 10.1

 

 

EMPLOYMENT AGREEMENT

BETWEEN

CHRISTINE A. CARBERRY

AND

KERYX BIOPHARMACEUTICALS, INC.

 

 

 


EMPLOYMENT AGREEMENT

 

1 . Effective Date      1   
2 . Employment      1   
3 . Employment Period      1   
4 . Extent of Service      2   
5 . Compensation and Benefits      2   
   (a)      Base Salary      2   
   (b)      Incentive, Savings and Retirement Plans      2   
   (c)      Welfare Benefit Plans      3   
   (d)      Expenses      3   
   (e)      Vacation      3   
6. Termination of Employment      4   
   (a)      Death      4   
   (b)      Disability      4   
   (c)      Termination by the Company      4   
   (d)      Termination by Executive      5   
   (e)      Notice of Termination      6   
   (f)        Date of Termination      6   
7 . Obligations of the Company upon Termination      6   
   (a)      Termination by Executive for Good Reason; Termination by the Company without Cause      6   
   (b)      Death or Disability      7   
   (c)      Termination by the Company for Cause; Resignation by Executive Other than for Good Reason      8   
   (d)      Termination of the Agreement by the Company prior to the Start Date without Cause      8   
8 . Change in Control      9   
   (a)      Definition      9   
   (b)      Severance Benefits      10   
9 . Non-exclusivity of Rights      11   
10 . No Mitigation      11   
11 . Mandatory Reduction of Payments in Certain Events      11   


12 . Restrictions on Conduct of Executive      12   
   (a)      General      12   
   (b)      Definitions      13   
   (c)      Restrictive Covenants      14   
   (d)      Enforcement of Restrictive Covenants      15   
13 . Invention Assignment      16   
14. Return of Materials      17   
15. Successors and Assigns      17   
16 . Cooperation      17   
17 . Code Section 409A      17   
   (a)      General      17   
   (b)      Definitional Restrictions      17   
   (c)      Six-Month Delay in Certain Circumstances      18   
18 . Miscellaneous      19   
   (a)      Governing Law      19   
   (b)      Captions      19   
   (c)      Amendments      19   
   (d)      Notices      19   
   (e)      Severability      19   
   (f)        Withholding      19   
   (g)      Waivers      19   
   (h)      Entire Agreement      20   
   (i)       Arbitration      20   
   (j)       Timing of Release      20   
   (k)      Counterparts; Scanned Signatures      21   


EMPLOYMENT AGREEMENT

THIS EMPLOYMENT AGREEMENT (this “Agreement”) is made and entered into this 6th day of January, 2017 by and between Keryx Biopharmaceuticals, Inc., a Delaware corporation (the “Company”), and Christine A. Carberry (“Executive”), to be effective as of the Effective Date, as defined in Section 1.

BACKGROUND

The Company desires to engage Executive as Chief Operating Officer of the Company in accordance with the terms of this Agreement. Executive is willing to serve as such in accordance with the terms and conditions of this Agreement.

NOW THEREFORE, in consideration of the foregoing and of the mutual covenants and agreements set forth herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

1. Effective Date . The effective date of this Agreement (the “Effective Date”) shall be the date first written above.

2. Employment . Executive shall be employed as Chief Operating Officer of the Company commencing by no later than January 16, 2017 (the date on which Executive actually commences employment with the Company shall be the “Start Date”); provided, however, that if Executive does not commence employment by January 16, 2017 for any reason, then this Agreement shall become null and void and neither Executive nor the Company shall have any obligations hereunder other than as expressly set forth in Section 7(e) hereof. In her capacity as Chief Operating Officer, Executive shall have the duties, responsibilities and authority commensurate with such position as shall be assigned to her by the Chief Executive Officer (the “CEO”) and the Board of Directors of the Company (the “Board”), including but not limited to, managing the CMC/Tech Operations, Quality and Regulatory functions at the Company, and other corporate efforts, as requested and agreed to with the CEO. In her capacity as Chief Operating Officer, Executive will report directly to the CEO. The principal location of the Executive’s employment shall be at the Company’s offices in Boston, Massachusetts. The Executive understands and agrees that she may be required to travel from time to time for business reasons.

3. Employment Period . The Company agrees to continue to employ Executive, and Executive agrees to continue to serve the Company, on an “at will” basis, which means that, subject to the payment obligations imposed on the Company pursuant to this Agreement, either the Company or Executive may terminate Executive’s employment with the Company at any time, with or without Cause, as provided in Section 6 below. The period commencing with the Start Date and ending on the effective date of any termination of employment in accordance with the provisions hereof shall constitute the term of this Agreement (the “Employment Period”).

 

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4. Extent of Service . During the Employment Period, Executive agrees to devote her full business time, attention, energy and best efforts to the business and affairs of the Company and to use Executive’s reasonable best efforts to perform faithfully and efficiently the responsibilities assigned to Executive hereunder. During the Employment Period it shall not be a violation of this Agreement for Executive to (A) manage personal investments, or (B) devote time to charitable and community activities or, with the approval of the CEO, industry or professional activities including service on the board of directors of another corporation, so long as such activities do not interfere or conflict with the performance of Executive’s responsibilities as an employee of the Company in accordance with this Agreement.

5. Compensation and Benefits .

(a) Base Salary . During the Employment Period, the Company will pay to Executive a base salary at the rate of U.S. $385,000 per year (“Base Salary”), less normal withholdings, payable in approximately equal bi-weekly or other installments as are or become customary under the Company’s payroll practices for its employees from time to time. The Compensation Committee of the Board shall review Executive’s Base Salary annually and, in its sole discretion, may increase Executive’s Base Salary from year to year. Such adjusted salary then shall become Executive’s Base Salary for purposes of this Agreement. The annual review of Executive’s Base Salary by the Board will consider, among other things, Executive’s own performance and the Company’s performance.

(b) Incentive, Savings and Retirement Plans . During the Employment Period, Executive shall be entitled to participate in all incentive, savings and retirement plans, practices, policies and programs available to other senior executive officers of the Company (“Peer Executives”), and on the same basis as such Peer Executives. Without limiting the foregoing, the following shall apply:

(i) Discretionary Annual Bonus . For each year during the Employment Period, Executive shall be eligible to receive a discretionary annual bonus, not to exceed 40% of her Base Salary (the “Annual Bonus”). The Compensation Committee, in its sole discretion, will establish performance goals and objectives from year to year on which the Annual Bonus will be based, and the Compensation Committee likewise reserves the sole discretion to modify such goals and objectives, or the final amount of the Annual Bonus, based upon events occurring during the related year or its assessment of the Company’s or the Executive’s performance in general. The Compensation Committee will provide the Executive with such goals and objectives and any modifications it may make thereto, which shall be presented to the Executive within a reasonable time following the start of the fiscal year. Unless otherwise provided herein, no Annual Bonus shall be deemed to have been earned by Executive for any year in which Executive is not actively employed by the Company on the last day of the fiscal year to which the bonus relates. The Company shall pay the Annual Bonus no later than two and a half months after the end of the fiscal year to which the applicable bonus relates.

 

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(ii) Equity Grants . On the Start Date, the Company shall grant to Executive under the Company’s 2013 Incentive Plan (the “Plan”):

 

  1. 85,000 restricted shares of Company common stock (the “Restricted Stock”). The Restricted Stock will vest over three years with the first one-third vesting on the first anniversary of the Start Date and thereafter the remaining shares shall vest in equal quarterly installments through the third anniversary of the Start Date, conditioned upon Executive’s continuing employment, and subject to other terms and conditions set forth in the award certificate memorializing the Restricted Stock and the Plan. The vesting of the Restricted Stock shall accelerate in full upon the occurrence of a Change-in-Control, as such term is defined in this Agreement.

 

  2. 170,000 stock options (the “Stock Options”). The Stock Options will vest over three years with the first one-third vesting on the first anniversary of the Start Date and thereafter the remaining shares shall vest in equal quarterly installments through the third anniversary of the Start Date, conditioned upon Executive’s continuing employment, and subject to other terms and conditions set forth in the award certificate memorializing the Stock Options and the Plan. The vesting of the Stock Options shall accelerate in full upon the occurrence of a Change-in-Control, as such term is defined in this Agreement.

During the Employment Period, Executive may be eligible for additional stock-based awards under the Company’s incentive plans, as determined by the Compensation Committee from time to time. Nothing herein requires the Board or the Compensation Committee to make additional grants of options or other awards in any year.

(c) Welfare Benefit Plans . During the Employment Period, Executive and Executive’s eligible dependents shall be eligible for participation in, and shall receive all benefits under, the welfare benefit plans, practices, policies and programs provided by the Company (including, without limitation, medical, prescription drug, dental, disability, and employee life insurance plans and programs) (“Welfare Plans”) to the extent available to other Peer Executives.

(d) Expenses . During the Employment Period, Executive shall be entitled to receive prompt reimbursement for all reasonable expenses incurred by Executive in the course of performing her duties and responsibilities under this Agreement, in accordance with the policies, practices and procedures of the Company with respect to travel, entertainment and other business expenses, including but not limited to professional fees associated with maintaining your financial credentials.

(e) Vacation . During the Employment Period, Executive will be entitled to four weeks of paid vacation per calendar year, subject to and in accordance with the Company’s vacation policies. In accordance with Company policy, vacation days cannot be accrued and any vacation days not used in any calendar year will be forfeited.

 

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6. Termination of Employment .

(a) Death . Executive’s employment shall terminate automatically upon Executive’s death during the Employment Period.

(b) Disability . If the Company determines in good faith that Executive has become Disabled (as defined below) during the Employment Period, it may give to Executive written notice of its intention to terminate Executive’s employment. In such event, Executive’s employment with the Company shall terminate effective on the 30th day after receipt of such written notice by Executive (the “Disability Effective Date”), provided that, within the 30 days after such receipt, Executive shall not have returned to full-time performance of Executive’s duties. For purposes of this Agreement, Executive shall be Disabled if either of the following conditions is met, as determined by the Board in good faith:

(i) Executive is unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for one or more periods totaling one hundred and twenty (120) days in any twelve (12) month period; or

(ii) Executive is, by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for one or more periods totaling one hundred and twenty (120) days in any twelve (12) month period, receiving income replacement benefits for a period of not less than three months under an accident and health plan covering employees of the Company.

Nothing in this section is intended to conflict with the rights and obligations contained in the Family and Medical Leave Act.

(c) Termination by the Company . The Company may terminate Executive’s employment during the Employment Period with or without Cause. For purposes of this Agreement, a termination shall be considered to be for “Cause” if it occurs in conjunction with a determination by the Board that any of the following has occurred:

(i) Executive’s conviction of, pleading guilty to, or confession to a felony or any crime involving any act of dishonesty, fraud, misappropriation or embezzlement;

 

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(ii) Executive’s misconduct or gross negligence in connection with the performance of her duties hereunder, including a violation of the Company’s written policies or Code of Conduct and Ethics;

(iii) Executive’s engaging in any fraudulent, disloyal or unprofessional conduct which is, or is likely to be, materially injurious to the Company, its financial condition, or its reputation;

(iv) Executive’s failure to perform her duties with the Company (other than any such failure resulting from Executive’s Disability);

(v) Executive’s failure to meet performance standards which may be agreed upon by Executive and the Company in writing from time to time (with the understanding that failure to meet the performance criteria established with respect to an Annual Bonus alone shall not constitute Cause for purposes of this Agreement); or

(vi) Executive’s material breach of the covenants set forth in Section 12 of this Agreement, or material breach of any other provisions of this Agreement.

If the Company determines that it has grounds to terminate Executive’s employment for Cause pursuant to the provisions of clauses (iv), (v), or (vi) of this subsection (c), then it will first deliver to Executive a written notice setting forth with specificity the occurrence deemed to give rise to a right to terminate her employment for Cause, and Executive will have 30 days after the receipt of such written notice to cease such actions or otherwise correct any such failure or breach. If Executive does not cease such actions or otherwise correct such failure or breach within such 30-day period, or having once received such written notice and ceased such actions or corrected such failure or breach, Executive at any time thereafter again so acts, fails, or breaches, the Company may terminate her employment for Cause immediately. The Company may terminate Executive’s employment without Cause, or for Cause pursuant to the provisions of clauses (i), (ii), or (iii) of this subsection (c), immediately.

(d) Termination by Executive . Executive’s employment may be terminated by Executive with or without Good Reason. Executive’s termination without Good Reason shall require 30 days’ prior written notice to the Company. Executive’s termination for Good Reason must occur within a period of 90 days after the occurrence of an event of Good Reason. For purposes of this Agreement, “Good Reason” shall mean any of the following, without Executive’s consent:

(i) a material diminution in Executive’s Base Salary, which for purposes of this Agreement shall mean a reduction of more than 15%;

(ii) a material diminution in Executive’s title, position, authority, duties, or responsibilities;

 

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(iii) a material change in the geographic location of the Executive’s principal place of business, which for purposes of this Agreement shall mean a location more than thirty-five (35) miles from the Company’s offices in Boston, Massachusetts at which the Executive was principally employed except for required travel on the Company’s business; or

(iv) any other action or inaction that constitutes a material breach by the Company of this Agreement.

A termination by Executive shall not constitute termination for Good Reason unless Executive shall first have delivered to the Company a written notice setting forth with specificity the occurrence deemed to give rise to a right to terminate for Good Reason (which notice must be given no later than 60 days after the initial occurrence of such event), and there shall have passed a reasonable time (not less than 30 days) within which the Company may take action to correct, rescind or otherwise substantially reverse the occurrence supporting termination for Good Reason as identified by Executive. Good Reason shall not include Executive’s death or Disability. The parties intend, believe and take the position that a resignation by the Executive for Good Reason as defined above effectively constitutes an involuntary separation from service within the meaning of Section 409A of the Code and Treas. Reg. §1.409A-1(n)(2).

(e) Notice of Termination . Any termination by the Company or Executive shall be communicated by Notice of Termination to the other party hereto given in accordance with Section 18(d) of this Agreement. For purposes of this Agreement, a “Notice of Termination” means a written notice which (i) indicates the specific termination provision in this Agreement relied upon, (ii) to the extent applicable, sets forth in reasonable detail the facts and circumstances claimed to provide a basis for termination of Executive’s employment under the provision so indicated, and (iii) if the Date of Termination (as defined below) is other than the date of receipt of such notice, specifies the termination date. The failure by the Company or Executive to set forth in the Notice of Termination any fact or circumstance which contributes to a showing of Cause or Good Reason shall not waive any right of the Company or Executive hereunder or preclude the Company or Executive from asserting such fact or circumstance in enforcing its rights hereunder.

(f) Date of Termination . “Date of Termination” means (i) if Executive’s employment is terminated other than by reason of death or Disability, the date of receipt of the Notice of Termination or any later date specified therein, or (ii) if Executive’s employment is terminated by reason of death or Disability, the Date of Termination shall be the date of death of Executive or the Disability Effective Date, as the case may be.

7. Obligations of the Company upon Termination .

(a) Termination by Executive for Good Reason; Termination by the Company without Cause . If, during the Employment Period, the Company shall terminate Executive’s employment without Cause, or Executive shall terminate her

 

6


employment for Good Reason, then and, with respect to the payments and benefits described in clause (ii), (iv), and (v) below, only if Executive shall have executed and not revoked a release of claims in a form satisfactory to the Company:

(i) the Company shall pay to Executive in a lump sum in cash within 60 days after the Date of Termination, the exact payment date to be determined by the Company (or such later date as may be required pursuant to Section 17 hereof), the sum of (1) Executive’s Base Salary through the Date of Termination to the extent not theretofore paid, (2) the Annual Bonus earned by the Executive for the fiscal year immediately prior to the year in which the Date of Termination occurs, if any, to the extent not theretofore paid, and (3) any accrued but unused vacation pay to the extent not theretofore paid (the sum of the amounts described in clauses (1), (2) and (3) shall be hereinafter referred to as the “Accrued Obligations”); and

(ii) the Company shall pay to Executive twelve (12) months of severance pay based on Executive’s Base Salary as of the Date of Termination (the “Severance Pay”). The foregoing Severance Pay shall be paid in equal installments over the severance period in accordance with the Company’s usual payroll schedule, commencing on the date that the release referred to above may no longer be revoked (or such later date as may be required pursuant to Section 17). In addition, the Executive shall receive a cash payment equal to the total monthly premium payment (both the Company’s portion and the Executive’s portion of such premium) under the Company’s group healthcare plan as in effect on the Date of Termination multiplied by twelve (12), payable in a lump sum within sixty (60) days following the Date of Termination, and

(iii) to the extent not theretofore paid or provided, the Company shall timely pay or provide to Executive any other amounts or benefits required to be paid or provided or which Executive is entitled to receive under any plan, program, policy or practice or contract or agreement of the Company and its affiliated companies (such other amounts and benefits shall be hereinafter referred to as the “Other Benefits”), and

(iv) any vested portion of stock options granted to Executive by the Company shall remain exercisable by the Executive for a period of six (6) months following the Date of Termination (or, if earlier, the normal expiration date of such stock options), and any unvested portions of stock options granted to Executive by the Company shall lapse and be forfeited without consideration as of the Date of Termination.

(b) Death or Disability. If Executive’s employment is terminated by reason of Executive’s death or Disability during the Employment Period, this Agreement shall terminate without further obligations to Executive or Executive’s legal representatives under this Agreement, other than for payment of Accrued Obligations and the timely payment or provision of Other Benefits. Accrued Obligations shall be paid to Executive or Executive’s estate or beneficiaries, as applicable, in a lump sum in cash within 60 days after the Date of Termination. With respect to the provision of Other Benefits, the term “Other Benefits” as used in this Section 7(b) shall include

 

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without limitation, and Executive or Executive’s estate and/or beneficiaries shall be entitled to receive, benefits under such plans, programs, practices and policies relating to death, disability or retirement benefits, if any, as are applicable to Executive on the Date of Termination. In addition, in the event of such a termination, and provided that Executive or her estate or beneficiaries, if applicable, executes and does not revoke a release of claims in a form acceptable to the Company:

(i) any vested portion of stock options granted to Executive by the Company shall remain exercisable by the Executive and/or her estate or beneficiaries for a period of six (6) months following the Date of Termination (or, if earlier, the normal expiration date of such stock options), and any unvested portion of stock options granted to Executive by the Company shall lapse and be forfeited without consideration as of the Date of Termination; and

(ii) if Executive’s employment terminates due to death, the Compensation Committee of the Board shall determine in good faith the extent to which any of the performance goals and objectives established pursuant to Section 5(b)(i) above were met as of the time Executive’s death. If, based on that determination, the Compensation Committee of the Board determines that a bonus is due, the Company shall pay Executive’s estate an amount equal to such bonus, pro-rated for the portion of the fiscal year elapsed as of the time of Executive’s death.

(c) Termination by the Company for Cause; Resignation by Executive Other than for Good Reason . If Executive’s employment shall be terminated for Cause during the Employment Period, or Executive shall resign other than for Good Reason during the Employment Period, this Agreement shall terminate without further obligations to Executive, other than for payment of Accrued Obligations minus the Annual Bonus earned by the Executive for the fiscal year immediately prior to the year in which the Date of Termination occurs, if any, to the extent not theretofore paid, and the timely payment or provision of Other Benefits. Accrued Obligations shall be paid to Executive in a lump sum in cash within 60 days after the Date of Termination. In addition, in the event of such a termination, any unvested equity awards shall lapse and be forfeited without consideration on the Date of Termination.

(d) Termination of the Agreement by the Company prior to the Start Date without Cause . If, during the time period between the Effective Date and the Start Date, the Company shall terminate this Agreement without Cause, and only if Executive shall have executed and not revoked a release of claims in a form satisfactory to the Company, then the Company shall pay to Executive twelve (12) months of severance pay based on Executive’s anticipated Base Salary as of the Start Date. The foregoing shall be paid in equal installments over a twelve (12) month period in accordance with the Company’s usual payroll schedule, commencing on the date that the release referred to above may no longer be revoked (or such later date as may be required pursuant to Section 17).

 

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8. Change in Control .

(a) Definition . For the purposes of this Agreement, a “Change in Control” shall mean:

(i) the acquisition by an individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the Securities Exchange Act of 1934, as amended (the “Act”)) of beneficial ownership of any capital stock of the Company if, after such acquisition, such individual, entity or group beneficially owns (within the meaning of Rule 13d-3 promulgated under the Act) 30% or more of either (x) the then-outstanding shares of common stock of the Company (the “Outstanding Company Common Stock”) or (y) the combined voting power of the then-outstanding securities of the Company entitled to vote generally in the election of directors (the “Outstanding Company Voting Securities”);  provided ,  however , that for purposes of this subsection (i), the following acquisitions shall not constitute a Change in Control: (A) any acquisition directly from the Company (excluding an acquisition pursuant to the exercise, conversion or exchange of any security exercisable for, convertible into or exchangeable for common stock or voting securities of the Company, unless the individual, entity or group exercising, converting or exchanging such security acquired such security directly from the Company or an underwriter or agent of the Company), (B) any acquisition by any employee benefit plan (or related trust) sponsored or maintained by the Company or any corporation controlled by the Company, (C) any acquisition by any corporation pursuant to a Business Combination (as defined below) which complies with clauses (x) and (y) of subsection (iii) of this definition, or (D) any acquisition by Baupost Group Securities, L.L.C. or any of its affiliates (“Baupost”), unless after giving effect to such acquisition Baupost owns more than 49% of either the Outstanding Company Common Stock or the Outstanding Company Voting Securities (in each case, measured on a fully-diluted basis taking into account the full conversion of any securities convertible into common stock and, for the avoidance of doubt, not in accordance with Rule 13d-3 promulgated under the Act), or unless such acquisition is in conjunction with an acquisition by a third party not deemed to be an affiliate of Baupost which when considered with Baupost, would constitute a group under Section 13 under the Act; or

(ii) such time as the Continuing Directors (as defined below) do not constitute a majority of the Board (or, if applicable, the Board of Directors of a successor corporation to the Company), where the term “Continuing Director’ means at any date a member of the Board (x) who was a member of the Board on the Start Date of this Agreement or (y) who was nominated or elected subsequent to such date by at least a majority of the directors who were Continuing Directors at the time of such nomination or election or whose election to the Board was recommended or endorsed by at least a majority of the directors who were Continuing Directors at the time of such nomination or election; provided , however , that there shall be excluded from this clause (y) any individual whose initial assumption of office occurred as a result of an actual or threatened election

 

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contest with respect to the election or removal of directors or other actual or threatened solicitation of proxies or consents, by or on behalf of a person other than the Board; or

(iii) the consummation of a merger, consolidation, reorganization, recapitalization or share exchange involving the Company or a sale or other disposition of all or substantially all of the assets of the Company (a “Business Combination”), unless, immediately following such Business Combination, each of the following two conditions is satisfied: (x) all or substantially all of the individuals and entities who were the beneficial owners of the Outstanding Company Common Stock and Outstanding Company Voting Securities immediately prior to such Business Combination beneficially own, directly or indirectly, more than 50% of the then-outstanding shares of common stock and the combined voting power of the then-outstanding securities entitled to vote generally in the election of directors, respectively, of the resulting or acquiring corporation in such Business Combination (which shall include, without limitation, a corporation which as a result of such transaction owns the Company or substantially all of the Company’s assets either directly or through one or more subsidiaries) (such resulting or acquiring corporation is referred to herein as the “Acquiring Corporation”) in substantially the same proportions as their ownership of the Outstanding Company Common Stock and Outstanding Company Voting Securities, respectively, immediately prior to such Business Combination and (y) no Person (excluding the Acquiring Corporation or any employee benefit plan (or related trust) maintained or sponsored by the Company or by the Acquiring Corporation) beneficially owns, directly or indirectly, 30% or more of the then-outstanding shares of common stock of the Acquiring Corporation, or of the combined voting power of the then-outstanding securities of such corporation entitled to vote generally in the election of directors (except to the extent that such ownership existed prior to the Business Combination).

(b) Severance Benefits . Upon the occurrence of a Change in Control, if, within one year after the effective date of the Change in Control, Executive’s employment is terminated by the Company or the successor corporation to the Company without Cause, or Executive resigns for Good Reason, then in addition to payment of the Accrued Obligations and Other Benefits, and provided that Executive shall have executed and not revoked a general release of claims in a form satisfactory to the Company: (i) the Executive shall receive a cash payment equal to the sum of (A) 100% of the Executive’s annual Base Salary as of the Date of Termination or, if higher, at the rate in effect immediately prior to a Change in Control, and (B) the Annual Bonus earned by the Executive for the fiscal year immediately prior to the year in which the Date of Termination occurs, if any, payable in a lump sum within sixty (60) days following the Date of Termination; and (ii) the Executive shall receive a cash payment equal to the total monthly premium payment (both the Company’s portion and the Executive’s portion of such premium) under the Company’s group healthcare plan as in effect on the Date of Termination multiplied by twelve (12), payable in a lump sum within sixty (60) days following the Date of Termination. The foregoing shall be in lieu of and not in addition to any amounts that Executive would otherwise be entitled to receive under Section 7 hereof in the event of a termination without Cause or resignation for Good Reason.

 

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9. Non-exclusivity of Rights . Nothing in this Agreement shall prevent or limit Executive’s continuing or future participation in any employee benefit plan, program, policy or practice provided by the Company or its affiliated companies and for which Executive may qualify, except as specifically provided herein. Amounts that are vested benefits or which Executive is otherwise entitled to receive under any plan, policy, practice or program of the Company or any of its affiliated companies at or subsequent to the Date of Termination shall be payable in accordance with such plan, policy, practice or program except as explicitly modified by this Agreement.

10. No Mitigation . In no event shall Executive be obligated to seek other employment or take any other action by way of mitigation of the severance amounts payable to Executive under any of the provisions of this Agreement and such amounts shall not be reduced whether or not Executive obtains other employment.

11. Mandatory Reduction of Payments in Certain Events .

(a) Anything in this Agreement to the contrary notwithstanding, in the event it shall be determined that any payment or distribution by the Company to or for the benefit of Executive (whether paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise) (a “Payment”) would be subject to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then, prior to the making of any Payment to Executive, a calculation shall be made comparing (i) the net benefit to Executive of the Payment after payment of the Excise Tax, to (ii) the net benefit to Executive if the Payment had been limited to the extent necessary to avoid being subject to the Excise Tax. If the amount calculated under (i) above is less than the amount calculated under (ii) above, then the Payment shall be limited to the extent necessary to avoid being subject to the Excise Tax (the “Reduced Amount”). The reduction of the Payments due hereunder, if applicable, shall be made in such a manner as to maximize the economic present value of all Payments actually made to Executive, determined by the Determination Firm (as defined in Section 11(b) below) as of the date of the Change in Control using the discount rate required by Section 280G(d)(4) of the Code.

(b) The determination of whether an Excise Tax would be imposed, the amount of such Excise Tax, and the calculation of the amounts referred to Section 11(a)(i) and (ii) above shall be made by an independent, nationally recognized accounting firm or compensation consulting firm mutually acceptable to the Company and Executive (the “Determination Firm”) which shall provide detailed supporting calculations. Any determination by the Determination Firm shall be binding upon the Company and Executive. As a result of the uncertainty in the application of Section 4999 of the Code at the time of the initial determination by the Determination Firm hereunder, it is possible that Payments which Executive was entitled to, but did not receive pursuant to Section 11(a), could have been made without the imposition of the Excise Tax (“Underpayment”). In such event, the Determination Firm shall determine the amount of

 

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the Underpayment that has occurred and any such Underpayment shall be promptly paid by the Company to or for the benefit of Executive, but no later than December 31 of the year after the year in which the Underpayment is determined to exist.

(c) In the event that the provisions of Code Section 280G and 4999 or any successor provisions are repealed without succession, this Section 11 shall be of no further force or effect.

12. Restrictions on Conduct of Executive .

(a) General . Executive and the Company understand and agree that the purpose of the provisions of this Section 12 is to protect the legitimate business interests of the Company, as more fully described below, and is not intended to impair or infringe upon Executive’s right to work, earn a living, or acquire and possess property from the fruits of her labor. Executive hereby acknowledges that Executive has received good and valuable consideration for the post-employment restrictions set forth in this Section 12 in the form of the compensation and benefits provided for herein. Executive hereby further acknowledges that the post-employment restrictions set forth in this Section 12 are reasonable and that they do not, and will not, unduly impair her ability to earn a living after the termination of this Agreement.

In addition, the parties acknowledge: (A) that Executive’s services under this Agreement require special expertise and talent in the provision of Competitive Services and that Executive will have substantial contacts with customers, suppliers, advertisers and vendors of the Company; (B) that pursuant to this Agreement, Executive will be placed in a position of trust and responsibility and she will have access to a substantial amount of Confidential Information and Trade Secrets and that the Company is placing her in such position and giving her access to such information in reliance upon her agreement to comply with the obligations set forth in this Section 12; (C) that due to her management duties, Executive will be the repository of a substantial portion of the goodwill of the Company and would have an unfair advantage in competing with the Company; (D) that due to Executive’s special experience and talent, the loss of Executive’s services to the Company under this Agreement cannot reasonably or adequately be compensated solely by damages in an action at law; (E) that Executive is capable of competing with the Company; and (F) that Executive is capable of obtaining gainful, lucrative and desirable employment that does not violate the restrictions contained in this Agreement.

Therefore, subject to the limitations of reasonableness imposed by law, Executive shall be subject to the restrictions set forth in this Section 12.

 

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(b) Definitions . The following capitalized terms used in this Section 12 shall have the meanings assigned to them below, which definitions shall apply to both the singular and the plural forms of such terms:

“Competitive Services” means services involving the acquisition, development or commercialization of oral iron pharmaceutical products that are the same as or substantially similar to the oral iron pharmaceutical products offered or provided by the Company or are in competition with the Company’s products.

“Confidential Information” means all data and information relating to the business of the Company that is disclosed to Executive or of which Executive becomes aware as a consequence of her employment and that has value to the Company and is not generally disclosed to those not employed or otherwise engaged by the Company. “Confidential Information” shall include, but is not limited to, financial plans and data concerning the Company; management planning information; business plans; operational methods; market studies; marketing plans or strategies; product development techniques or plans; customer lists; details of customer contracts; current and anticipated customer requirements; past, current and planned research and development; business acquisition plans; and new personnel acquisition plans. “Confidential Information” shall not include information that has become generally available to the public by the act of one who has the right to disclose such information without violating any right or privilege of the Company. This definition shall not limit any definition of “confidential information” or any equivalent term under state or federal law.

“End Date” means the last day of Executive’s employment with the Company for any reason whatsoever.

“Person” means any individual or any corporation, partnership, joint venture, limited liability company, association or other entity or enterprise.

“Principal or Representative” means a principal, owner, partner, shareholder, joint venturer, investor, member, trustee, director, officer, manager, employee, agent, representative or consultant.

“Protected Customers” means any Person to whom the Company sold its products or services or solicited to sell its products or services during the Employment Period and (a) with whom Executive dealt on behalf of the Company; (b) whose dealings with the Company were coordinated or supervised by Executive; or (c) about whom Executive obtained Trade Secrets or Confidential Information in the ordinary course of business as a result of her employment.

“Protected Employees and Contractors” means employees and independent contractors of the Company who were employed or engaged by the Company at any time within six (6) months prior to the End Date.

Protected Providers ” means any service provider, vendor or supplier with whom the Company conducted business or solicited to conduct business during the twelve (12) months prior to the End Date.

 

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“Restricted Period” means the Employment Period and the one (1) year period following the End Date.

Restricted Territory ” means countries where Keryx has the right to market Auryxia, including, but not limited to, North America, European Union, Eastern Europe, Central and Latin America.

“Restrictive Covenants” means the restrictive covenants contained in Section 12(c) hereof.

“Trade Secret” means all information, without regard to form, including, but not limited to, technical or nontechnical data, a formula, a pattern, a compilation, a program, a device, a method, a technique, a drawing, a process, financial data, financial plans, product plans, distribution lists or a list of actual or potential customers, advertisers or suppliers which is not commonly known by or available to the public and which information: (A) derives economic value, actual or potential, from not being generally known to, and not being readily ascertainable by proper means by, other persons who can obtain economic value from its disclosure or use; and (B) is the subject of efforts that are reasonable under the circumstances to maintain its secrecy. This definition shall not limit any definition of “trade secret” or any equivalent term under state or federal law.

(c) Restrictive Covenants .

(i) Restriction on Disclosure and Use of Confidential Information and Trade Secrets . Executive understands and agrees that the Confidential Information and Trade Secrets constitute valuable assets of the Company, and may not be converted to Executive’s own use. Accordingly, Executive hereby agrees that throughout the Employment Period and at all times after the End Date, for so long as the information at issue remains either Confidential Information or a Trade Secret, Executive will not, directly or indirectly, reveal, divulge, or disclose to any Person not expressly authorized by the Company any Confidential Information or Trade Secrets and will not, directly or indirectly, use or make use of any Confidential Information or Trade Secrets in connection with any business activity other than that of the Company.

Anything herein to the contrary notwithstanding, Executive shall not be restricted from disclosing or using Confidential Information or Trade Secrets that are required to be disclosed by law, court order or other valid legal process; provided , however , that in the event disclosure is required by law, Executive shall provide the Company with prompt, written notice of such requirement so that the Company may seek an appropriate protective order prior to any such required disclosure by Executive.

(ii) Non-Solicitation of Protected Employees and Contractors . Executive understands and agrees that the relationship between the Company and each of its Protected Employees and Contractors constitutes a valuable asset of

 

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the Company and may not be converted to Executive’s own use. Accordingly, Executive hereby agrees that, during the Restricted Period, Executive shall not, directly or indirectly, on Executive’s own behalf or as a Principal or Representative of any Person or otherwise, solicit or induce any Protected Employee or Contractor to terminate his or her relationship with the Company or to enter into an employment, consulting or similar relationship with any other Person.

(iii) Non-Solicitation of Protected Customers . Executive understands and agrees that the relationship between the Company and each of its Protected Customers constitutes a valuable asset of the Company and may not be converted to Executive’s own use. Accordingly, Executive hereby agrees that, during the Restricted Period, Executive shall not, directly or indirectly, on Executive’s own behalf or as a Principal or Representative of any Person, solicit, divert, take away or attempt to solicit, divert or take away a Protected Customer for the purpose of providing or selling Competitive Services.

(iv) Non-Interference with Protected Providers . Executive understands and agrees that the relationship between the Company and each of its Protected Providers constitutes a valuable asset of the Company and may not be converted to Executive’s own use. Executive hereby agrees that, during the Restricted Period, Executive shall not, directly or indirectly, solicit or induce or attempt to solicit or induce any Protected Provider to cease, reduce or alter its relationship with the Company.

(v) Non-Competition with the Company . In consideration of the compensation and benefits being paid and to be paid by the Company to Executive hereunder and the equity awards granted by the Company, Executive hereby agrees that, during the Restricted Period, Executive will not, directly or indirectly, engage in or provide Competitive Services within the Restricted Territory, whether on her own behalf or as a Principal or Representative of any other Person, in a capacity that involves the exercise of any job duties or responsibilities the same as or similar to the job duties and responsibilities executed by Executive on behalf of the Company; provided , however , that the foregoing shall not be deemed to prohibit the ownership by Executive of not more than five percent (5%) of any class of securities of any corporation having a class of securities registered pursuant to the Exchange Act, which investment does not exceed 3% of Executive’s net worth.

(d) Enforcement of Restrictive Covenants .

(i) Rights and Remedies Upon Breach . In the event Executive breaches, or threatens to commit a breach of, any of the provisions of the Restrictive Covenants, the Company shall have the right and remedy to enjoin, preliminarily and permanently, without the necessity of posting bond, Executive from violating or threatening to violate the Restrictive Covenants and to have the

 

15


Restrictive Covenants specifically enforced by any court of competent jurisdiction, it being agreed that any breach or threatened breach of the Restrictive Covenants could cause irreparable injury to the Company and that money damages may not provide an adequate remedy to the Company. The foregoing rights and remedies shall be in addition to, and not in lieu of, any other rights and remedies available to the Company at law or in equity.

(ii) Severability of Covenants . The parties hereunder agree that the Restrictive Covenants shall be considered and construed as separate and independent covenants. Should any part or provision of any Restrictive Covenant be held invalid, void or unenforceable in any court of competent jurisdiction, such invalidity, voidness or unenforceability shall not render invalid, void or unenforceable any other part or provision of this Agreement.

(iii) Reformation . The parties hereunder agree that it is their intention that the Restrictive Covenants be enforced in accordance with their terms to the maximum extent possible under applicable law. The parties further agree that, in the event any court of competent jurisdiction shall find that any provision hereof is not enforceable in accordance with its terms, the court shall reform the Restrictive Covenants such that they shall be enforceable to the maximum extent permissible at law.

13. Invention Assignment . Executive agrees that she will promptly and fully disclose in writing to the Company all inventions, designs, concepts, discoveries, developments, improvements, and innovations, whether or not they merit patent, trademark or copyright protection, conceived of, designed or reduced to practice by Executive, either solely or in concert with others, at any time during her employment, which (i) relate in any manner, whether at the time of conception, design or reduction to practice, to the Company’s business or its actual or demonstrably anticipated research or development; (ii) result from any work performed by Executive on behalf of the Company; or (iii) result from the use of the Company’s equipment, supplies, facilities, Confidential Information or Trade Secrets (collectively referred to as “Inventions”).

Executive acknowledges and agrees that he will keep and maintain adequate written records of all such Inventions at all stages thereof in the form of notes, sketches, drawings, photographs, printouts, and/or reports relating thereto. These records are and shall remain the property of, and be available to, the Company or its designee(s) at all times. Executive further acknowledges that all such Inventions shall be the exclusive property of the Company. As such, Executive hereby assigns her entire right, title, and interest in and to all such Inventions to the Company or its designee(s). Executive will, at the Company’s request and expense, execute specific transfers, assignments, documents or other instruments and take such further action as may be considered necessary by the Company at any time during or subsequent to Executive’s employment to obtain and defend any intellectual property rights and vest complete title and ownership to such Inventions to the Company or its designee(s).

 

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14. Return of Materials . Executive agrees that she will not retain or destroy, and will immediately return to the Company on or prior to her last day of employment, or at any other time the Company requests such return, any and all property of the Company that is in her possession or subject to her control, including, but not limited to, keys, credit and identification cards, equipment, client files and information, and all Confidential Information and Trade Secrets. Executive will not make, distribute or retain copies of any such information or property. Executive agrees that she will reimburse the Company for all of its costs, including reasonable attorneys’ fees, of recovering the above materials and otherwise enforcing compliance with this provision if she does not return the materials in compliance with this provision.

15. Successors and Assigns .

(a) This Agreement is personal to Executive and shall not be assignable by Executive. This Agreement shall inure to the benefit of and be enforceable by Executive’s legal representatives.

(b) The Company may assign this Agreement without the consent of Executive. This Agreement shall inure to the benefit of and be binding upon the Company and its successors and assigns.

16. Cooperation . Both during and after her employment, Executive shall provide Executive’s reasonable cooperation in connection with any action or proceeding (or any appeal from any action or proceeding) which relates to events occurring during Executive’s employment hereunder. The Company shall reimburse Executive for any reasonable out-of-pocket expenses incurred in connection with Executive’s performance of obligations under this Section 16 at the request of the Company. If Executive is entitled to be paid or reimbursed for any expenses under this Section 16, the amount reimbursable in any one calendar year shall not affect the amount reimbursable in any other calendar year, and the reimbursement of an eligible expense must be made no later than December 31 of the year after the year in which the expense was incurred.

17. Code Section 409A .

(a) General . This Agreement shall be interpreted and administered in a manner so that any amount or benefit payable hereunder shall be paid or provided in a manner that is either exempt from or compliant with the requirements Section 409A of the Code and applicable Internal Revenue Service guidance and Treasury Regulations issued thereunder (and any applicable transition relief under Section 409A of the Code). Nevertheless, the tax treatment of the benefits provided under the Agreement is not warranted or guaranteed. Neither the Company nor its directors, officers, employees or advisers shall be held liable for any taxes, interest, penalties or other monetary amounts owed by Executive as a result of the application of Section 409A of the Code.

(b) Definitional Restrictions . Notwithstanding anything in this Agreement to the contrary, to the extent that any amount or benefit that would constitute

 

17


non-exempt “deferred compensation” for purposes of Section 409A of the Code would otherwise be payable or distributable hereunder, or a different form of payment would be effected, by reason of a Change in Control or the Executive’s Disability or termination of employment, such amount or benefit will not be payable or distributable to the Executive, and/or such different form of payment will not be effected, by reason of such circumstance unless (i) the circumstances giving rise to such Change in Control, Disability or termination of employment, as the case may be, meet any description or definition of “change in control event,” “disability” or “separation from service,” as the case may be, in Section 409A of the Code and applicable regulations (without giving effect to any elective provisions that may be available under such definition), or (ii) the payment or distribution of such amount or benefit would be exempt from the application of Section 409A of the Code by reason of the short-term deferral exemption or otherwise. This provision does not prohibit the vesting of any amount upon a Change in Control, Disability or termination of employment, however defined. If this provision prevents the payment or distribution of any amount or benefit, such payment or distribution shall be made on the date, if any, on which an event occurs that constitutes a Section 409A-compliant “change in control event,” “disability” or “separation from service,” as the case may be, or such later date as may be required by subsection (c) below. If this provision prevents the application of a different form of payment of any amount or benefit, such payment shall be made in the same form as would have applied absent such designated event or circumstance.

(c) Six-Month Delay in Certain Circumstances . Notwithstanding anything in this Agreement to the contrary, if any amount or benefit that would constitute non-exempt “deferred compensation” for purposes of Section 409A of the Code would otherwise be payable or distributable under this Agreement by reason of Executive’s separation from service during a period in which she is a Specified Employee (as defined below), then, subject to any permissible acceleration of payment by the Company under Treas. Reg. Section 1.409A-3(j)(4)(ii) (domestic relations order), (j)(4)(iii) (conflicts of interest), or (j)(4)(vi) (payment of employment taxes):

(i) the amount of such non-exempt deferred compensation that would otherwise be payable during the six-month period immediately following Executive’s separation from service will be accumulated through and paid or provided on the first day of the seventh month following Executive’s separation from service (or, if Executive dies during such period, within 30 days after Executive’s death) (in either case, the “Required Delay Period”); and

(ii) the normal payment or distribution schedule for any remaining payments or distributions will resume at the end of the Required Delay Period.

For purposes of this Agreement, the term “Specified Employee” has the meaning given such term in Code Section 409A and the final regulations thereunder: provided, however , that the Company’s Specified Employees and its application of the six-month delay rule of Code Section 409A(a)(2)(B)(i) shall be determined in accordance

 

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with rules adopted by the Board or a committee thereof, which shall be applied consistently with respect to all nonqualified deferred compensation arrangements of the Company, including this Agreement.

18. Miscellaneous .

(a) Governing Law . This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts, without reference to principles of conflict of laws.

(b) Captions . The captions of this Agreement are not part of the provisions hereof and shall have no force or effect.

(c) Amendments . This Agreement may not be amended or modified otherwise than by a written agreement executed by the parties hereto or their respective successors and legal representatives.

(d) Notices . All notices and other communications hereunder shall be in writing and shall be given by hand delivery to the other party or by registered or certified mail, return receipt requested, postage prepaid, addressed as follows:

 

If to Executive :   Christine A. Carberry
  235 Parsons Road
  Rye, NH 03870
If to the Company :   Keryx Biopharmaceuticals, Inc.
  One Marina Park Drive
  Boston, MA 02110
  Attention: General Counsel

or to such other address as either party shall have furnished to the other in writing in accordance herewith. Notice and communications shall be effective when actually received by the addressee.

(e) Severability . The invalidity or unenforceability of any provision of this Agreement shall not affect the validity or enforceability of any other provision of this Agreement.

(f) Withholding . The Company may withhold from any amounts payable under this Agreement such Federal, state, local or foreign taxes as shall be required to be withheld pursuant to any applicable law or regulation.

(g) Waivers . Executive’s or the Company’s failure to insist upon strict compliance with any provision of this Agreement or the failure to assert any right Executive or the Company may have hereunder, shall not be deemed to be a waiver of such provision or right or any other provision or right of this Agreement.

 

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(h) Entire Agreement . This Agreement contains the entire agreement between the Company and Executive with respect to the subject matter hereof and, from and after the Effective Date, this Agreement shall supersede any other agreement between the parties with respect to the subject matter hereof.

(i) Arbitration . In the event that a dispute arises between the parties regarding the formation, interpretation and/or the terms and conditions of this Agreement and/or if there arises any other claim or legal dispute between the parties with respect to Executive’s employment or the termination thereof (the “Dispute”), the complaining party shall submit the Dispute in writing to the other party for resolution. If the Dispute is not resolved between the parties within thirty (30) days of the date the Dispute is submitted in writing to the other party, the complaining party must make a demand for final and binding arbitration in Boston, MA before an arbitrator pursuant to the Employment Arbitration Rules of the American Arbitration Association in effect at the time of the Dispute (the “AAA Rules”) if the complaining party wishes to pursue the Dispute (“Demand for Arbitration”). Provided , however, that the foregoing shall not preclude the Company from immediately seeking injunctive or other equitable relief in a court of competent jurisdiction in connection with Executive’s breach or threatened breach of the Restrictive Covenants or the provisions set forth in Sections 13 or 14 of this Agreement. The parties expressly understand that by agreeing to this arbitration provision, they are agreeing to waive any rights to a civil action and/or jury trial regarding any Disputes between them. The parties shall share all costs, filing fees, and administrative fees for the arbitration equally as they come due; the parties shall be responsible for their own attorneys’ fees, witness fees, and travel costs. The arbitrator shall have the authority to rule on any and all issues properly presented in the Demand for Arbitration and/or pursuant to the AAA Rules and may award any and all relief provided under applicable law. The arbitrator’s award may be enforced, vacated, modified or corrected as set forth in the Federal Arbitration Act, 9 U.S.C § 1 et seq. This Agreement shall be governed by the Federal Arbitration Act, 9 U.S.C § 1 et seq., as amended, and the applicable rules of the American Arbitration Association set forth in this Agreement. This Agreement shall be binding upon, and shall inure to the benefit of Executive, the Company and their respective permitted successors and assigns.

(j) Timing of Release . Whenever in this Agreement a payment or benefit is conditioned on the Executive’s execution of a release of claims, the Company shall provide such release to the Executive promptly following the Date of Termination, and such release must be executed and all revocation periods shall have expired in accordance with terms set forth in the release, but in no case later than sixty (60) days after the Date of Termination; failing which such payment or benefit shall be forfeited. If such payment or benefit constitutes non-exempt “deferred compensation,” then, subject to Section 17(c) above, such payment or benefit (including any installment payments) that would have otherwise been payable during such 60-day period shall be accumulated and paid on the 60th day after the Date of Termination provided such release shall have been executed and such revocation periods shall have expired. If such payment or benefit is exempt from Section 409A of the Code, the Company may elect to make or commence payment at any time during such 60-day period.

 

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(k) Counterparts; Scanned Signatures . This Agreement may be executed in one or more counterparts, all of which shall be considered one and the same agreement, and shall become a binding agreement when one or more counterparts have been signed by each party and delivered to the other party. A counterpart executed and delivered by PDF or facsimile shall be sufficient for the Agreement to become effective.

IN WITNESS WHEREOF, Executive has hereunto set Executive’s hand and, pursuant to the authorization from the Board, the Company has caused these presents to be executed in its name on its behalf, all as of the day and year first above written.

 

/s/ Christine A. Carberry

Christine A. Carberry
KERYX BIOPHARMACEUTICALS, INC.
By:  

/s/ Gregory P. Madison

Gregory P. Madison
President & CEO

 

21

Exhibit 99.1

 

LOGO

Keryx Biopharmaceuticals Announces Recent Business Progress and Reviews Corporate Strategy at 35 th Annual J.P. Morgan Healthcare Conference

 

  Enters 2017 with positive momentum for Auryxia ® (ferric citrate) in Dialysis; preliminary unaudited fourth quarter net U.S. product sales of $8.2  million

 

  Submitted supplemental new drug application (sNDA) seeking Auryxia label expansion to treat iron deficiency anemia in adults with non-dialysis dependent chronic kidney disease

 

  Expands management’s operational and strategic expertise with the appointment of two executives

SAN FRANCISCO, CA , January 8, 2017 – Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), a biopharmaceutical company focused on bringing innovative medicines to people with renal disease, today announced its recent business progress and reviewed its corporate strategy to drive continued growth. Greg Madison, Keryx’s chief executive officer, will review this progress as part of a live webcast of the company’s corporate presentation at the 35th Annual J.P. Morgan Healthcare Conference on Wednesday, January 11 at 2:30 p.m. PST (5:30 p.m. EST).

“As we enter 2017, with the successful return of Auryxia to dialysis patients in November and the potential approval and launch of this medicine in iron deficiency anemia, non-dialysis dependent chronic kidney disease, we believe we are well positioned for growth,” said Greg Madison, president and chief executive officer of Keryx Biopharmaceuticals. “The potential expanded indication would enable us to leverage our commercial infrastructure and significantly increase the number of people that can potentially be treated with Auryxia.”

Business Progress

Keryx is making important progress toward achieving its vision to become a leading renal company. It has generated momentum since the resupply of Auryxia for the treatment of hyperphosphatemia in adults with chronic kidney disease (CKD) on dialysis. In addition, the potential approval of ferric citrate in late 2017 for the treatment of iron deficiency anemia (IDA) in adults with non-dialysis dependent (NDD) CKD may be a significant near-term milestone. The section below announces the company’s recent progress toward achieving its vision and selected preliminary unaudited fourth quarter and year-end 2016 financial results.

Auryxia Commercial Progress

 

    The company reported prescription demand for the fourth quarter of 2016 was approximately 8,700 prescriptions, which included approximately 4,500 prescriptions for the month of December, the first full month of sales post resupply of Auryxia. This compares to approximately 5,000 prescriptions for the month of July 2016, the last full month of sales prior to the previously announced supply interruption.

 

    Today, Keryx announced that the U.S. Food and Drug Administration (FDA) has approved Patheon’s manufacturing facility in France to manufacturer supply of Auryxia for the U.S. The approval of this site provides Keryx with a third manufacturing site for finished Auryxia drug product and provides a redundant source to help ensure continuous supply of this medicine.

Potential Label Expansion Opportunity

 

    The company announced that the sNDA for Auryxia has been submitted to the FDA seeking label expansion to include the treatment of IDA in adults with NDD-CKD. The company will outline its commercial plan for Auryxia, should it be approved for this expanded indication, while attending the J.P. Morgan Healthcare conference.

 

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LOGO

 

    Keryx also announced that detailed results from its pivotal Phase 3 trial that evaluated ferric citrate for the treatment of IDA in adults with stage 3 - 5 NDD-CKD has been submitted for publication in a peer-reviewed scientific journal. Publication of the data is a key component of the company’s strategy to advance understanding of the potential importance of Auryxia to treat this difficult disease.

 

    Abstracts related to clinical trials evaluating IDA, NDD-CKD have been accepted for presentation at the International Society of Nephrology (ISN) World Congress of Nephrology (WCN) in April 2017, a global not-for-profit society dedicated to improving kidney care and reducing the incidence and impact of kidney disease worldwide.

Two New Executive Team Appointments

Today, the company announced that it has appointed Christine Carberry as chief operating officer and Melissa Bradford-Klug as chief business officer, both will report to Greg Madison. Ms. Carberry will start on January 16, 2017 and be responsible for driving a stronger focus on operational excellence and execution. Ms. Bradford-Klug started on January 3, 2017 and is responsible for business development, corporate strategy and alliance management for the company.

Ms. Carberry brings to Keryx approximately 30 years of biotech and pharmaceutical leadership, including most recently as an executive team member and senior vice president, quality, technical operations, program and alliance management at Forum Pharmaceuticals. Prior to Forum, Ms. Carberry spent 25 years at Biogen and held roles of increasing responsibility, culminating as vice president, program and alliance management. She brings operational excellence in technical operations and strategic development, including research, development and lifecycle management for commercial medicines.

Ms. Bradford-Klug brings to Keryx more than 17 years of senior strategic planning and business development experience in the life sciences industry. Ms. Bradford-Klug joins Keryx most recently from AMAG Pharmaceuticals where she served as senior vice president of business development and completed multiple value adding transactions. Prior to AMAG, she held leadership roles with Mallinckrodt Pharmaceuticals, Baxter International and Eli Lilly and Company.

Mr. Madison added, “I am thrilled to have Christine and Melissa join our management team during this important time in the evolution of our organization. With their appointments, we believe we have the depth of expertise and the bandwidth to manage the business operations while simultaneously seeking to build a leading renal company. Our entire organization is excited to maximize the potential we have with Auryxia and execute our strategic plan and we welcome Christine and Melissa who will be instrumental in achieving our vision.”

Preliminary Unaudited Financial Data

Total revenues for the quarter ended December 31, 2016 are expected to be approximately $9.5 million, compared with $5.8 million during the same period in 2015. Total revenue expectations for the fourth quarter of 2016 consist of approximately $8.2 million in ex-factory Auryxia net U.S. product sales, compared to $4.8 million in the fourth quarter of 2015, which were recorded based on actual prescriptions written during the period. Total expected revenue for the fourth quarter of 2016 also include $1.3 million in license revenues as compared to $1.0 million during the same period in 2015.

For the year ended 2016, total revenues are expected to be approximately $31.9 million as compared to $13.7 million in 2015. Total expected revenues for 2016 include $27.1 million of Auryxia net U.S. product sales and $4.8 million in license revenues as compared to $10.1 million and $3.5 million, respectively in 2015.

 

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LOGO

 

Cost of goods sold for the quarter ended December 31, 2016 are expected to be approximately $13.3 million, compared with $1.1 million during the same period in 2015. Expected cost of goods sold for the fourth quarter of 2016 include an approximately $11.8 million write-off of work-in-process inventory that was determined to no longer be suitable for commercial manufacture. For the year ended 2016, total cost of goods sold are expected to be approximately $37.7 million, as compared to $4.5 million in 2015. Total expected 2016 cost of goods includes approximately $25.6 million in write-offs of work-in-process inventory that was determined to no longer be suitable for commercial manufacture and approximately $2.6 million related to manufacturing charges incurred as a result of not fully utilizing planned production at the company’s third-party drug product manufacturers. Total 2015 cost of goods sold included $2.6 million related to manufacturing charges incurred as a result of not fully utilizing planned production at the company’s third-party drug product manufacturers.

Cash and cash equivalents as of December 31, 2016 totaled approximately $112.1 million.

The preliminary unaudited financial data for the quarter and the year ended December 31, 2016 set forth above is derived from preliminary internal financial reports. Keryx has not yet finalized its complete results of operations for the year ended December 31, 2016. In connection with the finalization of its year-end closing and reporting processes, the completion of its financial statements for the year ended December 31, 2016 and the completion of the audit of its financial statements for the year ended December 31, 2016, Keryx and its auditors may identify items that would require Keryx to make adjustments, some of which could be material, to the preliminary unaudited financial data set forth above.

Webcast

Keryx will webcast its corporate presentation and breakout session at the 35 th Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2017 at 2:30 p.m. PST (5:30 p.m. EST). A link to the live webcast is available via Keryx’s website, www.keryx.com , in the Webcasts and Presentations section. An archived version of the presentation will be available on Keryx’s website for 15 days following conclusion of the live presentation.

About Iron Deficiency Anemia, NDD-CKD

Iron deficiency anemia is a common complication in patients with non-dialysis dependent chronic kidney disease (NDD-CKD), and the prevalence and severity of IDA increases as kidney disease progresses. It is estimated that there are approximately 1.6 million people living in the U.S. with stage 3-5 non-dialysis dependent chronic kidney disease and iron deficiency anemia. Efficacy and tolerability of current oral iron supplements are mixed. Intravenous (IV) iron administration is associated with important risks and burdens.

About Auryxia

Auryxia (ferric citrate) was approved by the U.S. Food and Drug Administration on September 5, 2014 and is indicated in the U.S. for the control of serum phosphorus levels in patients with CKD on dialysis. The U.S. approval of Auryxia was based on data from the company’s Phase 3 registration program in dialysis patients. In the Phase 3 clinical trials, Auryxia effectively reduced serum phosphorus levels to within the KDOQI guidelines range of 3.5 to 5.5 mg/dL.

 

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Auryxia binds with dietary phosphate in the GI tract and precipitates as ferric phosphate. The unbound portion of Auryxia has been shown to increase serum iron parameters including ferritin and transferrin saturation (TSAT). Iron absorption from Auryxia may lead to excessive elevations in iron stores. Accordingly, physicians should assess and monitor iron parameters before starting and while on Auryxia, and may need to decrease or discontinue IV iron for these patients. The most common adverse events for Auryxia treated patients were gastrointestinal related, including diarrhea, nausea, vomiting and constipation. For more information about Auryxia and the U.S. full prescribing information, visit www.Auryxia.com.

Use of ferric citrate in patients with NDD-CKD and IDA, as highlighted above, is investigational and has not been determined to be safe or efficacious.

IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA ® (ferric citrate)

Contraindication:  Patients with iron overload syndrome, e.g. hemochromatosis, should not take Auryxia ® .

Iron Overload:  Iron absorption from Auryxia may lead to increased iron in storage sites. Iron parameters should be monitored prior to and while on Auryxia. Patients receiving IV iron may require a reduction in dose or discontinuation of IV iron therapy.

Accidental Overdose of Iron:  Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep Auryxia away from children as it contains iron. Call a poison control center or your physician in case of an accidental overdose in a child.

Patients with Gastrointestinal Bleeding or Inflammation:  Safety has not been established for these patients.

Adverse Events:  The most common adverse events with Auryxia were diarrhea (21%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Gastrointestinal adverse reactions were the most common reason for discontinuing Auryxia (14%). Auryxia contains iron and may cause dark stools, which is considered normal with oral medications containing iron.

Drug Interactions:  Doxycycline should be taken at least 1 hour before Auryxia. Ciprofloxacin should be taken at least 2 hours before or after Auryxia.

For Full Prescribing Information for Auryxia, please visit  http://auryxia.com/important-safety-information/

Forward Looking Statements

Some of the statements included in this press release, particularly those regarding expected revenues and expenses, the commercialization and ongoing clinical development of Auryxia and the expected impact of the new members of management, including those statements related to Preliminary Unaudited Year-end Financial Data and the submission of an sNDA to the FDA to expand the label of ferric citrate to include the treatment of IDA in adults with stage 3-5 NDD-CKD and the potential approval in this indication and the impact thereof on Keryx, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: the completion of our financial statements for the year ended December 31, 2016 and the audit thereof; whether we can increase adoption of Auryxia in patients with CKD on dialysis; whether we can maintain our operating expenses to projected levels while continuing our current clinical, regulatory and

 

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LOGO

 

commercial activities; whether we will able to identify and negotiate acceptable terms with a commercialization partner in the E.U.; whether we or a partner can successfully launch Fexeric ® in the E.U.; whether Riona ® will be successfully marketed in Japan by our Japanese partner, Japan Tobacco, Inc. and its subsidiary Torii Pharmaceutical Co., Ltd; the risk that the FDA may not concur with our interpretation of our Phase 3 study results in NDD- CKD, supportive data, conduct of the studies, or any other part of our regulatory submission and could ultimately deny approval of ferric citrate for the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk that if approved for use in NDD-CKD that we may not be able to successfully market Auryxia for use in this indication; our ability to continue to supply Auryxia following the recent resupply to the market; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at  http://www.keryx.com . The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts is a commercial stage company focused on bringing innovative medicines to people with renal disease. Keryx developed and commercializes Auryxia ® (ferric citrate), an iron-based phosphate binder, in the U.S. Ferric citrate is marketed as Riona ®  by Keryx’s Japanese partner, Japan Tobacco Inc. and Torii Pharmaceutical Co. Ltd. In September 2015, the European Commission granted European market authorization for Fexeric ® (ferric citrate coordination complex). Keryx has programs underway to leverage its development and commercial infrastructure, including evaluation of iron deficiency anemia in adults with non-dialysis depended chronic kidney disease and in-licensing medicines for renal disease. For more information about Keryx, please visit  www.keryx.com .

KERYX BIOPHARMACEUTICALS CONTACTS:

Amy Sullivan

Vice President, Corporate Affairs

T: 617.466.3519

amy.sullivan@keryx.com

Lora Pike

Senior Director, Investor Relations

T: 617.466.3511

lora.pike@keryx.com

 

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SLIDE 0

Greg Madison President & Chief Executive Officer Keryx Biopharmaceuticals, Inc. 35th Annual J.P. Morgan Healthcare Conference January 9 – 11, 2017 Building a Leading Renal Company Exhibit 99.2


SLIDE 1

Disclaimers Forward-looking Statements Some of the statements included in this presentation, particularly those regarding expected revenues, the commercialization and ongoing clinical development of Auryxia and the expected impact of the new members of management, including those statements related to Preliminary Unaudited Year-end Financial Data and the submission of an sNDA to the FDA to expand the label of ferric citrate to include the treatment of IDA in adults with stage 3-5 NDD-CKD and the potential approval in this indication and the impact thereof on Keryx, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: the completion of our financial statements for the year ended December 31, 2016 and the audit thereof; whether we can increase adoption of Auryxia in patients with CKD on dialysis; whether we can maintain our operating expenses to projected levels while continuing our current clinical, regulatory and commercial activities; whether we will able to identify and negotiate acceptable terms with a commercialization partner in the E.U.; whether we or a partner can successfully launch Fexeric® in the E.U.; whether Riona® will be successfully marketed in Japan by our Japanese partner, Japan Tobacco, Inc. and its subsidiary Torii Pharmaceutical Co., Ltd; the risk that the FDA may not concur with our interpretation of our Phase 3 study results in NDD- CKD, supportive data, conduct of the studies, or any other part of our regulatory submission and could ultimately deny approval of ferric citrate for the treatment of IDA in adults with stage 3-5 NDD-CKD; the risk that if approved for use in NDD-CKD that we may not be able to successfully market Auryxia for use in this indication; our ability to continue to supply Auryxia following the recent resupply to the market; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward looking statements set forth in this presentation speak only as of the date of this presentation. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This presentation is available on our website at http://www.keryx.com. The information found on our website is not incorporated by reference into this presentation and is included for reference purposes only.      Preliminary Unaudited Financial Results The preliminary unaudited financial data for the quarter and the year ended December 31, 2016 set forth above is derived from preliminary internal financial reports. Keryx has not yet finalized its complete results of operations for the year ended December 31, 2016. In connection with the finalization of its year-end closing and reporting processes, the completion of its financial statements for the year ended December 31, 2016 and the completion of the audit of its financial statements for the year ended December 31, 2016, Keryx and its auditors may identify items that would require Keryx to make adjustments, some of which could be material, to the preliminary unaudited financial data set forth above.


SLIDE 2

Building a Leading Renal Company Today Near Term Future One medicine, multiple indications Multi-product company focused on improving the lives of people with renal disease One medicine, one indication Auryxia is currently indicated for the control of serum phosphorus levels in CKD patients on dialysis; Ferric citrate is being evaluated for use in non-dialysis dependent CKD patients as a treatment for iron deficiency anemia.


SLIDE 3

Positive momentum for Auryxia in dialysis ~8,700 prescriptions for 4Q16, including ~4,500 prescriptions in December Well Positioned for Growth in 2017 Commercial Update Financial Highlights* Corporate ~$8.2 million in 4Q16 net U.S. Auryxia product sales; ~$27.1 million for full year 2016 ~$112.1 million in cash and cash equivalents as of December 31, 2016 Added two new executives with broad operational and strategic experience Christine Carberry appointed as chief operating officer Melissa Bradford-Klug appointed as chief business officer Expansion Opportunity Submitted sNDA for Auryxia for iron deficiency anemia in non-dialysis dependent chronic kidney disease (IDA, NDD-CKD) Prescriptions include demand data provided to the company from third party sources. *Financial data represent preliminary unaudited results for the quarter and year ended December 31, 2016.


SLIDE 4

Leverage Auryxia’s MOA to Potentially Manage Two Complications Associated with CKD Phosphate Management Anemia Management 2 1 3 The ferric iron component binds to dietary phosphate in the GI tract and precipitates as ferric phosphate This compound is insoluble and excreted in the stool Ferric citrate has been shown to increase serum iron parameters through systemic absorption which is managed by the body’s GI regulatory mechanisms Auryxia is currently indicated for the control of serum phosphorus levels in CKD patients on dialysis; Ferric citrate is being evaluated for use in non-dialysis dependent CKD patients as a treatment for iron deficiency anemia.


SLIDE 5

Significant Opportunity Exists to Increase Number of People Treated with Auryxia ~ $2.2B Market ~$2.8B Market Market sizes are based on Auryxia dollars; Dialysis market size based on 350,000 patients, 6 tablets/day, $5.04 WAC/tablet, and a 42% gross to net adjustment. IDA near-term potential market size based on 650,000 patients, 4 tablets/day, $5.04 WAC/tablet, and a 42% gross to net adjustment. IDA market development market size based on 250,000 – 400,000 patients, 4 tablets/day, $5.04 WAC/tablet, and a 42% gross to net adjustment. Auryxia is currently indicated for the control of serum phosphorus levels in CKD patients on dialysis. Ferric citrate is being evaluated for use in non-dialysis dependent CKD patients as a treatment for iron deficiency anemia. $1.1 – 1.7B Market Sources: http://www.kidney.org/kidneydisease; U.S. Renal Data System, USRDS 2013 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2013; Decision Resources, Biotrends, Chart Trends – Bone and Mineral Metabolism in Dialysis 2013 (US); imputed 3% growth per year. Spherix Caseload Dynamics 2015. CKD stage 3 – 5D 16 million adults ~2.2 million under care of a nephrologist ~450,000 Dialysis ~1.7 million NDD-CKD Near-term Potential ~650,000 treated for IDA Current Indication ~350,000 treated with phosphate binder 26 million adults with CKD in the U.S. Market Development 250,000 – 400,000 with Hgb < 12 estimated to have IDA


SLIDE 6

Phosphate Management Growth Driver Marketed Medicine, Auryxia® Today Hyperphosphatemia in people with CKD on Dialysis Building a Leading Renal Company


SLIDE 7

Overview/Recent Accomplishments: Three FDA-approved drug product manufacturing sites provide redundant supply to support growth Sound commercial strategy and expanded field force engagement set stage for growth Strong commercial fundamentals remain in place 2017 program goals: Drive growth and ensure that patients have access to the benefits of Auryxia Hyperphosphatemia in Dialysis Program Overview


SLIDE 8

Current Indication: Control of Serum Phosphorus Levels in People on Dialysis Auryxia Goal Auryxia becomes an established 1st-line phosphate binder in dialysis. Sources: http://www.kidney.org/kidneydisease; U.S. Renal Data System, USRDS 2013 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2013; Decision Resources, Biotrends, Chart Trends – Bone and Mineral Metabolism in Dialysis 2013 (US); imputed 3% growth per year. Spherix Caseload Dynamics 2015. CKD stage 3 – 5D 16 million adults ~2.2 million under care of a nephrologist ~450,000 Dialysis NDD-CKD* 1.7 million ~350,000 treated with phosphate binders


SLIDE 9

Importance of Managing Serum Phosphorus Levels in People with ESRD % of ESRD Patients Serum Phosphorus Levels Sources: DOPPS, Keryx data on file, Cosmos study data. 30% - 40% of ESRD patients have serum phosphorus levels above 5.5 mg/dL Serum phosphorus levels above 5.5 mg/dL are associated with higher rates of morbidity and mortality When managed within KDOQI target range, mortality rates are significantly reduced Case-study data at ASN 2016 showed that the majority of patients switched to Auryxia were brought into KDOQI target ranges after six months of treatment


SLIDE 10

Strong Auryxia Demand Since Resupply Goal: Regain Pre-interruption Momentum as Quickly as Possible Supply Interruption Prescriptions Filled Sources: IMS, Davita Rx, Fresenius Rx and Keryx data on file.


SLIDE 11

Positive indicators from market insights Auryxia brand perceptions remain strong despite supply interruption High prescriber intention to restart prior Auryxia patients Auryxia utilization expectations at or above pre-interruption levels Strong demand coming from both recapture of prior patients (~70%) and new patient starts (~30%) 4Q Metrics* ~8,700 prescriptions during 4Q16, including ~4,500 prescriptions in December ~$8.2 million in ex-factory sales Approximately 4 weeks of inventory in channel Positive Momentum in Dialysis Source: Speherix RealTime Dynamix November 2016 *Financial data represent preliminary unaudited results for the quarter and year ended December 31, 2016


SLIDE 12

Iron Deficiency Anemia, NDD-CKD Potential Late 2017 Launch Near-Term Growth Opportunity Iron Deficiency Anemia in People with NDD-Chronic Kidney Disease Building a Leading Renal Company


SLIDE 13

Achievements: Completed Pivotal Phase 3 Trial: Comprehensive data of final results presented at ASN in November Demonstrated statistically significant differences versus placebo for the primary and all pre-specified secondary endpoints Submitted publication to peer-reviewed journal Submitted sNDA January 2017 2017 program goals: Raise awareness of clinical trial data through publication of results Prepare for potential launch in late 2017 IDA, NDD-CKD Program Overview Potential to be first FDA-approved oral iron medicine for IDA, NDD-CKD


SLIDE 14

Source: ASN 2016, effects of ferric citrate in adults with non-dialysis dependent chronic kidney disease and iron deficiency anemia: Phase 3 Clinical Trial, Stephen Fishbane Pivotal Phase 3 Trial: Efficacy Results


SLIDE 15

Ferric Citrate (n=117) Placebo (n=116) Any TEAE 93 (79.5%) 75 (64.7%) Diarrhea 24 (20.5%) 19 (16.4%) Constipation 22(18.8%) 15 (12.9%) Feces discolored 17 (14.5%) 0 (0%) Nausea 13 (11.1%) 3 (2.6%) Abdominal pain 7 (6.0%) 2 (1.7%) Fatigue 0 (0%) 6 (5.2%) Hyperkalaemia 8 (6.8%) 4 (3.4%) Hypertension 5 (4.3%) 6 (5.2%) Source: ASN 2016, effects of ferric citrate in adults with non-dialysis dependent chronic kidney disease and iron deficiency anemia: Phase 3 Clinical Trial, Stephen Fishbane Pivotal Phase 3 Trial: Safety Results


SLIDE 16

Auryxia IDA, NDD-CKD Launch Planning Highlights Conduct primary and secondary research with nephrologists and support staff Generate key market and customer insights Situational Analysis Identify opportunities and leverage points Formulate product positioning Develop strategic priorities Strategy Development Key deliverables, timelines, and milestones critical for the successful launch of Auryxia for IDA, NDD-CKD Launch Plan


SLIDE 17

Market Insights: Need Exists for Effective, Well Tolerated, Convenient IDA Treatment Goal: Position Auryxia as a new standard of care for the management of IDA in NDD-CKD Physician Perceptions of Current Treatment Options for IDA Oral Iron Widely available, inexpensive Nephrologists report low satisfaction with existing oral iron therapies due to poor tolerability and absorption IV Iron Viewed by most nephrologists as effective treatment Selectively used in NDD-CKD patients with IDA due to: Logistical constraints Potential serious adverse reactions Sources: http://www.kidney.org/kidneydisease; U.S. Renal Data System, USRDS 2013 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2013; Decision Resources, Biotrends, Chart Trends – Bone and Mineral Metabolism in Dialysis 2013 (US); imputed 3% growth per year. Spherix Caseload Dynamics 2015. CKD stage 3 – 5D 16 million adults ~2.2 million under the care of a nephrologist Dialysis 450,000 ~1.7 million NDD-CKD ~650,000 treated for IDA 350,000 treated with phosphate binder (current indication)


SLIDE 18

Oral Iron Satisfaction is Low Compared to Other CKD Treatments Speherix RealTime Dynamix June 2016 Overall, how satisfied are you with the performance of each drug class / product below. Please rate each on a scale of 1 to 10, where "1" is "Not at all satisfied" and "10" is "Extremely Satisfied“ (n=198, aggregated May and June)


SLIDE 19

Large Near-term Opportunity Treated Patients Represent a ~$2.8 Billion Market Of ~1.7 million NDD-CKD patients under care of a nephrologist, ~650,000 are treated for IDA IDA near-term potential market size based on 650,000 patients, 4 tablets/day, $5.04 WAC/tablet, and a 42% gross to net adjustment. . Auryxia is currently indicated for the control of serum phosphorus levels in CKD patients on dialysis. Ferric citrate is being evaluated for use in non-dialysis dependent CKD patients as a treatment for iron deficiency anemia. Source: Spherix Caseload Dynamics 2015.


SLIDE 20

Market Development: Effective Oral Treatment Option Could Expand the Number of NDD-CKD Patients Treated for IDA Auryxia is currently indicated for the control of serum phosphorus levels in CKD patients on dialysis. Ferric citrate is being evaluated for use in non-dialysis dependent CKD patients as a treatment for iron deficiency anemia. Market Development KDIGO Guidelines for IDA Anemia defined as Hgb levels <12 g/dL Low Hgb levels lead to iron studies to diagnose IDA For adult NDD-CKD patients with anemia not on iron or ESA therapy, KDIGO suggests a 1-3 month trial of oral iron therapy if: An increase in Hgb concentration without starting ESA treatment is desired* and TSAT is ≤30% and ferritin is ≤500 ng/ml Sources: http://www.kidney.org/kidneydisease; U.S. Renal Data System, USRDS 2013 Annual Data Report: Atlas of Chronic Kidney Disease and End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2013; Decision Resources, Biotrends, Chart Trends – Bone and Mineral Metabolism in Dialysis 2013 (US); imputed 3% growth per year. Spherix Caseload Dynamics 2015. CKD stage 3 – 5D 16 million adults ~2.2 million under care of a nephrologist Dialysis 450,000 ~1.7 million NDD-CKD ~650,000 treated for IDA ~350,000 treated with phosphate binder (current indication) 26 million adults with CKD in the U.S. 250,000 – 400,000 with Hgb < 12 estimated to have IDA


SLIDE 21

Market Development: >500,000 People Under Care of a Nephrologist with CKD with Below Normal Hemoglobin Hgb < 12 Hgb >12 Additional $1.1 – 1.7 Billion Market Development Potential 250,000 – 400,000 of those with below normal hemoglobin estimated to have iron deficiency anemia IDA market development market size based on 250,000 – 400,000 patients, 4 tablets/day, $5.04 WAC/tablet, and a 42% gross to net adjustment. . Auryxia is currently indicated for the control of serum phosphorus levels in CKD patients on dialysis. Ferric citrate is being evaluated for use in non-dialysis dependent CKD patients as a treatment for iron deficiency anemia. Source: Spherix Caseload Dynamics 2015.


SLIDE 22

Auryxia Strategic Priorities in IDA, NDD-CKD Establish a new oral iron-centric treatment paradigm for anemia in NDD-CKD Differentiate Auryxia from traditional oral irons Position Auryxia as a new standard of care for the management of IDA in NDD-CKD


SLIDE 23

Marketing Market Access & Reimbursement Sales IDA, NDD-CKD Launch Preparations Well Underway Medical Affairs Workstreams Function Branded Promotion Speaker Programs Advisory Boards KOL Engagement Patient Education Conferences Advocacy Payer Mix Formulary Access Patient Services Corporate Accounts Value Proposition Pricing Targeting Salesforce Sizing Training Sales Cycle Incentive Comp Samples Medical Education Disease Awareness Data Generation Medical Comms Health Outcomes Advisory Boards Med Info MSL Activity


SLIDE 24

Current commercial infrastructure Current Keryx phosphate binder nephrology targets account for ~80% of oral iron prescriptions in CKD Broad awareness and familiarity of Auryxia Established access and reimbursement Similar payer mix dynamics to dialysis Existing formulary coverage would provide access to majority of IDA, NDD/CKD patients Existing reimbursement hub would provide patient support IDA, NDD-CKD Indication Would Provide Significant Leverage IMS, custom data summary for prescription oral Iron and phosphate binder prescribing, Aug 2015-Jul 2016.


SLIDE 25

Portfolio Expansion Opportunity Building a Leading Renal Company Future


SLIDE 26

Building a Leading Renal Company: Three Strategic Pathways Drive and Support Keryx’s Planned Growth GROW INSPIRE Maximize Auryxia’s Potential Grow in US dialysis market Launch & grow in US IDA, NDD- CKD market Expand Portfolio Build Keryx by adding strategic assets to our portfolio Manage Growth & Talent Create a culture of success Appropriately staff with high-quality talent to support planned growth Expand Portfolio Manage Growth & Talent Maximize Auryxia’s Potential


SLIDE 27

Focus: Medicines that Build off Core Business Areas Based on Proximity to Core Business Related Adjacencies Kidney Related Transplant Surgeon /Hospital New Therapeutic Areas Hematology Gastroenterology Core: Current Call-point Nephrologist office Dialysis center


SLIDE 28

Significant revenues from maximizing Auryxia: A market leading medicine for the treatment of two complications of CKD Broad renal portfolio that leverages existing infrastructure Strong balance sheet Well Positioned to Build a Leading Renal Company Momentum in Dialysis and IDA Expansion Opportunity Drive Growth & Investment in Portfolio Expansion 2017 Anticipated Future Profile Drive growth in dialysis Launch in IDA, NDD-CKD, upon potential approval Execute on strategic plan


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Greg Madison President & Chief Executive Officer Keryx Biopharmaceuticals, Inc. 35th Annual J.P. Morgan Healthcare Conference January 9-11, 2017 Building a Leading Renal Company