10-Q
Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

Form 10-Q

 

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2018

or

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                      to                     

Commission File Number: 001-35420

 

 

ChemoCentryx, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   94-3254365

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification No.)

850 Maude Avenue

Mountain View, California

  94043
(Address of Principal Executive Offices)   (Zip Code)

(650) 210-2900

(Registrant’s Telephone Number, Including Area Code)

 

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ☒    No  ☐

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    ☒  Yes    ☐  No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer   

 

Accelerated filer

 
Non-accelerated filer  

☐  (Do not check if a smaller reporting company)

 

Smaller reporting company

 
Emerging growth company      

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13 (a) of the Exchange Act.  ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ☐    No  ☒

The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of July 31, 2018 was 50,378,571.

 

 

 


Table of Contents

CHEMOCENTRYX, INC.

QUARTERLY REPORT ON FORM 10-Q

For the quarterly period ended June 30, 2018

Table of Contents

 

PART I. FINANCIAL INFORMATION

     Page  

Item 1.

  Financial Statements (Unaudited)   
  Condensed Consolidated Balance Sheets – June 30, 2018 and December 31, 2017      3  
  Condensed Consolidated Statements of Operations – Three and Six Months Ended June 30, 2018 and 2017      4  
  Condensed Consolidated Statements of Comprehensive Loss – Three and Six Months Ended June 30, 2018 and 2017      5  
  Condensed Consolidated Statements of Cash Flows – Six Months Ended June 30, 2018 and 2017      6  
  Notes to Condensed Consolidated Financial Statements      7  

Item 2.

  Management’s Discussion and Analysis of Financial Condition and Results of Operations      19  

Item 3.

  Quantitative and Qualitative Disclosures About Market Risk      27  

Item 4.

  Controls and Procedures      27  

PART II. OTHER INFORMATION

  

Item 1.

  Legal Proceedings      28  

Item 1A.

  Risk Factors      28  

Item 2.

  Unregistered Sales of Equity Securities and Use of Proceeds      28  

Item 3.

  Defaults Upon Senior Securities      28  

Item 4.

  Mine Safety Disclosures      28  

Item 5.

  Other Information      28  

Item 6.

  Exhibits      28  

EXHIBIT INDEX

     29  

SIGNATURES

     30  


Table of Contents

PART I. FINANCIAL INFORMATION

 

Item 1.

Financial Statements

CHEMOCENTRYX, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and par value data)

(unaudited)

 

     June 30,     December 31,  
     2018     2017  
Assets     

Current assets:

    

Cash and cash equivalents

   $ 68,752     $ 40,020  

Short-term investments

     113,289       87,271  

Accounts receivable

     164       51,090  

Prepaid expenses and other current assets

     2,720       1,449  
  

 

 

   

 

 

 

Total current assets

     184,925       179,830  

Property and equipment, net

     1,614       1,210  

Long-term investments

     19,765       7,929  

Other assets

     306       359  
  

 

 

   

 

 

 

Total assets

   $ 206,610     $ 189,328  
  

 

 

   

 

 

 
Liabilities and Stockholders’ Equity     

Current liabilities:

    

Accounts payable

   $ 1,022     $ 1,400  

Accrued liabilities

     11,018       8,575  

Deferred revenue

     56,668       22,962  
  

 

 

   

 

 

 

Total current liabilities

     68,708       32,937  

Long-term debt, net

     14,700       4,676  

Noncurrent deferred revenue

     93,885       72,197  

Other non-current liabilities

     419       251  
  

 

 

   

 

 

 

Total liabilities

     177,712       110,061  

Commitments

    

Stockholders’ equity:

    

Preferred stock, $0.001 par value, 10,000,000 shares authorized; no shares issued and outstanding

     —         —    

Common stock, $0.001 par value, 200,000,000 shares authorized; 50,309,988 and 48,837,060 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively

     50       49  

Additional paid-in capital

     381,923       368,553  

Note receivable

     (16     (16

Accumulated other comprehensive loss

     (237     (119

Accumulated deficit

     (352,822     (289,200
  

 

 

   

 

 

 

Total stockholders’ equity

     28,898       79,267  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 206,610     $ 189,328  
  

 

 

   

 

 

 

See accompanying notes.

 

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Table of Contents

CHEMOCENTRYX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2018     2017     2018     2017  

Revenue:

        

Collaboration and license revenue

   $ 15,022     $ 8,937     $ 24,568     $ 17,167  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     15,022       8,937       24,568       17,167  

Operating expenses:

        

Research and development

     17,759       14,329       32,501       24,299  

General and administrative

     4,748       4,184       9,408       8,757  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     22,507       18,513       41,909       33,056  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (7,485     (9,576     (17,341     (15,889

Other income (expense):

        

Interest income

     792       336       1,405       653  

Interest expense

     (181     —         (355     —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income, net

     611       336       1,050       653  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (6,874   $ (9,240   $ (16,291   $ (15,236
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and diluted net loss per common share

   $ (0.14   $ (0.19   $ (0.33   $ (0.32
  

 

 

   

 

 

   

 

 

   

 

 

 

Shares used to compute basic and diluted net loss per common share

     49,542       48,224       49,198       48,169  
  

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes.

 

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CHEMOCENTRYX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(in thousands)

(unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2018     2017     2018     2017  

Net loss

   $ (6,874   $ (9,240   $ (16,291   $ (15,236

Unrealized gain (loss) on available-for-sale securities

     65       (29     (118     (63
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive loss

   $ (6,809   $ (9,269   $ (16,409   $ (15,299
  

 

 

   

 

 

   

 

 

   

 

 

 

See accompanying notes.

 

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CHEMOCENTRYX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

     Six Months Ended
June 30,
 
     2018     2017  

Operating activities

    

Net loss

   $ (16,291   $ (15,236

Adjustments to reconcile net loss to net cash provided by operating activities:

    

Depreciation of property and equipment

     227       203  

Stock-based compensation

     5,167       4,853  

Noncash interest (income) expense, net

     (480     206  

Changes in assets and liabilities:

    

Accounts receivable

     50,926       29,987  

Prepaids and other current assets

     (475     (1,582

Other assets

     53       (72

Accounts payable

     (378     704  

Other liabilities

     2,480       (126

Deferred revenue

     8,063       (6,949
  

 

 

   

 

 

 

Net cash provided by operating activities

     49,292       11,988  

Investing activities

    

Purchases of property and equipment, net

     (631     (308

Purchases of investments

     (99,762     (76,926

Maturities of investments

     62,450       73,250  
  

 

 

   

 

 

 

Net cash used in investing activities

     (37,943     (3,984

Financing activities

    

Proceeds from exercise of stock options and employee stock purchase plan

     7,881       1,769  

Employees’ tax withheld and paid for restricted stock units

     (473     (297

Borrowings under credit facility agreement, net of issuance costs

     9,975       —    
  

 

 

   

 

 

 

Net cash provided by financing activities

     17,383       1,472  
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

     28,732       9,476  

Cash and cash equivalents at beginning of period

     40,020       12,024  
  

 

 

   

 

 

 

Cash and cash equivalents at end of period

   $ 68,752     $ 21,500  
  

 

 

   

 

 

 

Supplemental disclosures of cash flow information

    

Cash paid for interest

   $ 173     $ —    

See accompanying notes.

 

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CHEMOCENTRYX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2018

(unaudited)

 

1.

Description of Business

ChemoCentryx, Inc. (the Company) commenced operations in 1997. The Company is a clinical-stage biopharmaceutical company focused on developing new medications targeted at inflammatory disorders, autoimmune diseases and cancer. The Company’s principal operations are in the United States and it operates in one segment.

Unaudited Interim Financial Information

The financial information filed is unaudited. The Condensed Consolidated Financial Statements included in this report reflect all adjustments (consisting only of normal recurring adjustments) that the Company considers necessary for the fair statement of the results of operations for the interim periods covered and of the financial condition of the Company at the date of the interim balance sheet. The December 31, 2017 Condensed Consolidated Balance Sheet was derived from audited financial statements. The results for interim periods are not necessarily indicative of the results for the entire year or any other interim period. The Condensed Consolidated Financial Statements should be read in conjunction with the Company’s financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission on March 12, 2018.

 

2.

Summary of Significant Accounting Policies

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States (GAAP) requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from these estimates.

Concentration of Credit Risk

The Company invests in a variety of financial instruments and, by its policy, limits the amount of credit exposure with any one issuer, industry or geographic area.

Accounts receivable are typically unsecured and are concentrated in the pharmaceutical industry and government sector. Accordingly, the Company may be exposed to credit risk generally associated with pharmaceutical companies and government funded entities. The Company has not historically experienced any significant losses due to concentration of credit risk.

Accounts receivable consists of the following (in thousands):

 

     June 30,
2018
     December 31,
2017
 

Vifor (1)

   $ 164      $ 51,090  

 

  (1)

As of December 31, 2017, accounts receivable excluded the $10.0 million cash commitment received from Vifor in February 2018 in connection with the agreement that harmonized the geographic commercialization rights underlying the agreements for both avacopan and CCX140 drug candidates, which we refer to as the Avacopan Amendment. See “Note 8. Collaboration and License Agreements” for a detailed discussion.

Net Loss Per Share

Basic net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents.

Diluted net loss per share is computed by dividing net loss attributable to common stockholders by the sum of the weighted-average number of common shares outstanding and dilutive common stock equivalent shares outstanding for the period. The Company’s potentially dilutive common stock equivalent shares, which include incremental common shares issuable upon (i) the exercise of outstanding stock options and warrants, (ii) vesting of restricted stock units (RSUs) and restricted stock awards (RSAs), and (iii) the purchase from contributions to the 2012 Employee Stock Purchase Plan (the ESPP), (calculated based on the treasury stock method), are only included in the calculation of diluted net loss per share when their effect is dilutive.

 

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For the six months ended June 30, 2018 and 2017, the following potentially dilutive securities were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:

 

     Six Months Ended
June 30,
 
     2018      2017  

Options to purchase common stock, including purchases from contributions to ESPP

     10,827,826        10,435,490  

Restricted stock units

     480,454        476,447  

Restricted stock awards

     37,713        95,866  

Warrants to purchase common stock

     150,000        150,000  
  

 

 

    

 

 

 
     11,495,993        11,157,803  
  

 

 

    

 

 

 

Comprehensive Loss

Comprehensive loss comprises net loss and other comprehensive loss. For the periods presented other comprehensive loss consists of unrealized losses on the Company’s available-for-sale securities. For the three and six months ended June 30, 2018 and 2017, there were no sales of investments, and therefore there were no reclassifications.

Revenue Recognition

Effective January 1, 2018, the Company adopted Accounting Standards Codification (ASC) Topic 606, Revenue from Contracts with Customers (ASC 606) using the modified retrospective transition method. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

The Company enters into corporate collaborations under which it may obtain upfront license fees, research and development funding and development and regulatory and commercial milestone payments and royalty payments. The Company’s performance obligations under these arrangements may include licenses of intellectual property, distribution rights, research and development services, delivery of manufactured product, and/or participation on joint steering committees.

Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from upfront license fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgement to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring proportional performance for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of proportional performance each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

Milestone payments: At the inception of each arrangement that includes development, regulatory or commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price. ASC 606 suggests two alternatives to use when estimating the amount of variable consideration: the expected value method and the most likely amount method. Under the expected value method, an entity considers the sum of

 

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probability-weighted amounts in a range of possible consideration amounts. Under the most likely amount method, an entity considers the single most likely amount in a range of possible consideration amounts. Whichever method is used, it should be consistently applied throughout the life of the contract; however, it is not necessary for the Company to use the same approach for all contracts. The Company expects to use the most likely amount method for development and regulatory milestone payments. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis. The Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability or achievement of each such milestone and any related constraint, and if necessary, adjusts its estimates of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.

Commercial milestones and royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and in which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue when the related sales occur. To date, the Company has not recognized any royalty revenue resulting from its collaboration arrangements.

Up-front payments and fees are recorded as deferred revenue upon receipt or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional.

Upon adoption of ASC 606 under the modified retrospective transition method, the Company recognized the cumulative effect of initially applying the new revenue standard of $47.3 million as an adjustment to the opening balance of accumulated deficit and an increase in deferred revenue. The comparative information has not been restated and continues to be reported under the accounting standards in effect for those periods. Before the adoption of ASC 606, the Company recognized upfront fees straight-line under ASC 605 over the estimated performance period and recognized milestones when earned under the milestone method of accounting. See “Note 2. Summary of Significant Accounting Policies – Revenue Recognition” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the SEC on March 12, 2018 for a detailed discussion.

The impact of adoption on the Company’s consolidated statement of operations and balance sheet was as follows (in thousands):

 

     For the Three Months Ended June 30, 2018  
     As
Reported
     Balances Without
Adoption of ASC606
     Effect of
Change
 

Statement of Operations

        

Collaboration and license revenue

   $ 15,022      $ 14,758      $ 264  

Loss from operations

     (7,485      (7,749      264  

Net loss

     (6,874      (7,138      264  
     For the Six Months Ended June 30, 2018  
     As
Reported
     Balances Without
Adoption of ASC606
     Effect of
Change
 

Statement of Operations

        

Collaboration and license revenue

   $ 24,568      $ 19,122      $ 5,446  

Loss from operations

     (17,341      (22,787      5,446  

Net loss

     (16,291      (21,737      5,446  

 

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     June 30, 2018  
     As
Reported
     Balances Without
Adoption of ASC606
     Effect of
Change
 

Balance Sheet

        

Liabilities:

        

Deferred revenue

   $ 56,668      $ 20,349      $ 36,319  

Noncurrent deferred revenue

     93,885        88,319        5,566  

Stockholders’ equity:

        

Accumulated deficit

     (352,822      (310,937      (41,885

Recent Accounting Pronouncements

In June 2018, the Financial Accounting Standard Board issued Accounting Standards Update No. 2018-07, Compensation – Stock Compensation (Topic 718). The new standard simplifies the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees, with certain exceptions. The new standard will be effective for the Company on January 1, 2019. The Company is currently evaluating the impact of the adoption of this standard on its financial statements and does not expect the adoption of this accounting guidance to have a material impact on the consolidated financial statements.

On December 22, 2017, the Tax Cuts and Jobs Act (“the Act”) was enacted into law. Accounting Standards Codification (ASC) 740, Income Taxes, requires companies to recognize the effect of the tax law changes in the period of enactment. Shortly after the enactment of the Act, the SEC staff issued Staff Accounting Bulletin No. 118 (SAB 118) to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Act. The Company has adjusted its deferred tax assets and liabilities based on the reduction of the U.S. federal corporate tax rate from 34% to 21% and assessed the realizability of its deferred tax assets based on its current understanding of the provisions of the new law. The Company considers its accounting for the impacts of the new law to be provisional and the Company will continue to assess the impact of the recently enacted tax law (and expected further guidance from federal and state tax authorities as well as further guidance for the associated income tax accounting) on its business and consolidated financial statements for the remainder of 2018. No adjustments were made to the provisional estimate during the three and six months ended June 30, 2018.

In February 2016, the Financial Accounting Standard Board issued Accounting Standards Update No. 2016-12, Leases (Topic 842). The new standard requires that all lessees recognize the assets and liabilities that arise from leases on the balance sheet and disclose qualitative and quantitative information about their leasing arrangements. The new standard will be effective for the Company on January 1, 2019. The Company is currently evaluating the impact of the adoption of this standard on its financial statements. However, the Company expects the adoption of this accounting guidance to result in an increase in lease assets and a corresponding increase in lease liabilities on its balance sheets.

The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the consolidated financial statements as a result of future adoption.

 

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3.

Cash Equivalents and Investments

The amortized cost and fair value of cash equivalents and investments at June 30, 2018 and December 31, 2017 were as follows (in thousands):

 

     June 30, 2018  
     Amortized      Gross Unrealized      Fair  
     Cost      Gains      Losses      Value  

Money market fund

   $ 36,883      $ —        $ —        $ 36,883  

U.S. treasury securities

     22,962        —          (26      22,936  

Commercial paper

     61,987        —          —          61,987  

Corporate debt securities

     67,263        —          (211      67,052  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total available-for-sale securities

   $ 189,095      $ —        $ (237    $ 188,858  
  

 

 

    

 

 

    

 

 

    

 

 

 

Classified as:

           

Cash equivalents

            $ 55,804  

Short-term investments

              113,289  

Long-term investments

              19,765  
           

 

 

 

Total available-for-sale securities

            $ 188,858  
           

 

 

 

 

     December 31, 2017  
     Amortized      Gross Unrealized      Fair  
     Cost      Gains      Losses      Value  

Money market fund

   $ 29,848      $ —        $ —        $ 29,848  

U.S. treasury securities

     29,005        —          (52      28,953  

Commercial paper

     46,184        —          —          46,184  

Corporate debt securities

     27,095        —          (67      27,028  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total available-for-sale securities

   $ 132,132      $ —        $ (119    $ 132,013  
  

 

 

    

 

 

    

 

 

    

 

 

 

Classified as:

           

Cash equivalents

            $ 36,813  

Short-term investments

              87,271  

Long-term investments

              7,929  
           

 

 

 

Total available-for-sale securities

            $ 132,013  
           

 

 

 

Cash equivalents in the tables above exclude cash of $12.9 million and $3.2 million as of June 30, 2018 and December 31, 2017, respectively. All available-for-sale securities held as of June 30, 2018 had contractual maturities of less than two years. There have been no significant realized gains or losses on available-for-sale securities for the periods presented. No significant available-for-sale securities held as of June 30, 2018 have been in a continuous unrealized loss position for more than 12 months. As of June 30, 2018, unrealized losses on available-for-sale investments are not attributed to credit risk and are considered to be temporary. The Company believes that it is more likely than not that investments in an unrealized loss position will be held until maturity or the recovery of the cost basis of the investment. The Company believes it has no other-than-temporary impairments on its securities because it does not intend to sell these securities and it believes it is not more likely than not that it will be required to sell these securities before the recovery of their amortized cost basis. To date, the Company has not recorded any impairment charges on marketable securities related to other-than-temporary declines in market value.

 

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4.

Fair Value Measurements

The Company determines the fair value of financial assets and liabilities using three levels of inputs as follows:

Level 1—Inputs which include quoted prices in active markets for identical assets and liabilities.

Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

Recurring Fair Value Measurements

The Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows (in thousands) as of June 30, 2018 and December 31, 2017:

 

     June 30, 2018  
Description    Level 1      Level 2      Level 3      Total  

Money market fund

   $ 36,883      $ —        $ —        $ 36,883  

U.S. treasury securities

     —          22,936        —          22,936  

Commercial paper

     —          61,987        —          61,987  

Corporate debt securities

     —          67,052        —          67,052  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets

   $ 36,883      $ 151,975      $ —        $ 188,858  
  

 

 

    

 

 

    

 

 

    

 

 

 
     December 31, 2017  
Description    Level 1      Level 2      Level 3      Total  

Money market fund

   $ 29,848      $ —        $ —        $ 29,848  

U.S. treasury securities

     —          28,953        —          28,953  

Commercial paper

     —          46,184        —          46,184  

Corporate debt securities

     —          27,028        —          27,028  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total assets

   $ 29,848      $ 102,165      $ —        $ 132,013  
  

 

 

    

 

 

    

 

 

    

 

 

 

During the six months ended June 30, 2018, there were no transfers between Level 1 and Level 2 financial assets. When the Company uses observable market prices for identical securities that are traded in less active markets, the Company classifies its marketable debt instruments as Level 2. When observable market prices for identical securities are not available, the Company prices its marketable debt instruments using non-binding market consensus prices that are corroborated with observable market data; quoted market prices for similar instruments; or pricing models, such as a discounted cash flow model, with all significant inputs derived from or corroborated with observable market data. Non-binding market consensus prices are based on the proprietary valuation models of pricing providers or brokers. These valuation models incorporate a number of inputs, including non-binding and binding broker quotes; observable market prices for identical or similar securities; and the internal assumptions of pricing providers or brokers that use observable market inputs and, to a lesser degree, unobservable market inputs. The Company corroborates non-binding market consensus prices with observable market data using statistical models when observable market data exists. The discounted cash flow model uses observable market inputs, such as LIBOR-based yield curves, prime rate, currency spot and forward rates, and credit ratings.

 

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Other Fair Value Measurements

The carrying amount and estimated fair value of financial instruments not recorded at fair value at June 30, 2018 and December 31, 2017 were as follows (in thousands):

 

     June 30, 2018      December 31, 2017  
     Carrying
Amount
     Estimated
Fair Value
     Carrying
Amount
     Estimated
Fair Value
 

Long-term debt, net (1)

   $ 14,700      $ 14,709      $ 4,676      $ 4,812  

 

  (1)

Carrying amounts of long-term debt were net of unamortized debt discounts of $300,000 and $324,000 as of June 30, 2018 and December 31, 2017, respectively.

The fair value of the Company’s long-term debt is estimated using the net present value of future debt payments, discounted at an interest rate that is consistent with market interest rates, which is a Level 2 input.

 

5.

Accrued Liabilities

Accrued liabilities consist of the following (in thousands):

 

     June 30,      December 31,  
     2018      2017  

Research and development related

   $ 8,026      $ 4,962  

Compensation related

     1,909        2,345  

Consulting and professional services

     822        1,012  

Other

     261        256  
  

 

 

    

 

 

 
   $ 11,018      $ 8,575  
  

 

 

    

 

 

 

 

6.

Long-term Debt

On December 28, 2017 (the Closing Date), the Company entered into a Loan and Security Agreement with Hercules Capital, Inc. (Hercules) pursuant to which term loans in an aggregate principal amount of up to $50.0 million (the Credit Facility) are available to the Company in three tranches, subject to certain terms and conditions. Under the first tranche, the Company may borrow through June 2018 an amount up to $15.0 million, of which $5.0 million was advanced to the Company on the Closing Date and the remaining $10.0 million was advanced in June 2018. Upon satisfaction of certain terms and conditions, the second tranche is available under the Credit Facility, which would allow the Company to borrow up to an additional $10.0 million through December 15, 2018. The third tranche, which would allow the Company to borrow up to an additional $25.0 million, would be available upon Hercules’ approval through June 15, 2019.

Advances under the Credit Facility will bear an interest rate equal to the greater of (i) 8.05% plus the prime rate as reported from time to time in The Wall Street Journal minus 4.75%, and (ii) 8.05%. For advances under the first tranche, the Company will make interest-only payments through July 1, 2020, and will then repay the principal balance and interest on the advances in equal monthly installments after the interest-only period and continuing through December 1, 2021. For advances made under the second and third tranches, the Company will make interest-only payments for the first 30 months, and will then repay the principal balance and interest on the advances in equal monthly installments after the interest-only period with each advance repaid 48 months after it is drawn.

The Company may prepay advances under the Credit Facility, in whole or in part, at any time, subject to a prepayment charge equal to: (a) 2.0% of amounts so prepaid, if such prepayment occurs during the first year following the Closing Date; (b) 1.5% of the amount so prepaid, if such prepayment occurs during the second year following the Closing Date; and (c) 1.0% of the amount so prepaid, if such prepayment occurs after the second year following the Closing Date. The Credit Facility is secured by substantially all of the Company’s assets, excluding intellectual property.

In addition, Hercules has the right to participate, in an amount up to $2.0 million, in any subsequent equity financing broadly marketed to multiple investors in an amount greater than $20.0 million. The Credit Facility also includes customary affirmative and negative covenants, including restrictions on the payment of dividends, and events of default, the occurrence and continuance of which provide Hercules with the right to demand immediate repayment of all principal and unpaid interest under the Credit Facility, and to exercise remedies against the Company and the collateral securing the Credit Facility. The Company was in compliance with all loan covenants for all periods presented.

 

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The Company will pay an end-of-term charge for each tranche which will occur on the earliest of (i) the applicable tranche maturity date; (ii) the date that the Company prepays all of the outstanding principal under each tranche in full, or (iii) the date the loan payments are accelerated due to an event of default. For the first tranche, the end of term charge is the greater of (a) 6.25% of the aggregate amount of the advances and (b) 6.25% of the aggregate amount of the advances plus 50% of the unfunded portion of the first tranche. In the case of the second and third tranches, the charge is 6.25% of the aggregate amount of the advances applicable to such tranche.

In addition, the Company pays a commitment charge of 1% of the advances made under the Credit Facility, with a minimum charge of $162,500 paid on the Closing Date. Also, the Company reimbursed Hercules for costs incurred related to the Credit Facility. These charges were recorded as discounts to the carrying value of the loan and are amortized over the term of the loan using the effective interest method.

As of June 30, 2018, the Company had outstanding borrowings under the Credit Facility of $14.7 million, net of discounts of $0.3 million. Future minimum principal payments, which exclude the end of term charge, related to the Credit Facility as of June 30, 2018 are as follows (in thousands):

 

     Amounts  

Year ending December 31:

  

Remaining of fiscal year 2018

   $ —    

2019

     —    

2020

     4,785  

2021

     10,215  
  

 

 

 

Total minimum payments

     15,000  

Less: amount representing debt discount

     (300
  

 

 

 

Present value of remaining debt payments

     14,700  

Less: current portion

     —    
  

 

 

 

Noncurrent portion

   $ 14,700  
  

 

 

 

 

7.

Related-Party Transactions

Bio-Techne

Bio-Techne Corporation, formerly Techne Corporation, is one of the Company’s principal stockholders. In connection with the Company’s initial public offering (IPO) in February 2012, Bio-Techne received a warrant with a ten-year term to purchase 150,000 shares of the Company’s common stock at an exercise price per share equal to $20.00 per share, or 200% of the IPO price of its common stock, which was outstanding as of June 30, 2018. The Company had an accounts payable balance due to Bio-Techne for the purchases of research materials of approximately $1,100 and $6,000 as of June 30, 2018 and December 31, 2017, respectively.

 

8.

Collaboration and License Agreements

Avacopan Agreements

In May 2016, the Company entered into an exclusive collaboration and license agreement with Vifor pursuant to which the Company granted Vifor exclusive rights to commercialize avacopan in Europe and certain other markets (the Avacopan Agreement). Avacopan is the Company’s lead drug candidate for the treatment of patients with anti-neutrophil cytoplasmic auto-antibody associated vasculitis (AAV) and other rare diseases. The Avacopan Agreement also provided Vifor with an exclusive option to negotiate during 2016 a worldwide license agreement for one of the Company’s other drug candidates, CCX140, an orally-administered inhibitor of the chemokine receptor known as CCR2. In connection with the Avacopan Agreement, the Company received a non-refundable upfront payment of $85.0 million, comprising $60.0 million in cash and $25.0 million in the form of an equity investment to purchase 3,333,333 shares of the Company’s common stock at a price of $7.50 per share.

In February 2017, Vifor and the Company expanded the Vifor territories under the Avacopan Agreement to include all markets outside the United States and China (the Avacopan Amendment). In connection with this February 2017 arrangement, the Company received a $20.0 million upfront payment for the expanded rights. In June 2018, Vifor and the Company further expanded the Vifor territories under the Avacopan Agreement to provide Vifor with exclusive commercialization rights in China (the Avacopan Letter Agreement). The Company retains control of ongoing and future development of avacopan (other than country-specific development in the licensed territories) and all commercialization rights to avacopan in the United States. In consideration for this June 2018 arrangement, the Company received a $5.0 million payment for the expanded rights.

Upon achievement of certain regulatory and commercial milestones with avacopan, the Company will receive additional payments of up to $460.0 million under the Avacopan Agreement. In addition, the Company will receive royalties, with rates ranging from the low teens to the mid-twenties, on future potential net sales of avacopan by Vifor in the licensed territories. In December 2017, the Company achieved a $50.0 million regulatory milestone when the European Medicines Agency (EMA) validated the Company’s Conditional marketing authorisation (CMA) application for avacopan for the treatment of AAV.

 

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The Company identified the following material promises under the Avacopan Agreement, the Avacopan Amendment, and the Avacopan Letter Amendment: (1) the license related to avacopan; (2) the development and regulatory services for the submission of the marketing authorisation application (MAA); and (3) an exclusive option to negotiate a worldwide license agreement for CCX140, which expired in 2016. The Company considered that the license has standalone functionality and is capable of being distinct. However, the Company determined that the license is not distinct from the development and regulatory services within the context of the agreement because Vifor is dependent on the Company to execute the development and regulatory activities in order for Vifor to benefit from the license. As such, the license is combined with the development and regulatory services into a single performance obligation. The exclusive option related to CCX140 is a separate performance obligation and the Company determined that its transaction price is not material. As such, the transaction price under this arrangement will be allocated to the license and the development and regulatory services.

As of June 30, 2018, the transaction price of $153.0 million consists of the following:

 

   

$78.0 million upfront payment under the May 2016 Avacopan Agreement. Of the total $85.0 million upfront payment received under the May 2016 Avacopan Agreement, $7.0 million was allocated to the issuance of 3,333,333 shares of the Company’s common stock valued at $2.10 per share, the closing stock price on the effective date of the agreement, May 9, 2016. The remaining $78.0 million was allocated to the transaction price under this arrangement;

 

   

$20.0 million upfront payment under the February 2017 Avacopan Amendment;

 

   

$50.0 million regulatory milestone payment achieved upon the validation of the Company’s CMA application by the EMA, for avacopan for the treatment of AAV in December 2017; and

 

   

$5.0 million payment under the Avacopan Letter Agreement.

The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

The Company determined that the combined performance obligation will be performed over the duration of the contract, which began on the effective date of May 9, 2016 and ends upon completion of development and regulatory services. The Company will use a cost-based input method to measure proportional performance and to calculate the corresponding amount of revenue to recognize. The Company believes this is the best measure of progress because other measures do not reflect how the Company transfers its performance obligation to Vifor. In applying the cost-based input method of revenue recognition, the Company measures actual costs incurred relative to budgeted costs to fulfill the combined performance obligation. These costs consist primarily of third-party contract costs. Revenue will be recognized based on actual costs incurred as a percentage of total budgeted costs as the Company completes its performance obligations.

For the three and six months ended June 30, 2018, the Company recognized $12.9 million and $21.1 million of collaboration and license revenue under the Avacopan Agreement, the Avacopan Amendment, and the Avacopan Letter Agreement, respectively.

Prior to the adoption of ASC 606 on January 1, 2018, the Company accounted for its performance obligations under the Avacopan Agreement and Avacopan Amendment as one combined unit of accounting with the upfront fees being recognized over the estimated period of performance. See “Note 10. Collaboration and License Agreements – Avacopan Agreements” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the SEC on March 12, 2018, for further discussion. For the three and six months ended June 30, 2017, the Company recognized $6.2 million and $11.9 million of collaboration and license revenue under the Avacopan Agreement and Avacopan Amendment under ASC 605, respectively.

 

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CCX140 Agreement

In December 2016, the Company entered into a second collaboration and license agreement with Vifor pursuant to which the Company granted Vifor exclusive rights to commercialize CCX140 (the CCX140 Agreement) in markets outside the United States and China. CCX140 is an orally-administered inhibitor of the chemokine receptor known as CCR2. The Company retains marketing rights in the United States and China, while Vifor has commercialization rights in the rest of the world. Pursuant to the CCX140 Agreement, the Company is responsible for the clinical development of CCX140 in rare renal diseases and is reimbursed for Vifor’s equal share of such development cost. Vifor retains an option to solely develop and commercialize CCX140 in more prevalent forms of chronic kidney disease (CKD). Should Vifor later exercise the CKD option, the Company would receive co-promotion rights for CKD in the United States. Under the terms of the CCX140 Agreement, the Company received a non-refundable upfront payment of $50.0 million in 2017.

In June 2018, the Company and Vifor entered into a letter agreement to expand Vifor’s rights to include the right to exclusively commercialize CCX140 in China (the CCX140 Letter Agreement). In connection with the CCX140 Letter Agreement, the Company received a payment of $5.0 million. The Company and Vifor also entered into an amendment to the CCX140 Agreement (the CCX140 Amendment) to clarify the timing of certain payments with respect to development funding of the CCX140 program by Vifor, and the Company received a non-refundable payment of $11.5 million. The Company retains control of ongoing and future development of CCX140 (other than country-specific development in the licensed territories), and all commercialization rights to CCX140 in the United States.

Upon achievement of certain regulatory and commercial milestones with CCX140, the Company will receive additional payments of up to $625.0 million under the CCX140 Agreement. In addition, the Company will receive tiered royalties, with rates ranging from ten to the mid-twenties, on net sales of CCX140 in the licensed territories.

The Company identified the following material promises under the CCX140 Agreement, the CCX140 Amendment, and CCX140 Letter Agreement: (1) the license related to CCX140; and (2) the development and regulatory services for the submission of the MAA. The Company considered that the license has standalone functionality and is capable of being distinct. However, the Company determined that the license is not distinct from the development and regulatory services within the context of the agreement because Vifor is dependent on the Company to execute the development and regulatory activities in order for Vifor to benefit from the license. As such, the license is combined with the development and regulatory services into a single performance obligation.

As of June 30, 2018, the transaction price of $112.9 million consists of the following:

 

   

$50.0 million upfront payment under the CCX140 Agreement;

 

   

$57.9 million of CCX140 development funding by Vifor; and

 

   

$5.0 million upfront payment under the CCX140 Letter Agreement.

The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

The Company determined that the combined performance obligation will be performed over the duration of the contract, which began on the effective date of December 22, 2016 and ends upon completion of development and regulatory services. The Company will use a cost-based input method to measure proportional performance and to calculate the corresponding amount of revenue to recognize. The Company believes this is the best measure of progress because other measures do not reflect how the Company transfers its performance obligation to Vifor. In applying the cost-based input method of revenue recognition, the Company measures actual costs incurred relative to budgeted costs to fulfill the combined performance obligation. These costs consist primarily of third-party contract costs. Revenue will be recognized based on actual costs incurred as a percentage of total budgeted costs as the Company completes its performance obligations. For the three and six months ended June 30, 2018, the Company recognized $2.0 million and $3.3 million of collaboration and license revenue under the CCX140 Agreement, the CCX140 Amendment, and the CCX140 Letter Agreement, respectively.

Prior to the adoption of ASC 606 on January 2, 2018, the Company accounted for its performance obligations under the CCX140 Agreement as one combined unit of accounting with the upfront fee of $50.0 million being recognized over the estimated period of performance. See “Note 10. Collaboration and License Agreements – CCX140 Agreement” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the SEC on March 12, 2018, for further discussion. For the three and six months ended June 30, 2017, the Company recognized $2.7 million and $5.2 million of collaboration and license revenue under the CCX140 Agreement under ASC 605, respectively.

 

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The following table presents the contract assets and liabilities for all of the Company’s revenue contracts as of the following dates (in thousands):

 

     June 30,      December 31,  
     2018      2017  

Contract asset:

     

Accounts receivable

   $ 164      $ 51,090  

Contract liability:

     

Deferred revenue (1)

     (150,553      (95,159

 

  (1)

Upon adoption of ASC 606 under the modified retrospective transition method, the Company recognized the cumulative effect of initially applying the new revenue standard of $47.3 million as an adjustment to the opening balance of accumulated deficit and an increase in deferred revenue. See “Note 2. Summary of Significant Accounting Policies – Revenue Recognition” for a detailed discussion.

During the three and six months ended June 30, 2018, the Company recognized the following revenue as a result of changes in the contract asset and the contract liability balances (in thousands):

 

     Three Months Ended
June 30, 2018
     Six Months Ended
June 30, 2018
 

Revenue recognized in the period from:

     

Amount included in contract liability at the beginning of the period

   $ 14,019      $ 22,957  

Performance obligations satisfied (or partially satisfied) in previous periods

   $ 784      $ (1,157

 

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9.

Equity Incentive Plans

Stock Options

During the six months ended June 30, 2018, the Company had the following activities under its equity incentive plans:

 

     Available for
Grant
    Shares     Weighted Average
Exercise Price
     Weighted
Average
Remaining
Contractual
Term
(in years)
     Aggregate
Intrinsic Value
 

Balance at December 31, 2017

     2,028,880       10,203,571     $ 7.68        

Shares authorized

     1,940,000       —            

Granted (1)

     (2,232,772     2,003,912       9.69        

Exercised (2)

     79,585       (1,328,002     6.29        

Forfeited and expired

     59,851       (59,851     6.77        
  

 

 

   

 

 

         

Outstanding at June 30, 2018

     1,875,544       10,819,630     $ 8.23        6.73      $ 55,342,765  
  

 

 

   

 

 

         

Vested and expected to vest, net of estimated forfeiture at June 30, 2018

       10,500,905     $ 8.23        6.66      $ 53,750,543  
    

 

 

         

Exercisable at June 30, 2018

       6,631,144     $ 8.52        5.32      $ 32,691,716  
    

 

 

         

 

(1)

The difference between shares granted in the number of shares available for grant and outstanding options represents the RSUs and RSAs granted for the period.

(2)

Shares presented as available for grant represents shares repurchased for tax withholding upon vesting of RSUs.

Restricted Stock

During the six months ended June 30, 2018, the activity for restricted stock is summarized as follows:

 

     Shares      Weighted Average
Grant-Date
Fair Value
 

Balance at December 31, 2017

     508,444      $ 5.79  

Granted

     228,860        11.32  

Vested

     (219,137      5.70  

Canceled

     —          —    
  

 

 

    

Unvested at June 30, 2018

     518,167      $ 8.27  
  

 

 

    

Stock-based Compensation

Total stock-based compensation expense was $2.7 million and $5.2 million during the three and six months ended June 30, 2018, respectively, and $2.5 million and $4.9 million during the same periods ended June 30, 2017, respectively. As of June 30, 2018, $17.0 million, $3.0 million, and $101,000 of total unrecognized compensation expenses associated with outstanding employee stock options, unvested restricted stock, and the ESPP, net of estimated forfeitures, were expected to be recognized over a weighted-average period of 2.70, 1.57, and 0.38 years, respectively.

 

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Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis should be read in conjunction with our financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the financial statements and accompanying notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the Securities and Exchange Commission, or SEC, on March 12, 2018.

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “aim,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential” or “continue” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

 

   

the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs;

 

   

our ability to advance drug candidates into, and successfully complete, clinical trials;

 

   

the commercialization of our drug candidates;

 

   

the implementation of our business model, strategic plans for our business, drug candidates and technology;

 

   

the scope of protection we are able to establish and maintain for intellectual property rights covering our drug candidates and technology;

 

   

estimates of our expenses, future revenues, capital requirements and our needs for additional financing;

 

   

the timing or likelihood of regulatory filings and approvals;

 

   

our ability to maintain and establish collaborations or obtain additional government grant funding;

 

   

our financial performance; and

 

   

developments relating to our competitors and our industry.

These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those included in “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the SEC on March 12, 2018.

Any forward-looking statement in this Quarterly Report on Form 10-Q reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, industry and future growth. Given these uncertainties, you should not place undue reliance on these forward-looking statements. For all forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

ChemoCentryx®, the ChemoCentryx logo, Traficet™ and Traficet-EN™ are our trademarks in the United States, the European Community, Australia and Japan. EnabaLink® and RAM® are our trademarks in the United States. Each of the other trademarks, trade names or service marks appearing in this Quarterly Report on Form 10-Q belongs to its respective holder.

Unless the context requires otherwise, in this Quarterly Report on Form 10-Q the terms “ChemoCentryx,” “we,” “us” and “our” refer to ChemoCentryx, Inc., a Delaware corporation, and our subsidiary taken as a whole unless otherwise noted.

 

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Overview

ChemoCentryx is a biopharmaceutical company developing new medications targeted at inflammatory disorders, autoimmune diseases and cancer. Each of our drug candidates selectively blocks a specific chemoattractant receptor, leaving the rest of the immune system intact. Our drug candidates are small molecules, which are orally administered, offering significant quality of life benefits, since patients swallow a capsule or pill instead of having to visit a clinic for an infusion or undergo an injection.

In 2016, we executed on our strategy to form an alliance with a partner that could provide upfront commitments and milestones to support the clinical development of our leading two drug candidates, avacopan and CCX140, to registration and pay us royalties upon sales in international markets, while we develop our own commercial infrastructure to sell directly in the United States.

To help communicate the breadth of our drug discovery platform, we have segmented our pipeline into early stage and late stage drug candidates.

Late Stage Drug Candidates

We have chosen to focus initially on orphan indications, where drug candidates tend to enjoy a faster path to market and better reimbursement. Our leading drug candidates address areas of clear unmet need, where the current standard of care, or SOC, is insufficient to halt progression of the disease and/or where today’s treatment options come with serious side effects, such as those which accompany the prolonged use of steroids:

Avacopan (CCX168) – Complement Inhibition in Orphan Diseases

Avacopan (formerly CCX168) is an orally-administered complement inhibitor targeting the C5a receptor, or C5aR, and is being developed for orphan diseases, including (i) anti-neutrophil cytoplasmic auto-antibody associated vasculitis, or AAV, a devastating autoimmune disease that damages blood vessels and can lead to kidney failure; (ii) complement 3 glomerulopathy, or C3G, a debilitating disease that can lead to kidney failure; and (iii) hidradenitis suppurativa, or HS.

Avacopan has been granted orphan drug designation by the U.S. Food and Drug Administration, or FDA, for the treatment of AAV and C3G and by the European Medicines Agency, or EMA, for the treatment of C3G and microscopic polyangiitis and granulomatosis with polyangiitis, both forms of AAV. Additionally, avacopan has been granted PRIority MEdicines, or PRIME, designation from the EMA, to expedite its clinical development, and to potentially accelerate its marketing authorization.

Following completion of two Phase II clinical trials in patients with AAV, in which avacopan was well-tolerated and provided effective steroid-free control of the disease, we launched the Phase III ADVOCATE trial in December 2016. The FDA and the EMA concurred with the design of the study. ADVOCATE is a randomized, double-blind two-arm study which enrolled 316 patients at approximately 200 sites in the United States, Canada, Europe, Australia and New Zealand. Patient enrollment of the Phase III ADVOCATE trial was completed in July 2018 and we expect to report topline data from this study in the fourth quarter of 2019. We recently launched a registration-supporting clinical trial to study avacopan for the treatment of patients with C3G and plan to initiate clinical studies for the treatment of patients with HS in 2018.

CCX140 – Chronic and Orphan Kidney Diseases

CCX140, an orally-administered inhibitor of the chemokine receptor known as CCR2, has been in development for diabetic nephropathy, or DN, a form of chronic kidney disease, or CKD, and is now being developed for focal segmental glomerulosclerosis, or FSGS, a rare renal disease characterized by progressive proteinuria, excess protein in the urine, and impaired renal function.

A global Phase II clinical trial of CCX140 in patients with DN met its primary endpoint by demonstrating that CCX140 given orally once daily added to a SOC renin-angiotensin-aldosterone system inhibitor treatment resulted in a statistically significant reduction in proteinuria, beyond that achieved with SOC alone, with the most pronounced effect shown in the highest proteinuric patients. Based on the safety and efficacy data related to reduction in proteinuria observed in the Phase II trial in DN, we launched our clinical development program of CCX140 for the treatment of patients with primary FSGS, for which there are currently no FDA-approved treatments.

 

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Kidney Health Alliance with Vifor

In May 2016, we announced a partnership, which we refer to as the Avacopan Agreement, with Vifor (International) Ltd., and/or its affiliates, or collectively, Vifor, a European-based world leader specializing in kidney disease. While under this agreement we retained all rights to the United States and China, we granted Vifor exclusive commercialization rights to avacopan in Europe and certain other international markets. In December 2016, we entered into an additional agreement with Vifor, which we refer to as the CCX140 Agreement, relating to CCX140, our other late stage drug candidate. Under this second agreement, we again retained all rights to the United States and China and we granted Vifor exclusive worldwide commercialization rights outside of the United States and China. In February 2017, we announced a further agreement with Vifor that harmonized the geographic commercialization rights underlying the agreements for both drug candidates, which we refer to as the Avacopan Amendment. In June 2018, we entered into additional agreements with Vifor to further expand Vifor’s exclusive commercialization rights to include China under the Avacopan Agreement and the CCX140 Agreement.

We have secured $215 million in upfront cash payments and milestones pursuant to our agreements with Vifor and are eligible for additional substantial milestone payments. Through our alliance, we maintain the commercialization rights to avacopan and CCX140 in the United States, and also retain control of the clinical development programs for orphan renal disease. Vifor gained the exclusive commercialization rights for all other international markets, and is obligated to pay us tiered royalties, with rates ranging from ten to the mid-twenties, on potential net sales.

At a future time defined in the CCX140 Agreement, Vifor has an option to solely develop and commercialize CCX140 in more prevalent forms of CKD. Should Vifor later exercise the CKD option, we would receive co-promotion rights for CKD in the United States, and we estimate that the clinical development and registration process for CKD would end at approximately the same time as Orphan Drug exclusivity.

Early Stage Drug Candidates

While the science has led us to focus initially on kidney disease, our target specific and selective approach designed to stop the spread of inflammatory disease-inducing cells shows promise in other disease areas. Over time we plan to bring forward drug candidates to treat other inflammatory and autoimmune disorders, as well as cancer, where our drug candidate CCX872 has shown promise in a Phase Ib trial for advanced pancreatic cancer. We expect that our ability to do so will grow as we increase our scale and start to earn revenues and royalties from the commercialization of our late stage kidney disease franchise.

Since commencing our operations in 1997, our efforts have focused on research, development and the advancement of our drug candidates into and through clinical trials. As a result, we have incurred significant losses. We have funded our operations primarily through the sale of convertible preferred and common stock, contract revenue under our collaborations, government contracts and grants and borrowings under equipment financing arrangements.

As of June 30, 2018, we had an accumulated deficit of $352.8 million. We expect to continue to incur net losses as we develop our drug candidates, expand clinical trials for our drug candidates currently in clinical development, expand our research and development activities, expand our systems and facilities, seek regulatory approvals and engage in commercialization preparation activities in anticipation of FDA approval of our drug candidates. In addition, if a product is approved for commercialization, we will need to expand our organization. Significant capital is required to launch a product and many expenses are incurred before revenues are received. We are unable to predict the extent of any future losses or when we will become profitable, if at all.

Recent Developments and Corporate Highlights

In June 2018, we expanded our commercial alliance with Vifor to provide Vifor with exclusive commercialization rights in China for avacopan and CCX140, in exchange for upfront cash payments totaling $21.5 million. We will retain all rights to commercialize CCX140 and avacopan in the United States and Vifor will have exclusive rights to commercialize CCX140 and avacopan in all other countries. We retain control of all ongoing and future development of CCX140 and avacopan, other than country-specific development in the Vifor territories.

Critical Accounting Policies and Significant Judgments and Estimates

There have been no material changes in our critical accounting policies during the six months ended June 30, 2018, as compared to those disclosed in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the SEC on March 12, 2018, other than the following:

 

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Effective January 1, 2018, we adopted Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers, or ASC 606, using the modified retrospective transition method. This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 606, we recognize revenue when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract and determine those that are performance obligations and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

We enter into corporate collaborations under which we may obtain upfront license fees, research and development funding and development and regulatory and commercial milestone payments and royalty payments. Our performance obligations under these arrangements may include licenses of intellectual property, distribution rights, research and development services, delivery of manufactured product, and/or participation on joint steering committees.

Licenses of intellectual property: If the license to our intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, we recognize revenue from upfront license fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, we utilize judgement to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring proportional performance for purposes of recognizing revenue from non-refundable, up-front fees. We evaluate the measure of proportional performance each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.

Milestone payments: At the inception of each arrangement that includes development, regulatory or commercial milestone payments, we evaluate whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price. ASC 606 suggests two alternatives to use when estimating the amount of variable consideration: the expected value method and the most likely amount method. Under the expected value method, an entity considers the sum of probability-weighted amounts in a range of possible consideration amounts. Under the most likely amount method, an entity considers the single most likely amount in a range of possible consideration amounts. Whichever method is used, it should be consistently applied throughout the life of the contract; however, it is not necessary for us to use the same approach for all contracts. We expect to use the most likely amount method for development and regulatory milestone payments. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within our or the licensee’s control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis. We recognize revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, we re-evaluate the probability or achievement of each such milestone and any related constraint, and if necessary, adjust our estimates of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.

Commercial milestones and royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and in which the license is deemed to be the predominant item to which the royalties relate, we recognize revenue when the related sales occur. To date, we have not recognized any royalty revenue resulting from our collaboration arrangements.

Up-front payments and fees are recorded as deferred revenue upon receipt or when due, and may require deferral of revenue recognition to a future period until we perform our obligations under these arrangements. Amounts payable to us are recorded as accounts receivable when our right to consideration is unconditional.

 

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Results of Operations

Revenue

We have not generated any revenue from product sales. For the periods presented, our revenue was derived from collaboration and license revenue related to the Avacopan Agreement and CCX140 Agreement, in each case, as amended, and the related letter agreements. Total revenues for the periods as compared to the same periods in the prior year were as follows (in thousands):

 

     Three Months Ended
June 30
     Six Months Ended
June 30
 
     2018      2017      2018      2017  

Collaboration and license revenue

   $ 15,022      $ 8,937      $ 24,568      $ 17,167  

Dollar increase

   $ 6,085         $ 7,401     

Percentage increase

     68%           43%     

On January 1, 2018, we adopted ASC 606 under the modified retrospective transition method and recognized the cumulative effect of initially applying the new revenue standard of $47.3 million as an adjustment to the opening balance of accumulated deficit and an increase in deferred revenue. Revenue recognized prior to January 1, 2018 has not been restated and continues to be reported under the accounting standards in effect for those periods.

For the three and six months ended June 30, 2018, we use a cost-based input method to measure proportional performance and to calculate the corresponding amount of revenue to recognize. In applying the cost-based input method of revenue recognition, we measure actual costs incurred relative to budgeted costs to fulfill the combined performance obligation. These costs consist primarily of third-party contract costs. Revenue is recognized based on actual costs incurred as a percentage of total budgeted costs as we complete our performance obligations.

Before the adoption of ASC 606, we recognized upfront fees straight-line under ASC 605 over the estimated performance period and recognized milestone when earned under the milestone method of accounting. For the three and six months ended June 30, 2017, revenue recognized represents amortization of the upfront license fee commitments from Vifor pursuant to the Avacopan Agreement and CCX140 Agreement, in each case, as amended.

Research and development expenses

Research and development expenses represent costs incurred to conduct basic research, the discovery and development of novel small molecule therapeutics, development of our suite of proprietary drug discovery technologies, preclinical studies and clinical trials of our drug candidates. We recognize all research and development expenses as they are incurred. These expenses consist primarily of salaries and related benefits, including stock-based compensation, third-party contract costs relating to research, formulation, manufacturing, preclinical study and clinical trial activities, laboratory consumables, and allocated facility costs. Total research and development expenses for the three and six months ended June 30, 2018, as compared to the same periods in the prior year, were as follows (in thousands):

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2018      2017      2018      2017  

Research and development expenses

   $ 17,759      $ 14,329      $ 32,501      $ 24,299  

Dollar increase

   $ 3,430         $ 8,202     

Percentage increase

     24%           34%     

The increases in research and development expenses from 2017 to 2018 for the three and six month periods were primarily due to the initiation and patient enrollment of the avacopan Phase II clinical trial in patients with C3G and start-up expenses related to the CCX140 Phase II clinical trials in patients with FSGS. Continued patient enrollment of the avacopan Phase III ADVOCATE trial in patients with AAV also contributed to the increase in research and development expenses for the six-month period.

 

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The following table summarizes our research and development expenses (in thousands):

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2018      2017      2018      2017  

Phase I

   $ 789      $ 362      $ 1,079      $ 744  

Phase II

     4,891        2,320        8,018        3,372  

Phase III

     8,045        8,261        15,691        13,346  

Research and drug discovery

     4,034        3,386        7,713        6,837  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total R&D

   $ 17,759      $ 14,329      $ 32,501      $ 24,299  
  

 

 

    

 

 

    

 

 

    

 

 

 

We track development expenses that are directly attributable to our clinical development candidates by phase of clinical development. Such development expenses include third-party contract costs relating to formulation, manufacturing, preclinical studies and clinical trial activities. We allocate research and development salaries, benefits or indirect costs to our development candidates and we have included such costs in research and development expenses. All remaining research and development expenses are reflected in “Research and drug discovery” which represents early stage drug discovery programs. Such expenses include allocated employee salaries and related benefits, stock-based compensation, consulting and contracted services to supplement our in-house laboratory activities, laboratory consumables and allocated facility costs associated with these earlier stage programs.

At any given time, we typically have several active early stage research and drug discovery projects. Our internal resources, employees and infrastructure are not directly tied to any individual research or drug discovery project and are typically deployed across multiple projects. As such, we do not maintain information regarding these costs incurred for our early stage research and drug discovery programs on a project specific basis. We expect our research and development expenses to increase as we advance our development programs further and increase the number and size of our clinical trials. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming. We or our partners may never succeed in achieving marketing approval for any of our drug candidates. The probability of success for each drug candidate may be affected by numerous factors, including preclinical data, clinical data, competition, manufacturing capability and commercial viability. Our strategy includes entering into additional partnerships with third parties for the development and commercialization of some of our independent drug candidates.

The successful development of our drug candidates is highly uncertain and may not result in approved products. Completion dates and completion costs can vary significantly for each drug candidate and are difficult to predict for each product. Given the uncertainty associated with clinical trial enrollments and the risks inherent in the development process, we are unable to determine the duration and completion costs of the current or future clinical trials of our drug candidates or if, or to what extent, we will generate revenues from the commercialization and sale of any of our drug candidates. We anticipate we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to the scientific and clinical success of each drug candidate, as well as ongoing assessment as to each drug candidate’s commercial potential. We will need to raise additional capital or may seek additional strategic alliances in the future in order to complete the development and commercialization of our drug candidates, including avacopan, CCX140 and CCX872.

General and administrative expenses

Total general and administrative expenses for the three and six months ended June 30, 2018, as compared to the same periods in the prior year, were as follows (in thousands):

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2018      2017      2018      2017  

General and administrative expenses

   $ 4,748      $ 4,184      $ 9,408      $ 8,757  

Dollar increase

   $ 564         $ 651     

Percentage increase

     13%           7%     

General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation and travel expenses, in executive, finance, business and corporate development and other administrative functions. Other general and administrative expenses include allocated facility-related costs not otherwise included in research and development expenses, legal costs of pursuing patent protection of our intellectual property, and professional fees for auditing, tax, and legal services.

 

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The increases from 2017 to 2018 for the three and six month periods were primarily due to higher employee-related expenses, including those associated with our commercialization planning efforts, partially offset by a decrease in professional fees.

We anticipate that our general and administrative expenses will increase substantially in the future primarily because of (i) increased pre-commercial activities and personnel costs to support the potential launch of avacopan for the treatment of AAV in the United States and (ii) expenses related to costs of operating as a public company primarily preparing for future integrated audits.

Other income (expense), net

Other income (expense), net primarily consists of interest income earned on our marketable securities. Total other income (expense), net, for the three and six month periods, as compared to the same periods in the prior year, were as follows (in thousands):

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2018     2017      2018     2017  

Interest income

   $ 792     $ 336      $ 1,405     $ 653  

Interest expense

     (181     —          (355     —    
  

 

 

   

 

 

    

 

 

   

 

 

 

Total other income, net

   $ 611     $ 336      $ 1,050     $ 653  
  

 

 

   

 

 

    

 

 

   

 

 

 

Dollar increase

   $ 275        $ 397    

Percentage increase

     82        61  

The increases in total other income (expense), net from 2017 to 2018 for the three and six month periods were primarily due to increased interest income resulting from higher cash and investment balances and a higher return on the investment portfolio in 2018, partially offset by interest expense related to the loan and security agreement with Hercules Capital, Inc., or the Credit Facility. We expect that interest expense to increase in the future if we borrow additional amounts under the Credit Facility.

Liquidity and Capital Resources

As of June 30, 2018, we had approximately $201.8 million in cash, cash equivalents and investments. The following table shows a summary of our cash flows for the six months ended June 30, 2018 and 2017 (in thousands):

 

     Six Months Ended
June 30,
 
     2018      2017  

Cash provided by (used in)

     

Operating activities

   $ 49,292      $ 11,988  

Investing activities

   $ (37,943    $ (3,984

Financing activities

   $ 17,383      $ 1,472  

Operating activities.    Net cash provided by operating activities was $49.3 million for the six months ended June 30, 2018, compared to $12.0 million for the same period in 2017. This increase was primarily due to changes in working capital items, which was partially offset by a higher net loss. For the six months ended June 30, 2018, changes in working capital included the receipt of $50.0 million milestone payment in connection with the Avacopan Agreement, $10.0 million upfront commitment under the Avacopan Amendment, $10.0 million of aggregate payments under the June 2018 Avacopan Letter Agreement and the CCX140 Letter Agreement and $11.5 million payment for CCX140 development funding by Vifor. For the same period in 2017, changes in working capital included $30.0 million from the first installment of the upfront commitment under the CCX140 Agreement.

Investing activities.    Net cash used in investing activities for the periods presented primarily relate to the purchases of investments and maturities of investments used to fund the day-to-day needs of our business.

Financing activities.    Net cash provided by financing activities was $17.4 million for the six months ended June 30, 2018, compared to $1.5 million for the same period in 2017. Net cash provided by financing activities for both periods presented included proceeds from the exercise of stock options and stock purchases from contributions to our 2012 Employee Stock Purchase Plan, and cash used for tendered ChemoCentryx, Inc. common stock to satisfy employee tax withholding requirements upon vesting of restricted stock units. For the six months ended June 30, 2018, net cash provided by financing activities also included $10.0 million received under the Credit Facility.

 

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In December 2017, we entered into the Credit Facility with Hercules, under which we may borrow up to $50.0 million in three tranches, subject to certain terms and conditions. Under the first tranche, we may borrow up to $15.0 million, of which we borrowed $5.0 million in December 2017 and $10.0 million in June 2018. Upon satisfaction of certain milestones, the second tranche is available under the Credit Facility, which would allow us to borrow up to an additional $10.0 million through December 15, 2018. The third tranche, which would allow us to borrow up to an additional $25.0 million, will be available upon Hercules’ approval through June 15, 2019. We intend to use the net proceeds from the Credit Facility for general corporate purposes, which may include the repayment of debt and working capital. We were in compliance with all loan covenants as of June 30, 2018. See “Note 6. Long-term Debt” in the Notes to Condensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for additional information regarding our borrowings.

As of June 30, 2018, we had approximately $201.8 million in cash, cash equivalents and investments. We believe that our available cash, cash equivalents and investments will be sufficient to fund our anticipated level of operations for at least 12 months following our financial statement issuance date, August 9, 2018. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially.

Our future capital requirements are difficult to forecast and will depend on many factors, including:

 

   

the terms and timing of any other collaborative, licensing and other arrangements that we may establish;

 

   

the initiation, progress, timing and completion of preclinical studies and clinical trials for our drug candidates and potential drug candidates;

 

   

the number and characteristics of drug candidates that we pursue;

 

   

the progress, costs and results of our clinical trials;

 

   

the outcome, timing and cost of regulatory approvals;

 

   

delays that may be caused by changing regulatory approvals;

 

   

the cost and timing of hiring new employees to support continued growth;

 

   

the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims;

 

   

the cost and timing of procuring clinical and commercial supplies of our drug candidates;

 

   

the cost and timing of establishing sales, marketing and distribution capabilities; and

 

   

the extent to which we acquire or invest in businesses, products or technologies.

Contractual Obligations and Commitments

Except for the additional borrowing of $10.0 million under the Credit Facility, there have been no material changes outside the ordinary course of our business to the contractual obligations we reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the SEC on March 12, 2018. See “Note 6. Long-term Debt” in the Notes to Condensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for additional information regarding our borrowings.

Recent Accounting Pronouncements

See “Note 2. Summary of Significant Accounting Policies” in the Notes to Condensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for a full description of recently issued accounting pronouncements, including the respective expected dates of adoption and effects on our consolidated financial position and results of operations.

 

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Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Our market risks at June 30, 2018 have not changed significantly from those discussed in “Item 7A. Quantitative and Qualitative Disclosures About Market Risk” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the SEC on March 12, 2018, other than the following:

Advances under the Credit Facility will bear an interest rate equal to the greater of (i) 8.05% plus the prime rate as reported from time to time in The Wall Street Journal minus 4.75%, and (ii) 8.05%. We are affected by market risk exposure primarily through the effect of changes in interest rates on amounts payable under the Credit Facility. At June 30, 2018, borrowings under the Credit Facility totaled $15.0 million with an interest rate of 8.3%. The Company will make interest-only payments through July 1, 2020, and will then repay the principal balance and interest on the advances in equal monthly installments after the interest-only period and continuing through December 1, 2021. If the amount outstanding under the Credit Facility remained at this level for an entire year and interest rate increased by 1%, our annual interest expense would increase by an additional $150,000. See “Note 6. Long-term Debt” in the Notes to Condensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for additional information regarding our borrowings.

 

Item 4.

Controls and Procedures

Conclusions Regarding the Effectiveness of Disclosure Controls and Procedures

As of June 30, 2018, management, with the participation of our Disclosure Committee, performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act. Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including the Chief Executive Officer and the Chief Financial and Administrative Officer, to allow timely decisions regarding required disclosures.

Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective. Based on this evaluation, our Chief Executive Officer and Chief Financial and Administrative Officer concluded that, as of June 30, 2018, the design and operation of our disclosure controls and procedures were effective.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting during the three months ended June 30, 2018, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION

 

Item 1.

Legal Proceedings

Not Applicable.

 

Item 1A.

Risk Factors

There have been no material changes to the risk factors included in “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the SEC on March 12, 2018.

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

Not Applicable.

 

Item 3.

Defaults Upon Senior Securities

Not Applicable.

 

Item 4.

Mine Safety Disclosures

Not Applicable.

 

Item 5.

Other Information

Not Applicable.

 

Item 6.

Exhibits

A list of exhibits is set forth on the Exhibit Index immediately preceding the signature page of this Quarterly Report on Form 10-Q, and is incorporated herein by reference.

 

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EXHIBIT INDEX

 

Exhibit
Number

  

Description

  10.1    Letter Agreement dated as of June 6, 2018 between the Registrant and Vifor (International) Ltd. regarding Grant of Rights to CCX168 in China
  10.2    Letter Agreement dated as of June 6, 2018 between the Registrant and Vifor (International) Ltd. regarding Grant of Rights to CCX140 in China
  10.3†    Amendment to Collaboration and License Agreement, effective as of June 6, 2018 between the Registrant and Vifor Fresenius Medical Care Renal Pharma Ltd.
  31.1    Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
  31.2    Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
  32.1    Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
  32.2    Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
  101    The following information from the Registrant’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2018, formatted in XBRL (Extensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Operations, (iii) Condensed Consolidated Statements of Comprehensive Loss, (iv) Condensed Consolidated Statements of Cash Flows, and (v) the Notes to Condensed Consolidated Financial Statements.

 

Confidential treatment has been requested for portions of this exhibit. These portions have been omitted and filed separately with the SEC.

 

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SIGNATURES

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

 

      CHEMOCENTRYX, INC.
Date: August 9, 2018       /s/ Thomas J. Schall, Ph.D.
     

Thomas J. Schall, Ph.D.

President and Chief Executive Officer

(Principal Executive Officer)

Date: August 9, 2018       /s/ Susan M. Kanaya
     

Susan M. Kanaya

Executive Vice President,

Chief Financial and Administrative Officer and Secretary

(Principal Financial Officer)

Date: August 9, 2018       /s/ Pui San Kwan
     

Pui San Kwan

Vice President, Finance

(Principal Accounting Officer)

 

 

30

EX-10.1

Exhibit 10.1

 

LOGO

June 6, 2018

Vifor (International) Ltd.

Rechenstrasse 37

CH-9014 St. Gallen

Switzerland

 

  Re:

Grant of Rights to CCX168 in China

Ladies and Gentlemen:

As you know, Vifor Fresenius Medical Care Renal Pharma Ltd. (“VFMCRP”) and ChemoCentryx, Inc. (“ChemoCentryx”) are parties to that certain Collaboration and License Agreement, dated May 9, 2016, amended May 22, 2017 (the “VFMCRP Agreement”), pursuant to which ChemoCentryx granted VFMCRP an exclusive license to commercialize ChemoCentryx’s proprietary C5aR inhibitor known as CCX168 in certain countries. ChemoCentryx and Vifor (International) Ltd. (“Vifor”) have entered into a Letter Agreement on 10 February 2017 to expand the territory and to grant an option to Vifor to include China in the territory upon payment of five million U.S. dollars (the “LA1”). Capitalized terms used but not otherwise defined in this letter agreement (this “Letter”) will have the meanings provided in the VFMCRP Agreement. The VFMCRP Agreement and the LA1 were originally entered into between Vifor (International) Ltd. (“Vifor”) and ChemoCentryx and were subsequently assigned by Vifor to VFMCRP, so that references in the VFMCRP Agreement to VIT now refer to VFMCRP.

Vifor, VFMCRP and ChemoCentryx agree that Vifor will have the right to exercise the rights granted in LA1 with respect to CCX168 in China, notwithstanding the assignment of LA1 to VFMCRP, so that Vifor will have a license to CCX168 in China that is consistent with the rights granted to VFMCRP in the VFMCRP Agreement and in LA1, and the parties understand that Vifor intends to assign such rights to VFMCRP prior to June 30, 2019.

ChemoCentryx and Vifor, intending to be legally bound, hereby agree as follows:

1.    “Vifor Territory” means the People’s Republic of China, the Hong Kong Special Administrative Region of the People’s Republic of China and the Macao Special Administrative Region of the People’s Republic of China (together referred as “China”).

 

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1.

Confidential


2.    Subject to the terms and conditions of this Letter and the agreement referenced in Section 8(a) if and when entered into, as applicable, ChemoCentryx hereby grants to Vifor an exclusive (even as to ChemoCentryx), royalty bearing license, with the right to grant sublicenses as provided under the terms of Section 2.2 of the VFMCRP Agreement (as applied to Vifor in place of VFMCRP and with China being deemed a Major Market Country), under the ChemoCentryx Know-How and ChemoCentryx Patents (as applied to the Vifor Territory in place of the VIT Territory as referenced in such defined terms in the VFMCRP Agreement) (a) to seek Regulatory Approval and Pricing and Reimbursement Approval for and Commercialize the Product in the Field in the Vifor Territory and (b) to conduct those Development activities in the Field in the Vifor Territory allocated to Vifor in the Development Plan.

3.    Notwithstanding Section 2 above, if Vifor intends to grant a sublicense under the foregoing license, Vifor shall notify ChemoCentryx in writing. Any such sublicense shall be subject to and consistent with all terms of the VFMCRP Agreement, as if the sublicense were granted by VFMCRP under the VFMCRP Agreement as amended by the amendment attached hereto as Exhibit A. No such sublicense may be granted unless and until Vifor and ChemoCentryx enter into an agreement governing at least the following:

(a)    Development of the Product for the sublicensed country(ies), which would be considered Additional Studies and subject to the approval of the JSC (with decision-making authority as provided in the VFMCRP Agreement, as applied to the Vifor Territory in place of the VFMCRP Territory), unless agreed otherwise by ChemoCentryx and Vifor in writing;

(b)    Economic terms identical to the VFMCRP Agreement applicable to the rights for the sublicensed country(ies), including allocation of costs for any activities conducted therein;

(c)    ChemoCentryx’s rights to use any data and results generated with respect to the sublicensed country(ies);

(d)    Rights to obtain licenses to Third Party intellectual property rights in the sublicensed country(ies); and

(e)    Consequences for the sublicensee’s breach of its sublicense agreement with Vifor.

4.    ChemoCentryx and Vifor intend that prior to June 30, 2019, Vifor will assign the rights granted in Section 2 above to VFMCRP.

5.    No activities will be conducted prior to June 30, 2019 under the license granted in Section 3 above with respect to the Vifor Territory except with the prior written approval of ChemoCentryx, which shall not be unreasonably withheld. Any Development of the Product in the Vifor Territory will be conducted pursuant to the Development Plan.

6.    In consideration for the rights granted under this Letter, Vifor shall make a non-refundable, non-creditable payment to ChemoCentryx of five million United States dollars (US$5,000,000), payable within ten (10) Business Days after the date of this Letter.

7.    If VFMCRP and ChemoCentryx enter into the amendment attached hereto as Exhibit A by June 30, 2019, then this Letter will immediately terminate and be of no force and effect.

 

2.

Confidential


8.    If VFMCRP and ChemoCentryx do not enter into the amendment attached hereto as Exhibit A by June 30, 2019, then as promptly as possible following such date:

(a)    ChemoCentryx and Vifor shall enter into a collaboration and license agreement that sets forth the terms and conditions for the Vifor Territory consistent with the VFMCRP Agreement but with necessary changes, as discussed by ChemoCentryx and Vifor as of the date of this Letter; and

(b)    ChemoCentryx and VFMCRP shall amend the VFMCRP Agreement with necessary changes to take into account the agreement for the Vifor Territory referenced in Section 8(a), as discussed by ChemoCentryx and Vifor as of the date of this Letter.

9.    This Letter may be executed in any number of counterparts, each of which shall be an original, but all of which together shall constitute one instrument. This Letter may be executed and delivered electronically or by facsimile and upon such delivery such electronic or facsimile signature will be deemed to have the same effect as if the original signature had been delivered to the other party.

10.    This Letter shall be governed by and construed in accordance with the laws of the State of New York without reference to any rules of conflict of laws.

11.    This Letter constitutes the entire agreement, both written and oral, between ChemoCentryx and Vifor with respect to the subject matter hereof, and any and all prior agreements with respect to the subject matter hereof, either written or oral, expressed or implied, are superseded hereby, merged and canceled, and are null and void and of no effect.

 

3.

Confidential


If the foregoing is acceptable to you, please sign this Letter in the space provided below and return it to me.

 

Sincerely,
CHEMOCENTRYX, INC.
By:  

/s/ Thomas J. Schall, Ph.D.

Name:   Thomas J. Schall, Ph.D.
Title:   Chief Executive Officer

Agreed to and accepted as of the date of this Letter:

 

VIFOR (INTERNATIONAL) LTD.
By:  

/s/ Chris Springer

Name:   Dr. Chris Springer
Title:   Chief Strategy Officer (CSO), Executive Vice President
By:  

/s/ Oliver P. Kronenberg

Name:   Oliver P. Kronenberg
Title:   Group General Counsel

VFMCRP agrees that notwithstanding the rights granted to VFMCRP with respect to China in the VFMCRP Agreement, ChemoCentryx shall have the right to grant, and Vifor shall have the right to obtain, the license set forth in this Letter.

 

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD.
By:  

/s/ David Bevan

Name:   David Bevan
Title:   CEO
By:  

/s/ Marcus Kracht

Name:   Marcus Kracht
Title:   Deputy CEO

 

Confidential


Exhibit A

AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT

This AMENDMENT TO THE COLLABORATION AND LICENSE AGREEMENT (the “Amendment”) is effective as of [            ], 2018 (the “Amendment Effective Date”) by and between CHEMOCENTRYX, INC., a Delaware corporation, having an address at 850 Maude Avenue, Mountain View, CA 94043, U.S. (“ChemoCentryx”), and VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD., a corporation organized under the laws of Switzerland, having an address at Rechenstrasse 37, CH-9014 St. Gallen, Switzerland (“VFMCRP”). ChemoCentryx and VFMCRP may be referred to herein individually as a “Party” or collectively as the “Parties”.

RECITALS

A.    ChemoCentryx and VFMCRP are parties to that certain Collaboration and License Agreement, dated May 9, 2016, amended May 22, 2017 (the “Agreement”), pursuant to which ChemoCentryx granted VFMCRP an exclusive license to commercialize ChemoCentryx’s proprietary C5aR inhibitor known as CCX168 in certain countries. The Agreement was originally entered into between Vifor (International) Ltd. (“VIT”) and ChemoCentryx and was subsequently assigned by VIT to VFMCRP.

B.    On June 6, 2018, ChemoCentryx and VIT entered into a letter agreement pursuant to which ChemoCentryx granted Vifor an exclusive license to commercialize CCX168 in China, and Vifor paid ChemoCentryx five million United States dollars (US$5,000,000). Such letter agreement is terminated concurrently with the Parties’ entry into this Agreement.

C.    This Amendment, which is being entered into in accordance with Section 16.2 of the Agreement, provides for a territory expansion to include China in accordance with the terms and conditions of this Amendment.

NOW, THEREFORE, the Parties agree as follows:

 

1.

AMENDMENT OF THE AGREEMENT

The Parties hereby agree to amend the terms of the Agreement as provided below, effective as of the Amendment Effective Date. Except to the extent the Agreement is explicitly amended by this Amendment, the Agreement will remain in full force and effect in accordance with its terms. Capitalized terms used in this Amendment that are not otherwise defined herein shall have the meanings such terms are given in the Agreement.

1.1    Section 1.85 of the Agreement is hereby deleted and replaced in its entirety with the following:

1.85    “Major Market Countries” means France, Switzerland, Germany, Italy, Spain, the United Kingdom, Brazil, Japan, Canada, Mexico, South Korea and China.

1.2    Section 1.134 of the Agreement is hereby deleted and replaced in its entirety with the following:

1.134    “VFMCRP Territory” means the world, excluding the U.S.


1.5    The definitions 1.137 and 1.138 which were inserted by the amendment 1 between the Parties are hereby deleted.

1.6    The Sections 2.11 and 8.5 which were inserted by amendment 1 between the Parties are hereby deleted.

1.7    Section 9.4 of the Agreement is hereby deleted and replaced in its entirety with the following:

9.4    Records; Audit. VFMCRP shall keep, and shall cause its Affiliates and Sublicensees to keep, complete and accurate records pertaining to the sale or other disposition of the Product in sufficient detail to permit ChemoCentryx to confirm the accuracy of commercial milestone and royalty payments due hereunder. Such records shall be kept for such period of time required by Applicable Laws, but in no case less than three (3) years following the end of the Calendar Quarter to which they pertain. ChemoCentryx shall have the right to have an independent, certified public accountant reasonably acceptable to VFMCRP audit such records of VFMCRP to confirm Net Sales, royalties, and other payments for a period covering not more than three (3) years following the Calendar Quarter to which they pertain. Such audits may be exercised only once for any period and no more than once per Calendar Year during normal business hours upon reasonable prior written notice to the audited Party. Any such auditor shall not disclose VFMCRP’s confidential information to ChemoCentryx, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by VFMCRP or the amount of payments by VFMCRP under this Agreement. Any amounts shown to be owed but unpaid shall be paid within thirty (30) days after the accountant’s report, plus interest (as set forth in Section 9.5) from the original due date. Any overpayment by VFMCRP revealed by an audit shall be credited against future payments owed by VFMCRP to ChemoCentryx (and if no further payments are due, shall be refunded by ChemoCentryx at the request of VFMCRP). ChemoCentryx shall bear the full cost of such audit unless such audit discloses an underpayment by VFMCRP of more than five percent (5%) of the amount of royalties or other payments due under this Agreement for any applicable Calendar Quarter, in which case, VFMCRP shall bear the cost of such audit.

 

2.

MISCELLANEOUS

2.1    Full Force and Effect. This Amendment amends the terms of the Agreement and is deemed incorporated into the Agreement. The provisions of the Agreement, as amended by this Amendment, remain in full force and effect.

2.2    Entire Agreement. The Agreement, as amended by this Amendment constitute the entire agreement, both written and oral, between the Parties with respect to the subject matter hereof, and any and all prior agreements with respect to the subject matter hereof, either written or oral, expressed or implied, are superseded hereby, merged and canceled, and are null and void and of no effect.

2.3    Counterparts. This Amendment may be executed in one or more counterparts, each of which will be an original and all of which together will constitute one instrument.

 

2


IN WITNESS WHEREOF, the Parties have executed this Amendment as of the Amendment Effective Date.

 

CHEMOCENTRYX, INC.     VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD.
By:  

 

    By:  

 

Name:  

 

    Name:  

 

Title:  

 

    Title:  

 

      By:  

 

      Name:  

 

      Title:  

 

 

Confidential

EX-10.2

Exhibit 10.2

 

LOGO

June 6, 2018

Vifor (International) Ltd.

Rechenstrasse 37

CH-9014 St. Gallen

Switzerland

 

  Re:

Grant of Rights to CCX140 in China

Ladies and Gentlemen:

As you know, Vifor Fresenius Medical Care Renal Pharma Ltd. (“VFMCRP”) and ChemoCentryx, Inc. (“ChemoCentryx”) are parties to that certain Collaboration and License Agreement, dated December 22, 2016 (the “VFMCRP Agreement”), pursuant to which ChemoCentryx granted VFMCRP an exclusive license to commercialize ChemoCentryx’s proprietary C5aR inhibitor known as CCX140 in certain countries. Capitalized terms used but not otherwise defined in this letter agreement (this “Letter”) will have the meanings provided in the VFMCRP Agreement. The VFMCRP Agreement was originally entered into between Vifor (International) Ltd. (“Vifor”) and ChemoCentryx and was subsequently assigned by Vifor to VFMCRP, so that references in the VFMCRP Agreement to VIT now refer to VFMCRP.

Vifor, VFMCRP and ChemoCentryx agree that Vifor will have the right to exercise the rights granted to VFMCRP with respect to CCX140 in China, notwithstanding the assignment of the VFMCRP Agreement to VFMCRP, so that Vifor will have a license to CCX168 in China that is consistent with the rights granted to VFMCRP in the VFMCRP Agreement, with the understanding that Vifor intends to assign such rights to VFMCRP prior to June 30, 2019.

ChemoCentryx and Vifor, intending to be legally bound, hereby agree as follows:

1.    “Vifor Territory” means the People’s Republic of China, the Hong Kong Special Administrative Region of the People’s Republic of China and the Macao Special Administrative Region of the People’s Republic of China (together referred as “China”).

2.    Subject to the terms and conditions of this Letter and the agreement referenced in Section 8(a) if and when entered into, as applicable, ChemoCentryx hereby grants to Vifor an exclusive (even as to ChemoCentryx), royalty bearing license, with the right to grant sublicenses as provided under the terms of Section 2.2 of the VFMCRP Agreement (as applied to Vifor in place of VFMCRP and with China being deemed a Major Market Country), under the

 

650 210.2900 Voice

650 210.2910 Fax

850 Maude Avenue

  
Mountain View, CA 94043, USA    Medicines In Motion        

 

1.

Confidential


ChemoCentryx Know-How and ChemoCentryx Patents (as applied to the Vifor Territory in place of the VIT Territory as referenced in such defined terms in the VFMCRP Agreement) (a) to seek Regulatory Approval and Pricing and Reimbursement Approval for and Commercialize the Product in the Field in the Vifor Territory and (b) to conduct those Development activities in the Field in the Vifor Territory allocated to Vifor in the Development Plan.

3.    Notwithstanding Section 2 above, if Vifor intends to grant a sublicense under the foregoing license, Vifor shall notify ChemoCentryx in writing. Any such sublicense shall be subject to and consistent with all terms of the VFMCRP Agreement, as if the sublicense were granted by VFMCRP under the VFMCRP Agreement as amended by the amendment attached hereto as Exhibit A. No such sublicense may be granted unless and until Vifor and ChemoCentryx enter into an agreement governing at least the following:

(a)    Development of the Product for the sublicensed country(ies), which would be considered Additional Studies and subject to the approval of the JSC (with decision-making authority as provided in the VFMCRP Agreement, as applied to the Vifor Territory in place of the VFMCRP Territory), unless agreed otherwise by ChemoCentryx and Vifor in writing;

(b)    Economic terms identical to the VFMCRP Agreement applicable to the rights for the sublicensed country(ies), including allocation of costs for any activities conducted therein;

(c)    ChemoCentryx’s rights to use any data and results generated with respect to the sublicensed country(ies);

(d)    Rights to obtain licenses to Third Party intellectual property rights in the sublicensed country(ies); and

(e)    Consequences for the sublicensee’s breach of its sublicense agreement with Vifor.

4.    ChemoCentryx and Vifor intend that prior to June 30, 2019, Vifor will assign the rights granted in Section 2 above to VFMCRP.

5.    No activities will be conducted prior to June 30, 2019 under the license granted in Section 3 above with respect to the Vifor Territory except with the prior written approval of ChemoCentryx, which shall not be unreasonably withheld. Any Development of the Product in the Vifor Territory will be conducted pursuant to the Development Plan.

6.    In consideration for the rights granted under this Letter, Vifor shall make a non-refundable, non-creditable payment to ChemoCentryx of five million United States dollars (US$5,000,000), payable within ten (10) Business Days after the date of this Letter.

7.    If VFMCRP and ChemoCentryx enter into the amendment attached hereto as Exhibit A by June 30, 2019, then this Letter will immediately terminate and be of no force and effect.

 

2.

Confidential


8.    If VFMCRP and ChemoCentryx do not enter into the amendment attached hereto as Exhibit A by June 30, 2019, then as promptly as possible following such date:

(a)    ChemoCentryx and Vifor shall enter into a collaboration and license agreement that sets forth the terms and conditions for the Vifor Territory consistent with the VFMCRP Agreement but with necessary changes, as discussed by ChemoCentryx and Vifor as of the date of this Letter; and

(b)    ChemoCentryx and VFMCRP shall amend the VFMCRP Agreement with necessary changes to take into account the agreement for the Vifor Territory referenced in Section 8(a), as discussed by ChemoCentryx and Vifor as of the date of this Letter.

9.    This Letter may be executed in any number of counterparts, each of which shall be an original, but all of which together shall constitute one instrument. This Letter may be executed and delivered electronically or by facsimile and upon such delivery such electronic or facsimile signature will be deemed to have the same effect as if the original signature had been delivered to the other party.

10.    This Letter shall be governed by and construed in accordance with the laws of the State of New York without reference to any rules of conflict of laws.

11.    This Letter constitutes the entire agreement, both written and oral, between ChemoCentryx and Vifor with respect to the subject matter hereof, and any and all prior agreements with respect to the subject matter hereof, either written or oral, expressed or implied, are superseded hereby, merged and canceled, and are null and void and of no effect.

 

3.

Confidential


If the foregoing is acceptable to you, please sign this Letter in the space provided below and return it to me.

 

Sincerely,
CHEMOCENTRYX, INC.
By:  

/s/ Thomas J. Schall, Ph.D.

Name:   Thomas J. Schall, Ph.D.
Title:   Chief Executive Officer

Agreed to and accepted as of the date of this Letter:

 

VIFOR (INTERNATIONAL) LTD.
By:  

/s/ Chris Springer

Name:   Dr. Chris Springer
Title:   Chief Strategy Officer (CSO), Executive Vice President
By:  

/s/ Oliver P. Kronenberg

Name:   Dr. Oliver P. Kronenberg
Title:   Group General Counsel

VFMCRP agrees that notwithstanding the rights granted to VFMCRP with respect to China in the VFMCRP Agreement, ChemoCentryx shall have the right to grant, and Vifor shall have the right to obtain, the license set forth in this Letter.

 

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD.
By:  

/s/ David Bevan

Name:   David Bevan
Title:   CEO
By:  

/s/ Marcus Kracht

Name:   Marcus Kracht
Title:   Deputy CEO

 

Confidential


Exhibit A

AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT

This AMENDMENT TO THE COLLABORATION AND LICENSE AGREEMENT (the “Amendment”) is effective as of [            ], 2018 (the “Amendment Effective Date”) by and between CHEMOCENTRYX, INC., a Delaware corporation, having an address at 850 Maude Avenue, Mountain View, CA 94043, U.S. (“ChemoCentryx”), and VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD., a corporation organized under the laws of Switzerland, having an address at Rechenstrasse 37, CH-9014 St. Gallen, Switzerland (“VFMCRP”). ChemoCentryx and VFMCRP may be referred to herein individually as a “Party” or collectively as the “Parties”.

RECITALS

A.    ChemoCentryx and VFMCRP are parties to that certain Collaboration and License Agreement, dated December 22, 2016, amended June 6, 2018 (the “Agreement”), pursuant to which ChemoCentryx granted VFMCRP an exclusive license to commercialize ChemoCentryx’s proprietary C5aR inhibitor known as CCX140 in certain countries. The Agreement was originally entered into between Vifor (International) Ltd. (“VIT”) and ChemoCentryx and was subsequently assigned by VIT to VFMCRP.

B.    On June 6, 2018, ChemoCentryx and VIT entered into a letter agreement pursuant to which ChemoCentryx granted Vifor an exclusive license to commercialize CCX140 in China, and Vifor paid ChemoCentryx five million United States dollars (US$5,000,000). Such letter agreement is terminated concurrently with the Parties’ entry into this Agreement.

C.    This Amendment, which is being entered into in accordance with Section 16.2 of the Agreement, provides for a territory expansion to include China in accordance with the terms and conditions of this Amendment.

NOW, THEREFORE, the Parties agree as follows:

 

1.

AMENDMENT OF THE AGREEMENT

The Parties hereby agree to amend the terms of the Agreement as provided below, effective as of the Amendment Effective Date. Except to the extent the Agreement is explicitly amended by this Amendment, the Agreement will remain in full force and effect in accordance with its terms. Capitalized terms used in this Amendment that are not otherwise defined herein shall have the meanings such terms are given in the Agreement.

1.1    Section 1.95 of the Agreement is hereby deleted and replaced in its entirety with the following:

1.95    “Major Market Countries” means France, Switzerland, Germany, Italy, Spain, the United Kingdom, Brazil, Japan, Canada, Mexico, South Korea and China.


1.2    Section 1.128 of the Agreement is hereby deleted and replaced in its entirety with the following:

1.128    “Territory” means (i) the world, excluding the U.S., and (ii) upon VIT’s obtaining Regulatory Approval for CKD in the U.S. after exercise of the CKD Option, the U.S.

1.6    The Sections 2.9 and 8.5 of the Agreement are hereby deleted.

1.7    Section 9.4 of the Agreement is hereby deleted and replaced in its entirety with the following:

9.4    Records; Audit. VFMCRP shall keep, and shall cause its Affiliates and Sublicensees to keep, complete and accurate records pertaining to the sale or other disposition of the Product in sufficient detail to permit ChemoCentryx to confirm the accuracy of commercial milestone and royalty payments due hereunder. Such records shall be kept for such period of time required by Applicable Laws, but in no case less than three (3) years following the end of the Calendar Quarter to which they pertain. ChemoCentryx shall have the right to have an independent, certified public accountant reasonably acceptable to VFMCRP audit such records of VFMCRP to confirm Net Sales, royalties, and other payments for a period covering not more than three (3) years following the Calendar Quarter to which they pertain. Such audits may be exercised only once for any period and no more than once per Calendar Year during normal business hours upon reasonable prior written notice to the audited Party. Any such auditor shall not disclose VFMCRP’s confidential information to ChemoCentryx, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by VFMCRP or the amount of payments by VFMCRP under this Agreement. Any amounts shown to be owed but unpaid shall be paid within thirty (30) days after the accountant’s report, plus interest (as set forth in Section 9.5) from the original due date. Any overpayment by VFMCRP revealed by an audit shall be credited against future payments owed by VFMCRP to ChemoCentryx (and if no further payments are due, shall be refunded by ChemoCentryx at the request of VFMCRP). ChemoCentryx shall bear the full cost of such audit unless such audit discloses an underpayment by VFMCRP of more than five percent (5%) of the amount of royalties or other payments due under this Agreement for any applicable Calendar Quarter, in which case, VFMCRP shall bear the cost of such audit.

 

2.

MISCELLANEOUS

2.1    Full Force and Effect. This Amendment amends the terms of the Agreement and is deemed incorporated into the Agreement. The provisions of the Agreement, as amended by this Amendment, remain in full force and effect.

2.2    Entire Agreement. The Agreement, as amended by this Amendment constitute the entire agreement, both written and oral, between the Parties with respect to the subject matter hereof, and any and all prior agreements with respect to the subject matter hereof, either written or oral, expressed or implied, are superseded hereby, merged and canceled, and are null and void and of no effect.

2.3    Counterparts. This Amendment may be executed in one or more counterparts, each of which will be an original and all of which together will constitute one instrument.

 

2


IN WITNESS WHEREOF, the Parties have executed this Amendment as of the Amendment Effective Date.

 

CHEMOCENTRYX, INC.     VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD.
By:  

 

    By:  

 

Name:  

 

    Name:  

 

Title:  

 

    Title:  

 

      By:  

 

      Name:  

 

      Title:  

 

 

Confidential

EX-10.3

Exhibit 10.3

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

AMENDMENT TO COLLABORATION AND LICENSE AGREEMENT

This AMENDMENT TO THE COLLABORATION AND LICENSE AGREEMENT (the “Amendment”) is effective as of June 6, 2018 (the “Amendment Effective Date”) by and between CHEMOCENTRYX, INC., a Delaware corporation, having an address at 850 Maude Avenue, Mountain View, CA 94043, U.S. (“ChemoCentryx”), and VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD., a corporation organized under the laws of Switzerland, having an address at Rechenstrasse 37, CH-9014 St. Gallen, Switzerland (“VFMCRP”). ChemoCentryx and VFMCRP may be referred to herein individually as a “Party” or collectively as the “Parties”.

RECITALS

A.    ChemoCentryx and VFMCRP are parties to that certain Collaboration and License Agreement, dated December 22, 2016 (the “Agreement”), pursuant to which ChemoCentryx granted VFMCRP an exclusive license to commercialize ChemoCentryx’s proprietary CCR2 inhibitor known as CCX140 in certain countries. The Agreement was originally entered into between Vifor (International) Ltd. (“VIT”) and ChemoCentryx and was subsequently assigned by VIT to VFMCRP.

B.    Based on input from EMA and FDA, the Parties have revised the Development Plan for the Initial Indication to include two parallel tracks as further described below, each having an initial phase and a subsequent phase.

C.    The Parties have determined it is in their mutual interests to enter into this Amendment, in accordance with Section 16.2 of the Agreement, to address the parallel development tracks.

NOW, THEREFORE, the Parties agree as follows:

 

1.

AMENDMENT OF THE AGREEMENT

The Parties hereby agree to amend the terms of the Agreement as provided below, effective as of the Amendment Effective Date. Except to the extent the Agreement is explicitly amended by this Amendment, the Agreement will remain in full force and effect in accordance with its terms. Capitalized terms used in this Amendment that are not otherwise defined herein shall have the meanings such terms are given in the Agreement.

1.1    All references in the Agreement to “VIT” are hereby amended to refer instead to “VFMCRP”.

1.2    All references in Section 2.9 of the Agreement to “the date that is [***] after the Effective Date” are hereby amended to refer instead to “June 6, 2018”.

1.3    In consideration of the acceleration of the timing set forth in Section 1.2 above, VFMCRP shall pay ChemoCentryx a one-time, non-refundable, non-creditable payment of eleven million five hundred thousand United States dollars (US$11,500,000) within ten (10) Business Days after the Amendment Effective Date.

 

***

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Confidential


1.4    A new Section 4.3(d) is hereby added to the Agreement to read as follows:

(d)    Two-Track, Two-Phase Initial Indication Development Plan. Based on feedback received by the Parties from the EMA and FDA as of the Amendment Effective Date, the Parties have agreed to two parallel development tracks for the Product in the Initial Indication, one for patients with nephrotic syndrome and one for patients without nephrotic syndrome (each, a “Development Track”). In addition, each Development Track is divided into an initial phase, which is described in the amended Development Plan for the Initial Indication approved by the JSC as of the Amendment Effective Date (each, an “Initial Development Phase”), and a subsequent phase, which will be designed based on results of the Initial Development Phase (each, a “Subsequent Development Phase”). The Development Plan that includes the Initial Development Phase of each of the two Development Tracks is referred to as the “First-Phase Initial Indication Development Plan”. The Development Plan that includes the Subsequent Development Phase of each of the two Development Tracks is referred to as the “Subsequent-Phase Initial Indication Development Plan”.

1.5    Section 4.4(a) of the Agreement is hereby deleted and replaced in its entirety with the following:

(a)    Development Costs. The Parties agree that: (i) VFMCRP shall make the payments set forth in the table below as reimbursement for the costs and expenses ChemoCentryx incurs to conduct Development activities pursuant to the First-Phase Initial Development Plan, as such plan (including budget) was initially approved by the JSC; and (ii) the Parties shall share equally all costs and expenses ChemoCentryx incurs to conduct Development activities for the Initial Indication pursuant to (A) the First-Phase Initial Indication Development Plan, but only to the extent arising from an amendment to the First-Phase Fully-Burdened Budget, as described in Sections 4.4(b) and 4.4(c), and (B) the Subsequent-Phase Initial Indication Development Plan. VFMCRP’s fifty percent (50%) share of such costs and expenses will be based on the First-Phase Fully-Burdened Budget and the Subsequent-Phase Fully-Burdened Budget, as defined below.

Promptly after the Amendment Effective Date, the Parties shall negotiate in good faith to determine a mechanism by which VFMCRP will pay its fifty percent (50%) share of the Subsequent-Phase Fully-Burdened Budget, and will use reasonable efforts to conclude such negotiation and enter into an amendment of this Agreement incorporating such mechanism within four (4) months after the Amendment Effective Date.

 

Payment Due Date

   Development Funding
Payment
First-Phase Initial Indication Development Plan (as initially approved by the JSC)

Payable within ten (10) Business Days after the Amendment Effective Date

   [***]

Payable on December 31, 2018

   [***]

Payable on June 15, 2019

   [***]

 

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Confidential


First-Phase Fully-Burdened Budget” means [***] of the total budget (which will include Third Party costs only) set forth in the First-Phase Initial Indication Development Plan. For clarity, with respect to any amendments of such plan or budget therein, VFMCRP will be responsible for [***] of its fifty percent (50%) share of the total budget increase resulting from such amendment. For example, if the budget is amended to be increased by [***], VFMCRP will be responsible for [***] thereof. The Parties acknowledge and agree that the premium on Third Party costs included in the First-Phase Fully-Burdened Budget accounts for the Parties’ internal costs incurred to conduct Development activities under the First-Phase Initial Indication Development Plan.

Subsequent-Phase Fully-Burdened Budget” means [***] of the total budget (which will include Third Party costs only) set forth in the Subsequent-Phase Initial Indication Development Plan. For clarity, VFMCRP will be responsible for [***] of its fifty percent (50%) share of the total budget. For example, if the total budget is [***], the Subsequent-Phase Fully-Burdened Budget will equal [***], and VFMCRP will be responsible for [***] thereof. The Parties acknowledge and agree that the premium on Third Party costs included in the Subsequent-Phase Fully-Burdened Budget accounts for the Parties’ internal costs incurred to conduct Development activities under the Subsequent-Phase Initial Indication Development Plan.

1.6    The reference to “Initial Indication Fully-Burdened Budget” in Section 4.4(b) of the Agreement is hereby replaced with “First-Phase Fully-Burdened Budget or Subsequent-Phase Fully-Burdened Budget, as applicable”.

1.7    Section 4.4(c) of the Agreement is hereby deleted and replaced in its entirety with the following:

(c)    True-Up Payments. If the budget in the First-Phase Initial Indication Development Plan or the budget in the Subsequent-Phase Initial Indication Development Plan is increased pursuant to Section 4.4(b), then ChemoCentryx may invoice VFMCRP for its share of such increase as determined under Section 4.4(a), and VFMCRP shall pay such invoice within thirty (30) days after receipt thereof. ChemoCentryx shall provide VFMCRP with a statement setting forth all Third Party costs incurred or accrued for activities under the First-Phase Initial Indication Development Plan and for activities under the Subsequent-Phase Initial Indication Development Plan within ninety (90) days after completion of all such activities under the applicable Development Plan. If the total of such Third Party costs is less than the then-current budget in the applicable Development Plan and VFMCRP has made all payments due and payable based upon such then-current budget, then VFMCRP may credit against subsequent payment(s) to be made to ChemoCentryx by VFMCRP under this Agreement the amount by which the total of the payments actually paid to ChemoCentryx for such Development Plan is greater than the total of the payments that VFMCRP would have paid to ChemoCentryx based on the actual Third Party costs for activities under the First-Phase Initial Indication Development Plan or Subsequent-Phase Initial Indication Development Plan, as applicable.

1.8    The references to “Initial Indication Fully-Burdened Budget” in Section 4.4(d) of the Agreement are hereby replaced with “First-Phase Fully-Burdened Budget plus the Subsequent-Phase Fully-Burdened Budget”.

 

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2.

MISCELLANEOUS

2.1    Full Force and Effect. This Amendment amends the terms of the Agreement and is deemed incorporated into the Agreement. The provisions of the Agreement, as amended by this Amendment, remain in full force and effect.

2.2    Entire Agreement. The Agreement, as amended by this Amendment constitute the entire agreement, both written and oral, between the Parties with respect to the subject matter hereof, and any and all prior agreements with respect to the subject matter hereof, either written or oral, expressed or implied, are superseded hereby, merged and canceled, and are null and void and of no effect.

2.3    Counterparts. This Amendment may be executed in one or more counterparts, each of which will be an original and all of which together will constitute one instrument.

 

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IN WITNESS WHEREOF, the Parties have executed this Amendment as of the Amendment Effective Date.

 

CHEMOCENTRYX, INC.   VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD.
By:  

/s/ Thomas J. Schall, Ph.D.

    By:  

/s/ David Bevan

Name:   Thomas J. Schall, Ph.D.     Name:   David Bevan
Title:   Chief Executive Officer     Title:   CEO
      By:  

/s/ Marcus Kracht

      Name:   Marcus Kracht
      Title:   Deputy CEO

 

Confidential

EX-31.1

Exhibit 31.1

CERTIFICATION OF CHIEF EXECUTIVE OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Thomas J. Schall, Ph.D., certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of ChemoCentryx, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

/s/ Thomas J. Schall, Ph.D.

Thomas J. Schall, Ph.D.
Chief Executive Officer

Date: August 9, 2018

 

EX-31.2

Exhibit 31.2

CERTIFICATION OF CHIEF FINANCIAL OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Susan M. Kanaya, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of ChemoCentryx, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

/s/ Susan M. Kanaya

Susan M. Kanaya
Chief Financial and Administrative Officer

Date: August 9, 2018

 

EX-32.1

Exhibit 32.1

CERTIFICATION

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)

In connection with the Quarterly Report on Form 10-Q of ChemoCentryx, Inc. (the “Company”) for the period ended June 30, 2018, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Thomas J. Schall, Ph.D., as Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: August 9, 2018       /s/ Thomas J. Schall, Ph.D.
      Thomas J. Schall, Ph.D.
      Chief Executive Officer

The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

EX-32.2

Exhibit 32.2

CERTIFICATION

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)

In connection with the Quarterly Report on Form 10-Q of ChemoCentryx, Inc. (the “Company”) for the period ended June 30, 2018, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Susan M. Kanaya, as Chief Financial and Administrative Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: August 9, 2018       /s/ Susan M. Kanaya
      Susan M. Kanaya
      Chief Financial and Administrative Officer

The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.