UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.WASHINGTON, DC 20549

 

 

FORMForm 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 September 30, 20172018

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 Itsits 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)

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 daysdays.    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 RegulationS-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, anon-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”company,” and “emerging growth company” inRule 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   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)13 (a) of the Exchange Act.  ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-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 October 31, 2017,2018 was 48,766,664.50,525,716.

 

 

 


CHEMOCENTRYX, INC.

QUARTERLY REPORT ON FORM10-Q

For the quarterly period ended September 30, 20172018

Table of Contents

 

PART I. FINANCIAL INFORMATION

   Page 

Item 1.

 Financial Statements (Unaudited)  
 Condensed Consolidated Balance Sheets – September 30, 20172018 and December 31, 20162017   3 
 Condensed Consolidated Statements of Operations – Three and Nine Months Ended September 30, 20172018 and 20162017   4 
 Condensed Consolidated Statements of Comprehensive Loss – Three and Nine Months Ended September 30, 20172018 and 20162017   5 
 Condensed Consolidated Statements of Cash Flows – Nine Months Ended September 30, 20172018 and 20162017   6 
 Notes to Condensed Consolidated Financial Statements   7 

Item 2.

 Management’s Discussion and Analysis of Financial Condition and Results of Operations   1419 

Item 3.

 Quantitative and Qualitative Disclosures About Market Risk   2128 

Item 4.

 Controls and Procedures   2128 

PART II. OTHER INFORMATION

  

Item 1.

 Legal Proceedings   2229 

Item 1A.

 Risk Factors   2229 

Item 2.

 Unregistered Sales of Equity Securities and Use of Proceeds   2231 

Item 3.

 Defaults Upon Senior Securities   2231 

Item 4.

 Mine Safety Disclosures   2231 

Item 5.

 Other Information   2231 

Item 6.

 Exhibits   22

SIGNATURES

2431 

EXHIBIT INDEX

   2332

SIGNATURES

33 


PART I. FINANCIAL INFORMATION

 

Item 1.

Financial Statements

CHEMOCENTRYX, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and par value data)

(unaudited)

 

  September 30, December 31, 
  2017 2016   September 30,
2018
 December 31,
2017
 
Assets      

Current assets:

      

Cash and cash equivalents

  $17,961  $12,024   $24,114  $40,020 

Short-term investments

   102,603  105,740    149,004  87,271 

Accounts receivable

   530  30,205    336  51,090 

Prepaid expenses and other current assets

   1,299  722    2,613  1,449 
  

 

  

 

   

 

  

 

 

Total current assets

   122,393  148,691    176,067  179,830 

Property and equipment, net

   970  905    1,594  1,210 

Long-term investments

   4,204  5,997    12,878  7,929 

Other assets

   381  279    222  359 
  

 

  

 

   

 

  

 

 

Total assets

  $127,948  $155,872   $190,761  $189,328 
  

 

  

 

   

 

  

 

 
Liabilities and Stockholders’ Equity      

Current liabilities:

      

Accounts payable

  $1,353  $671   $576  $1,400 

Accrued liabilities

   8,185  8,645    11,727  8,575 

Deferred revenue

   34,872  29,019    49,025  22,962 
  

 

  

 

   

 

  

 

 

Total current liabilities

   44,410  38,335    61,328  32,937 

Deferred revenue

   46,027  67,547 

Long-term debt, net

   14,727  4,676 

Noncurrent deferred revenue

   92,809  72,197 

Othernon-current liabilities

   214  101    425  251 
  

 

  

 

   

 

  

 

 

Total liabilities

   90,651  105,983    169,289  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; 48,772,716 shares and 48,057,920 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively

   49  48 

Common stock, $0.001 par value, 200,000,000 shares authorized; 50,428,507 and 48,837,060 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively

   50  49 

Additionalpaid-in capital

   366,187  356,966    385,339  368,553 

Note receivable

   (16 (16   (16 (16

Accumulated other comprehensive loss

   (68 (50   (189 (119

Accumulated deficit

   (328,855 (307,059   (363,712 (289,200
  

 

  

 

   

 

  

 

 

Total stockholders’ equity

   37,297  49,889    21,472  79,267 
  

 

  

 

   

 

  

 

 

Total liabilities and stockholders’ equity

  $127,948  $155,872   $190,761  $189,328 
  

 

  

 

   

 

  

 

 

See accompanying notes.

CHEMOCENTRYX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

 

  Three Months Ended Nine Months Ended 
  September 30, September 30, 
  2017 2016 2017 2016   Three Months Ended
September 30,
 Nine��Months Ended
September 30,
 
  2018 2017 2018 2017 

Revenue:

          

Collaboration and license revenue

  $9,029  $4,131  $26,196  $6,751   $8,975  $9,029  $33,543  $26,196 

Grant revenue

   —    120   —    295 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Total revenue

   9,029  4,251  26,196  7,046    8,975  9,029  33,543  26,196 

Operating expenses:

          

Research and development

   12,315  8,389  36,614  28,696    15,135  12,315  47,636  36,614 

General and administrative

   3,624  3,193  12,381  11,154    5,373  3,624  14,781  12,381 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Total operating expenses

   15,939  11,582  48,995  39,850    20,508  15,939  62,417  48,995 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Loss from operations

   (6,910 (7,331 (22,799 (32,804   (11,533 (6,910 (28,874 (22,799

Other income:

     

Other income (expense):

     

Interest income

   350  259  1,003  506    1,066  350  2,471  1,003 

Interest expense

   (423  —    (778  —   
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Total other income, net

   350  259  1,003  506    643  350  1,693  1,003 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Net loss

  $(6,560 $(7,072 $(21,796 $(32,298  $(10,890 $(6,560 $(27,181 $(21,796
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Basic and diluted net loss per common share

  $(0.13 $(0.15 $(0.45 $(0.70  $(0.22 $(0.13 $(0.55 $(0.45
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

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

   48,602  47,763  48,314  45,942    50,341  48,602  49,579  48,314 
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

See accompanying notes.

CHEMOCENTRYX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(in thousands)

(unaudited)

 

  Three Months Ended Nine Months Ended 
  September 30, September 30,   Three Months Ended
September 30,
 Nine Months Ended
September 30,
 
  2017 2016 2017 2016   2018 2017 2018 2017 

Net loss

  $(6,560 $(7,072 $(21,796 $(32,298  $(10,890 $(6,560 $(27,181 $(21,796

Other comprehensive income (loss):

     

Unrealized gain (loss) onavailable-for-sale securities

   45  (84 (18 36    48  45  (70 (18
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

Comprehensive loss

  $(6,515 $(7,156 $(21,814 $(32,262  $(10,842 $(6,515 $(27,251 $(21,814
  

 

  

 

  

 

  

 

   

 

  

 

  

 

  

 

 

See accompanying notes.

CHEMOCENTRYX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

  Nine Months Ended
September 30,
 
  2017 2016   Nine Months Ended
September 30,
 
  2018 2017 

Operating activities

      

Net loss

  $(21,796 $(32,298  $(27,181 $(21,796

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

      

Depreciation of property and equipment

   311  260    371  311 

Stock-based compensation

   6,841  6,488    7,969  6,841 

Noncash interest expense, net

   63  142 

Noncash interest (income) expense, net

   (714 63 

Changes in assets and liabilities:

      

Accounts receivable

   29,675  (120   50,754  29,675 

Prepaids and other current assets

   (577 (196   (1,164 (577

Other assets

   (102 (125   137  (102

Accounts payable

   682  165    (824 682 

Other liabilities

   (347 2,331    3,053  (347

Deferred revenue

   (15,667 71,249    (656 (15,667
  

 

  

 

   

 

  

 

 

Net cash provided by (used in) operating activities

   (917 47,896    31,745  (917

Investing activities

      

Purchases of property and equipment, net

   (376 (89   (755 (376

Purchases of investments

   (104,201 (116,958   (173,739 (104,201

Maturities of investments

   109,050  62,574    108,050  109,050 
  

 

  

 

   

 

  

 

 

Net cash provided by (used in) investing activities

   4,473  (54,473   (66,444 4,473 

Financing activities

      

Proceeds from issuance of common stock

   —    7,000 

Proceeds from exercise of stock options and employee stock purchase plan

   2,678  621    9,291  2,678 

Employees’ tax withheld and paid for restricted stock units

   (297  —      (473 (297

Borrowings under credit facility agreement, net of issuance costs

   9,975   —   
  

 

  

 

   

 

  

 

 

Net cash provided by financing activities

   2,381  7,621    18,793  2,381 
  

 

  

 

   

 

  

 

 

Net increase in cash and cash equivalents

   5,937  1,044 

Net increase (decrease) in cash and cash equivalents

   (15,906 5,937 

Cash and cash equivalents at beginning of period

   12,024  12,823    40,020  12,024 
  

 

  

 

   

 

  

 

 

Cash and cash equivalents at end of period

  $17,961  $13,867   $24,114  $17,961 
  

 

  

 

   

 

  

 

 

Supplemental disclosures of cash flow information

   

Cash paid for interest

  $426  $—   

See accompanying notes.

CHEMOCENTRYX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 20172018

(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, 20162017 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 reportAnnual Report on Form10-K for the year ended December 31, 20162017, filed with the Securities and Exchange Commission on March 14, 2017.12, 2018.

 

2.

Summary of Significant Accounting Policies

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted accounting principles in the United States of America (U.S. GAAP)(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):

 

   September 30,
2017
   December 31,
2016
 

Vifor (International) Ltd.(1)

  $530   $30,000 

U.S. Food and Drug Administration

   —      205 
  

 

 

   

 

 

 
  $530   $30,205 
  

 

 

   

 

 

 
   September 30,
2018
   December 31,
2017
 

Vifor (1)

  $336   $51,090 

 

 (1)

As of September 30,December 31, 2017, accounts receivable excluded the remaining $30.0$10.0 million cash commitments duecommitment received from Vifor $20.0 million of which is due in December 2017 in connection with the CCX140 Agreement and $10.0 million of which is due(International) Ltd. and/or its affiliates (collectively, 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.

As of December 31, 2016, accounts receivable excluded the $20.0 million cash commitment which is due from Vifor in December 2017 in connection with the CCX140 Agreement. See Note 7, “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.

For the nine months ended September 30, 20172018 and 2016,2017, the following potentially dilutive securities were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:

 

  Nine Months Ended 
  September 30,   Nine Months Ended
September 30,
 
  2017   2016   2018   2017 

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

   10,131,143    9,363,696    10,816,005    10,131,143 

Restricted stock units

   456,346    340,344    473,687    456,346 

Restricted stock awards

   95,866    —      37,713    95,866 

Warrants to purchase common stock

   150,000    150,000    150,000    150,000 
  

 

   

 

   

 

   

 

 
   10,833,355    9,854,040    11,477,405    10,833,355 
  

 

   

 

   

 

   

 

 

Comprehensive Loss

Comprehensive loss comprises net loss and other comprehensive income (loss). For the periods presented other comprehensive income (loss) consists of unrealized gains and losses on the Company’savailable-for-sale securities. For the three and nine months ended September 30, 20172018 and 2016,2017, there were no sales of investments, and therefore there were no reclassifications from accumulated other comprehensive loss to net loss.reclassifications.

Recent Accounting PronouncementsRevenue Recognition

In May 2014,Effective January 1, 2018, the Financial Accounting Standard Board (FASB) issuedCompany adopted Accounting Standards Update (ASU)No. 2014-09,Codification (ASC) Topic 606, Revenue from Contracts with Customers. The new standard’s core principle isCustomers (ASC 606) using the modified retrospective transition method. This standard applies to all contracts with customers, except for contracts that a reporting entity will recognizeare within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments. Under ASC 606, the Company recognizes revenue when it transfersits customer obtains control of promised goods or services, to customers in an amount that reflects the consideration to which the entityCompany expects to be entitledreceive in exchange for those goods or services. On July 9, 2015,To determine revenue recognition for arrangements that the FASB votedCompany 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 delay the effective dateperformance 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

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

Statement of Operations

      

Collaboration and license revenue

  $8,975   $4,727   $4,248 

Loss from operations

   (11,533   (15,781   4,248 

Net loss

   (10,890   (15,138   4,248 
   For the Nine Months Ended September 30, 2018 
   As
Reported
   Balances Without
Adoption of ASC606
   Effect
of Change
 

Statement of Operations

      

Collaboration and license revenue

  $33,543   $23,849   $9,694 

Loss from operations

   (28,874   (38,568   9,694 

Net loss

   (27,181   (36,875   9,694 

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

Balance Sheet

      

Liabilities:

      

Deferred revenue

  $49,025   $19,382   $29,643 

Noncurrent deferred revenue

   92,809    84,815    7,994 

Stockholders’ equity:

      

Accumulated deficit

   (363,712   (326,075   (37,637

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 one year.aligning it with the accounting for share-based payments to employees, with certain exceptions. The new standard would becomewill be effective for the Company beginning in the first quarter of 2018. Early application would be permitted in 2017. Entities would have the option of using either a full retrospective or a modified retrospective approach to adopt this new guidance. In 2016, the FASB updated the guidance for reporting revenue gross versus net to improve the implementation guidance on principal versus agent considerations, and for identifying performance obligations and the accounting of intellectual property licenses. In addition, the FASB introduced practical expedients and made narrow scope improvements to the new accounting guidance.

The Company currently plans to adopt the accounting standard update on January 1, 2018, using the modified retrospective approach. The cumulative effect of adopting the accounting standard update will be recorded to the Company’s accumulated deficit on January 1, 2018.2019. The Company is currently analyzingevaluating the impact of the adoption of this standard on its collaboration agreementsfinancial statements and does not expect the adoption of this accounting guidance to determinehave a material impact on the differencesconsolidated 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 treatment under ASUNo. 2014-09 compared tofor certain income tax effects of the current accounting treatment. During 2016, the Company entered into two license and collaboration agreements.Act. The Company has primarily derivedadjusted its revenuesdeferred tax assets and liabilities based on the reduction of the U.S. federal corporate tax rate from license34% to 21% and collaboration agreements.assessed the realizability of its deferred tax assets based on its current understanding of the provisions of the new law. The considerationCompany considers its accounting for the impacts of the new law to be provisional and the Company is eligiblewill continue to receive under these agreements includes upfront payments, research and development funding, milestone payments, and royalties. Each license and collaboration agreement is unique and will need to be assessed separately under the five-step process under the new standard. The new revenue recognition standard differs from the current accounting standard in many respects, such as in the accounting for variable consideration and the measurement of progress toward completion of performance obligations. While the Company has not completed its ongoing assessment ofassess the impact of adoption, the adoption of ASUNo. 2014-09 may have a material effectrecently 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.statements for the remainder of 2018. No adjustments were made to the provisional estimate during the three and nine months ended September 30, 2018.

In February 2016, the FASBFinancial Accounting Standard Board issued ASUAccounting Standards Update No. 2016-12,2016-02, 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 itstheir 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.

In March 2016,The Company has reviewed other recent accounting pronouncements and concluded they are either not applicable to the FASB issued ASUNo. 2016-09, Improvements to Employee Share-Based Payment Accounting, whichbusiness or that no material effect is intended to simplify several aspects of the accounting for share-based payment award transactions, including the income tax consequences, an option to recognize gross stock compensation expense with actual forfeitures recognized as they occur, as well as certain classificationsexpected on the statementconsolidated financial statements as a result of cash flows. Under this guidance, on a prospective basis, companies will no longer record excess tax benefitsfuture adoption.

In August 2018, the SEC adopted amendments to certain disclosure requirements in Securities Act Release No. 33-10532, Disclosure Update and tax deficiencies from stock option exercisesSimplification. These amendments eliminate, modify, or integrate into other SEC requirements certain disclosure rules. Among the amendments is the requirement to present an analysis of changes in additionalpaid-in capital (APIC). Instead, they will record all excess tax benefits and tax deficiencies as income tax expense or benefitstockholders’ equity in the interim financial statements included in quarterly reports on Form 10-Q. The analysis, which can be presented as a footnote or separate statement, of operations. In addition,is required for the guidance eliminatescurrent and comparative quarter and year-to-date interim periods. The amendments are effective for the requirement that excess tax benefits be realized before companies can recognize them. The ASU requires a cumulative-effect adjustmentCompany in its interim financial statements for previously unrecognized excess tax benefits in opening retained earnings in the annual period of adoption.quarter ended March 31, 2019. The Company adopted ASUNo. 2016-09 on January 1, 2017. Upondoes not anticipate that the adoption the Company recognized the excess tax benefit balance of $2.1 million as of January 1, 2017 asthese SEC amendments will have a deferred tax asset with a corresponding increasematerial effect to the Company’s deferred tax asset valuation allowance. Additionally, as provided for under this new guidance, the Company elected to continue to estimate forfeitures. The adoptionfinancial position, results of this aspect of the guidance did not have a material impact on the Company’s financial statements.operations, cash flows or stockholders’ equity.

3. Cash Equivalents and Investments

3.Cash Equivalents and Investments

The amortized cost and fair value of cash equivalents and investments at September 30, 20172018 and December 31, 20162017 were as follows (in thousands):

 

   September 30, 2017 
   Amortized   Gross Unrealized   Fair 
   Cost   Gains   Losses   Value 

Money market fund

  $17,098   $—     $—     $17,098 

U.S. treasury securities

   46,687    —      (50   46,637 

Commercial paper

   32,066    —      —      32,066 

Corporate debt securities

   28,122    —      (18   28,104 
  

 

 

   

 

 

   

 

 

   

 

 

 

Totalavailable-for-sale securities

  $123,973   $—     $(68  $123,905 
  

 

 

   

 

 

   

 

 

   

 

 

 

Classified as:

        

Cash equivalents

        $17,098 

Short-term investments

         102,603 

Long-term investments

         4,204 
        

 

 

 

Totalavailable-for-sale securities

        $123,905 
        

 

 

 

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

Money market fund

  $21,152   $—     $—     $21,152 

U.S. treasury securities

   22,919    —      (31   22,888 

Commercial paper

   39,690    —      —      39,690 

Asset-backed securities

   29,037    —      (8   29,029 

Corporate debt securities

   70,399    —      (150   70,249 
  

 

   

 

   

 

   

 

 

Total available-for-sale securities

  $183,197   $—     $(189  $183,008 
  

 

   

 

   

 

   

 

 

Classified as:

        

Cash equivalents

        $21,126 

Short-term investments

         149,004 

Long-term investments

         12,878 
        

 

 

Total available-for-sale securities

        $183,008 
        

 

 
  December 31, 2016   December 31, 2017 
  Amortized   Gross Unrealized   Fair   Amortized   Gross Unrealized   Fair 
  Cost   Gains   Losses   Value   Cost   Gains   Losses   Value 

Money market fund

  $9,746   $—     $—     $9,746   $29,848   $—     $—     $29,848 

U.S. treasury securities

   49,693    1    (22   49,672    29,005    —      (52   28,953 

Commercial paper

   16,183    —      —      16,183    46,184    —      —      46,184 

Corporate debt securities

   45,911    —      (29   45,882    27,095    —      (67   27,028 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Totalavailable-for-sale securities

  $121,533   $1   $(51  $121,483   $132,132   $—     $(119  $132,013 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Classified as:

                

Cash equivalents

        $9,746         $36,813 

Short-term investments

         105,740          87,271 

Long-term investments

         5,997          7,929 
        

 

         

 

 

Totalavailable-for-sale securities

        $121,483         $132,013 
        

 

         

 

 

Cash equivalents in the tables above exclude cash of $0.9$3.0 million and $2.3$3.2 million as of September 30, 20172018 and December 31, 2016,2017, respectively. Allavailable-for-sale securities held as of September 30, 20172018 had contractual maturities of less than two years. There have been no significant realized gains or losses onavailable-for-sale securities for the periods presented. No significantavailable-for-sale securities held as of September 30, 20172018 have been in a continuous unrealized loss position for more than 12 months. As of September 30, 2017,2018, unrealized losses onavailable-for-sale investments are not attributed to credit risk and are

considered to be temporary. The Company believes that it ismore-likely-than-not 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.

 

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 arewere as follows (in thousands) as of September 30, 20172018 and December 31, 2016:2017 (in thousands):

 

  September 30, 2017   September 30, 2018 
Description  Level 1   Level 2   Level 3   Total   Level 1   Level 2   Level 3   Total 

Money market fund

  $17,098   $—     $—     $17,098   $21,152   $—     $—     $21,152 

U.S. treasury securities

   —      46,637    —      46,637    —      22,888    —      22,888 

Commercial paper

   —      32,066    —      32,066    —      39,690    —      39,690 

Asset-backed securities

   —      29,029    —      29,029 

Corporate debt securities

   —      28,104    —      28,104    —      70,249    —      70,249 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total assets

  $17,098   $106,807   $—     $123,905   $21,152   $161,856   $—     $183,008 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 
  December 31, 2016   December 31, 2017 
Description  Level 1   Level 2   Level 3   Total   Level 1   Level 2   Level 3   Total 

Money market fund

  $9,746   $—     $—     $9,746   $29,848   $—     $—     $29,848 

U.S. treasury securities

   —      49,672    —      49,672    —      28,953    —      28,953 

Commercial paper

   —      16,183    —      16,183    —      46,184    —      46,184 

Corporate debt securities

   —      45,882    —      45,882    —      27,028    —      27,028 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total assets

  $9,746   $111,737   $—     $121,483   $29,848   $102,165   $—     $132,013 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

During the nine months ended September 30, 2017,2018, 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 usingnon-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, includingnon-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 corroboratesnon-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.

Other Fair Value Measurements

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

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

Long-term debt, net(1)

  $14,727   $14,867   $4,676   $4,812 

(1)

Carrying amounts of long-term debt were net of unamortized debt discounts of $273,000 and $324,000 as of September 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):

 

  September 30,   December 31, 
  2017   2016   September 30,
2018
   December 31,
2017
 

Research and development related

  $5,285   $5,482   $7,590   $4,962 

Compensation related

   1,990    2,460    2,419    2,345 

Consulting and professional services

   529    421    1,086    1,012 

Other

   381    282    632    256 
  

 

   

 

   

 

   

 

 
  $8,185   $8,645   $11,727   $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. As of September 30, 2018, the Company had borrowed $15.0 million under the Credit Facility, which is the full amount available under the first tranche. The Company may borrow up to an additional $10.0 million through December 15, 2018 under the second tranche. 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.

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 $0.9 million. 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 September 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 September 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

   (273
  

 

 

 

Present value of remaining debt payments

   14,727 

Less: current portion

   —   
  

 

 

 

Noncurrent portion

  $14,727 
  

 

 

 

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 aten-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 September 30, 2017.2018. The Company had an accounts payable balance due to Bio-Techne for the purchases of research materials of approximately $1,000$460 and $25,000$6,000 as of September 30, 20172018 and December 31, 2016,2017, respectively.

 

7.8.

Collaboration and License Agreements

Avacopan Agreements

In May 2016, the Company entered into an exclusive collaboration and license agreement with Vifor (International) Ltd. (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 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 and China. 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 administeredorally-administered inhibitor of the chemokine receptor known as CCR2.

In connection with the Avacopan Agreement, the Company received anon-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.

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 September 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 considerationpayment received under the May 2016 Avacopan Agreement, $7.0 million was initially allocated as of June 30, 2016 as follows:

$7.0 million forto 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;

 

$12.520.0 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 was creditable against an upfront fee payable by Vifor, shouldbegan on the parties enter intoeffective date of May 9, 2016 and ends upon completion of development and regulatory services. The Company will use a worldwidecost-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 nine months ended September 30, 2018, the Company recognized $7.6 million and $28.8 million of collaboration and license agreement for CCX140. The amount creditable decreased ratably intorevenue under the fourth quarter of 2016. In October 2016,Avacopan Agreement, the amount creditable expiredAvacopan Amendment, and was reclassifiedthe Avacopan Letter Agreement, respectively.

Prior to the amortizable portionadoption of deferred revenueASC 606 on January 1, 2018, the Company accounted for its performance obligations under the Avacopan Agreement and Avacopan Amendment as discussed below.

The remainingone combined unit of accounting with the upfront consideration of $65.5 million will befees being recognized over the estimated period of performance underperformance. See “Note 10. Collaboration and License Agreements – Avacopan Agreements” in the Avacopan Agreement, which approximates 4.2 years, ending in June 2020. The deliverables under the Avacopan Agreement consist of intellectual property licenses, development and regulatory servicesCompany’s Annual Report on Form 10-K for the submission offiscal year ended December 31, 2017, filed with the Marketing Authorization Application (MAA). The Company considered the provisions of the revenue recognition multiple-element arrangement guidance and concluded that the license and the development and regulatory activitiesSEC on March 12, 2018, for the submission of the MAA do not have stand-alone value because the rights conveyed to do not permit Vifor to perform all efforts necessary to use the Company’s technology to bring the compound through development and, upon regulatory approval, commercialization of the compound. Accordingly, the Company combined these deliverables and allocated the remaining upfront consideration of $65.5 million into a single unit of accounting.

Following the October 2016 expiration of the $12.5 million potentially creditable towards a CCX140 license agreement, such amount was reclassified to the amortizable portion of deferred revenue, which continues to be recognized over the estimated period of performance under the Avacopan Agreement ending in June 2020.

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). 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 and China. In connection with this arrangement, the Company received a $20.0 million upfront cash commitment for the expanded rights, $10.0 million of which was received in February 2017. The remaining $10.0 million is due in February 2018 and is not reflected in accounts receivable as of September 30, 2017. The February 2017 Avacopan Amendment and the original May 2016 Avacopan Agreement are accounted for as a combined agreement. The February 2017 Avacopan Amendment did not represent a material modification given among other factors, there were no changes to the Company’s deliverables under the arrangement. As such, the additional upfront commitment of $20.0 million under the Avacopan Amendment will be recognized over the remaining estimated period of performance ending in June 2020.further discussion. For the three and nine months ended September 30, 2017, the Company recognized $6.2 million and $18.2 million respectively, of collaboration and license revenue under the Avacopan Agreement and the Avacopan Amendment compared to $4.1 million and $6.8 million in the same periods ended September 30, 2016. Upon achievement of certain regulatory and commercial milestones with avacopan, the Company will receive additional payments of up to $510.0 million under the Avacopan Agreement. In addition, the Company will receive royalties, with rates ranging from the low teens to themid-twenties, on future potential net sales of avacopan by Vifor in the licensed territories.ASC 605, respectively.

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 U.S.United States and China,.China. CCX140 is an orally-administered inhibitor of the chemokine receptor known as CCR2. The Company retains marketing rights in the U.S.United States and China, while Vifor has commercialization rights in the rest of the world. Pursuant to the CCX140 Agreement, the Company will beis responsible for the clinical development of CCX140 in rare renal diseases and will beis 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, ChemoCentryxthe Company would receiveco-promotion rights infor CKD in the U.S.

United States. Under the terms of the CCX140 Agreement, the Company received anon-refundable upfront commitmentpayment of $50.0 million $30.0 millionin 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 which was received in January 2017.$5.0 million. The remaining $20.0 million, which is due onCompany and Vifor also entered into an amendment to the first anniversaryCCX140 Agreement (the CCX140 Amendment) to clarify the timing of certain payments with respect to development funding of the CCX140 Agreement, was not reflected in accounts receivable asprogram by Vifor, and the Company received a non-refundable payment of September 30, 2017. The upfront commitment of $50.0 million will be recognized over the estimated period of performance under the CCX140 Agreement, which approximates 5.0 years, ending in December 2021. The deliverables under the CCX140 Agreement consist of intellectual property licenses, development and regulatory services for the submission of the MAA.$11.5 million. The Company considered the provisionsretains control of the revenue recognition multiple-element arrangement guidanceongoing and concluded that the license and thefuture development and regulatory activities for the submission of the MAA do not have stand-alone value because the rights conveyed to do not permit Vifor to perform all efforts necessary to use the Company’s technology to bring the compound through development and, upon regulatory approval, commercialization of the compound. Accordingly, the Company combined these deliverables and allocated the upfront consideration of $50.0 million into a single unit of accounting.

For the three and nine months ended September 30, 2017, the Company recognized $2.8 million and $8.0 million of collaboration and license revenue under the CCX140 Agreement, respectively, of which $2.5 million and $7.5 million were associated with the recognition of upfront commitment. The remaining amounts represented collaboration revenue derived from funding of CCX140 (other than country-specific development services from Vifor. 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 themid-twenties, on net sales of CCX140 in the licensed territories.

UnderThe Company identified the Avacopan Agreement andfollowing 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 future contingent payments related tothe license is not distinct from the development and regulatory milestones meetservices within the definitioncontext of a substantive milestone under the accounting guidance. Accordingly, revenue for the achievement of these milestones will be recognized in the period when the milestoneagreement because Vifor is achieved. The Company will be eligible to receive contingent payments related to commercial milestones baseddependent 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 of Vifor and these payments are not considered to be milestones under the accounting guidance. These contingent commercial milestone payments will be included in the allocation of arrangement consideration if and when achieved, resulting in an accounting treatment similar to the upfront payment. obligation.

As of September 30, 2017,2018, the transaction price of $113.5 million consists of the following:

$50.0 million upfront payment under the CCX140 Agreement;

$58.5 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 had not received any milestone paymentstransfers 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 nine months ended September 30, 2018, the Company recognized $1.5 million and $4.8 million of collaboration and license revenue under the AvacopanCCX140 Agreement, or the CCX140 Agreement. The Company expects to recognize royalty revenue in the period of sale of the related product, based on the underlying contract terms. The Avacopan AgreementAmendment, and the CCX140 Letter Agreement, arerespectively.

Prior to the adoption of ASC 606 on January 2, 2018, the Company accounted for its performance obligations under the CCX140 Agreement as separate arrangements.

8.Government Grant

In April 2016,one combined unit of accounting with the Company was awarded an Orphan Products Development grant byupfront fee of $50.0 million being recognized over the U.S. Foodestimated period of performance. See “Note 10. Collaboration and Drug Administration to support the clinical development of avacopanLicense Agreements – CCX140 Agreement” in the amount of $500,000, which was fully recognized and received as of September 30, 2017. The term ofCompany’s Annual Report on Form 10-K for the grant expired in May 2017. Duringfiscal year ended December 31, 2017, filed with the SEC on March 12, 2018, for further discussion. For the three and nine months ended September 30, 2017, the Company did not recognize any grantrecognized $2.8 million and $8.0 million of collaboration and license revenue under the CCX140 Agreement under ASC 605, respectively.

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

   September 30,   December 31, 
   2018   2017 

Contract asset:

    

Accounts receivable

  $336   $51,090 

Contract liability:

    

Deferred revenue(1)

   (141,834   (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 nine months ended September 30, 2016,2018, the Company recognized $120,000the following revenue as a result of changes in the contract asset and $295,000, respectively, of grant revenue.the contract liability balances (in thousands):

 

   Three Months Ended
September 30, 2018
   Nine Months Ended
September 30, 2018
 

Revenue recognized in the period from:

    

Amount included in contract liability at the beginning of the period

  $8,719   $30,960 

Performance obligations satisfied (or partially satisfied) in previous periods

  $(2,604  $(2,867

9.

Equity Incentive Plans

Stock Options

During the nine months ended September 30, 2017,2018, the Company had the following option activities under its equity incentive plans:

 

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

Balance at December 31, 2016

   1,655,524  9,345,515  $7.72     

Balance at December 31, 2017

   2,028,880  10,203,571  $7.68     

Shares authorized

   1,900,000          1,940,000   —        

Granted(1)

   (1,914,238 1,634,500  6.95        (2,420,772 2,191,912  9.92     

Exercised(2)

   40,208  (405,912 5.85        79,585  (1,439,754 6.23     

Forfeited and expired(3)

   489,862  (476,528 6.47     

Forfeited and expired

   162,686  (162,686 7.77     
  

 

  

 

        

 

  

 

      

Balance at September 30, 2017

   2,171,356  10,097,575  $7.73    6.35   $10,544 

Outstanding at September 30, 2018

   1,790,379  10,793,043  $8.32    6.50   $49,384,541 
  

 

  

 

        

 

  

 

      

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

   10,504,655  $8.32    6.43   $48,192,358 
   

 

      

Exercisable at September 30, 2018

   6,824,579  $8.47    5.13   $31,173,388 
   

 

      

 

(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.

(3)The difference between shares forfeited and expired in the number of shares available for grant and outstanding options represents the RSUs canceled for the period.

Restricted Stock

During the nine months ended September 30, 2017,2018, the activity for restricted stock is summarized as follows:

 

      Weighted Average   Shares   Weighted Average
Grant-Date

Fair Value
 
      Grant-Date 
  Shares   Fair Value 

Balance at December 31, 2016

   471,650   $4.60 

Balance at December 31, 2017

   508,444   $5.79 

Granted

   279,738    6.72    228,860    11.32 

Vested

   (185,842   4.26    (225,904   5.78 

Canceled

   (13,334   3.57    —      —   
  

 

     

 

   

Unvested at September 30, 2017

   552,212   $5.81 

Unvested at September 30, 2018

   511,400   $8.26 
  

 

     

 

   

Stock-based Compensation

Total stock-based compensation expense was $1.9$2.8 million and $6.8$8.0 million during the three and nine months ended September 30, 2017,2018, respectively, and $1.8$1.9 million and $6.5$6.8 million respectively, during the same periods ended September 30, 2016.2017. As of September 30, 2017, $9.62018, $16.0 million, $2.0$2.5 million, and $23,000$31,000 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 2.52, 1.72,2.59, 1.33, and 0.12 years, respectively.

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 Form10-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 Form10-K for the fiscal year ended December 31, 2016,2017, filed with the Securities and Exchange Commission, or SEC, on March 14, 2017.12, 2018.

Forward-Looking Statements

This Quarterly Report on Form10-Q contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form10-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 Form10-K for the fiscal year ended December 31, 2016,2017, filed with the SEC on March 14, 2017.12, 2018 and in this Quarterly Report on Form10-Q.

Any forward-looking statement in this Quarterly Report on Form10-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™ andTraficet-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 Form10-Q belongs to its respective holder.

Unless the context requires otherwise, in this Quarterly Report on Form10-Q the terms “ChemoCentryx,” “we,” “us” and “our” refer to ChemoCentryx, Inc., a Delaware corporation, and our subsidiary taken as a whole.whole unless otherwise noted.

Overview

ChemoCentryx is a biopharmaceutical company developing new medications targeted at inflammatory disorders, autoimmune diseases and cancer. Each of our drug candidates is designed to selectively blocksblock a specific chemokine or chemoattractant receptors,receptor, leaving the rest of the immune system intact. Our drug candidates are small molecules, which are orally administered, offeringand, if approved, could address unmet medical needs, including improved efficacy, and offer 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 commitmentsfees and milestonesmilestone payments to support the clinical development of our two 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 us managecommunicate the wide arraybreadth of opportunities,our drug discovery platform, we have segmented our pipeline into early stage and late stage compounds.drug candidates.

Late Stage CompoundsDrug Candidates

We have chosen to focus initially on kidney disease, particularly on rareorphan indications, where orphan 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 and Rare Diseases

Avacopan (formerly CCX168) is an orally-administered complement inhibitor targeting the C5a receptor, or C5aR, and is being developed for orphan and rare diseases, including 1)(i) anti-neutrophil cytoplasmic auto-antibody associated vasculitis, or AAV, a devastating autoimmune disease that destroysdamages blood vessels and can lead to kidney failure; 2) atypical hemolytic uremic syndrome, or aHUS, a rare, life threatening disease; and 3)(ii) complement 3 glomerulopathy, or C3G, a debilitating kidney disease that can lead to kidney failure.failure; and (iii) hidradenitis suppurativa, or HS, a chronic, inflammatory, debilitating skin disease characterized by recurrent, painful, nodules and abscesses, ultimately leading to the formation of draining fistulas (also known as sinus tracts) as well as scarring.

Avacopan has been granted orphan drug designation by the U.S. Food and Drug Administration, or FDA, for the treatment of AAV aHUS 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, and C3G.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, the results ofin which demonstrated that avacopan was safe, 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-blindtwo-arm study that is planned to enroll 300which enrolled 316 patients at approximately 200 sites in the United States, Canada, Europe, Australia, New Zealand and New Zealand. We expect to complete patientJapan. Patient enrollment of the Phase III ADVOCATE trial was completed in mid-2018. We recentlyJuly 2018 and we expect to report topline data from this study in the fourth quarter of 2019. Additionally, we launched a registration-supporting clinical trial to study avacopan for the treatment of patients with C3G and also plan to initiate the samea large placebo-controlled Phase II clinical study for the treatment of patients with aHUSHS in 2017; designed to potentially support registration of avacopan in these indications.late 2018.

CCX140—CCX140 – Chronic and RareOrphan Kidney Diseases

CCX140, is 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—proteinuria, excess protein in the urine—urine, and impaired renal function. CCX140 has been granted orphan drug designation by the FDA for the treatment of FSGS.

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 ana SOC renin-angiotensin-aldosterone system inhibitor treatment resulted in a statistically significant reduction in proteinuria, beyond that achieved with SOC alone.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 plan to initiate in 2017 alaunched our clinical endpoint trialdevelopment program of CCX140 for the treatment of patients with primary FSGS, for which there are currently noFDA-approved treatments.

Global 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, fordisease. While under this agreement we retained all rights to the commercialUnited States and China, we granted Vifor exclusive commercialization rights to avacopan in Europe and certain other international markets,markets. In December 2016, we entered into an additional agreement with Vifor, which we refer to as the Avacopan Agreement. We expanded our partnership with Vifor in December 2016 with an additional deal forCCX140 Agreement, relating to CCX140, our other late stage drug candidate, CCX140, wherebycandidate. 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, which we refer to as the CCX140 Agreement; and inChina. In February 2017, we announced a further dealagreement with Vifor for avacopan 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 $155$215 million in upfront cash payments and commitments, plus substantial potential milestone paymentsmilestones pursuant to our agreements with Vifor.Vifor and are eligible for additional substantial milestone payments. Through our alliance, we maintain the commercialcommercialization rights ofto avacopan and CCX140 in the United States, and China, and also retain control of the clinical development programs for rareorphan renal disease. Vifor gainsgained the commercialexclusive commercialization rights for all other international markets, and willis obligated to pay us tiered royalties, with rates ranging from ten to themid-twenties, on potential net sales.

At a future time defined in the contract,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 receiveco-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 CompoundsDrug Candidates

While the science has led us to focuswe have focused initially on kidney disease, our targeted blocking systemourtarget 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 IIb trial for non-operableadvanced pancreatic cancer. OurWe expect that our ability to do so will grow as we increase our scale and to the extent that we 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 September 30, 2017,2018, we had an accumulated deficit of $328.9$363.7 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.

JOBS Act

In April 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an emerging growth company can utilize the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for implementing new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to delay such adoption of new or revised accounting standards, and as a result, we may not implement new or revised accounting standards on the relevant dates on which adoption of such standards is required for other companies.

Subject to certain conditions set forth in the JOBS Act, as an emerging growth company, we intend to rely on certain of these exemptions, including without limitation, providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404 and implementing any requirement that may be adopted regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis). These exemptions will apply for a period of five years following the completion of our IPO although if the market value of our common stock that is held by nonaffiliates exceeds $700 million as of any June 30 before that time, we would cease to be an emerging growth company as of the following December 31.

Critical Accounting Policies and Significant Judgments and Estimates

There have been no material changes in our critical accounting policies during the nine months ended September 30, 2017,2018, 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 Form10-K for the fiscal year ended December 31, 2016,2017, filed with the SEC on March 14, 2017.12, 2018, other than the following:

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 fromnon-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, were-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 cumulativecatch-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.

Results of Operations

Revenue

We have not generated any revenue from product sales. For the periods presented, our revenues wererevenue was derived from (i) the recognition of the upfront paymentscollaboration and license revenue related to the Avacopan Agreement Avacopan Amendment and CCX140 Agreement; (ii) collaboration revenue underAgreement, in each case, as amended, and the CCX140 Agreement and (iii) grant revenue from the FDA Orphan Products Development grant to support the clinical development of avacopan for the treatment of patients with AAV.related letter agreements. Total revenuerevenues for the periods as compared to the same periods in the prior year were as follows (in thousands):

 

   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2017  2016   2017  2016 

Collaboration and license revenue

  $9,029  $4,131   $26,196  $6,751 

Grant revenue

   —     120    —     295 
  

 

 

  

 

 

   

 

 

  

 

 

 

Total revenue

  $9,029  $4,251   $26,196  $7,046 
  

 

 

  

 

 

   

 

 

  

 

 

 

Dollar increase

  $4,778    $19,150  

Percentage increase

   112    272 
   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
   2018  2017   2018  2017 

Collaboration and license revenue

  $8,975  $9,029   $33,543  $26,196 

Dollar increase (decrease)

  $(54   $7,347  

Percentage increase (decrease)

   (1)%     28 

The increasesOn 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 revenue from 2016deferred revenue. Revenue recognized prior to 2017January 1, 2018 has not been restated and continues to be reported under the accounting standards in effect for those periods.

For the three and nine month periods were due to; (i)months ended September 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 nine months ended September 30, 2017, revenue recognized represents amortization of the upfront license fee commitments from Vifor pursuant to the Avacopan Agreement Avacopan Amendment and CCX140 Agreement, in each case, as well as (ii) collaboration revenue for development services under the CCX140 Agreement in the 2017 periods. These increases were partially offset by a decrease in grant revenue from the FDA to support the clinical development of avacopan for the treatment of patients with AAV.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 nine months ended September 30, 2017,2018, as compared to the same periodperiods in the prior year, were as follows (in thousands):

 

  Three Months Ended
September 30,
   Nine Months Ended
September 30,
   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
  2017 2016   2017 2016   2018 2017   2018 2017 

Research and development expenses

  $12,315  $8,389   $36,614  $28,696   $15,135  $12,315   $47,636  $36,614 

Dollar increase

  $3,926    $7,918    $2,820    $11,022  

Percentage increase

   47    28    23    30 

The increase in research and development expenses from 20162017 to 20172018 for the three month period was primarily attributabledue to higher inthe advancement of the avacopan ADVOCATE Phase III clinicalpivotal trial which completed enrollment in July 2018. The increase in research and development expenses from 2017 to 2018 for the nine month period was primarily due to the initiation and patient enrollment of the avacopan ADVOCATEPhase II clinical trial in patients with AAVC3G and higherstart-up, initiation and patient enrollment of the CCX140 Phase II clinical development expense due to start-up expenses related to the clinical trial of avacopan for the treatment of C3G. These increases were partially offset by lower Phase II expenses due to the completion of the avacopan

CLEAR and CLASSIC clinical trials for the treatment of AAV in 2016. Decreased Phase I development expense was due to the completion of enrollment in the clinical trial for CCX872 in patients with advanced pancreatic cancer in 2016.

Research and development expenses increased from 2016 to 2017 for the nine month period primarily due to the initiation andFSGS. Continued patient enrollment of the avacopan Phase III ADVOCATE trial in patients with AAV and start-up expenses relatedalso contributed to the Phase II clinical trial of avacopanincrease in research and development expenses for the treatment of C3G. These increases were partially offset by lower Phase II clinical development expense primarily due to the completion of the avacopan CLEAR and CLASSIC clinical trials for the treatment of AAV in 2016 and lower Phase I development expense due to the completion of enrollment in the clinical trial for CCX872 in patients with advanced pancreatic cancer in 2016.nine month period.

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

 

  Three Months Ended
September 30,
   Nine Months Ended
September 30,
   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
  2017   2016   2017   2016   2018   2017   2018   2017 

Phase I

  $218   $802   $962   $5,299   $104   $218   $1,183   $962 

Phase II

   3,760    1,192    6,476    9,780    3,536    3,760    11,554    6,476 

Phase III

   5,067    3,247    19,069    3,515    7,480    5,067    23,171    19,069 

Research and drug discovery

   3,270    3,148    10,107    10,102    4,015    3,270    11,728    10,107 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total R&D

  $12,315   $8,389   $36,614   $28,696   $15,135   $12,315   $47,636   $36,614 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

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 ourin-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 CCX872 and vercirnon.CCX872.

General and administrative expenses

Total general and administrative expenses for the three and nine months ended September 30, 2017,2018, as compared to the same periods in the prior year, were as follows (in thousands):

 

  Three Months Ended
September 30,
   Nine Months Ended
September 30,
   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
      2017         2016           2017         2016       2018 2017   2018 2017 

General and administrative expenses

  $3,624  $3,193   $12,381  $11,154   $5,373  $3,624   $14,781  $12,381 

Dollar increase

  $431    $1,227    $1,749    $2,400  

Percentage increase

   13    11    48    19 

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.

The increaseincreases from 20162017 to 20172018 for the three and nine month period wasperiods were primarily due to higher accounting related feesemployee-related expenses, including those associated with preparing to meet the requirements pursuant to the Sarbanes-Oxley Act of 2002. The increase from 2016 to 2017 for the nine month period was primarily due toour commercialization planning efforts, and higher intellectual property related expenses and accounting related fees partially offset by lower travel expenses.professional fees.

We expectanticipate that our general and administrative expenses will increase substantially in the future as we expand our operatingprimarily because of increasedpre-commercial activities and incur additional expenses associated with preparingpersonnel costs to meetsupport the requirements pursuant topotential launch of avacopan for the Sarbanes-Oxley Acttreatment of 2002, includingAAV in connection with the expiration of our status as an emerging growth company, expected to occur in 2017.United States.

Other income, net

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

 

  Three Months Ended
September 30,
   Nine Months Ended
September 30,
   Three Months Ended
September 30,
   Nine Months Ended
September 30,
 
      2017         2016           2017         2016       2018 2017   2018 2017 

Interest income

  $350  $259   $1,003  $506   $1,066  $350   $2,471  $1,003 

Interest expense

   (423  —      (778  —   
  

 

  

 

   

 

  

 

   

 

  

 

   

 

  

 

 

Total other income, net

  $350  $259   $1,003  $506   $643  $350   $1,693  $1,003 
  

 

  

 

   

 

  

 

   

 

  

 

   

 

  

 

 

Dollar increase

  $91    $497    $293    $690  

Percentage increase

   35    98    84    69 

The increases in total other income, net from 20162017 to 20172018 for the three and nine 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 2017 due2018, partially offset by interest expense related to the receipt of upfront payments totaling $125.0 million received from Viforloan and security agreement with Hercules Capital, Inc., or the Credit Facility. We expect that interest expense to increase in connection with the Avacopan Agreement, Avacopan Amendment and CCX140 Agreement.future if we borrow additional amounts under the Credit Facility or if interest rates continue to rise.

Liquidity and Capital Resources

As of September 30, 2017,2018, we had approximately $124.8$186.0 million in cash, cash equivalents and investments. Such amounts exclude $30.0 million in remaining upfront commitments in connection with the December 2016 CCX140 Agreement and February 2017 Avacopan Amendment, which are due on the first anniversary of these agreements. The following table shows a summary of our cash flows for the nine months ended September 30, 20172018 and 20162017 (in thousands):

   Nine Months Ended
September 30,
 
   2018   2017 

Cash provided by (used in)

    

Operating activities

  $31,745   $(917

Investing activities

  $(66,444  $4,473 

Financing activities

  $18,793   $2,381 

   Nine Months Ended
September 30,
 
       2017           2016     

Cash provided by (used in)

    

Operating activities

  $(917  $47,896 

Investing activities

   4,473    (54,473

Financing activities

   2,381    7,621 

Operating activities.    Net cash used inprovided by operating activities was $0.9$31.7 million for the nine months ended September 30, 2017,2018, compared to $47.9 million provided bynet cash used in operating activities of $0.9 million for the same period in 2016.2017. This changeincrease was primarily due to changes in working capital items.items, which was partially offset by a higher net loss. For the nine months ended September 30, 2017,2018, changes in working capital included the receipt of $30.0$50.0 million milestone payment in connection with the Avacopan Agreement, $10.0 million upfront commitment under the Avacopan Amendment, $10.0 million of accounts receivableaggregate 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. For the same period in 2016, changes in working capital included the receipt of $78.0 million, most of which was included as deferred revenue, in connection with the Avacopan Agreement.

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

Financing activities.    Net cash provided by financing activities was $2.4$18.8 million for the nine months ended September 30, 2017,2018, compared to $7.6$2.4 million for the same period in 2016.2017. Net cash provided by financing activities for both periods presented included proceeds from the exercise of stock options and stock purchases from employee purchases of stock undercontributions to our 2012 Employee Stock Purchase Plan. For the nine months ended September 30, 2016, netPlan, and cash provided also included the receipt of $7.0 million in net proceeds from the issuance of 3,333,333 shares of our common stock in connection with the Avacopan Agreement. For the nine months ended September 30, 2017, cash used for financing activities included $0.3 million (the value of withheld shares), for tendered ChemoCentryx, Inc. common stock to satisfy employee tax withholding requirements upon vesting of restricted stock units. For the nine months ended September 30, 2018, net cash provided by financing activities also included $10.0 million received under the Credit Facility.

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 September 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 Form10-Q for additional information regarding our borrowings.

As of September 30, 2017,2018, we had approximately $124.8$186.0 million in cash, cash equivalents and investments, excluding the $30.0 million in remaining upfront commitments in connection with the December 2016 CCX140 Agreement and the February 2017 Avacopan Amendment, which are due on the first anniversary of these agreements.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, November 7, 2017.8, 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

ThereExcept for the additional borrowing of $10.0 million under the Credit Facility in June 2018, there have been no material changes outside the ordinary course of our business to the contractual obligations we reported in our Annual Report on Form10-K for the fiscal year ended December 31, 2016,2017, filed with the SEC on March 14, 2017.12, 2018. See “Note 6. Long-term Debt” in the Notes to Condensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form10-Q for additional information regarding our borrowings.

Recent Accounting Pronouncements

See “Note 2. Summary of Significant Accounting Policies” in the notesNotes to condensed consolidated financial statementsCondensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form10-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.

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Our market risks at September 30, 20172018 have not changed significantly from those discussed in “Item 7A. Quantitative and Qualitative Disclosures About Market Risk” of our Annual Report on Form10-K for the fiscal year ended December 31, 2016,2017, filed with the SEC on March 14, 2017.12, 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 September 30, 2018, borrowings under the Credit Facility totaled $15.0 million with an interest rate of 8.55%. 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 Form10-Q for additional information regarding our borrowings.

 

Item 4.

Controls and Procedures

Conclusions Regarding the Effectiveness of Disclosure Controls and Procedures

As of September 30, 2017,2018, 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 Rules13a-15(e) and15d-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 SEC’sSecurities 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 September 30, 2017,2018, 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 September 30, 2017,2018, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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 Form10-K for the fiscal year ended December 31, 2016,2017, filed with the SEC on March 14, 2017.12, 2018, other than the risk factors below.

Risks Related to Our Business

The development of new drugs is a highly risky undertaking which involves a lengthy process, and our drug discovery and development activities therefore may not result in products that are approved for marketing and sale by the applicable regulatory authorities on the time schedule we have planned, or at all, or result in substantial payments to us.

Our drug candidates are in the early stages of drug discovery or clinical trials and are prone to the risks of failure inherent in drug development. As of September 30, 2018, nine of our drug candidates have been tested in human beings. We will need to conduct significant additional preclinical studies and clinical trials before we can demonstrate that any of our drug candidates is safe and effective to the satisfaction of the FDA, the EMA and other regulatory authorities. Preclinical studies and clinical trials are expensive and uncertain processes that take years to complete. For example, we incurred significant expenses related to the IND filing and the completed single ascending dose Phase I clinical trial for CCX915, our first generation CCR2 drug candidate, which did not advance into Phase II clinical trials because its pharmacokinetic, or PK, properties in humans did not meet our expectations. Failure can occur at any stage of the process, and we cannot assure you that any of our drug candidates will demonstrate safety and efficacy in clinical trials or result in commercially successful products. For example, we have a Conditional Marketing Authorization, or CMA, application pending for avacopan for the treatment of patients with anti-neutrophil cytoplasmic AAV, which is under review by the EMA’s Committee for Medicinal Products for Human Use, or CHMP, and for which, as part of its standard review protocol, we have received the CHMP’s Day 120 list of questions. These questions raise a number of issues with respect to our CMA application within the categories of quality, clinicaland non-clinical that fit within the CHMP’s categorization scheme as “major objections” and as such will need to be resolved to the satisfaction of the CHMP before it would be able to make a recommendation for conditional marketing authorization in the European Union. While we believe that the issues raised by the CHMP in its Day 120 list of questions are all potentially addressable and that we will be able to provide adequate responses, we can provide no assurance regarding if or when we will be able to address these issues to the satisfaction of the CHMP, whether we will ultimately be successful in obtaining a CMA or, if successful, that the indication for which we ultimately receive a CMA will not be narrower than the indication for which we are currently seeking conditional approval.

We cannot assure you that our ongoing clinical trials or any future clinical trial of any of our other drug candidates will be completed on schedule, or at all, or whether our planned clinical trials will start in a timely manner. The commencement of our planned clinical trials could be substantially delayed or prevented by a number of factors, including:

 

delays or failures in obtaining sufficient quantities of the active pharmaceutical ingredient, or API, and/or drug product;

delays or failures in reaching agreement on acceptable clinical trial agreement terms or clinical trial protocols with prospective sites;

delays or failures in obtaining institutional review board, or IRB, or ethics committee approval to conduct a clinical trial at a prospective site;

the need to successfully complete, on a timely basis, preclinical safety pharmacology or toxicology studies;

the limited number of, and competition for, suitable sites to conduct the clinical trials;

the limited number of, and competition for, suitable patients for enrollment in the clinical trials; and

delays or failures in obtaining regulatory approval to commence a clinical trial.

The completion of our clinical trials could also be substantially delayed or prevented by a number of factors, including:

slower than expected rates of patient recruitment and enrollment;

failure of patients to complete the clinical trials;

failure of our third party vendors to timely or adequately perform their contractual obligations relating to the clinical trials;

inability or unwillingness of patients or medical investigators to follow our clinical trial protocols;

inability to monitor patients adequately during or after treatment;

termination of the clinical trials by one or more clinical trial sites;

unforeseen safety issues;

lack of efficacy demonstrated during clinical trials;

lack of adequate funding to continue the clinical trials;

the need for unexpected discussions with the FDA, EMA or other foreign regulatory agencies regarding the scope or design of our clinical trials or the need to conduct additional trials;

unforeseen delays by the FDA, EMA or other foreign regulatory agencies after submission of our results;

an unfavorable FDA or EMA inspection of our contract manufacturers of API or drug product; and

inspection of the clinical trial preliminary results, operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold.

Any failure or significant delay in completing clinical trials for our drug candidates would harm the commercial prospects for our drug candidates and adversely affect our financial results.

Additionally, changes in regulatory requirements and guidance may occur and we may need to amend clinical trial protocols to reflect these changes. Amendments may require us to resubmit our clinical trial protocols to regulatory agencies and ethics committees for reexamination, which may impact the costs, timing or successful completion of a clinical trial. If we experience delays in completion of, or if we terminate, any of our clinical trials, the commercial prospects for our drug candidates may be harmed and our ability to generate product revenues will be delayed. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of a drug candidate.

Our clinical trials may be suspended or terminated at any time for a number of safety-related reasons. For example, we may voluntarily suspend or terminate our clinical trials if at any time we believe that our drug candidates present an unacceptable safety risk to the clinical trial patients. In addition, IRBs or regulatory agencies may order the temporary discontinuation or termination of our clinical trials at any time if they believe that the clinical trials are not being conducted in accordance with applicable regulatory requirements, including if they present an unacceptable safety risk to patients. Administering any drug candidate to humans may produce undesirable side effects. The existence of undesirable side effects resulting from our drug candidates could cause us or regulatory authorities, such as the FDA, to interrupt, delay or halt clinical trials of our drug candidates and could result in the FDA or other regulatory agencies denying further development or approval of our drug candidates for any or all targeted indications.

Further, chemokine receptors and chemoattractant receptors are a novel class of targets. As a result, we may experience unforeseen adverse side effects with our existing and future drug candidates, including CCX140 and avacopan. Although we have not observed significant harmful side effects in prior studies of our drug candidates, later trials could reveal such side effects. The PK profile of preclinical studies may not be indicative of results in any clinical trial. For example, prior to commencing our preclinical studies of our CCX140 drug candidate, we studied another drug candidate that targeted CCR2, which we abandoned after PK results were not as favorable in humans as in earlier preclinical animal studies. We have not completed studies on the long-term effects associated with the use of our drug candidates. Completion of studies of these long-term effects may be required for regulatory approval and would delay our introduction of our drug candidates into the market. These studies could also be required at any time after regulatory approval of any of our drug candidates. Absence of long-term data may also limit the approved uses of our products, if any, to short-term use. Some or all of our drug candidates may prove to be unsafe for human use.

In addition, we are party to collaboration and license agreements with Vifor, the Avacopan Agreement and the CCX140 Agreement, which require Vifor to make substantial payments to us upon achievement of certain regulatory and commercial milestones. However, Vifor has the right to terminate the Avacopan Agreement and the CCX140 Agreement at its convenience, in which case we would not receive such payments.

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 followingpreceding the signature page of this Quarterly Report on Form10-Q, and is incorporated herein by reference.

EXHIBIT INDEX

 

Exhibit
Number

  

Description

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 Form10-Q for the quarterly period ended September 30, 2017,2018, 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.

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: November 7, 20178, 2018/s/ Thomas J. Schall, Ph.D.
 

/s/

Thomas J. Schall, Ph.D.

 

Thomas J. Schall, Ph.D.

President and Chief Executive Officer

(Principal Executive Officer)

Date: November 7, 2017

8, 2018
/s/ Susan M. Kanaya
 

/s/

Susan M. Kanaya

 

Susan M. Kanaya

Executive Vice President,

Chief Financial and Administrative Officer and Secretary

(Principal Financial andOfficer)
Date: November 8, 2018/s/ Pui San Kwan

Pui San Kwan

Vice President, Finance
(Principal Accounting Officer)

 

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