UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.WASHINGTON, DC 20549

FORM10-Q

Form 10-Q

(Mark One)

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

For the quarterly period ended September 30, 2017March 31, 2022

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.)

835 Industrial Road, Suite 600

San Carlos, California

94070

(Address of Principal Executive Offices)

(Zip Code)

(650) 210-2900

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Delaware

Title of each class

Trading Symbol(s)

94-3254365

Name of each exchange on which registered

(State or Other Jurisdiction of

Incorporation or Organization)Common Stock, par value $0.001 per share

CCXI

(I.R.S. Employer

Identification No.)The Nasdaq Stock Market LLC

850 Maude Avenue

Mountain View, California 94043

(Address of Principal Executive Offices) (Zip Code)

(650)210-2900

(Registrant’s Telephone Number, Including Area Code)

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

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of RegulationS-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes  YesNo  ☐

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

Non-accelerated filer☐  (Do not check if a smaller reporting company)

Smaller reporting company

Emerging Growth Companygrowth 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,April 29, 2022 was 48,766,664.71,193,352.



CHEMOCENTRYX, INC.

QUARTERLY REPORT ON FORM 10-Q

For the quarterly period ended September 30, 2017March 31, 2022

Table of Contents

 

PART I. FINANCIAL INFORMATION

Page

PART I. FINANCIAL INFORMATION

Page

Item 1.

Financial Statements (Unaudited)

3

Condensed Consolidated Balance Sheets – September 30, 2017March 31, 2022 and December 31, 20162021

3

Condensed Consolidated Statements of Operations – Three and Nine Months Ended September 30, 2017March 31, 2022 and 20162021

4

Condensed Consolidated Statements of Comprehensive Loss – Three and Nine Months Ended September 30, 2017March 31, 2022 and 20162021

5

Condensed Consolidated Statements of Stockholders’ Equity – Three Months Ended March 31, 2022 and 2021

6

Condensed Consolidated Statements of Cash Flows – NineThree Months Ended September 30, 2017March 31, 2022 and 20162021

6

7

Notes to Condensed Consolidated Financial Statements

7

8

Item 2.

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

14

20

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

21

26

Item 4.

Controls and Procedures

21

27

PART II. OTHER INFORMATION

Item 1.

Legal Proceedings22

Item 1A.1.

Legal Proceedings

Risk Factors22

28

Item 1A.

Risk Factors

28

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

22

29

Item 3.

Defaults Upon Senior Securities

22

29

Item 4.

Mine Safety Disclosures

22

29

Item 5.

Other Information22

Item 6.5.

Other Information

Exhibits22

29

SIGNATURES

24

Item 6.

Exhibits

29

EXHIBIT INDEX

30

SIGNATURES

23

31

2


PART I. FINANCIAL INFORMATION

Item 1.Financial Statements

Item 1. Financial Statements

CHEMOCENTRYX, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and par value data)

(unaudited)

 

 

March 31,

 

 

December 31,

 

 

 

2022

 

 

2021

 

 

 

(unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

40,577

 

 

$

49,978

 

Short-term investments

 

 

300,024

 

 

 

214,514

 

Accounts receivable, net

 

 

2,781

 

 

 

411

 

Accounts receivable from related party

 

 

29

 

 

 

43

 

Inventory

 

 

2,897

 

 

 

851

 

Prepaid expenses and other current assets

 

 

5,324

 

 

 

3,380

 

Total current assets

 

 

351,632

 

 

 

269,177

 

Property and equipment, net

 

 

31,482

 

 

 

32,269

 

Long-term investments

 

 

31,235

 

 

 

97,856

 

Operating lease right-of-use assets

 

 

24,592

 

 

 

24,806

 

Other assets

 

 

1,512

 

 

 

1,544

 

Total assets

 

$

440,453

 

 

$

425,652

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

5,423

 

 

$

6,746

 

Accrued and other current liabilities

 

 

25,547

 

 

 

26,358

 

Long-term debt, current

 

 

19,128

 

 

 

18,920

 

Deferred revenue from related party

 

 

18,709

 

 

 

10,993

 

Total current liabilities

 

 

68,807

 

 

 

63,017

 

Long-term debt, net

 

 

4,554

 

 

 

4,715

 

Non-current deferred revenue from related party

 

 

62,094

 

 

 

24,772

 

Non-current lease liabilities

 

 

46,062

 

 

 

46,830

 

Other non-current liabilities

 

 

217

 

 

 

198

 

Total liabilities

 

 

181,734

 

 

 

139,532

 

Commitments (Note 7)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.001 par value, 10,000,000 shares authorized;
   
0 shares issued and outstanding

 

 

0

 

 

 

0

 

Common stock, $0.001 par value, 200,000,000 shares authorized;
  
71,142,102 and 70,357,557 shares issued and outstanding at
   March 31, 2022 and December 31, 2021, respectively

 

 

71

 

 

 

70

 

Additional paid-in capital

 

 

916,224

 

 

 

903,646

 

Note receivable

 

 

(16

)

 

 

(16

)

Accumulated other comprehensive loss

 

 

(1,855

)

 

 

(483

)

Accumulated deficit

 

 

(655,705

)

 

 

(617,097

)

Total stockholders’ equity

 

 

258,719

 

 

 

286,120

 

Total liabilities and stockholders’ equity

 

$

440,453

 

 

$

425,652

 

   September 30,  December 31, 
   2017  2016 
Assets   

Current assets:

   

Cash and cash equivalents

  $17,961  $12,024 

Short-term investments

   102,603   105,740 

Accounts receivable

   530   30,205 

Prepaid expenses and other current assets

   1,299   722 
  

 

 

  

 

 

 

Total current assets

   122,393   148,691 

Property and equipment, net

   970   905 

Long-term investments

   4,204   5,997 

Other assets

   381   279 
  

 

 

  

 

 

 

Total assets

  $127,948  $155,872 
  

 

 

  

 

 

 
Liabilities and Stockholders’ Equity   

Current liabilities:

   

Accounts payable

  $1,353  $671 

Accrued liabilities

   8,185   8,645 

Deferred revenue

   34,872   29,019 
  

 

 

  

 

 

 

Total current liabilities

   44,410   38,335 

Deferred revenue

   46,027   67,547 

Othernon-current liabilities

   214   101 
  

 

 

  

 

 

 

Total liabilities

   90,651   105,983 

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 

Additionalpaid-in capital

   366,187   356,966 

Note receivable

   (16  (16

Accumulated other comprehensive loss

   (68  (50

Accumulated deficit

   (328,855  (307,059
  

 

 

  

 

 

 

Total stockholders’ equity

   37,297   49,889 
  

 

 

  

 

 

 

Total liabilities and stockholders’ equity

  $127,948  $155,872 
  

 

 

  

 

 

 

See accompanying notes.

3


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
March 31,

 

 

2022

 

 

2021

 

Revenue:

     

 

 

 

 

 

Collaboration and license revenue

  $9,029  $4,131  $26,196  $6,751 

Product sales, net

 

$

5,353

 

 

$

0

 

Collaboration and license revenue from related party

 

 

106

 

 

 

10,223

 

Grant revenue

   —    120   —    295 

 

 

0

 

 

 

130

 

  

 

  

 

  

 

  

 

 

Total revenue

   9,029  4,251  26,196  7,046 

 

 

5,459

 

 

 

10,353

 

Operating expenses:

     

 

 

 

 

 

 

Cost of sales

 

 

205

 

 

 

0

 

Research and development

   12,315  8,389  36,614  28,696 

 

 

17,476

 

 

 

23,418

 

General and administrative

   3,624  3,193  12,381  11,154 
  

 

  

 

  

 

  

 

 

Selling, general and administrative

 

 

26,011

 

 

 

16,262

 

Total operating expenses

   15,939  11,582  48,995  39,850 

 

 

43,692

 

 

 

39,680

 

  

 

  

 

  

 

  

 

 

Loss from operations

   (6,910 (7,331 (22,799 (32,804

 

 

(38,233

)

 

 

(29,327

)

Other income:

     

Other expense:

 

 

 

 

 

 

Interest income

   350  259  1,003  506 

 

 

222

 

 

 

305

 

  

 

  

 

  

 

  

 

 

Total other income, net

   350  259  1,003  506 
  

 

  

 

  

 

  

 

 

Interest expense

 

 

(597

)

 

 

(689

)

Total other expense, net

 

 

(375

)

 

 

(384

)

Net loss

  $(6,560 $(7,072 $(21,796 $(32,298

 

$

(38,608

)

 

$

(29,711

)

  

 

  

 

  

 

  

 

 

Net loss per common share

 

 

 

 

 

 

Basic and diluted net loss per common share

  $(0.13 $(0.15 $(0.45 $(0.70

 

$

(0.55

)

 

$

(0.43

)

  

 

  

 

  

 

  

 

 

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

   48,602  47,763  48,314  45,942 

 

 

70,835

 

 

 

69,608

 

  

 

  

 

  

 

  

 

 

See accompanying notes.

4


CHEMOCENTRYX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(in thousands)

(unaudited)

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

 

Three Months Ended
March 31,

 

  2017 2016 2017 2016 

 

2022

 

 

2021

 

Net loss

  $(6,560 $(7,072 $(21,796 $(32,298

 

$

(38,608

)

 

$

(29,711

)

Other comprehensive income (loss):

     

Unrealized gain (loss) onavailable-for-sale securities

   45  (84 (18 36 
  

 

  

 

  

 

  

 

 

Unrealized loss on available-for-sale securities

 

 

(1,372

)

 

 

(128

)

Comprehensive loss

  $(6,515 $(7,156 $(21,814 $(32,262

 

$

(39,980

)

 

$

(29,839

)

  

 

  

 

  

 

  

 

 

See accompanying notes.

5


CHEMOCENTRYX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(in thousands, except share data)

(unaudited)

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Note

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders'

 

 

 

Shares

 

 

 

Amount

 

 

Capital

 

 

Receivable

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance as of December 31, 2021

 

 

70,357,557

 

 

 

$

70

 

 

$

903,646

 

 

$

(16

)

 

$

(483

)

 

$

(617,097

)

 

$

286,120

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(38,608

)

 

 

(38,608

)

Unrealized loss on investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(1,372

)

 

 

 

 

 

(1,372

)

Issuance of common stock upon net exercise of warrant

 

 

66,833

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock under
   equity incentive and employee
   stock purchase plans

 

 

803,567

 

 

 

 

1

 

 

 

6,278

 

 

 

 

 

 

 

 

 

 

 

 

6,279

 

Repurchased shares upon vesting of
    restricted stock units for tax
    withholdings

 

 

(85,855

)

 

 

 

 

 

 

(3,126

)

 

 

 

 

 

 

 

 

 

 

 

(3,126

)

Employee stock-based compensation

 

 

 

 

 

 

 

 

 

9,182

 

 

 

 

 

 

 

 

 

 

 

 

9,182

 

Compensation expense related to
    options granted to consultants

 

 

 

 

 

 

 

 

 

244

 

 

 

 

 

 

 

 

 

 

 

 

244

 

Balance as of March 31, 2022

 

 

71,142,102

 

 

 

$

71

 

 

$

916,224

 

 

$

(16

)

 

$

(1,855

)

 

$

(655,705

)

 

$

258,719

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Note

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders'

 

 

 

Shares

 

 

 

Amount

 

 

Capital

 

 

Receivable

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balance as of December 31, 2020

 

 

69,452,466

 

 

 

$

69

 

 

$

870,788

 

 

$

(16

)

 

$

114

 

 

$

(485,342

)

 

$

385,613

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(29,711

)

 

 

(29,711

)

Unrealized loss on investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(128

)

 

 

0

 

 

 

(128

)

Issuance of common stock under
   equity incentive and employee
   stock purchase plans

 

 

370,987

 

 

 

 

1

 

 

 

2,162

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

2,163

 

Repurchased shares upon vesting of
    restricted stock units for tax
    withholdings

 

 

(80,960

)

 

 

 

0

 

 

 

(5,013

)

 

 

0

 

 

 

0

 

 

 

0

 

 

 

(5,013

)

Employee stock-based compensation

 

 

 

 

 

 

0

 

 

 

7,840

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

7,840

 

Compensation expense related to
    options granted to consultants

 

 

 

 

 

 

0

 

 

 

240

 

 

 

0

 

 

 

0

 

 

 

0

 

 

 

240

 

Balance as of March 31, 2021

 

 

69,742,493

 

 

 

$

70

 

 

$

876,017

 

 

$

(16

)

 

$

(14

)

 

$

(515,053

)

 

$

361,004

 

See accompanying notes.

6


CHEMOCENTRYX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

  Nine Months Ended
September 30,
 
  2017 2016 

 

Three Months Ended
March 31,

 

 

2022

 

 

2021

 

Operating activities

   

 

 

 

 

 

Net loss

  $(21,796 $(32,298

 

$

(38,608

)

 

$

(29,711

)

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

   

 

 

 

 

 

Stock-based compensation

 

 

9,426

 

 

 

8,080

 

Depreciation of property and equipment

   311  260 

 

 

1,017

 

 

 

117

 

Stock-based compensation

   6,841  6,488 

Noncash interest expense, net

   63  142 

Non-cash lease expense

 

 

215

 

 

 

594

 

Non-cash interest expense, net

 

 

1,228

 

 

 

997

 

Changes in assets and liabilities:

   

 

 

 

 

 

Accounts receivable

   29,675  (120

Accounts receivable, net

 

 

(2,370

)

 

 

7

 

Accounts receivable from related party

 

 

14

 

 

 

(9,980

)

Inventory

 

 

(2,046

)

 

 

0

 

Prepaids and other current assets

   (577 (196

 

 

(2,162

)

 

 

583

 

Other assets

   (102 (125

 

 

32

 

 

 

(4

)

Accounts payable

   682  165 

 

 

(1,329

)

 

 

1,201

 

Operating lease liabilities

 

 

(664

)

 

 

6,342

 

Other liabilities

   (347 2,331 

 

 

(960

)

 

 

418

 

Deferred revenue

   (15,667 71,249 
  

 

  

 

 

Deferred revenue from related party

 

 

45,038

 

 

 

(211

)

Net cash provided by (used in) operating activities

   (917 47,896 

 

 

8,831

 

 

 

(21,567

)

Investing activities

   

 

 

 

 

 

Purchases of property and equipment, net

   (376 (89

 

 

(224

)

 

 

(10,880

)

Purchases of investments

   (104,201 (116,958

 

 

(91,498

)

 

 

(95,278

)

Maturities of investments

   109,050  62,574 

 

 

70,385

 

 

 

166,826

 

  

 

  

 

 

Net cash provided by (used in) investing activities

   4,473  (54,473

Net cash (used in) provided by investing activities

 

 

(21,337

)

 

 

60,668

 

Financing activities

   

 

 

 

 

 

Proceeds from issuance of common stock

   —    7,000 

Proceeds from exercise of stock options and employee stock purchase plan

   2,678  621 

 

 

6,231

 

 

 

2,163

 

Employees’ tax withheld and paid for restricted stock units

   (297  —   
  

 

  

 

 

Net cash provided by financing activities

   2,381  7,621 
  

 

  

 

 

Net increase in cash and cash equivalents

   5,937  1,044 

Cash and cash equivalents at beginning of period

   12,024  12,823 
  

 

  

 

 

Cash and cash equivalents at end of period

  $17,961  $13,867 
  

 

  

 

 

Employees' tax withheld and paid for restricted stock units

 

 

(3,126

)

 

 

(5,013

)

Net cash provided by (used in) financing activities

 

 

3,105

 

 

 

(2,850

)

Net (decrease) increase in cash, cash equivalents and restricted cash

 

 

(9,401

)

 

 

36,251

 

Cash, cash equivalents and restricted cash at beginning of period

 

 

51,058

 

 

 

33,377

 

Cash, cash equivalents and restricted cash at end of period

 

$

41,657

 

 

$

69,628

 

Supplemental disclosures of cash flow information

 

 

 

 

 

Cash paid for interest

 

$

488

 

 

$

509

 

Right-of-use assets obtained in exchange for lease obligations

 

$

1

 

 

$

300

 

Purchases of property and equipment, net recorded in
accounts payable and accrued liabilities

 

$

6

 

 

$

2,807

 

See accompanying notes.

7


CHEMOCENTRYX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2017March 31, 2022

(unaudited)

1.
Description of Business

1.Description of Business

ChemoCentryx, Inc. (the Company) commenced operations in 1997. The Company is a clinical-stagefully integrated United States biopharmaceutical company focused on developingthe development and commercialization of new medications targeted attargeting inflammatory disorders, autoimmune diseases and cancer. The Company discovered, developed and is now commercializing TAVNEOSÒ (avacopan) in the U.S. as an adjunctive treatment for adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis), specifically granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), the two main forms of ANCA-associated vasculitis, in combination with standard therapy including glucocorticoids, and not for the elimination of glucocorticoids use. The Company’s principal operations are in the United StatesU.S. and it operates in one1 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, 20162021 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, 20162021 filed with the Securities and Exchange Commission on March 14, 2017.1, 2022.

2.Summary of Significant Accounting Policies
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.

For the three months ended March 31, 2022 and 2021, total revenue derived from the Company’s collaboration with Vifor (International) Ltd., and/or its affiliates, or collectively, Vifor, was 1.9% and 98.7%, respectively. Accounts receivable are typically unsecured and are concentrated within a few customers 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 
  

 

 

   

 

 

 

(1)As of September 30, 2017, accounts receivable excluded the remaining $30.0 million cash commitments due 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 in February 2018 in connection with the Avacopan Amendment.

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 amended and restated 2012 Employee Stock Purchase Plan (the Restated 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.

8


For the ninethree months ended September 30, 2017March 31, 2022 and 2016,2021, the following potentially dilutive securities were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:effect (in thousands):

  Nine Months Ended 

Three Months Ended

 

  September 30, 

March 31,

 

  2017   2016 

2022

 

 

2021

 

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

   10,131,143    9,363,696 

 

7,123

 

 

 

7,483

 

Restricted stock units

   456,346    340,344 

 

560

 

 

 

425

 

Restricted stock awards

   95,866    —   

 

15

 

 

 

14

 

Warrants to purchase common stock

   150,000    150,000 

Warrant to purchase common stock(1)

 

0

 

 

 

150

 

  

 

   

 

 

 

7,698

 

 

 

8,072

 

   10,833,355    9,854,040 
  

 

   

 

 

(1)
In 2012, the Company issued a warrant with a ten-year term to purchase 150,000 shares of its common stock at an exercise price of $20.00 per share. The warrant was exercised in January 2022.

Product Sales, net

The Company sells TAVNEOS to a limited number of specialty pharmacies and a specialty distributor. These customers subsequently dispense TAVNEOS directly to patients or resell it to hospitals and certain pharmacies. The Company recognizes product sales when the customer obtains control of the Company’s product, which occurs typically upon delivery to the customer. Product sales to these customers are recorded net of reserves established for distributor service fees and prompt payment discounts as stated in agreements, estimates for product returns, government rebates, chargebacks and the Company’s co-pay assistance program for patients. The Company estimates these reserves using the expected value approach. The Company believes its estimated reserves require significant judgment and may adjust these estimates as it accumulates historical data and assesses other quantitative and qualitative factors. Differences from actual results and changes to these estimates will be reported in the period that the differences become known.

Cost of Sales

Cost of sales for product sales and product supply consists primarily of direct and indirect costs related to the manufacturing of TAVNEOS products sold, including third-party manufacturing costs, packaging services, freight, storage costs, allocation of overhead costs of employees involved with production and net sales-based royalties expense. The Company began capitalizing costs related to inventory in October 2021 upon the U.S. Food and Drug Administration (FDA) approval of TAVNEOS. Manufacturing costs associated with campaigns initiated prior to FDA approval were recorded as research and development expense. Accordingly, cost of sales in the near term will likely be lower than in later periods given the sales of pre-approval inventory will carry little to no manufacturing costs given such costs were previously expensed to research and development expense.

Inventory

The Company values its inventories at the lower-of-cost or net realizable value on a first-in, first-out (FIFO) basis. Inventories include the cost for raw materials, third party contract manufacturing and packaging services, and indirect personnel and overhead associated with production. The Company performs an assessment of the recoverability of inventory during each reporting period, and writes down any excess and obsolete inventories to their net realizable value in the period in which the impairment is first identified. If they occur, such impairment charges are recorded as a component of cost of sales in the consolidated statements of operations. The Company capitalizes inventory costs associated with products when future commercialization is considered probable and the future economic benefit is expected to be realized, which is typically when regulatory approval is obtained for a drug candidate. As such, the Company begins capitalizing costs as inventory when a drug candidate receives regulatory approval. Prior to regulatory approval, the Company recorded inventory costs related to drug candidates as research and development expense.

Comprehensive Loss

Comprehensive loss comprises net loss and other comprehensive income (loss).loss. For the periods presented, other comprehensive income (loss)loss consists of unrealized gains and losseson the Company’savailable-for-sale securities. For the three and nine months ended September 30, 2017March 31, 2022 and 2016,2021, there were no 0sales of investments and therefore there were no reclassifications from accumulated otherof comprehensive loss to net loss..

9


Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standard Board (FASB) issued Accounting Standards Update (ASU)No. 2014-09, Revenue from Contracts with Customers. The new standard’s core principle is that a reporting entity will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. On July 9, 2015, the FASB voted to delay the effective date of the new standard by one year. The standard would become 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. The Company is currently analyzing its collaboration agreements to determine the differences in the accounting treatment under ASUNo. 2014-09 compared to the current accounting treatment. During 2016, the Company entered into two license and collaboration agreements. The Company has primarily derived its revenues from licensereviewed recent accounting pronouncements and collaboration agreements. concluded they are either not applicable to the business or that no material effect is expected on the consolidated financial statements as a result of future adoption.

3.
Cash Equivalents, Restricted Cash and Investments

Cash, Cash Equivalents and Restricted Cash

The considerationfollowing table provides a reconciliation of cash, cash equivalents and restricted cash shown in the Condensed Consolidated Statements of Cash Flows (in thousands):

 

 

March 31,

 

 

December 31,

 

 

 

2022

 

 

2021

 

Cash and cash equivalents

 

$

40,577

 

 

$

49,978

 

Restricted cash included in Other assets

 

 

1,080

 

 

 

1,080

 

Total cash, cash equivalents and restricted cash

 

$

41,657

 

 

$

51,058

 

Restricted cash as of March 31, 2022 and December 31, 2021 was held as collateral for stand-by letters of credit issued by the Company is eligible 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 underits landlord in connection with 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 assessmentlease of the impact of adoption, the adoption of ASUNo. 2014-09 may have a material effectCompany’s facility in San Carlos, California. See “Note 7. Commitments” for additional information on its financial statements.this lease.

In February 2016, the FASB issued ASUNo. 2016-12, Leases (Topic 842). The new standard requires all lessees recognize the assetsCash Equivalents and liabilities that arise from leases on the balance sheet and disclose qualitative and quantitative information about its 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.Investments

In March 2016, the FASB issued ASUNo. 2016-09, Improvements to Employee Share-Based Payment Accounting, which 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 classifications on the statement of cash flows. Under this guidance, on a prospective basis, companies will no longer record excess tax benefits and tax deficiencies from stock option exercises in additionalpaid-in capital (APIC). Instead, they will record all excess tax benefits and tax deficiencies as income tax expense or benefit in the statement of operations. In addition, the guidance eliminates the requirement that excess tax benefits be realized before companies can recognize them. The ASU requires a cumulative-effect adjustment for previously unrecognized excess tax benefits in opening retained earnings in the annual period of adoption. The Company adopted ASUNo. 2016-09 on January 1, 2017. Upon adoption, the Company recognized the excess tax benefit balance of $2.1 million as of January 1, 2017 as a deferred tax asset with a corresponding increase 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 adoption of this aspect of the guidance did not have a material impact on the Company’s financial statements.

3.Cash Equivalents and Investments

The amortized cost and fair value of cash equivalents and investments at September 30, 2017March 31, 2022 and December 31, 20162021 were as follows (in thousands):

  September 30, 2017 

 

March 31, 2022

 

  Amortized   Gross Unrealized   Fair 

 

Amortized

 

 

Gross Unrealized

 

 

Fair

 

  Cost   Gains   Losses   Value 

 

Cost

 

 

Gains

 

 

Losses

 

 

Value

 

Money market fund

  $17,098   $—     $—     $17,098 

 

$

37,331

 

 

$

0

 

 

$

0

 

 

$

37,331

 

U.S. treasury securities

   46,687    —      (50   46,637 

 

115,369

 

 

 

1

 

 

 

(708

)

 

 

114,662

 

Non-U.S. government securities

 

16,743

 

 

 

0

 

 

 

(180

)

 

 

16,563

 

Commercial paper

   32,066    —      —      32,066 

 

73,868

 

 

 

0

 

 

 

0

 

 

 

73,868

 

Asset-backed securities

 

32,400

 

 

 

0

 

 

 

(212

)

 

 

32,188

 

Corporate debt securities

   28,122    —      (18   28,104 

 

 

94,734

 

 

 

14

 

 

 

(770

)

 

 

93,978

 

  

 

   

 

   

 

   

 

 

Totalavailable-for-sale securities

  $123,973   $—     $(68  $123,905 

 

$

370,445

 

 

$

15

 

 

$

(1,870

)

 

$

368,590

 

  

 

   

 

   

 

   

 

 

 

 

 

 

 

 

 

 

 

Classified as:

        

 

 

 

 

 

 

 

 

 

 

Cash equivalents

        $17,098 

 

 

 

 

 

 

 

 

$

37,331

 

Short-term investments

         102,603 

 

 

 

 

 

 

 

 

300,024

 

Long-term investments

         4,204 

 

 

 

 

 

 

 

 

 

31,235

 

        

 

 

Totalavailable-for-sale securities

        $123,905 

 

 

 

 

 

 

 

 

$

368,590

 

        

 

 

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

Money market fund

  $9,746   $—     $—     $9,746 

U.S. treasury securities

   49,693    1    (22   49,672 

Commercial paper

   16,183    —      —      16,183 

Corporate debt securities

   45,911    —      (29   45,882 
  

 

 

   

 

 

   

 

 

   

 

 

 

Totalavailable-for-sale securities

  $121,533   $1   $(51  $121,483 
  

 

 

   

 

 

   

 

 

   

 

 

 

Classified as:

        

Cash equivalents

        $9,746 

Short-term investments

         105,740 

Long-term investments

         5,997 
        

 

 

 

Totalavailable-for-sale securities

        $121,483 
        

 

 

 

10


 

 

December 31, 2021

 

 

 

Amortized

 

 

Gross Unrealized

 

 

Fair

 

 

 

Cost

 

 

Gains

 

 

Losses

 

 

Value

 

Money market fund

 

$

41,960

 

 

$

0

 

 

$

0

 

 

$

41,960

 

U.S. treasury securities

 

 

40,397

 

 

 

0

 

 

 

(160

)

 

 

40,237

 

Government-sponsored agencies

 

 

16,821

 

 

 

0

 

 

 

(56

)

 

 

16,765

 

Commercial paper

 

 

111,868

 

 

 

0

 

 

 

0

 

 

 

111,868

 

Asset-backed securities

 

 

39,988

 

 

 

0

 

 

 

(62

)

 

 

39,926

 

Corporate debt securities

 

 

103,779

 

 

 

7

 

 

 

(212

)

 

 

103,574

 

Total available-for-sale securities

 

$

354,813

 

 

$

7

 

 

$

(490

)

 

$

354,330

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Classified as:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

 

 

 

 

 

 

 

 

 

$

41,960

 

Short-term investments

 

 

 

 

 

 

 

 

 

 

 

214,514

 

Long-term investments

 

 

 

 

 

 

 

 

 

 

 

97,856

 

Total available-for-sale securities

 

 

 

 

 

 

 

 

 

 

$

354,330

 

Cash equivalents in the tables above exclude cash of $0.9$3.2 million and $2.3$8.0 million as of September 30, 2017March 31, 2022 and December 31, 2016,2021, respectively. Allavailable-for-sale securities held as of September 30, 2017March 31, 2022 had contractual maturities of less than two years. years.There have been no0 significant realized gains or losses onavailable-for-sale securities for the periods presented. No significantThe Company applies the specific identification method to determine the cost basis of the securities sold. NaNavailable-for-sale securities held as of September 30, 2017March 31, 2022 have been in a continuous unrealized loss position for more than 12 months.As of September 30, 2017,March 31, 2022, unrealized losses onavailable-for-sale investments are not attributed to credit risk and are

considered to be temporary.risk. The Company believes that it ismore-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 impairmentsthat an allowance for credit losses is unnecessary because the unrealized losses on itscertain of the Company’s marketable securities because it does not intendare due 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.market factors. To date, the Company has not recorded any impairment charges on marketable securities related to other-than-temporary declines in market value.securities.

4.Fair Value Measurements
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, 2017March 31, 2022 and December 31, 2016:2021 (in thousands):

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

Money market fund

  $17,098   $—     $—     $17,098 

U.S. treasury securities

   —      46,637    —      46,637 

Commercial paper

   —      32,066    —      32,066 

Corporate debt securities

   —      28,104    —      28,104 
  

 

   

 

   

 

   

 

 

Total assets

  $17,098   $106,807   $—     $123,905 
  

 

   

 

   

 

   

 

 

 

 

 

 

 

 

 

 

 

  December 31, 2016 

 

March 31, 2022

 

Description  Level 1   Level 2   Level 3   Total 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Money market fund

  $9,746   $—     $—     $9,746 

 

$

37,331

 

 

$

0

 

 

$

0

 

 

$

37,331

 

U.S. treasury securities

   —      49,672    —      49,672 

 

 

0

 

 

 

114,662

 

 

 

0

 

 

 

114,662

 

Non-U.S. government securities

 

 

0

 

 

 

16,563

 

 

 

0

 

 

 

16,563

 

Commercial paper

   —      16,183    —      16,183 

 

 

0

 

 

 

73,868

 

 

 

0

 

 

 

73,868

 

Asset-backed securities

 

 

0

 

 

 

32,188

 

 

 

0

 

 

 

32,188

 

Corporate debt securities

   —      45,882    —      45,882 

 

 

0

 

 

 

93,978

 

 

 

0

 

 

 

93,978

 

  

 

   

 

   

 

   

 

 

Total assets

  $9,746   $111,737   $—     $121,483 
  

 

   

 

   

 

   

 

 

Total available-for-sale securities

 

$

37,331

 

 

$

331,259

 

 

$

0

 

 

$

368,590

 

11


 

 

December 31, 2021

 

Description

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Money market fund

 

$

41,960

 

 

$

0

 

 

$

0

 

 

$

41,960

 

U.S. treasury securities

 

 

0

 

 

 

40,237

 

 

 

0

 

 

 

40,237

 

Government-sponsored agencies

 

 

0

 

 

 

16,765

 

 

 

0

 

 

 

16,765

 

Commercial paper

 

 

0

 

 

 

111,868

 

 

 

0

 

 

 

111,868

 

Asset-backed securities

 

 

0

 

 

 

39,926

 

 

 

0

 

 

 

39,926

 

Corporate debt securities

 

 

0

 

 

 

103,574

 

 

 

0

 

 

 

103,574

 

Total available-for-sale securities

 

$

41,960

 

 

$

312,370

 

 

$

0

 

 

$

354,330

 

During the ninethree months ended September 30, 2017,March 31, 2022, there were no0 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, currency spot and forward rates, and credit ratings.

5.Accrued Liabilities
Other Fair Value Measurements

The carrying amount and estimated fair value of financial instruments not recorded at fair value at March 31, 2022 and December 31, 2021 were as follows (in thousands):

 

 

March 31,

 

 

December 31,

 

 

 

2022

 

 

2021

 

 

 

Carrying
Amount

 

 

Estimated
Fair Value

 

 

Carrying
Amount

 

 

Estimated
Fair Value

 

Long-term debt, net (1)

 

$

23,682

 

 

$

25,170

 

 

$

23,635

 

 

$

25,046

 

(1)
Carrying amounts of long-term debt were net of unamortized debt discounts of $269 and $316 as of March 31, 2022 and December 31, 2021, 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 and Other Current Liabilities

Accrued and other current liabilities consist of the following (in thousands):

  September 30,   December 31, 

 

March 31,

 

 

December 31,

 

  2017   2016 

 

2022

 

 

2021

 

Research and development related

  $5,285   $5,482 

 

$

11,441

 

 

$

11,309

 

Compensation related

   1,990    2,460 

 

 

4,974

 

 

 

8,350

 

Consulting and professional services

   529    421 

 

 

2,127

 

 

 

1,348

 

Current portion of operating lease liability

 

 

2,915

 

 

 

2,810

 

End of term charge on the long-term debt

 

 

1,196

 

 

 

1,151

 

Other

   381    282 

 

 

2,894

 

 

 

1,390

 

  

 

   

 

 

 

$

25,547

 

 

$

26,358

 

  $8,185   $8,645 
  

 

   

 

 

6.Related-Party Transactions

Bio-Techne Corporation, formerly Techne Corporation,12


6.
Long-term Debt

In December 2017, 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 (as amended, the Credit Facility) were available to the Company. As of March 31, 2022, the Company had borrowed $20.0 million under the Credit Facility, with an interest rate of 8.05% per annum and the remaining available amount had expired. Advances under the Credit Facility bear an interest rate equal to the greater of either (i) 8.05% plus the prime rate as reported from time to time in The Wall Street Journal (the Prime Rate) minus 4.75%, and (ii) 8.05%. The Company made interest-only payments through June 2021 and the first principal and interest payment on July 1, 2021. The Credit Facility was subsequently amended in July 2021 and December 2021 to extend the interest-only payment period through August 1, 2022, and at which point the Company will then be obligated to repay the principal balance and interest on the advances in equal monthly installments through December 1, 2022. The Company is oneobligated to pay an end of term charge of $1.3 million in December 2022.

On January 8, 2020, the Company entered into an Amended and Restated Loan and Security Agreement (the Amended Loan Agreement) with Hercules, which amended and restated the agreement between the parties, and pursuant to which an additional term loan in an aggregate principal amount of up to $100.0 million (the Restated Credit Facility) is available to the Company at its discretion in 3 tranches. The first tranche of the Restated Credit Facility of up to $40.0 million was available to the Company through December 15, 2020, of which $20.0 million became available upon submission of the TAVNEOS New Drug Application (NDA) for the treatment of patients with ANCA-associated vasculitis. The second tranche of up to an additional $30.0 million was available to the Company through December 15, 2021 upon NDA approval of TAVNEOS for the treatment of ANCA-associated vasculitis. The third tranche of up to an additional $30.0 million would be available through December 15, 2022, subject to certain conditions.

Under the Restated Credit Facility, the Company borrowed $5.0 million from the first tranche with an interest rate of 8.50% per annum as of March 31, 2022. Advances under the Restated Credit Facility bear an initial interest rate equal to the greater of either (i) 8.50% plus the Prime Rate minus 5.25%, and (ii) 8.50%, which may be reduced upon the Company achieving certain cumulative net TAVNEOS revenue levels. For advances under the Restated Credit Facility, the Company was required to make interest only payments through September 1, 2022 and repay the principal balance and interest on the advances in equal monthly installments through February 1, 2024. However, upon satisfaction of certain conditions, the interest-only payment period and the principal balance repayment period may be extended. With the FDA approval of TAVNEOS in October 2021, the interest-only payment period and the principal balance repayment period was extended through March 1, 2023 and February 1, 2025, respectively. In addition, the Company will pay an end of term charge of 7.15% of the aggregate amount of the advances under the Restated Credit Facility in February 2025.

The Company paid a commitment fee of 1% of the advances made by Hercules, with a minimum charge of $162,500 for the Credit Facility and a minimum charge of $520,000 for the Restated Credit Facility. Also, the Company reimbursed Hercules for costs incurred related to the Restated 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.

In addition, the Company may prepay advances under the Restated Credit Facility, in whole or in part, at any time, subject to a prepayment charge that ranges from 1.0% to 2.0%, depending on the timing of the prepayment. The Restated Credit Facility is secured by substantially all of the Company’s principal stockholders. assets, excluding intellectual property. The Restated Credit Facility also includes customary loan covenants, with which the Company was in compliance for all periods presented.

In connection with the Restated Credit Facility, the Company also entered into a Right to Invest Agreement with Hercules, pursuant to which Hercules shall have the right to participate, in an amount up to $3.0 million, in any subsequent equity financing broadly marketed to multiple investors in an amount greater than $30.0 million. Hercules purchased $1.0 million of the Company’s common stock during the June 2020 equity follow-on offering.

13


As of March 31, 2022, the Company had outstanding borrowings under the Amended Loan Agreement of $23.7 million, net of discounts of $0.3 million. Future minimum principal payments, which exclude the end of term charge, as of March 31, 2022 are as follows (in thousands):

 

 

Amounts

 

Year ending December 31:

 

 

 

Remaining of fiscal year 2022

 

$

18,951

 

2023

 

 

1,979

 

2024

 

 

2,566

 

2025

 

 

455

 

Total minimum payments

 

 

23,951

 

Less: amount representing debt discount

 

 

(269

)

Present value of remaining debt payments

 

 

23,682

 

Less: current portion

 

 

(19,128

)

Non-current portion

 

$

4,554

 

7.
Commitments

Purchase Obligations

The Company has entered into noncancelable agreements with vendors to secure raw materials and contract manufacturing organizations (CMOs) to manufacture its commercial supply of TAVNEOS. Some of these agreements contain binding commitment provisions for orders placed under purchase orders and forecasted quantities within a specified time frame. As of March 31, 2022, the Company’s noncancelable contractual obligations under these terms of the agreements are approximately $9.7million. The Company enters into contracts in the normal course of business with CROs for clinical trials and with vendors for preclinical research studies, research supplies and other services and products for operating purposes. These contracts generally provide for termination on notice, and therefore are cancelable contracts and not included in the purchase obligations above.

Operating Leases

In May 2004, the Company entered into a noncancelable operating lease for its previous office and primary research facility located in Mountain View, California. In May 2019, the Company entered into a third amendment to the lease agreement for the same facility to extend the term of the lease through April 2021. In July 2020, the Company entered into a letter agreement to further extend the lease term through June 2021.

In July 2019, the Company entered into a ten-year operating lease for a 96,463 square foot facility in San Carlos, California to replace its previous headquarters located in Mountain View, California. Upon execution of the lease agreement, the Company provided the landlord an approximately $1.1 million security deposit in the form of a letter of credit. The lease commenced in June 2020and will expire in February 2031 subject to an option to extend the lease for five years. The lease extension option was not considered in the right-of-use asset or the lease liability as the Company did not consider it reasonably certain the option would be exercised. Monthly rent payments began in March 2021. Following a six-month period of discounted rent, the Company is obligated to pay an initial public offering (IPO)annual base rent at a rate of approximately $6.5 million, which is subject to scheduled 3% annual increases, plus certain operating expenses. The Company moved its headquarters to this new facility in February 2012, Bio-TechneApril 2021.

The Company was provided a tenant improvement allowance of $15.4 million plus an additional allowance of $4.8 million for the same. The additional allowance is repaid by the Company as additional rent in equal monthly payments at a rate of 7% per annum through the initial term of the lease. As of March 31, 2022, the Company received total tenant improvement allowance of $20.2 million. The Company has the right to sublease the facility, subject to landlord consent.

The balance sheet classification of the Company’s operating lease assets and liabilities was as follows (in thousands):

 

 

March 31,

 

 

December 31,

 

 

 

2022

 

 

2021

 

Balance Sheet

 

 

 

 

 

 

Assets:

 

 

 

 

 

 

Operating lease right-of-use assets

 

$

24,592

 

 

$

24,806

 

Liabilities:

 

 

 

 

 

 

Operating lease liabilities:

 

 

 

 

 

 

Accrued and other current liabilities (1)

 

$

2,915

 

 

$

2,810

 

Non-current lease liabilities

 

 

46,062

 

 

 

46,830

 

14


(1)
Includes current portion of operating lease liabilities.

The component of lease costs, which was included in operating expenses in the Company’s Condensed Consolidated Statements of Operations, was as follows (in thousands):

 

 

Three Months Ended
March 31,

 

 

 

2022

 

 

2021

 

Operating lease cost

 

$

1,375

 

 

$

1,742

 

During the three months ended March 31, 2022 and 2021, cash paid for amounts included in the measurement of lease liabilities was $2.0 million and $0.7 million, respectively, excluding the $0 and $5.9million tenant improvement allowance received in 2022 and 2021, respectively. These amounts were included in net cash used in operating activities in the Company’s Condensed Consolidated Statements of Cash Flows.

Future minimum lease payments under all noncancelable operating leases as of March 31, 2022 are as follows (in thousands):

 

 

Operating leases

 

Year ending December 31:

 

 

 

Remaining of fiscal year 2022

 

$

5,525

 

2023

 

 

7,535

 

2024

 

 

7,741

 

2025

 

 

7,952

 

2026

 

 

8,170

 

Thereafter

 

 

36,517

 

Total minimum payments

 

 

73,440

 

Less: interest

 

 

(24,463

)

Present value of lease liabilities

 

$

48,977

 

As of March 31, 2022, the remaining lease term was 8.9 years and the operating discount rate used to determine the operating lease liability was 9.5%.

Legal Proceedings

The Company is involved in a warrant withconsolidated securities class action (Homyk v. ChemoCentryx, Inc., 4:21-cv-03343-JST (N.D. Cal.)) and aten-year term shareholder derivative action (Napoli v. Schall, 3:22-cv-00499 (N.D. Cal)), as discussed in the Legal Proceedings section within this Quarterly Report on Form 10-Q. The shareholder derivative action is stayed pending entry of judgment in the consolidated securities class action. Given the early stage of these cases, the Company is unable to purchase 150,000estimate a range of potential loss, if any.

8.
Related-Party Transactions

Vifor

Vifor held 5,194,085 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.March 31, 2022. The Company had anhas collaboration agreements with Vifor: the Avacopan Agreements and the CCX140 Agreements (each as described below). See “Note 2. Summary of Significant Accounting Policies – Concentration of Credit Risk” for additional information on accounts payablereceivable balance due to Bio-Techne for the purchases of research materials of approximately $1,000 and $25,000 as of September 30, 2017 and December 31, 2016, respectively.from Vifor.

Avacopan Agreements

7.Collaboration and License 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 associatedANCA-associated vasculitis and other rare diseases. The Avacopan Agreement also provided Vifor with an exclusive option to negotiate during 2016 a worldwide license agreement for one of the Company’s other drug candidates, CCX140, an orally-administered inhibitor of the chemokine receptor known as CCR2. In connection with the Avacopan Agreement, the Company received a non-refundable upfront payment of $85.0 million, comprising $60.0 million in cash and $25.0 million in the form of an equity investment to purchase 3,333,333 shares of the Company’s common stock at a price of $7.50 per share.

15


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 amendment, 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, and together with the Avacopan Agreement and the Avacopan Amendment, the Avacopan Agreements). 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 StatesStates. In consideration for the Avacopan Letter Agreement, the Company received a $5.0 million payment for the expanded rights. In December 2017, the Company achieved a $50.0 million regulatory milestone when the European Medicines Agency (EMA) validated the Company’s conditional marketing authorization (CMA) application for avacopan for the treatment of ANCA-associated vasculitis.

In February 2021, the Company achieved a $10.0 million regulatory milestone when the Japanese NDA (JNDA) for TAVNEOS in the treatment of ANCA-associated vasculitis was filed with the Japanese Pharmaceuticals and China. Medical Device Agency (PMDA) by Vifor, through its sublicensee Kissei Pharmaceutical, Co., Ltd. (Kissei). In September 2021, the Japanese Ministry of Health, Labor and Welfare (MHLW) approved the JNDA for TAVNEOS for the treatment of patients with microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA), the two main forms of ANCA-associated vasculitis. As a result, the Company achieved a $20.0 million regulatory milestone. In November 2021, the EMA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for the Company’s TAVNEOS.

In January 2022, the European Commission approved TAVNEOS in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe active MPA or GPA. Accordingly, the Company achieved a $45.0 million regulatory milestone which the Company received in February 2022. Upon further achievement of certain regulatory and commercial milestones with TAVNEOS, the Company will receive additional payments of up to $385.0 million under the Avacopan Agreements. In addition, the Company will receive royalties, with rates ranging from the low teens to the mid-twenties, on future potential net sales of TAVNEOS by Vifor in the licensed territories.

The Company identified the following material promises under the Avacopan Agreement also provided Vifor withAgreements: (1) the license related to avacopan; (2) the development and regulatory services for the submission of the marketing authorization application (MAA); and (3) an exclusive option to negotiate during 2016 a worldwide license agreement for oneCCX140, 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 Company’s other drug candidates, CCX140, an orally administered inhibitor ofagreement because Vifor is dependent on the chemokine receptor known as CCR2.

In connectionCompany 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 is allocated to the license and the development and regulatory services.

As of March 31, 2022, the transaction price of $228.0 million comprised the following:

$78.0 million upfront payment under the May 2016 Avacopan Agreement. Of the total $85.0 million upfront payment received under the May 2016 Avacopan Agreement, the Company received anon-refundable upfront payment of $85.0$7.0 million comprising $60.0 million in cash and $25.0 million in the form of an equity investmentwas allocated to purchase 3,333,333 shares of the Company’s common stock at a price of $7.50 per share. The $85.0 million upfront consideration was initially allocated as of June 30, 2016 as follows:

$7.0 million for the issuance of 3,333,333 shares of the Company’s common stock valued at $2.10$2.10 per share, the closing stock price on the effective date of the agreement, May 9, 2016.

The remaining $12.578.0 million which was creditable against anallocated to the transaction price under this arrangement;
$20.0 million upfront fee payablepayment 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 ANCA-associated vasculitis in December 2017;
$30.0 million regulatory milestone payments achieved upon the acceptance and the approval of the JNDA for TAVNEOS in the treatment of ANCA-associated vasculitis filed by Vifor, shouldthrough its Japanese sublicensee Kissei with the parties enter intoPMDA in 2021;
$45.0million regulatory milestone payment achieved upon the European Commission approving TAVNEOS in combination with a worldwide license agreementrituximab or cyclophosphamide regimen for CCX140. The amount creditable decreased ratably into the fourth quartertreatment of 2016. In October 2016, the amount creditable expiredadult patients with severe active MPA or GPA in 2022; and was reclassified to the amortizable portion of deferred revenue as discussed below.

The remaining
$5.0 million non-refundable upfront consideration of $65.5 million will be recognized over the estimated period of performancepayment under the Avacopan Agreement,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 approximates 4.2 years, ending in June 2020. The deliverables underbegan on the Avacopan Agreement consisteffective date of intellectual property licenses,May 9, 2016 and ends upon completion of development and regulatory services for the submission of the Marketing Authorization Application (MAA).services. The Company considereduses a

16


cost-based input method to measure proportional performance and to calculate the provisionscorresponding 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, multiple-element arrangement guidance and concluded that the license and the 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 measures actual costs incurred relative to budgeted costs to fulfill the combined these deliverables and allocated the remaining upfront considerationperformance obligation. These costs consist primarily of $65.5 million intothird-party contract costs. Revenue is recognized based on actual costs incurred as a single unitpercentage 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 andtotal budgeted costs as 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 ofcompletes its performance ending in June 2020. obligations.

For the three and nine months ended September 30, 2017,March 31, 2022, the Company recognized $6.2$0.1 million and $18.2 million, respectively, of collaboration and license revenue under the Avacopan Agreements, as compared to $9.9 million during the same period in 2021.

Avacopan Commercial Supply Agreement

In October 2020, the Company entered into a Manufacturing and Supply Agreement andwith Vifor (the Avacopan Commercial Supply Agreement). Under the Avacopan Amendment, comparedCommercial Supply Agreement, the Company supplies and sells TAVNEOS to $4.1 millionVifor and $6.8 millionits sublicensees for commercial use outside of the United States. Vifor will purchase TAVNEOS at a certain percentage mark up to the Company’s cost of goods, in accordance with the Avacopan Agreements. Vifor’s purchase of TAVNEOS is subject to certain binding forecast periods. The Avacopan Commercial Supply Agreement will expire upon the termination of the Avacopan Agreements or under certain circumstances as specified in the same periods ended September 30, 2016. Upon achievement of certain regulatory and commercial milestonesAvacopan Commercial Supply Agreement. In connection with avacopan,the Avacopan Commercial Supply Agreement, the Company will receive additional paymentsalso entered into a letter agreement with Vifor, pursuant to which the $6.2 million previously received from Vifor under the CCX140 Agreement (discussed below) is creditable to Vifor’s purchase of up to $510.0 millionTAVNEOS. For the three months ended March 31, 2022 and 2021, no product supply revenue was recognized 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.Commercial Supply Agreement.

CCX140 Agreements

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. Under the terms of the CCX140 Agreement, the Company received a non-refundable upfront payment of $50.0 million in 2017.

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

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

As of March 31, 2022, the transaction price of $66.5 million comprised the following:

$50.0 million upfront payment under the CCX140 Agreement;
$11.5 million of CCX140 development funding by Vifor; and
$5.0 million non-refundable upfront payment under the CCX140 Letter Agreement.

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 services. The Company uses a cost-based input method to measure proportional performance and to calculate the corresponding amount of revenue to recognize. The

17


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 is recognized based on actual costs incurred as a percentage of total budgeted costs as the Company completes its performance obligations.

In May 2020, the Company announced topline data from a 46 patient Phase II dose-ranging trial in the orphan kidney disorder, primary Focal Segmental Glomerulosclerosis (FSGS), called the LUMINA-1 trial. In the study, CCX140 did not demonstrate a meaningful reduction in proteinuria relative to the control group after 12 weeks of blinded treatment. As such, CCX140 will not be further developed in FSGS. As a result, the Company reduced the total anticipated FSGS budgeted costs and the corresponding transaction price related to development funding under the CCX140 Agreement by $47.2 million and recognized $46.7 million of contract revenue during the three months ended June 30, 2020. In addition, $6.2 million of deferred revenue previously received from Vifor under the CCX140 Agreements is creditable against Vifor’s purchases of TAVNEOS under the Avacopan Commercial Supply Agreement. 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 commitment of $50.0 million, $30.0 million of which was received in January 2017. The remaining $20.0 million, which is due on the first anniversary of the CCX140 Agreement, was not reflected in accounts receivable as 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. The Company considered the provisions of the revenue recognition multiple-element arrangement guidance and concluded that the license and the 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 Companyfully recognized $2.8 million and $8.0 million of collaboration and license revenue under the CCX140 Agreement, respectively,Agreements in 2021. Accordingly, 0 revenue was recognized during the three months ended March 31, 2022 compared to $0.3 million during the three months ended March 31, 2021.

The following table presents the contract assets and liabilities for all of which $2.5 million and $7.5 million were associated with the recognitionCompany’s revenue contracts as of upfront commitment. The remaining amounts represented collaboration revenue derived from funding of CCX140 development services from Vifor. Upon achievement of certain regulatory and commercial milestones with CCX140,the following dates (in thousands):

 

 

March 31,

 

 

December 31,

 

 

 

2022

 

 

2021

 

Contract asset:

 

 

 

 

 

 

Accounts receivable

 

$

29

 

 

$

43

 

Contract liability:

 

 

 

 

 

 

Deferred revenue

 

$

(80,803

)

 

$

(35,765

)

During the three months ended March 31, 2022, the Company will receive additional paymentsrecognized the following revenue as a result 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 CCX140changes in the licensed territories.

Under the Avacopan Agreementcontract asset and the CCX140 Agreement, the Company determined that future contingent payments related to regulatory milestones meet the definition of a substantive milestone under the accounting guidance. Accordingly, revenue for the achievement of these milestones will be recognized in the period when the milestone is achieved. The Company will be eligible to receive contingent payments related to commercial milestones based on the 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. As ofcontract liability balances (in thousands):

 

 

Three Months Ended
March 31,

 

 

 

2022

 

 

2021

 

Revenue recognized in the period from:

 

 

 

 

 

 

Amount included in contract liability at the
   beginning of the period

 

$

0

 

 

$

10,211

 

Performance obligations satisfied (or partially
   satisfied) in previous periods

 

$

2,254

 

 

$

8,443

 

9.
Government Grant

In September 30, 2017, the Company had not received any milestone payments under the Avacopan 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 Agreement and the CCX140 Agreement are accounted for as separate arrangements.

8.Government Grant

In April 2016,2019, the Company was awarded an Orphan Products Developmenta two-year $1.0 million grant byfrom the orphan drug office of the U.S. Food and Drug Administration to support the clinical development of avacopanTAVNEOS in patients with the amount of $500,000, whichrare kidney disease complement 3 glomerulopathy (C3G). The grant was extended for an additional four months in August 2021 and the grant revenue was fully recognized in 2021. Accordingly, 0 revenue was recognized during the three months ended March 31, 2022 compared to $0.1 million in the same period of 2021.As of March 31, 2022 and receivedDecember 31, 2021,$0and $28,000 was recorded as of September 30, 2017. The term of the grant expired in May 2017. accounts receivable, respectively.

18


10.
Stockholders’ Equity

Stock Options

During the three and nine months ended September 30, 2017, the Company did not recognize any grant revenue. During the three and nine months ended September 30, 2016, the Company recognized $120,000 and $295,000, respectively, of grant revenue.

9.Equity Incentive Plans

Stock Options

During the nine months ended September 30, 2017,March 31, 2022, 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
(Years)
   Aggregate
Intrinsic Value
(in thousands)
 

Balance at December 31, 2016

   1,655,524   9,345,515  $7.72     

Shares authorized

   1,900,000       

Granted(1)

   (1,914,238  1,634,500   6.95     

Exercised(2)

   40,208   (405,912  5.85     

Forfeited and expired(3)

   489,862   (476,528  6.47     
  

 

 

  

 

 

      

Balance at September 30, 2017

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

 

 

  

 

 

      

 

 

 

Available
for Grant

 

 

Shares

 

 

Weighted
Average
Exercise
Price

 

 

Weighted
Average
Remaining
Contractual
Term (in years)

 

 

Aggregate
Intrinsic Value

 

Balance at December 31, 2021

 

 

5,641,782

 

 

 

6,767,895

 

 

$

19.14

 

 

 

 

 

 

 

 

Shares authorized

 

 

0

 

 

 

0

 

 

 

 

 

 

 

 

 

 

 

Granted (1)

 

 

(1,624,830

)

 

 

1,082,730

 

 

 

29.64

 

 

 

 

 

 

 

 

Exercised (2)

 

 

0

 

 

 

(604,083

)

 

 

10.39

 

 

 

 

 

 

 

 

Forfeited and expired

 

 

145,939

 

 

 

(145,939

)

 

 

41.27

 

 

 

 

 

 

 

Outstanding at March 31, 2022

 

 

4,162,891

 

 

 

7,100,603

 

 

$

21.03

 

 

 

6.22

 

 

$

74,672,588

 

Vested and expected to vest, net of estimated forfeiture
   at March 31, 2022

 

 

 

 

 

6,785,124

 

 

$

20.36

 

 

 

6.08

 

 

$

74,199,516

 

Exercisable at March 31, 2022

 

 

 

 

 

4,672,389

 

 

$

13.93

 

 

 

4.73

 

 

$

68,152,545

 

(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.
(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 with a 1.5 share ratio reduction to the reserve shares for each RSU or RSA grant in accordance with the amended and restated 2012 Equity Incentive Award Plan.
(2)
Shares presented as available for grant represents shares repurchased for tax withholding upon vesting of RSUs.

Restricted Stock

During the ninethree months ended September 30, 2017,March 31, 2022, the activity for restricted stock is summarized as follows:

       Weighted Average 
       Grant-Date 
   Shares   Fair Value 

Balance at December 31, 2016

   471,650   $4.60 

Granted

   279,738    6.72 

Vested

   (185,842   4.26 

Canceled

   (13,334   3.57 
  

 

 

   

Unvested at September 30, 2017

   552,212   $5.81 
  

 

 

   

 

 

Shares

 

 

Weighted
Average
Grant-Date
Fair Value

 

Balance at December 31, 2021

 

 

413,510

 

 

$

45.94

 

Granted

 

 

361,400

 

 

 

29.83

 

Vested

 

 

(199,484

)

 

 

43.62

 

Unvested at March 31, 2022

 

 

575,426

 

 

$

36.63

 

Stock-based Compensation

Total stock-based compensation expense was $1.9 million and $6.8$9.4 million during the three and nine months ended September 30, 2017, respectively,March 31, 2022, and $1.8$8.1 million and $6.5 million, respectively, during the same periodsperiod ended September 30, 2016.March 31, 2021. As of September 30, 2017, $9.6March 31, 2022,$50.0 million, $2.0$15.2 million and $23,000 $0.1 millionof total unrecognized compensation expenses associated with outstanding employee stock options, unvested restricted stock, and the ESPP, net of estimated forfeitures, respectively, were expected to be recognized over a weighted-average period of 2.52, 1.72, 2.9, 2.8and 0.120.1 years, respectively.

19


Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis should be read in conjunction with our financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the financial statements and accompanying notes thereto and Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016,2021, filed with the Securities and Exchange Commission, or SEC, on March 14, 2017.1, 2022.

Forward-Looking Statements

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

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

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

the commercializationanticipated impact of the ongoing pandemic of novel coronavirus disease 2019, or COVID-19, and its variants on our drug candidates;business, preclinical studies and clinical trials;

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;

the impact or outcome of putative shareholder class action or putative shareholder derivative litigation;
the global economic and political environments;
our financial performance; and

developments relating to our competitors and our industry.

These statements relate to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Factors that may cause actual results to differ materially from current expectations include, among other things, those included in “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016,2021, filed with the SEC on March 14, 2017.1, 2022.

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

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

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

whole unless otherwise noted.

Overview

20


Overview

ChemoCentryx is a fully integrated United States biopharmaceutical company developingfocused on the development and commercialization of new medications targeted attargeting inflammatory disorders, autoimmune diseases and cancer. EachWe target the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies. In the U.S., we market TAVNEOSÒ (avacopan) as an adjunctive treatment for adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis, or ANCA-associated vasculitis, specifically granulomatosis with polyangiitis, or GPA, and microscopic polyangiitis, or MPA, the two main forms of our drug candidates selectively blocks a specific chemokine or chemoattractant receptors, leavingANCA-associated vasculitis, in combination with standard therapy including glucocorticoids, and not for the restelimination of the immune system intact. Our drug candidates are small molecules, which are orally administered, offering significant quality of life benefits, since patients swallow a capsule or pill instead of having to visit a clinic for an infusion or undergo an injection.glucocorticoid use.

In 2016October 2021, we executed on our strategy to form an alliance with a partner that could provide upfront commitmentsobtained regulatory approval and milestones to support the clinical development of our leading two drug candidates, avacopan and CCX140, to registration and pay us royalties upon sales in international markets, while we develop our own commercial infrastructure to sell directlylaunched TAVNEOS in the United States.

To help us manage the wide array of opportunities, we have segmented our pipeline into early stage and late stage compounds.

Late Stage Compounds

We have chosen to focus initially on kidney disease, particularly on rare 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) anti-neutrophil cytoplasmic auto-antibody associated vasculitis, or AAV, a devastating autoimmune disease that destroys blood vessels and can lead to kidney failure; 2) atypical hemolytic uremic syndrome, or aHUS, a rare, life threatening disease; and 3) complement 3 glomerulopathy, or C3G, a debilitating kidney disease that can lead to kidney failure.

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 byan orphan disease called ANCA-associated vasculitis, leading to the European Medicines Agency, or EMA,recent grant of orphan drug marketing exclusivity for the treatmenta period of microscopic polyangiitis and granulomatosis with polyangiitis, both forms of AAV, and C3G. 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 trialsseven years discussed further below. TAVNEOS also obtained regulatory approval in patients with AAV, the results of 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-blind two-arm study that is planned to enroll 300 patients at approximately 200 sites in the United States, Canada, Europe, Australia, and New Zealand. We expect to complete patient enrollment of the Phase III ADVOCATE trial in mid-2018. We recently launched a registration-supporting clinical trial to study avacopanJapan for the treatment of patients with MPA and GPA in 2021. In January 2022, the European Commission approved TAVNEOS in combination with a rituximab or cyclophosphamide regimen for the treatment of adult patients with severe active GPA or MPA. TAVNEOS received marketing authorization in all member states of the EU, as well as in Iceland, Liechtenstein and Norway. Also, in January 2022, the FDA granted a seven-year orphan drug marketing exclusive approval for TAVNEOS which began on October 7, 2021, the date of approval of the NDA. We are required to assure the availability of sufficient quantities of TAVNEOS to meet the needs of patients to maintain exclusivity.

ANCA-associated vasculitis is a group of rare diseases that affect small-to-medium sized blood vessels in the patient’s body. It involves inflammation of the blood vessels, which reduces blood flow and can result in organ damage and failure, with the kidney as the major target, and is often fatal if not treated. While a patient’s genetics and environment are thought to be contributing causes of the disease, the exact cause is currently unknown.

The two most common sub-types of ANCA-associated vasculitis are GPA and MPA. In GPA, small areas of inflammation called “granulomas” develop inside parts of the body. GPA typically involves the kidneys, lungs, ears, nose and throat. If a patient has GPA they may be at risk for serious complications, such as hearing loss, kidney damage, skin scarring, or blood clots. MPA also affects the lungs and kidneys. However, unlike GPA, a patient’s ears, nose and throat are less likely to be affected, and there is no granuloma formation.

We plan to capitalize on TAVNEOS’s potential to address multiple disease areas in the coming years. We consider TAVNEOS to be a ‘Pipeline in a Drug.’ We plan to continue or initiate clinical development in additional rare diseases, including severe hidradenitis suppurativa, or HS, complement 3 glomerulopathy, or C3G, and lupus nephritis, or LN.

Our goal is to change treatment paradigms in orphan and rare disease; specifically targeting the chronic inflammatory pathway while avoiding immuno-suppression. Each of our drug candidates and our first commercial drug product, TAVNEOS, are designed to selectively block a specific chemoattractant receptor. Separately, in our cancer program, we use a novel, orally-administered drug candidate, CCX559, designed to inhibit programmed death-ligand 1/programmed death protein 1, or PD-L1/PD-1, which we are developing for the treatment of a variety of cancers. Small molecule checkpoint inhibitors may have advantageous properties compared to approved monoclonal antibodies, such as better penetration into solid tumors, reduced immunogenicity, lack of Fc-mediated side effects, and the convenience of oral administration.

Highlights from our development pipeline include:

TAVNEOSÒ(avacopan):

We are also developing TAVNEOS for the treatment of severe HS. We reported initial topline data, including positive results in a subgroup analysis of patients with Hurley Stage III (considered to have severe HS) from the Phase II AURORA trial of TAVNEOS; however, the primary efficacy endpoint was not met in the overall study population. Pending interactions with regulatory agencies, we plan to advance TAVNEOS into Phase III clinical development for the treatment of severe HS in the second half of 2022.
We plan to develop TAVNEOS in additional complement-mediated renal indications, such as LN. We plan to initiate a clinical development program for TAVNEOS in LN in the samesecond half of 2022, pending interaction with regulatory agencies.
We also reported initial topline data from the Phase II ACCOLADE trial of TAVNEOS for the treatment of patients with aHUSC3G. We plan to review data from the ACCOLADE trial with FDA in 2017; designed to potentially support registrationsecond half of avacopan in these indications.2022.

21


CCX140—Chronic and Rare Kidney DiseasesImmuno-Oncology

CCX140

CCX559 is anour orally-administered inhibitor of the chemokine receptor known as CCR2, has been in development for diabetic nephropathy, or DN, a form of chronic kidney disease, or CKD, and is now being developed for focal segmental glomerulosclerosis, or FSGS, a rare renal disease characterized by progressive proteinuria—excess protein in the urine—and impaired renal function.

A Phase II clinical trial of CCX140 in patients with DN met its primary endpoint by demonstrating that CCX140 given orally once daily added to an SOC renin-angiotensin-aldosterone system inhibitor treatment resulted in a statistically significant reduction in proteinuria, beyond that achieved with SOC alone. Based on the safety and efficacy data related to reduction in proteinuria observed in the Phase II trial in DN,PD-L1/PD-1, which we plan to initiate in 2017 a clinical endpoint trial of CCX140are developing for the treatment of various cancers. This structurally novel small molecule displayed nanomolar potency and high selectivity for PD-L1. Results from in vitro studies suggested that CCX559 induced the dimerization and internalization of cell-surface PD-L1. CCX559, when orally administered in animal models, was observed to have anti-tumor activity, including the potential to induce complete responses. Safety pharmacology and toxicology studies in preclinical animal species supported the initiation of human trials in patients with FSGS, for which there are currently no FDA-approved treatments.

advanced tumors. We initiated a Phase I dose escalation study of CCX559 in patients with advanced solid tumors in the second quarter of 2021. We plan to report initial data from this study in 2022 and initiate a Phase 1b/2 clinical study in selected patient populations in the second half of 2022.

Our Strategy

Global Kidney Health Alliance with Vifor

In May 2016 we announced a partnership with Vifor (International) Ltd., or Vifor, a European-based world leader specializing in kidney disease, for the commercial rights to avacopan in Europe and certain other international markets, which we refer to as the Avacopan Agreement. We expanded our partnership with Vifor in December 2016 with an additional deal for our other late stage drug candidate, CCX140, whereby we granted Vifor worldwide rights outside of the United States and China, which we refer to as the CCX140 Agreement; and in February 2017, we announced a further deal 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.

We have secured $155 million in upfront cash payments and commitments, plus substantial potential milestone payments pursuantThe key elements to our agreements with Vifor. Through our alliance, we maintain the commercial rights of avacopan and CCX140scientific strategy are to:

Commercialize TAVNEOS® (avacopan) in the United States using our own resources, where we believe a company of our size can effectively compete in rare disease markets. We have deployed a specialty sales force primarily targeting that subset of nephrologists and China, and also retain control of the clinical development programs for rare renal disease. Vifor gains the commercial rights for all other international markets, and will pay us tiered royalties, with rates ranging from ten to the mid-twenties, on potential net sales.

At a future time defined in the contract, Vifor has an option to solely develop and commercialize CCX140 in more prevalent forms of CKD. Should Vifor later exercise the CKD option, we would receive co-promotion rights for CKDrheumatologists treating ANCA-associated vasculitis patients in the United States,States;

Continue to develop CCX559, our orally-administered inhibitor for PD-L1/PD-1 for various cancers;
Develop and we estimate that the clinical developmentcommercialize TAVNEOS for additional indications, including C3G, severe HS, and registration process for CKD would end at approximately the same timeadditional complement-mediated renal indications, such as Orphan Drug exclusivity.

Early Stage Compounds

While the science has led us to focus initially on kidney disease, our targeted blocking system 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 I trial for non-operable pancreatic cancer. Our ability to do so will grow as we increase our scale and start to earn revenues and royalties from the commercialization of our late stage kidney disease franchise.

Since commencing our operations in 1997, our efforts have focused on research, development and the advancement ofLN, if approved;

Develop our drug candidates into and through clinical trials. As a result, we have incurred significant losses. We have fundedestablish collaborations with pharmaceutical and biotechnology companies to further develop and market our operations primarily through the sale of convertible preferreddrug candidates; and common stock, revenue under our collaborations, government contracts
Discover and grants and borrowings under equipment financing arrangements.

develop new drug candidates.

As of September 30, 2017,March 31, 2022, we had an accumulated deficit of $328.9$655.7 million. We expect to continue to incur net losses as we continue to commercialize TAVNEOS in the United States, develop our drug candidates, expand clinical trials for our drug candidates currently in clinical development, and expand our research and development activities, expand ourorganization 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.facilities. Significant capital is required to launchcommercialize a drug 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 ActCOVID-19

In April 2012, the JOBS ActDecember 2019, a disease caused by a novel strain of coronavirus, COVID-19, was enacted. Section 107identified in Wuhan, China. This virus has spread globally, including countries in which we have active clinical trial sites or contract manufacturing sites. The length of the JOBS Act provides that an emerging growth company can utilizepandemic and its related restrictions and their consequences for us remain subject to a number of risks and uncertainties, including disease resurgence and variants. We experienced a delay in topline clinical data from our ongoing AURORA trial to the extended transition period providedfourth quarter of 2020, due to COVID-19, impacting certain sites where the trial was being conducted. We do not currently anticipate any material delays in Section 7(a)(2)(B)our commercial production 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, andTAVNEOS nor are we currently anticipating any material disruption in our clinical drug supply as a result weof the pandemic. However, the pandemic continues to be unpredictable, and impacts may not implement newbe foreseeable or revised accounting standards on the relevant dates on which adoption of such standards is required for other companies.expected.

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 significant judgments and estimates for our critical accounting policies during the ninethree months ended September 30, 2017,March 31, 2022, as compared to those disclosed in “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016,2021, filed with the SEC on March 14, 2017.1, 2022.

22


Results of Operations

Revenue

We have not generated any revenue from product sales. Forlaunched TAVNEOS and began commercial sales during the periods presented, our revenues were derived from (i) the recognition of the upfront payments related to the Avacopan Agreement, Avacopan Amendment and CCX140 Agreement; (ii) collaboration revenue under 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.quarter ended December 31, 2021. Total revenue for the periodsthree months ended March 31, 2022, as compared to the same periodsperiod in the prior year, werewas 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
March 31,

 

 

 

2022

 

 

2021

 

Product sales, net

 

$

5,353

 

 

$

 

Collaboration and license revenue from related party

 

 

106

 

 

 

10,223

 

Grant revenue

 

 

 

 

 

130

 

Total revenue

 

$

5,459

 

 

$

10,353

 

Dollar decrease

 

$

(4,894

)

 

 

 

Percentage decrease

 

 

(47

%)

 

 

 

The increases in revenue from 2016 to 2017 for

For the three months ended March 31, 2022, our revenue was primarily derived from TAVNEOS sales, as compared to the collaboration and nine month periods were due to; (i) amortizationlicense revenue generated in the same period of the upfront license fee commitments from Vifor pursuant2021 related to the Avacopan Agreement, Avacopan AmendmentAgreements and CCX140 Agreement, as well as (ii) collaboration revenue for development services under the CCX140 Agreement, in each case, as amended, and the 2017 periods.related letter agreements.

For the collaboration and license revenue, 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 increases werecosts 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.

The decrease in total revenue from 2021 to 2022 for the three months ended March 31 was attributable tothe $10.0 million milestone received in 2021 from Vifor for the February 2021 acceptance of the Japanese NDA, for TAVNEOS in the treatment of ANCA-associated vasculitis, which subsequently led to the September 2021 Japanese NDA approval of TAVNEOS. The impact of the increase in transaction price of the Avacopan Agreements from the $45.0 million non-refundable regulatory milestone received upon TAVNEOS approval in Europe during the first quarter of 2022 was offset by the impact of an increase in the estimated underlying development budget (which also occurred in the quarter ended March 31, 2022 but was unrelated to the increase in the transaction price) and therefore is currently estimated to be recognized over a four year period, subject to adjustment from time to time, as performance obligations under the Avacopan Agreements are fulfilled. This overall decrease in revenue was partially offset by a decreaseU.S. TAVNEOS net sales in grant revenue from the FDA to support the clinical development of avacopan for the treatment of patients with AAV.2022.

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,March 31, 2022, as compared to the same period in the prior year, were as follows (in thousands):

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

Research and development expenses

  $12,315  $8,389   $36,614  $28,696 

Dollar increase

  $3,926    $7,918  

Percentage increase

   47    28 

 

 

Three Months Ended
March 31,

 

 

 

2022

 

 

2021

 

Research and development expenses

 

 

$

17,476

 

 

 

$

23,418

 

Dollar decrease

 

 

$

(5,942

)

 

 

 

 

Percentage decrease

 

 

 

(25

%)

 

 

 

 

The increase in research and development expensesdecrease from 20162021 to 20172022 for the three month periodmonths ended March 31 was primarily attributable to higherthe manufacture of commercial drug supply which was accounted for as inventory in Phase III clinical development expenses duethe first quarter of 2022 as compared to the initiation and patient enrollmentsame period of 2021 in which such costs were expensed in anticipation of the avacopan ADVOCATE trial in patients with AAV and higher Phase II clinical development expense due to start-up expenses related to the clinical triallaunch of avacopanTAVNEOS for the treatment of C3G. These increasesANCA-associated vasculitis. Manufacturing costs associated with campaigns initiated prior to FDA approval were partially offset by lowerrecorded as research and development expense. Lower Phase II related expenses due to the completion of the avacopan

CLEAR and CLASSICTAVNEOS AURORA Phase IIb 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 and patient enrollment of the avacopan Phase III ADVOCATE trial in patients with AAV and start-up expenses relatedHS also

23


contributed to the Phase II clinical trial of avacopan for the treatment of C3G.decrease. These increasesdecreases were partially offset by lower Phase II clinicalhigher expenses, including those associated with the 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.CCX559, our orally-available small molecule checkpoint (PD-L1/PD-1) inhibitor.

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

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

 

Three Months Ended
March 31,

 

  2017   2016   2017   2016 

 

2022

 

 

2021

 

Phase I

  $218   $802   $962   $5,299 

 

$

2,671

 

$

17

 

Phase II

   3,760    1,192    6,476    9,780 

 

3,102

 

4,048

 

Phase III

   5,067    3,247    19,069    3,515 

 

7,487

 

10,910

 

Research and drug discovery

   3,270    3,148    10,107    10,102 

 

4,216

 

8,443

 

  

 

   

 

   

 

   

 

 

Total R&D

  $12,315   $8,389   $36,614   $28,696 
  

 

   

 

   

 

   

 

 

Total research and development expenses

 

$

17,476

 

 

$

23,418

 

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

At any given time, we typically have several active early stage research and drug discovery projects. Our internal resources, employees and infrastructure are not directly tied to any individual research or drug discovery project and are typically deployed across multiple projects. As such, we do not maintain information regarding these costs incurred for our early stage research and drug discovery programs on a project specific basis. We expect our research and development expenses to increase as we advance our development programs further and increase the number and size of our clinical trials. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming. We, or our partners, may never succeed in achieving marketing approval, as we did with TAVNEOS, 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 drug products. Completion dates and completion costs can vary significantly for each drug candidate and are difficult to predict for each drug 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 willmay 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, CCX872TAVNEOS, CCX559 and vercirnon.

CCX507.

GeneralSelling, general and administrative expenses

Total selling, general and administrative expenses for the three and nine months ended September 30, 2017,March 31, 2022, as compared to the same periodsperiod in the prior year, were as follows (in thousands):

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

 

Three Months Ended
March 31,

 

      2017         2016           2017         2016     

 

2022

 

 

2021

 

General and administrative expenses

  $3,624  $3,193   $12,381  $11,154 

Selling, general and administrative

 

 

$

26,011

 

 

$

16,262

 

Dollar increase

  $431    $1,227  

 

 

$

9,749

 

 

 

 

Percentage increase

   13    11 

 

60

%

 

 

 

 

General

Selling, general and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation and travel expenses, in executive, finance, commercial, business and corporate development and other administrative functions.functions, as well as costs associated with the launch and commercialization of TAVNEOS. Other selling, 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.

24


The increase from 20162021 to 20172022 for the three month period ended March 31 was primarily due to higher accounting relatedemployee-related expenses and professional fees, including those associated with preparing to meet the requirements pursuant to the Sarbanes-Oxley ActU.S. launch and commercialization of 2002. The increase from 2016 to 2017 for the nine month period was primarily due to higher intellectual property related expenses and accounting related fees partially offset by lower travel expenses.TAVNEOS.

We expectanticipate that our selling, general and administrative expenses will increase substantially in the future as we expand our operatingprimarily due to commercialization-related activities and incur additional expenses associated with preparingpersonnel costs to meetsupport the requirements pursuant to the Sarbanes-Oxley Actcommercialization of 2002, including in connection with the expiration of our statusTAVNEOS as an emerging growth company, expected to occuradjunctive treatment for adult patients with severe active ANCA-associated vasculitis in 2017.the United States.

Other income,expense, net

Other income,expense, net primarily consists of interest income earned on our marketable securities.securities and interest expense for our long-term debt. Total other income,expense, net for the three and nine month periods,period ended March 31, 2022, as compared to the same periodsperiod in the prior year was as follows (in thousands):

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

Interest income

  $350  $259   $1,003  $506 
  

 

 

  

 

 

   

 

 

  

 

 

 

Total other income, net

  $350  $259   $1,003  $506 
  

 

 

  

 

 

   

 

 

  

 

 

 

Dollar increase

  $91    $497  

Percentage increase

   35    98 

 

 

Three Months Ended
March 31,

 

 

 

2022

 

 

2021

 

Interest income

 

 

$

222

 

 

 

$

305

 

Interest expense

 

 

 

(597

)

 

 

 

(689

)

Total other expense, net

 

 

$

(375

)

 

 

$

(384

)

Dollar decrease

 

 

$

(9

)

 

 

 

 

Percentage decrease

 

 

 

(2

%)

 

 

 

 

The increases indecrease from total other income,expense, net from 20162021 to 20172022 for the three and nine month periods weremonths ended March 31 was primarily due to higherless interest expense and less interest income earned from lower cash and investment balances in 2017 due to the receipt of upfront payments totaling $125.0 million received from Vifor in connection with the Avacopan Agreement, Avacopan Amendment and CCX140 Agreement..

Liquidity and Capital Resources

As of September 30, 2017,March 31, 2022, we had approximately $124.8$372.9 million in cash, cash equivalents, restricted cash 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 ninethree months ended September 30, 2017March 31, 2022 and 20162021 (in thousands):

   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 

 

 

Three Months Ended
March 31,

 

 

 

2022

 

 

2021

 

Cash provided by (used in)

 

 

 

 

 

 

 

 

Operating activities

 

 

$

8,831

 

 

 

$

(21,567

)

Investing activities

 

 

$

(21,337

)

 

 

$

60,668

 

Financing activities

 

 

$

3,105

 

 

 

$

(2,850

)

Operating activities. Net Net cash used inprovided by operating activities was $0.9 $8.8million for the ninethree months ended September 30, 2017,March 31, 2022, compared to $47.9$21.6 million provided by operating activitiescash used for the same period in 2016.2021. This changeincrease was primarily due to changes in working capital items. For the nine months ended September 30, 2017, changes in working capital included the receipt of $30.0 million of accounts receivable 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 used in or provided by or used in investing activities for periods presented primarily relate to the purchases of investmentspurchase, sale and maturitiesmaturity of investments used to fund the day-to-day needs of our business.

Financing activities.Net cash provided byfinancing activities was $2.4$3.1 million for the ninethree months ended September 30, 2017,March 31, 2022, compared to $7.6cash used in financing activities of $2.9 million for the same period in 2016.2021. 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 amended and restated 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.units.

As of September 30, 2017,March 31, 2022, we had borrowed $20.0 million under the Credit Facility with Hercules Capital, Inc., or Hercules. We made interest-only payments through June 2021 and the first principal and interest payment on July 1, 2021. The Credit Facility was subsequently amended in July 2021 and December 2021 to extend the interest-only payment period through August 2022, at which point we will be obligated to repay the principal balance and interest on the advances in equal monthly installments through December 2022. In January 2020, we entered into the Restated Credit Facility, which provides for borrowings of up to an additional $100.0 million in three tranches, subject to certain terms and conditions. As of March 31, 2022, we had borrowed $5.0 million under the Restated Credit Facility. With the FDA approval of TAVNEOS in October 2021, the interest-only payment period and the principal balance repayment period was extended through March 1, 2023 and February 1, 2025, respectively. We are obligated to pay an end of

25


term charge of $1.3 million in December 2022. See “Note 6. Long-term Debt” in the Notes to Condensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for additional information regarding our borrowings.

As of March 31, 2022, we had approximately $124.8$372.9 million in cash, cash equivalents, restricted cash 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, restricted cash and investments will be sufficient to fund our anticipated level of operations and capital expenditures for at least 12 months following issuance of our financial statement issuance date, November 7, 2017.statement. 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 continuing sales of TAVNEOS as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis;
Vifor and any sublicensees’ ability to successfully commercialize and launch TAVNEOS and royalties therefrom;
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;candidates, including any delays as a result of the COVID-19 pandemic on our business, preclinical studies or clinical trials;

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;timelines and outcomes;

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

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;candidates and TAVNEOS;

the cost and timingeffectiveness of establishing sales, marketing and distribution capabilities;functions; and

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

Contractual Obligations and Commitments

There have been no material changes outside the ordinary course of our business to the contractual obligations we reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, filed with the SEC on March 14, 2017.

Recent Accounting Pronouncements

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

Item 3.Quantitative and Qualitative Disclosures About Market Risk

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Our market risks at September 30, 2017March 31, 2022 have not changed significantly from those discussed in “Item 7A. Quantitative and Qualitative Disclosures About Market Risk” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016,2021, filed with the SEC on March 14, 2017.1, 2022, other than the following:

We are affected by market risk exposure primarily through the effect of changes in interest rates on amounts payable under the Credit Facility and Restated Credit Facility. At March 31, 2022, borrowings under the Credit Facility totaled $20.0 million with an interest rate of 8.05%. Advances under the Credit Facility 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, or Prime Rate, minus 4.75%, and (ii) 8.05%. We made interest-only payments on our borrowings under the Credit Facility through June 2021 and the first principal and interest payment on July 1, 2021. The Credit Facility was subsequently amended in July 2021 and December 2021 to extend the interest-only payment period through August 1, 2022, and will then repay the principal balance and interest on the advances in equal monthly installments through December 1, 2022.

In addition, borrowings under the Restated Credit Facility totaled $5.0 million at March 31, 2022 with an interest rate equal to the greater of (i) 8.50% plus the Prime Rate minus 5.25%, and (ii) 8.50%, which may be reduced upon the Company achieving certain cumulative net TAVNEOS revenue levels. We are obligated to make interest-only payments on our borrowings under the Restated Credit Facility through February 1, 2023, and will then repay the principal balance and interest on the advances in equal monthly installments through February 1, 2025. If the total amounts outstanding under the Credit Facility and the Restated Credit Facility remained at this level for an entire year and the interest rates increased by 1%, our annual interest expense would increase by an

26


additional $250,000. See “Note 6. Long-term Debt” in the Notes to Condensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for additional information regarding our borrowings.

Item 4.Controls and Procedures

Item 4. Controls and Procedures

Conclusions Regarding the Effectiveness of Disclosure Controls and Procedures

As of September 30, 2017,March 31, 2022, management, with the participation of our Disclosure Committee, performed an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act. Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the 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,March 31, 2022, the design and operation of our disclosure controls and procedures were effective.

Changes in Internal Control overOver Financial Reporting

There has been no change in our internal control over financial reporting during the three months ended September 30, 2017,March 31, 2022, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

27


PART II. OTHER INFORMATION

Item 1.Legal Proceedings

The Company and its Chief Executive Officer were named as defendants in two putative shareholder class actions filed on May 5, 2021, and June 8, 2021, in the U.S. District Court for the Northern District of California. These cases have been consolidated into the lead case, Homyk v. ChemoCentryx, Inc., No. 4:21-cv-03343-JST (N.D. Cal.) (the “Homyk action”). The Homyk action alleges violations of Sections 10(b) and 20(a) of the Securities Exchange Act in connection with statements regarding the New Drug Application, or NDA, for TAVNEOS, and the underlying Phase III clinical trial, seeking an award of damages, interest and attorneys’ fees. A lead plaintiff was selected on January 28, 2022, and a consolidated amended complaint was filed on March 28, 2022. The Company’s motion to dismiss these claims will be filed on May 19, 2022 and heard sometime after August 3, 2022, when the motion is fully briefed. In addition, the Company, the Board of Directors and certain of our officers were named as defendants in a putative shareholder derivative action filed on January 25, 2022, in the U.S. District Court for the Northern District of California, Napoli v. Schall, 3:22-cv-00499 (N.D. Cal) (the “Napoli action”). On March 11, 2022, the Court entered a stipulation staying the Napoli action until judgment is entered in the Homyk action. The Company plans to vigorously defend against both actions. Given the early stages of both cases, the Company is unable to estimate a reasonably possible range of loss, if any, that may result from either litigation.

Item 1A.Risk Factors

Item 1A. Risk Factors

There have been no material changes to the risk factors included in “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016,2021, filed with the SEC on March 14, 2017.1, 2022, except the following:

We are subject to a securities class action lawsuit and a shareholder derivative action, and could become involved in further
securities class action or derivative litigation in the future that could divert management’s attention and adversely affect our
business and could subject us to significant liabilities. If an unfavorable ruling were to occur, the litigation could have a material
adverse impact.

The stock markets have from time-to-time experienced significant price and volume fluctuations that have affected the market prices for the shares of biotechnology and pharmaceutical companies. These broad market fluctuations as well a broad range of other factors, including the realization of any of the risks described in the “Risk Factors” section of our Annual Report on Form 10‐K for the fiscal year ended December 31, 2021, may cause the market price of the shares of our common stock to decline. In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biotechnology and pharmaceutical companies generally experience significant share price volatility. Litigation often is expensive and diverts management’s attention and resources, which could adversely affect our business. Any adverse determination in any such litigation or any amounts paid to settle any such actual or threatened litigation could require that we make significant payments. We are presently involved and may become involved in this type of litigation in the future. As of the date of this filing, a consolidated securities class action (Homyk v. ChemoCentryx, Inc., 4:21-cv-03343-JST (N.D. Cal.)) and a shareholder derivative action (Napoli v. Schall, 3:22-cv-00499 (N.D. Cal)) have been filed against us and/or certain of our officers and directors. The shareholder derivative action is stayed pending entry of judgment in the consolidated securities class action. Given the early stage of these cases, we are unable to estimate a range of potential loss. An unfavorable ruling in either lawsuit could have a materially adverse impact on us.

28


Item 2.Unregistered Sales of Equity Securities and Use of Proceeds

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

Not Applicable.

Item 3.Defaults Upon Senior Securities

Item 3. Defaults Upon Senior Securities

Not Applicable.

Item 4.Mine Safety Disclosures

Item 4. Mine Safety Disclosures

Not Applicable.

Item 5.Other Information

Item 5. Other Information

Not Applicable.

Item 6.Exhibits

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.

29


EXHIBIT INDEX

Exhibit

Number

Description

  31.1

10.1#

Amended and Restated Non-Employee Director Compensation Policy.

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

101.INS

The following information from

Inline XBRL Instance Document – the Registrant’s Quarterly Report on Form 10-Q forinstance document does not appear in the quarterly period ended September 30, 2017, formatted inInteractive Data File because 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)tags are embedded within the Notes to Condensed Consolidated Financial Statements.Inline XBRL document.

101.SCH

Inline XBRL Taxonomy Extension Schema Document

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

#

Indicates management contract or compensatory plan.

30


SIGNATURES

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, 2017

May 10, 2022

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

Thomas J. Schall, Ph.D.

President and Chief Executive Officer

(Principal Executive Officer)

Date: November 7, 2017May 10, 2022

/s/ Susan M. Kanaya

Susan M. Kanaya

Executive Vice President,

Chief Financial and Administrative Officer and Secretary

(Principal (Principal Financial and Accounting Officer)

31

24