ChemoCentryx, Inc. - Quarter Report: 2022 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
Form 10-Q
(Mark One)
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 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 its 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:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, par value $0.001 per share |
CCXI |
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
☒ |
|
Accelerated filer |
☐ |
Non-accelerated filer |
☐ |
|
Smaller reporting company |
☐ |
|
|
|
Emerging growth company |
☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13 (a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, as of July 29, 2022 was 71,355,872.
CHEMOCENTRYX, INC.
QUARTERLY REPORT ON FORM 10-Q
For the quarterly period ended June 30, 2022
Table of Contents
Page |
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Item 1. |
3 |
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Condensed Consolidated Balance Sheets – June 30, 2022 and December 31, 2021 |
3 |
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Condensed Consolidated Statements of Operations – Three and Six Months Ended June 30, 2022 and 2021 |
4 |
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5 |
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6 |
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Condensed Consolidated Statements of Cash Flows – Six Months Ended June 30, 2022 and 2021 |
8 |
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9 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
22 |
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Item 3. |
28 |
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Item 4. |
29 |
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Item 1. |
30 |
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Item 1A. |
30 |
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Item 2. |
31 |
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Item 3. |
31 |
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Item 4. |
31 |
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Item 5. |
31 |
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Item 6. |
31 |
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32 |
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33 |
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
CHEMOCENTRYX, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and par value data)
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
|
|
(unaudited) |
|
|
|
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
44,396 |
|
|
$ |
49,978 |
|
Short-term investments |
|
|
284,219 |
|
|
|
214,514 |
|
Accounts receivable, net |
|
|
4,759 |
|
|
|
411 |
|
Accounts receivable from related party |
|
|
187 |
|
|
|
43 |
|
Inventory |
|
|
5,474 |
|
|
|
851 |
|
Prepaid expenses and other current assets |
|
|
6,137 |
|
|
|
3,380 |
|
Total current assets |
|
|
345,172 |
|
|
|
269,177 |
|
Property and equipment, net |
|
|
30,856 |
|
|
|
32,269 |
|
Long-term investments |
|
|
17,551 |
|
|
|
97,856 |
|
Operating lease right-of-use assets |
|
|
24,359 |
|
|
|
24,806 |
|
Other assets |
|
|
1,452 |
|
|
|
1,544 |
|
Total assets |
|
$ |
419,390 |
|
|
$ |
425,652 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
7,592 |
|
|
$ |
6,746 |
|
Accrued and other current liabilities |
|
|
27,744 |
|
|
|
26,358 |
|
Long-term debt, current |
|
|
19,720 |
|
|
|
18,920 |
|
Deferred revenue from related party |
|
|
21,022 |
|
|
|
10,993 |
|
Total current liabilities |
|
|
76,078 |
|
|
|
63,017 |
|
Long-term debt, net |
|
|
4,005 |
|
|
|
4,715 |
|
Non-current deferred revenue from related party |
|
|
57,299 |
|
|
|
24,772 |
|
Non-current lease liabilities |
|
|
45,243 |
|
|
|
46,830 |
|
Other non-current liabilities |
|
|
235 |
|
|
|
198 |
|
Total liabilities |
|
|
182,860 |
|
|
|
139,532 |
|
) |
|
|
|
|
|
|
||
Stockholders’ equity: |
|
|
|
|
|
|
||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value, 200,000,000 shares authorized; |
|
|
71 |
|
|
|
70 |
|
Additional paid-in capital |
|
|
926,141 |
|
|
|
903,646 |
|
Note receivable |
|
|
(16 |
) |
|
|
(16 |
) |
Accumulated other comprehensive loss |
|
|
(2,310 |
) |
|
|
(483 |
) |
Accumulated deficit |
|
|
(687,356 |
) |
|
|
(617,097 |
) |
Total stockholders’ equity |
|
|
236,530 |
|
|
|
286,120 |
|
Total liabilities and stockholders’ equity |
|
$ |
419,390 |
|
|
$ |
425,652 |
|
See accompanying notes.
3
CHEMOCENTRYX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Product sales, net |
|
$ |
9,093 |
|
|
$ |
— |
|
|
$ |
14,446 |
|
|
$ |
— |
|
Product supply sales to related party |
|
|
866 |
|
|
|
— |
|
|
$ |
866 |
|
|
|
— |
|
Collaboration and license revenue from related party |
|
|
1,804 |
|
|
|
1,699 |
|
|
|
1,910 |
|
|
|
11,922 |
|
Grant revenue |
|
|
— |
|
|
|
114 |
|
|
|
— |
|
|
|
244 |
|
Total revenue |
|
|
11,763 |
|
|
|
1,813 |
|
|
|
17,222 |
|
|
|
12,166 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cost of sales |
|
|
803 |
|
|
|
— |
|
|
|
1,008 |
|
|
|
— |
|
Research and development |
|
|
14,355 |
|
|
|
20,853 |
|
|
|
31,831 |
|
|
|
44,271 |
|
Selling, general and administrative |
|
|
28,179 |
|
|
|
19,698 |
|
|
|
54,190 |
|
|
|
35,960 |
|
Total operating expenses |
|
|
43,337 |
|
|
|
40,551 |
|
|
|
87,029 |
|
|
|
80,231 |
|
Loss from operations |
|
|
(31,574 |
) |
|
|
(38,738 |
) |
|
|
(69,807 |
) |
|
|
(68,065 |
) |
Other expense: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
509 |
|
|
|
224 |
|
|
|
731 |
|
|
|
529 |
|
Interest expense |
|
|
(586 |
) |
|
|
(695 |
) |
|
|
(1,183 |
) |
|
|
(1,384 |
) |
Total other expense, net |
|
|
(77 |
) |
|
|
(471 |
) |
|
|
(452 |
) |
|
|
(855 |
) |
Net loss |
|
$ |
(31,651 |
) |
|
$ |
(39,209 |
) |
|
$ |
(70,259 |
) |
|
$ |
(68,920 |
) |
Net loss per common share |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted net loss per common share |
|
$ |
(0.44 |
) |
|
$ |
(0.56 |
) |
|
$ |
(0.99 |
) |
|
$ |
(0.99 |
) |
Shares used to compute basic and diluted net loss per common share |
|
|
71,234 |
|
|
|
69,788 |
|
|
|
71,035 |
|
|
|
69,698 |
|
See accompanying notes.
4
CHEMOCENTRYX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
(unaudited)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Net loss |
|
$ |
(31,651 |
) |
|
$ |
(39,209 |
) |
|
$ |
(70,259 |
) |
|
$ |
(68,920 |
) |
Unrealized loss on available-for-sale securities |
|
|
(455 |
) |
|
|
(67 |
) |
|
|
(1,827 |
) |
|
|
(195 |
) |
Comprehensive loss |
|
$ |
(32,106 |
) |
|
$ |
(39,276 |
) |
|
$ |
(72,086 |
) |
|
$ |
(69,115 |
) |
See accompanying notes.
5
CHEMOCENTRYX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share data)
(unaudited)
|
|
Common Stock |
|
|
Additional |
|
|
Note |
|
|
Accumulated |
|
|
Accumulated |
|
|
Total |
|
||||||||||
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Receivable |
|
|
Income (Loss) |
|
|
Deficit |
|
|
Equity |
|
|||||||
Balance as of March 31, 2022 |
|
|
71,142,102 |
|
|
$ |
71 |
|
|
$ |
916,224 |
|
|
$ |
(16 |
) |
|
$ |
(1,855 |
) |
|
$ |
(655,705 |
) |
|
$ |
258,719 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(31,651 |
) |
|
|
(31,651 |
) |
Unrealized loss on investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(455 |
) |
|
|
— |
|
|
|
(455 |
) |
Issuance of common stock under |
|
|
202,736 |
|
|
|
— |
|
|
|
1,782 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,782 |
|
Employee stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
7,872 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
7,872 |
|
Compensation expense related to |
|
|
— |
|
|
|
— |
|
|
|
263 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
263 |
|
Balance as of June 30, 2022 |
|
|
71,344,838 |
|
|
$ |
71 |
|
|
$ |
926,141 |
|
|
$ |
(16 |
) |
|
$ |
(2,310 |
) |
|
$ |
(687,356 |
) |
|
$ |
236,530 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Additional |
|
|
Note |
|
|
Accumulated |
|
|
Accumulated |
|
|
Total |
|
||||||||||
|
|
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 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(70,259 |
) |
|
|
(70,259 |
) |
Unrealized loss on investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,827 |
) |
|
|
— |
|
|
|
(1,827 |
) |
Issuance of common stock upon net exercise of warrant |
|
|
66,833 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Issuance of common stock under |
|
|
1,006,303 |
|
|
|
1 |
|
|
|
8,060 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
8,061 |
|
Repurchased shares upon vesting of |
|
|
(85,855 |
) |
|
|
— |
|
|
|
(3,126 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(3,126 |
) |
Employee stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
17,054 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
17,054 |
|
Compensation expense related to |
|
|
— |
|
|
|
— |
|
|
|
507 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
507 |
|
Balance as of June 30, 2022 |
|
|
71,344,838 |
|
|
$ |
71 |
|
|
$ |
926,141 |
|
|
$ |
(16 |
) |
|
$ |
(2,310 |
) |
|
$ |
(687,356 |
) |
|
$ |
236,530 |
|
See accompanying notes.
6
CHEMOCENTRYX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(in thousands, except share data)
(unaudited)
|
|
Common Stock |
|
|
Additional |
|
|
Note |
|
|
Accumulated |
|
|
Accumulated |
|
|
Total |
|
||||||||||
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Receivable |
|
|
Income (Loss) |
|
|
Deficit |
|
|
Equity |
|
|||||||
Balance as of March 31, 2021 |
|
|
69,742,493 |
|
|
$ |
70 |
|
|
$ |
876,017 |
|
|
$ |
(16 |
) |
|
$ |
(14 |
) |
|
$ |
(515,053 |
) |
|
$ |
361,004 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(39,209 |
) |
|
|
(39,209 |
) |
Unrealized loss on investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(67 |
) |
|
|
— |
|
|
|
(67 |
) |
Issuance of common stock under |
|
|
148,865 |
|
|
|
— |
|
|
|
1,099 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
1,099 |
|
Repurchased shares upon vesting of |
|
|
(5,383 |
) |
|
|
— |
|
|
|
(260 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(260 |
) |
Employee stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
7,454 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
7,454 |
|
Compensation expense related |
|
|
— |
|
|
|
— |
|
|
|
249 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
249 |
|
Balance as of June 30, 2021 |
|
|
69,885,975 |
|
|
$ |
70 |
|
|
$ |
884,559 |
|
|
$ |
(16 |
) |
|
$ |
(81 |
) |
|
$ |
(554,262 |
) |
|
$ |
330,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Additional |
|
|
Note |
|
|
Accumulated |
|
|
Accumulated |
|
|
Total |
|
||||||||||
|
|
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 |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(68,920 |
) |
|
|
(68,920 |
) |
Unrealized loss on investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(195 |
) |
|
|
— |
|
|
|
(195 |
) |
Issuance of common stock under |
|
|
519,852 |
|
|
|
1 |
|
|
|
3,261 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
3,262 |
|
Repurchased shares upon vesting of |
|
|
(86,343 |
) |
|
|
— |
|
|
|
(5,273 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(5,273 |
) |
Employee stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
15,294 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
15,294 |
|
Compensation expense related to |
|
|
— |
|
|
|
— |
|
|
|
489 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
489 |
|
Balance as of June 30, 2021 |
|
|
69,885,975 |
|
|
$ |
70 |
|
|
$ |
884,559 |
|
|
$ |
(16 |
) |
|
$ |
(81 |
) |
|
$ |
(554,262 |
) |
|
$ |
330,270 |
|
See accompanying notes.
7
CHEMOCENTRYX, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
|
|
Six Months Ended |
|
|||||
|
|
2022 |
|
|
2021 |
|
||
Operating activities |
|
|
|
|
|
|
||
Net loss |
|
$ |
(70,259 |
) |
|
$ |
(68,920 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
||
Stock-based compensation |
|
|
17,561 |
|
|
|
15,783 |
|
Depreciation of property and equipment |
|
|
2,041 |
|
|
|
1,120 |
|
Non-cash lease expense |
|
|
448 |
|
|
|
1,165 |
|
Non-cash interest expense, net |
|
|
1,698 |
|
|
|
1,771 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
||
Accounts receivable, net |
|
|
(4,348 |
) |
|
|
19 |
|
Accounts receivable from related party |
|
|
(144 |
) |
|
|
(21 |
) |
Inventory |
|
|
(4,623 |
) |
|
|
— |
|
Prepaids and other current assets |
|
|
(2,891 |
) |
|
|
994 |
|
Other assets |
|
|
92 |
|
|
|
19 |
|
Accounts payable |
|
|
846 |
|
|
|
2,636 |
|
Operating lease liabilities |
|
|
(1,363 |
) |
|
|
8,094 |
|
Other liabilities |
|
|
1,091 |
|
|
|
(214 |
) |
Deferred revenue from related party |
|
|
42,556 |
|
|
|
(1,864 |
) |
Net cash used in operating activities |
|
|
(17,295 |
) |
|
|
(39,418 |
) |
Investing activities |
|
|
|
|
|
|
||
Purchases of property and equipment, net |
|
|
(628 |
) |
|
|
(14,177 |
) |
Purchases of investments |
|
|
(126,757 |
) |
|
|
(198,944 |
) |
Maturities of investments |
|
|
134,128 |
|
|
|
299,555 |
|
Net cash provided by investing activities |
|
|
6,743 |
|
|
|
86,434 |
|
Financing activities |
|
|
|
|
|
|
||
Proceeds from exercise of stock options and employee stock purchase plan |
|
|
8,096 |
|
|
|
3,165 |
|
Employees' tax withheld and paid for restricted stock units |
|
|
(3,126 |
) |
|
|
(5,273 |
) |
Net cash provided by (used in) financing activities |
|
|
4,970 |
|
|
|
(2,108 |
) |
Net (decrease) increase in cash, cash equivalents and restricted cash |
|
|
(5,582 |
) |
|
|
44,908 |
|
Cash, cash equivalents and restricted cash at beginning of period |
|
|
51,058 |
|
|
|
33,377 |
|
Cash, cash equivalents and restricted cash at end of period |
|
$ |
45,476 |
|
|
$ |
78,285 |
|
Supplemental disclosures of cash flow information |
|
|
|
|
|
|
||
Cash paid for interest |
|
$ |
986 |
|
|
$ |
1,029 |
|
Right-of-use assets obtained in exchange for lease obligations |
|
$ |
1 |
|
|
$ |
455 |
|
Purchases of property and equipment, net recorded in |
|
$ |
— |
|
|
$ |
4,436 |
|
See accompanying notes.
8
CHEMOCENTRYX, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2022
(unaudited)
ChemoCentryx, Inc. (the Company) commenced operations in 1997. The Company is a fully integrated United States biopharmaceutical company focused on the development and commercialization of new medications targeting 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 U.S. and it operates in one segment.
Unaudited Interim Financial Information
The financial information filed is unaudited. The Condensed Consolidated Financial Statements included in this report reflect all adjustments (consisting only of normal recurring adjustments) that the Company considers necessary for the fair statement of the results of operations for the interim periods covered and of the financial condition of the Company at the date of the interim balance sheet. The December 31, 2021 Condensed Consolidated Balance Sheet was derived from audited financial statements. The results for interim periods are not necessarily indicative of the results for the entire year or any other interim period. The Condensed Consolidated Financial Statements should be read in conjunction with the Company’s financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 filed with the Securities and Exchange Commission on March 1, 2022.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States (GAAP) requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from these estimates.
Concentration of Credit Risk
The Company invests in a variety of financial instruments and, by its policy, limits the amount of credit exposure with any one issuer, industry or geographic area.
For the three and six months ended June 30, 2022 and 2021, total revenue derived from the Company’s collaboration with Vifor (International) Ltd., and/or its affiliates, or collectively, Vifor, was 22.7%, 93.7%, 16.1% and 98.0%, 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. Two customers represented 99% and 100% of the Company's accounts receivable at June 30, 2022 and December 31, 2021, respectively, and each of these customers represented 10% or greater of the Company's accounts receivable. For each of the three and six months ended June 30, 2022, these two customers represented 99% of the Company's product sales, net. The Company began commercializing TAVNEOS in the U.S. in October 2021 and had no product sales, net prior to October 2021.
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),
9
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.
For the three and six months ended June 30, 2022 and 2021, the following potentially dilutive securities were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect (in thousands):
|
Three and Six Months Ended |
|
|||||
|
June 30, |
|
|||||
|
2022 |
|
|
2021 |
|
||
Options to purchase common stock, including |
|
7,227 |
|
|
|
7,404 |
|
Restricted stock units |
|
599 |
|
|
|
432 |
|
Restricted stock awards |
|
33 |
|
|
|
15 |
|
Warrant to purchase common stock(1) |
|
— |
|
|
|
150 |
|
|
|
7,859 |
|
|
|
8,001 |
|
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.
10
Comprehensive Loss
Comprehensive loss comprises net loss and other comprehensive loss. For the periods presented, other comprehensive loss consists of unrealized losses on the Company’s available-for-sale securities. For the three and six months ended June 30, 2022 and 2021, there were no sales of investments and therefore there were no reclassifications of comprehensive loss.
Recent Accounting Pronouncements
The Company has reviewed recent accounting pronouncements and concluded they are either not applicable to the business or that no material effect is expected on the consolidated financial statements as a result of future adoption.
Cash, Cash Equivalents and Restricted Cash
The following table provides a reconciliation of cash, cash equivalents and restricted cash shown in the Condensed Consolidated Statements of Cash Flows (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
Cash and cash equivalents |
|
$ |
44,396 |
|
|
$ |
49,978 |
|
Restricted cash included in Other assets |
|
|
1,080 |
|
|
|
1,080 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
45,476 |
|
|
$ |
51,058 |
|
Restricted cash as of June 30, 2022 and December 31, 2021 was held as collateral for stand-by letters of credit issued by the Company to its landlord in connection with the lease of the Company’s facility in San Carlos, California. See “Note 7. Commitments” for additional information on this lease.
Cash Equivalents and Investments
The amortized cost and fair value of cash equivalents and investments at June 30, 2022 and December 31, 2021 were as follows (in thousands):
|
|
June 30, 2022 |
|
|||||||||||||
|
|
Amortized |
|
|
Gross Unrealized |
|
|
Fair |
|
|||||||
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
||||
Money market fund |
|
$ |
41,722 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
41,722 |
|
U.S. treasury securities |
|
|
97,758 |
|
|
|
— |
|
|
|
(958 |
) |
|
|
96,800 |
|
Non-U.S. government securities |
|
|
24,616 |
|
|
|
— |
|
|
|
(248 |
) |
|
|
24,368 |
|
Commercial paper |
|
|
77,750 |
|
|
|
— |
|
|
|
— |
|
|
|
77,750 |
|
Asset-backed securities |
|
|
19,517 |
|
|
|
— |
|
|
|
(213 |
) |
|
|
19,304 |
|
Corporate debt securities |
|
|
84,439 |
|
|
|
— |
|
|
|
(891 |
) |
|
|
83,548 |
|
Total available-for-sale securities |
|
$ |
345,802 |
|
|
$ |
— |
|
|
$ |
(2,310 |
) |
|
$ |
343,492 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Classified as: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
|
|
|
|
|
|
|
|
|
$ |
41,722 |
|
|||
Short-term investments |
|
|
|
|
|
|
|
|
|
|
|
284,219 |
|
|||
Long-term investments |
|
|
|
|
|
|
|
|
|
|
|
17,551 |
|
|||
Total available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
$ |
343,492 |
|
11
|
|
December 31, 2021 |
|
|||||||||||||
|
|
Amortized |
|
|
Gross Unrealized |
|
|
Fair |
|
|||||||
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
||||
Money market fund |
|
$ |
41,960 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
41,960 |
|
U.S. treasury securities |
|
|
40,397 |
|
|
|
— |
|
|
|
(160 |
) |
|
|
40,237 |
|
Government-sponsored agencies |
|
|
16,821 |
|
|
|
— |
|
|
|
(56 |
) |
|
|
16,765 |
|
Commercial paper |
|
|
111,868 |
|
|
|
— |
|
|
|
— |
|
|
|
111,868 |
|
Asset-backed securities |
|
|
39,988 |
|
|
|
— |
|
|
|
(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 $2.7 million and $8.0 million as of June 30, 2022 and December 31, 2021, respectively. All available-for-sale securities held as of June 30, 2022 had contractual maturities of less than two years. There have been no significant realized gains or losses on available-for-sale securities for the periods presented. The Company applies the specific identification method to determine the cost basis of the securities sold. As of June 30, 2022, unrealized losses on available-for-sale investments are not attributed to credit risk. The Company believes that it is more-likely-than-not that investments in an unrealized loss position will be held until maturity or the recovery of the cost basis of the investment. The Company believes that an allowance for credit losses is unnecessary because the unrealized losses on certain of the Company’s marketable securities are due to market factors. To date, the Company has not recorded any impairment charges on marketable securities.
The Company determines the fair value of financial assets and liabilities using three levels of inputs as follows:
Level 1—Inputs which include quoted prices in active markets for identical assets and liabilities.
Level 2—Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
Recurring Fair Value Measurements
The Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows as of June 30, 2022 and December 31, 2021 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
June 30, 2022 |
|
|||||||||||||
Description |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Money market fund |
|
$ |
41,722 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
41,722 |
|
U.S. treasury securities |
|
|
— |
|
|
|
96,800 |
|
|
|
— |
|
|
|
96,800 |
|
Non-U.S. government securities |
|
|
— |
|
|
|
24,368 |
|
|
|
— |
|
|
|
24,368 |
|
Commercial paper |
|
|
— |
|
|
|
77,750 |
|
|
|
— |
|
|
|
77,750 |
|
Asset-backed securities |
|
|
— |
|
|
|
19,304 |
|
|
|
— |
|
|
|
19,304 |
|
Corporate debt securities |
|
|
— |
|
|
|
83,548 |
|
|
|
— |
|
|
|
83,548 |
|
Total available-for-sale securities |
|
$ |
41,722 |
|
|
$ |
301,770 |
|
|
$ |
— |
|
|
$ |
343,492 |
|
12
|
|
December 31, 2021 |
|
|||||||||||||
Description |
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
||||
Money market fund |
|
$ |
41,960 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
41,960 |
|
U.S. treasury securities |
|
|
— |
|
|
|
40,237 |
|
|
|
— |
|
|
|
40,237 |
|
Government-sponsored agencies |
|
|
— |
|
|
|
16,765 |
|
|
|
— |
|
|
|
16,765 |
|
Commercial paper |
|
|
— |
|
|
|
111,868 |
|
|
|
— |
|
|
|
111,868 |
|
Asset-backed securities |
|
|
— |
|
|
|
39,926 |
|
|
|
— |
|
|
|
39,926 |
|
Corporate debt securities |
|
|
— |
|
|
|
103,574 |
|
|
|
— |
|
|
|
103,574 |
|
Total available-for-sale securities |
|
$ |
41,960 |
|
|
$ |
312,370 |
|
|
$ |
— |
|
|
$ |
354,330 |
|
During the three and six months ended June 30, 2022, there were no transfers between Level 1 and Level 2 financial assets. When the Company uses observable market prices for identical securities that are traded in less active markets, the Company classifies its marketable debt instruments as Level 2. When observable market prices for identical securities are not available, the Company prices its marketable debt instruments using non-binding market consensus prices that are corroborated with observable market data; quoted market prices for similar instruments; or pricing models, such as a discounted cash flow model, with all significant inputs derived from or corroborated with observable market data. Non-binding market consensus prices are based on the proprietary valuation models of pricing providers or brokers. These valuation models incorporate a number of inputs, including non-binding and binding broker quotes; observable market prices for identical or similar securities; and the internal assumptions of pricing providers or brokers that use observable market inputs and, to a lesser degree, unobservable market inputs. The Company corroborates non-binding market consensus prices with observable market data using statistical models when observable market data exists. The discounted cash flow model uses observable market inputs, such as LIBOR-based yield curves, currency spot and forward rates, and credit ratings.
Other Fair Value Measurements
The carrying amount and estimated fair value of financial instruments not recorded at fair value at June 30, 2022 and December 31, 2021 were as follows (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
||||||||||
|
|
Carrying |
|
|
Estimated |
|
|
Carrying |
|
|
Estimated |
|
||||
Long-term debt, net (1) |
|
$ |
23,725 |
|
|
$ |
25,271 |
|
|
$ |
23,635 |
|
|
$ |
25,046 |
|
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.
Accrued and other current liabilities consist of the following (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
Research and development related |
|
$ |
9,539 |
|
|
$ |
11,309 |
|
Compensation related |
|
|
6,737 |
|
|
|
8,350 |
|
Consulting and professional services |
|
|
1,329 |
|
|
|
1,348 |
|
|
|
3,035 |
|
|
|
2,810 |
|
|
End of term charge on the long-term debt |
|
|
1,196 |
|
|
|
1,151 |
|
Commercial manufacturing related |
|
|
3,013 |
|
|
|
|
|
Other |
|
|
2,895 |
|
|
|
1,390 |
|
|
|
$ |
27,744 |
|
|
$ |
26,358 |
|
13
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 June 30, 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 obligated 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 three 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 June 30, 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 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.
14
As of June 30, 2022, the Company had outstanding borrowings under the Amended Loan Agreement of $23.7 million, net of discounts of $0.2 million. Future minimum principal payments, which exclude the end of term charge, as of June 30, 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 |
|
|
(226 |
) |
Present value of remaining debt payments |
|
|
23,725 |
|
Less: current portion |
|
|
(19,720 |
) |
Non-current portion |
|
$ |
4,005 |
|
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 June 30, 2022, the Company’s noncancelable contractual obligations under these terms of the agreements are approximately $11.6 million. 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 2020 and 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 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 April 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 June 30, 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):
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
Balance Sheet |
|
|
|
|
|
|
||
Assets: |
|
|
|
|
|
|
||
Operating lease right-of-use assets |
|
$ |
24,359 |
|
|
$ |
24,806 |
|
Liabilities: |
|
|
|
|
|
|
||
Operating lease liabilities: |
|
|
|
|
|
|
||
Accrued and other current liabilities (1) |
|
$ |
3,035 |
|
|
$ |
2,810 |
|
Non-current lease liabilities |
|
|
45,243 |
|
|
|
46,830 |
|
15
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 |
|
|
Six Months Ended |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Operating lease cost |
|
$ |
1,375 |
|
|
$ |
1,740 |
|
|
$ |
2,750 |
|
|
$ |
3,482 |
|
During the six months ended June 30, 2022 and 2021, cash paid for amounts included in the measurement of lease liabilities was $4.0 million and $2.0 million, respectively, excluding the $0 and $7.7 million 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 June 30, 2022 are as follows (in thousands):
|
|
Operating leases |
|
|
Year ending December 31: |
|
|
|
|
Remaining of fiscal year 2022 |
|
$ |
3,683 |
|
2023 |
|
|
7,535 |
|
2024 |
|
|
7,741 |
|
2025 |
|
|
7,952 |
|
2026 |
|
|
8,170 |
|
Thereafter |
|
|
36,517 |
|
Total minimum payments |
|
|
71,598 |
|
Less: interest |
|
|
(23,320 |
) |
Present value of lease liabilities |
|
$ |
48,278 |
|
As of June 30, 2022, the remaining lease term was 8.7 years and the operating discount rate used to determine the operating lease liability was 9.5%.
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 has moved to dismiss these claims and expects the motion to be heard sometime after August 12, 2022. 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.
Vifor
Vifor held 5,194,085 shares of the Company’s common stock as of June 30, 2022. The Company has 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 receivable balance due from Vifor.
16
Avacopan Agreements
In May 2016, the Company entered into an exclusive collaboration and license agreement with Vifor pursuant to which the Company granted Vifor exclusive rights to commercialize avacopan in Europe and certain other markets (the Avacopan Agreement). Avacopan is the Company’s lead drug candidate for the treatment of patients with ANCA-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.
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 States. 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 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 Agreements: (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 a worldwide license agreement for CCX140, which expired in 2016. The Company considered that the license has standalone functionality and is capable of being distinct. However, the Company determined that the license is not distinct from the development and regulatory services within the context of the agreement because Vifor is dependent on the Company to execute the development and regulatory activities in order for Vifor to benefit from the license. As such, the license is combined with the development and regulatory services into a single performance obligation. The exclusive option related to CCX140 is a separate performance obligation and the Company determined that its transaction price is not material. As such, the transaction price under this arrangement is allocated to the license and the development and regulatory services.
As of June 30, 2022, the transaction price of $228.0 million comprised the following:
17
The Company will re-evaluate the transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.
The Company determined that the combined performance obligation will be performed over the duration of the contract, which began on the effective date of May 9, 2016 and ends upon completion of development and regulatory services. The Company uses a cost-based input method to measure proportional performance and to calculate the corresponding amount of revenue to recognize. The Company believes this is the best measure of progress because other measures do not reflect how the Company transfers its performance obligation to Vifor. In applying the cost-based input method of revenue recognition, the Company measures actual costs incurred relative to budgeted costs to fulfill the combined performance obligation. These costs consist primarily of third-party contract costs. Revenue is recognized based on actual costs incurred as a percentage of total budgeted costs as the Company completes its performance obligations.
For the three and six months ended June 30, 2022, the Company recognized $1.6 million and $1.7 million, respectively, of collaboration and license revenue under the Avacopan Agreements, as compared to $1.2 and $11.1 million, respectively, during the same periods in 2021.
Avacopan Commercial Supply Agreement
In October 2020, the Company entered into a Manufacturing and Supply Agreement with Vifor (the Avacopan Commercial Supply Agreement). Under the Avacopan Commercial Supply Agreement, the Company supplies and sells TAVNEOS to Vifor and its 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 Avacopan Commercial Supply Agreement. In connection with the Avacopan Commercial Supply Agreement, the Company also 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 TAVNEOS. During the three and six months ended June 30, 2022, the Company recognized $0.9 million of product supply revenue under the Avacopan Commercial Supply Agreement. There was no such product supply revenue for the three and six months ended June 30, 2021.
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 United States and China. CCX140 is an orally-administered inhibitor of the chemokine receptor known as CCR2. The Company retains marketing rights in the United States and China, while Vifor has commercialization rights in the rest of the world. Pursuant to the CCX140 Agreement, the Company is responsible for the clinical development of CCX140 in rare renal diseases and is reimbursed for Vifor’s equal share of such development cost. 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
18
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 June 30, 2022, the transaction price of $66.5 million comprised the following:
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 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, the Company would receive co-promotion rights for CKD in the United States.
The Company fully recognized collaboration and license revenue under the CCX140 Agreements in 2021. Accordingly, no revenue was recognized during the three and six months ended June 30, 2022 compared to $0.5 million and $0.8 million during the three and six months ended June 30, 2021.
The following table presents the contract assets and liabilities for all of the Company’s revenue contracts as of the following dates (in thousands):
|
|
June 30, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
Contract asset: |
|
|
|
|
|
|
||
Accounts receivable |
|
$ |
187 |
|
|
$ |
43 |
|
Contract liability: |
|
|
|
|
|
|
||
Deferred revenue |
|
$ |
(78,321 |
) |
|
$ |
(35,765 |
) |
19
During the three and six months ended June 30, 2022, the Company recognized the following revenue as a result of changes in the contract asset and the contract liability balances (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||
|
|
2022 |
|
|
2022 |
|
||
Revenue recognized in the period from: |
|
|
|
|
|
|
||
Amount included in contract liability at the |
|
$ |
2,483 |
|
|
$ |
2,483 |
|
Performance obligations satisfied (or partially |
|
$ |
— |
|
|
$ |
2,254 |
|
In September 2019, the Company was awarded a two-year $1.0 million grant from the orphan drug office of the U.S. Food and Drug Administration to support the clinical development of TAVNEOS in patients with the rare 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, no revenue was recognized during the three and six months ended June 30, 2022 compared to $0.1 million and $0.2 million in the same periods of 2021. As of June 30, 2022 and December 31, 2021, $0 and $28,000 was recorded as accounts receivable, respectively.
Stock Options
During the six months ended June 30, 2022, the Company had the following activities under its equity incentive plans:
|
|
|
Available |
|
|
Shares |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
|||||
Balance at December 31, 2021 |
|
|
5,641,782 |
|
|
|
6,767,895 |
|
|
$ |
19.14 |
|
|
|
|
|
|
|
|||
|
Shares authorized |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|||
|
Granted (1) |
|
|
(2,098,105 |
) |
|
|
1,402,398 |
|
|
|
27.94 |
|
|
|
|
|
|
|
||
|
Exercised (2) |
|
|
— |
|
|
|
(693,988 |
) |
|
|
10.47 |
|
|
|
|
|
|
|
||
|
Forfeited and expired |
|
|
256,874 |
|
|
|
(256,874 |
) |
|
|
43.56 |
|
|
|
|
|
|
|
||
Outstanding at June 30, 2022 |
|
|
3,800,551 |
|
|
|
7,219,431 |
|
|
$ |
20.81 |
|
|
|
6.08 |
|
|
$ |
72,849,218 |
|
|
Vested and expected to vest, net of estimated forfeiture |
|
|
|
|
|
6,904,798 |
|
|
$ |
20.25 |
|
|
|
5.94 |
|
|
$ |
72,382,158 |
|
||
Exercisable at June 30, 2022 |
|
|
|
|
|
4,733,359 |
|
|
$ |
14.10 |
|
|
|
4.58 |
|
|
$ |
67,465,870 |
|
20
Restricted Stock
During the six months ended June 30, 2022, the activity for restricted stock is summarized as follows:
|
|
Shares |
|
|
Weighted |
|
||
Balance at December 31, 2021 |
|
|
413,510 |
|
|
$ |
45.94 |
|
Granted |
|
|
463,803 |
|
|
|
28.29 |
|
Vested |
|
|
(245,840 |
) |
|
|
37.28 |
|
Unvested at June 30, 2022 |
|
|
631,473 |
|
|
$ |
36.34 |
|
Stock-based Compensation
Total stock-based compensation expense was $8.1 million and $17.6 million during the three and six months ended June 30, 2022, and $7.7 million and $15.8 million during the same periods ended June 30, 2021. As of June 30, 2022, $49.3 million, $15.4 million and $0.2 million of 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 2.8, 2.6 and 0.4 years, respectively.
On August 3, 2022, the Company entered into an Agreement and Plan of Merger with Amgen Inc. (Amgen) under which Amgen will acquire the Company for $52.00 per share in cash, representing an enterprise value of approximately $3.7 billion. The transaction is subject to the Company's stockholder approval, regulatory approvals and other customary closing conditions, and is expected to close in the fourth quarter of 2022.
21
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, 2021, filed with the Securities and Exchange Commission, or SEC, on March 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:
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 herein and in “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the SEC on March 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 and TAVNEOSÒ are our trademarks in the United States, the European Community, Australia and Japan. EnabaLink®and RAM® are our trademarks in the United States. Each of the other trademarks, trade names or service marks appearing in this Quarterly Report on Form 10-Q belongs to its respective holder.
Unless the context requires otherwise, in this Quarterly Report on Form 10-Q the terms “ChemoCentryx,” “we,” “us” and “our” refer to ChemoCentryx, Inc., a Delaware corporation, and our subsidiaries taken as a whole unless otherwise noted.
22
Overview
ChemoCentryx is a fully integrated United States biopharmaceutical company focused on the development and commercialization of new medications targeting inflammatory disorders, autoimmune diseases and cancer. We 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 ANCA-associated vasculitis, in combination with standard therapy including glucocorticoids, and not for the elimination of glucocorticoid use.
In October 2021, we obtained regulatory approval and launched TAVNEOS in the U.S. for the treatment of an orphan disease called ANCA-associated vasculitis, leading to the grant of orphan drug marketing exclusivity for a period of seven years discussed further below. TAVNEOS also obtained regulatory approval in Japan 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. In addition, TAVNEOS was approved in Canada in April 2022 and in the United Kingdom in May 2022.
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. The majority 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):
23
Immuno-Oncology
Our Strategy
The key elements to our commercial and scientific strategy are to:
As of June 30, 2022, we had an accumulated deficit of $687.4 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, organization systems and facilities. Significant capital is required to commercialize 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.
COVID-19
In December 2019, a disease caused by a novel strain of coronavirus, COVID-19, was identified 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 pandemic 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 fourth 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 our commercial production of TAVNEOS nor are we currently anticipating any material disruption in our clinical drug supply as a result of the pandemic. COVID-19 has also altered factors that impact the healthcare system, including patient appointments, safety precautions, healthcare practice staffing, and healthcare professional availability. These changes to the healthcare system may impact commercialization. However, the pandemic continues to be unpredictable, and impacts may not be foreseeable or expected.
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 six months ended June 30, 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, 2021, filed with the SEC on March 1, 2022.
24
Results of Operations
Revenue
We launched TAVNEOS and began commercial sales during the quarter ended December 31, 2021. We also earned revenue from selling TAVNEOS under our commercial supply agreement with Vifor. Total revenue for the three and six months ended June 30, 2022, as compared to the same periods in the prior year, was as follows (in thousands):
|
|
Three Months Ended |
|
|
|
Six Months Ended |
|
|||||||||||
|
|
2022 |
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
||||
Product sales, net |
|
$ |
9,093 |
|
|
$ |
— |
|
|
|
$ |
14,446 |
|
|
|
$ |
— |
|
Product supply sales to related party |
|
|
866 |
|
|
|
— |
|
|
|
|
866 |
|
|
|
|
— |
|
Collaboration and license revenue from related party |
|
|
1,804 |
|
|
|
1,699 |
|
|
|
|
1,910 |
|
|
|
|
11,922 |
|
Grant revenue |
|
|
— |
|
|
|
114 |
|
|
|
|
— |
|
|
|
|
244 |
|
Total revenue |
|
$ |
11,763 |
|
|
$ |
1,813 |
|
|
|
$ |
17,222 |
|
|
|
$ |
12,166 |
|
Dollar increase |
|
$ |
9,950 |
|
|
|
|
|
|
$ |
5,056 |
|
|
|
|
|
||
Percentage increase |
|
|
549 |
% |
|
|
|
|
|
|
42 |
% |
|
|
|
|
For the three and six months ended June 30, 2022, our revenue was primarily derived from TAVNEOS sales, as compared to the collaboration and license revenue generated in the same periods of 2021 related to the Avacopan Agreements and the CCX140 Agreement, in each case, as amended, and the 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 costs consist primarily of third-party contract costs. Revenue is recognized based on actual costs incurred as a percentage of total budgeted costs as we complete our performance obligations.
The decreases in collaboration and license revenue from 2021 to 2022 for the six months ended June 30 was attributable to the $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 first quarter of 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.
Research and development expenses
Research and development expenses represent costs incurred to conduct basic research, discovery and development of novel small molecule therapeutics, development of our suite of proprietary drug discovery technologies, preclinical studies and clinical trials of our drug candidates. We recognize all research and development expenses as they are incurred. These expenses consist primarily of salaries and related benefits, including stock-based compensation, third-party contract costs relating to research, formulation, manufacturing, preclinical study and clinical trial activities, laboratory consumables, and allocated facility costs. Total research and development expenses for the three and six months ended June 30, 2022, as compared to the same periods in the prior year, were as follows (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||||||
Research and development expenses |
|
|
$ |
14,355 |
|
|
|
$ |
20,853 |
|
|
|
$ |
31,831 |
|
|
|
$ |
44,271 |
|
Dollar decrease |
|
|
$ |
(6,498 |
) |
|
|
|
|
|
|
$ |
(12,440 |
) |
|
|
|
|
||
Percentage decrease |
|
|
|
(31 |
%) |
|
|
|
|
|
|
|
(28 |
%) |
|
|
|
|
The decrease from 2021 to 2022 for the three and six months ended June 30 was primarily attributable to the manufacturing costs arising from validation activities in support of NDA filing of TAVNEOS for the treatment of ANCA-associated vasculitis in 2021. Manufacturing validation costs and manufacturing costs associated with campaigns initiated prior to FDA approval of TAVNEOS were recorded as research and development expense. Lower Phase II related expenses due to the completion of the TAVNEOS AURORA Phase IIb clinical trial in patients with HS also contributed to the decrease in research and development
25
expense in 2022. These decreases were partially offset by costs associated with the development of 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 June 30, |
|
|
Six Months Ended June 30, |
|
|
||||||||||||||||||||||||||
|
|
2022 |
|
|
2021 |
|
|
Change |
|
|
% |
|
|
2022 |
|
|
2021 |
|
|
Change |
|
|
% |
|
|
||||||||
Phase I |
|
$ |
2,354 |
|
|
$ |
6,045 |
|
|
$ |
(3,691 |
) |
|
|
(61 |
%) |
|
$ |
5,025 |
|
|
$ |
6,062 |
|
|
$ |
(1,037 |
) |
|
|
(17 |
%) |
|
Phase II |
|
|
1,371 |
|
|
|
3,475 |
|
|
|
(2,104 |
) |
|
|
(61 |
%) |
|
|
4,473 |
|
|
|
7,523 |
|
|
|
(3,050 |
) |
|
|
(41 |
%) |
|
Phase III |
|
|
5,643 |
|
|
|
8,477 |
|
|
|
(2,834 |
) |
|
|
(33 |
%) |
|
|
13,130 |
|
|
|
19,387 |
|
|
|
(6,257 |
) |
|
|
(32 |
%) |
|
Research and drug discovery |
|
|
4,987 |
|
|
|
2,856 |
|
|
|
2,131 |
|
|
|
75 |
% |
|
|
9,203 |
|
|
|
11,299 |
|
|
|
(2,096 |
) |
|
|
(19 |
%) |
|
Total research and development expenses |
|
$ |
14,355 |
|
|
$ |
20,853 |
|
|
$ |
(6,498 |
) |
|
|
(31 |
%) |
|
$ |
31,831 |
|
|
$ |
44,271 |
|
|
$ |
(12,440 |
) |
|
|
(28 |
%) |
|
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 may 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 TAVNEOS, CCX559 and CCX507.
Selling, general and administrative expenses
Total selling, general and administrative expenses for the three and six months ended June 30, 2022, as compared to the same periods in the prior year, were as follows (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||||||
Selling, general and administrative |
|
|
$ |
28,179 |
|
|
|
$ |
19,698 |
|
|
|
$ |
54,190 |
|
|
|
$ |
35,960 |
|
Dollar increase |
|
|
$ |
8,481 |
|
|
|
|
|
|
|
$ |
18,230 |
|
|
|
|
|
||
Percentage increase |
|
|
|
43 |
% |
|
|
|
|
|
|
|
51 |
% |
|
|
|
|
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, as well as costs associated with the launch and commercialization of TAVNEOS. Other selling, general and administrative
26
expenses include allocated facility-related costs not otherwise included in research and development expenses, legal costs of pursuing patent protection of our intellectual property, and professional fees for auditing, tax, and legal services.
The increase from 2021 to 2022 for the three and six month periods ended June 30 were primarily due to higher employee-related expenses and professional fees, including those associated with the U.S. launch and commercialization of TAVNEOS.
We anticipate that our selling, general and administrative expenses will increase substantially in the future primarily due to commercialization-related activities and personnel costs to support the commercialization of TAVNEOS as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis in the United States.
Other expense, net
Other expense, net primarily consists of interest income earned on our marketable securities and interest expense for our long-term debt. Total other expense, net for the three and six month periods ended June 30, 2022, as compared to the same periods in the prior year were as follows (in thousands):
|
|
Three Months Ended |
|
|
Six Months Ended |
|
||||||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||||||
Interest income |
|
|
$ |
509 |
|
|
|
$ |
224 |
|
|
|
$ |
731 |
|
|
|
$ |
529 |
|
Interest expense |
|
|
|
(586 |
) |
|
|
|
(695 |
) |
|
|
|
(1,183 |
) |
|
|
|
(1,384 |
) |
Total other expense, net |
|
|
$ |
(77 |
) |
|
|
$ |
(471 |
) |
|
|
$ |
(452 |
) |
|
|
$ |
(855 |
) |
Dollar decrease |
|
|
$ |
(394 |
) |
|
|
|
|
|
|
$ |
(403 |
) |
|
|
|
|
||
Percentage decrease |
|
|
|
(84 |
%) |
|
|
|
|
|
|
|
(47 |
%) |
|
|
|
|
The decrease from total other expense, net from 2021 to 2022 for the three and six months ended June 30 were primarily due to lower interest expense and higher interest income earned from cash and investment at higher rate of return.
Liquidity and Capital Resources
As of June 30, 2022, we had approximately $347.2 million in cash, cash equivalents, restricted cash and investments. The following table shows a summary of our cash flows for the six months ended June 30, 2022 and 2021 (in thousands):
|
|
Six Months Ended |
|
|||||||
|
|
2022 |
|
|
2021 |
|
||||
Cash provided by (used in) |
|
|
|
|
|
|
|
|
||
Operating activities |
|
|
$ |
(17,295 |
) |
|
|
$ |
(39,418 |
) |
Investing activities |
|
|
$ |
6,743 |
|
|
|
$ |
86,434 |
|
Financing activities |
|
|
$ |
4,970 |
|
|
|
$ |
(2,108 |
) |
Operating activities. Net cash used in operating activities was $17.3 million for six months ended June 30, 2022, compared to $39.4 million for the same period in 2021. This decrease was primarily due to the milestone payment of $45.0 million received from our collaboration partner, Vifor, during the period, partially offset by changes to working capital items.
Investing activities. Net cash used in or provided by investing activities for periods presented primarily relate to the purchase, sale and maturity of investments used to fund the day-to-day needs of our business.
Financing activities. Net cash provided by financing activities was $5.0 million for the six months ended June 30, 2022, compared to cash used in financing activities of $2.1 million for the same period in 2021. Net cash provided by financing activities for both periods presented included proceeds from the exercise of stock options and stock purchases from contributions to our amended and restated 2012 Employee Stock Purchase Plan, and cash used for tendered ChemoCentryx, Inc. common stock to satisfy employee tax withholding requirements upon vesting of restricted stock units.
As of June 30, 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
27
million in three tranches, subject to certain terms and conditions. As of June 30, 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 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 June 30, 2022, we had approximately $346.2 million in cash, cash equivalents and investments. We believe that our available cash, cash equivalents and investments will be sufficient to fund our anticipated level of operations and capital expenditures for at least 12 months following issuance of our financial 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:
Recent Accounting Pronouncements
See “Note 2. Summary of Significant Accounting Policies” in the Notes to Condensed Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Our market risks at June 30, 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, 2021, filed with the SEC on March 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 June 30, 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 June 30, 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
28
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 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
Conclusions Regarding the Effectiveness of Disclosure Controls and Procedures
As of June 30, 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 Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including the Chief Executive Officer and the Chief Financial and Administrative Officer, to allow timely decisions regarding required disclosures.
Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective. Based on this evaluation, our Chief Executive Officer and Chief Financial and Administrative Officer concluded that, as of June 30, 2022, the design and operation of our disclosure controls and procedures were effective.
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting during the three months ended June 30, 2022, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
29
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 has moved to dismiss these claims and expects the motion to be heard sometime after August 12, 2022. 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
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, 2021, filed with the SEC on March 1, 2022, except the following:
Inflation could adversely affect our business and results of operations.
While inflation in the United States has been relatively low in recent years, during 2021 and 2022, the economy in the United States encountered a material level of inflation. The impact of COVID-19, geopolitical developments such as the Russia-Ukraine conflict and global supply chain disruptions continue to increase uncertainty in the outlook of near-term and long-term economic activity, including whether inflation will continue and how long, and at what rate. Increases in inflation raise our costs for commodities, labor, materials and services and other costs required to grow and operate our business, and failure to secure these on reasonable terms may adversely impact our financial condition. Additionally, increases in inflation, along with the uncertainties surrounding COVID-19, geopolitical developments and global supply chain disruptions, have caused, and may in the future cause, global economic uncertainty and uncertainty about the interest rate environment. A failure to adequately respond to these risks could have a material adverse impact on our financial condition, results of operations or cash flows.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Not Applicable.
Item 3. Defaults Upon Senior Securities
Not Applicable.
Item 4. Mine Safety Disclosures
Not Applicable.
Item 5. Other Information
Not Applicable.
Item 6. Exhibits
A list of exhibits is set forth on the Exhibit Index immediately preceding the signature page of this Quarterly Report on Form 10-Q, and is incorporated herein by reference.
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EXHIBIT INDEX
Exhibit Number |
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Description |
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31.1 |
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Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2 |
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Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32.1 |
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Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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|
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32.2 |
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Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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|
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101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. |
|
|
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101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document |
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|
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101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
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101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase Document |
|
|
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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) |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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CHEMOCENTRYX, INC. |
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Date: August 8, 2022 |
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/s/ Thomas J. Schall, Ph.D. |
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|
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Thomas J. Schall, Ph.D. President and Chief Executive Officer (Principal Executive Officer) |
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|
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Date: August 8, 2022 |
|
/s/ Susan M. Kanaya |
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|
|
|
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Susan M. Kanaya Executive Vice President, Chief Financial and Administrative Officer and Secretary (Principal Financial Officer) |
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|
|
Date: August 8, 2022 |
|
/s/ Yi Ching Yau |
|
|
|
|
|
Yi Ching Yau Senior Vice President Finance and Principal Accounting Officer |
33