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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
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☑ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2023
OR
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☐ |
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: 001-36740
FIBROGEN, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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77-0357827 |
(State or Other Jurisdiction of Incorporation or Organization) |
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(I.R.S. Employer Identification No.) |
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409 Illinois Street |
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San Francisco, CA |
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94158 |
(Address of Principal Executive Offices) |
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(Zip Code) |
(415) 978-1200
Registrant’s telephone number, including area code:
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol |
Name of each exchange on which registered |
Common Stock, $0.01 par value |
FGEN |
The Nasdaq Global Select Market |
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 (§ 232.405 of this chapter) 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:
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Large accelerated filer |
☑ |
Accelerated filer |
☐ |
Non-accelerated filer |
☐ |
Smaller reporting company |
☐ |
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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 Exchange Act Rule 12b-2). Yes ☐ No ☑
The number of shares of common stock outstanding as of October 31, 2023 was 98,340,219.
FIBROGEN, INC.
TABLE OF CONTENTS
1
Table of Contents
FIBROGEN, INC.
PART I—FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share amounts)
(Unaudited)
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September 30, 2023 |
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December 31, 2022 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
120,914 |
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$ |
155,700 |
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Short-term investments |
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130,426 |
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266,308 |
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Accounts receivable, net ($22,916 and $12,088 from related parties) |
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31,694 |
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16,299 |
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Inventories |
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40,696 |
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40,436 |
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Prepaid expenses and other current assets |
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40,378 |
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14,083 |
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Total current assets |
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364,108 |
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492,826 |
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Restricted time deposits |
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2,072 |
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2,072 |
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Long-term investments |
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— |
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4,348 |
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Property and equipment, net |
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14,512 |
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20,605 |
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Equity method investment in unconsolidated variable interest entity |
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4,534 |
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5,061 |
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Operating lease right-of-use assets |
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71,248 |
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79,893 |
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Other assets |
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3,952 |
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5,282 |
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Total assets |
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$ |
460,426 |
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$ |
610,087 |
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Liabilities, redeemable non-controlling interests and deficit |
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Current liabilities: |
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Accounts payable |
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$ |
19,220 |
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$ |
30,758 |
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Accrued and other current liabilities ($29,157 and $63,886 to a related party) |
|
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170,986 |
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219,773 |
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Deferred revenue ($5,482 and $9,259 to related parties) |
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7,325 |
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12,739 |
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Operating lease liabilities, current |
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11,884 |
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10,292 |
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Total current liabilities |
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209,415 |
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273,562 |
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Product development obligations |
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16,942 |
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16,917 |
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Deferred revenue, net of current ($4,671 and $31,044 to a related party) |
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154,206 |
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185,722 |
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Operating lease liabilities, non-current |
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70,035 |
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79,593 |
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Senior secured term loan facilities, non-current |
|
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71,666 |
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|
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— |
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Liability related to sale of future revenues, non-current |
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49,109 |
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|
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49,333 |
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Other long-term liabilities ($668 and $0 to a related party) |
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4,255 |
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6,440 |
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Total liabilities |
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575,628 |
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|
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611,567 |
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Commitments and Contingencies (Note 12) |
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Redeemable non-controlling interests |
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21,480 |
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— |
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Stockholders’ deficit: |
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Preferred stock, $0.01 par value; 125,000 shares authorized; no shares issued and outstanding at September 30, 2023 and December 31, 2022 |
|
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— |
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— |
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Common stock, $0.01 par value; 225,000 shares authorized at September 30, 2023 and December 31, 2022; 98,339 and 94,166 shares issued and outstanding at September 30, 2023 and December 31, 2022 |
|
|
983 |
|
|
|
942 |
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Additional paid-in capital |
|
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1,634,459 |
|
|
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1,541,019 |
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Accumulated other comprehensive loss |
|
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(6,923 |
) |
|
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(5,720 |
) |
Accumulated deficit |
|
|
(1,785,688 |
) |
|
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(1,557,688 |
) |
Total stockholders’ deficit attributable to FibroGen |
|
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(157,169 |
) |
|
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(21,447 |
) |
Nonredeemable non-controlling interests |
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20,487 |
|
|
|
19,967 |
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Total deficit |
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(136,682 |
) |
|
|
(1,480 |
) |
Total liabilities, redeemable non-controlling interests and deficit |
|
$ |
460,426 |
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|
$ |
610,087 |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
2
Table of Contents
FIBROGEN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenue: |
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License revenue (includes $0, $0, $0 and $22,590 from a related party) |
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$ |
2,649 |
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|
$ |
— |
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$ |
9,649 |
|
|
$ |
22,590 |
|
Development and other revenue (includes $2,358, $1,414, $5,821, and $8,419 from a related party) |
|
|
6,775 |
|
|
|
2,453 |
|
|
|
15,825 |
|
|
|
19,672 |
|
Product revenue, net (includes $26,463, $14,914, $68,347 and $50,873 from a related party) |
|
|
29,390 |
|
|
|
17,359 |
|
|
|
77,439 |
|
|
|
59,495 |
|
Drug product revenue, net (from a related party) |
|
|
1,320 |
|
|
|
(4,077 |
) |
|
|
17,701 |
|
|
|
4,610 |
|
Total revenue |
|
|
40,134 |
|
|
|
15,735 |
|
|
|
120,614 |
|
|
|
106,367 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
4,243 |
|
|
|
4,308 |
|
|
|
13,441 |
|
|
|
15,355 |
|
Research and development |
|
|
61,194 |
|
|
|
75,182 |
|
|
|
231,158 |
|
|
|
235,163 |
|
Selling, general and administrative |
|
|
25,573 |
|
|
|
29,902 |
|
|
|
91,029 |
|
|
|
90,722 |
|
Restructuring charge |
|
|
12,606 |
|
|
|
— |
|
|
|
12,606 |
|
|
|
— |
|
Total operating costs and expenses |
|
|
103,616 |
|
|
|
109,392 |
|
|
|
348,234 |
|
|
|
341,240 |
|
Loss from operations |
|
|
(63,482 |
) |
|
|
(93,657 |
) |
|
|
(227,620 |
) |
|
|
(234,873 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other, net |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(5,022 |
) |
|
|
(84 |
) |
|
|
(10,464 |
) |
|
|
(321 |
) |
Interest income and other income (expenses), net |
|
|
4,296 |
|
|
|
1,798 |
|
|
|
7,984 |
|
|
|
6,672 |
|
Total interest and other, net |
|
|
(726 |
) |
|
|
1,714 |
|
|
|
(2,480 |
) |
|
|
6,351 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(64,208 |
) |
|
|
(91,943 |
) |
|
|
(230,100 |
) |
|
|
(228,522 |
) |
Provision for (benefit from) income taxes |
|
|
84 |
|
|
|
114 |
|
|
|
(77 |
) |
|
|
250 |
|
Investment income in unconsolidated variable interest entity |
|
|
677 |
|
|
|
407 |
|
|
|
2,023 |
|
|
|
1,293 |
|
Net loss |
|
$ |
(63,615 |
) |
|
$ |
(91,650 |
) |
|
$ |
(228,000 |
) |
|
$ |
(227,479 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted |
|
$ |
(0.65 |
) |
|
$ |
(0.98 |
) |
|
$ |
(2.35 |
) |
|
$ |
(2.43 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares used to calculate net loss per share - basic and diluted |
|
|
98,245 |
|
|
|
93,767 |
|
|
|
96,901 |
|
|
|
93,431 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
3
Table of Contents
FIBROGEN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Net loss |
|
$ |
(63,615 |
) |
|
$ |
(91,650 |
) |
|
$ |
(228,000 |
) |
|
$ |
(227,479 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments |
|
|
(1,033 |
) |
|
|
(436 |
) |
|
|
(3,618 |
) |
|
|
(28 |
) |
Available-for-sale investments: |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on investments, net of tax effect |
|
|
360 |
|
|
|
20 |
|
|
|
2,415 |
|
|
|
(3,155 |
) |
Other comprehensive gain (loss), net of taxes |
|
|
(673 |
) |
|
|
(416 |
) |
|
|
(1,203 |
) |
|
|
(3,183 |
) |
Comprehensive loss |
|
|
(64,288 |
) |
|
|
(92,066 |
) |
|
|
(229,203 |
) |
|
|
(230,662 |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
4
Table of Contents
FIBROGEN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
(In thousands, except share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For The Three Month Period |
|
|
|
Common Stock |
|
|
Additional Paid-in |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Nonredeemable Non-Controlling |
|
|
Total |
|
|
|
Redeemable Non-Controlling |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Income (Loss) |
|
|
Deficit |
|
|
Interests |
|
|
Equity (Deficit) |
|
|
|
Interests |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Note 3) |
|
Balance at June 30, 2023 |
|
|
98,204,243 |
|
|
$ |
982 |
|
|
$ |
1,625,067 |
|
|
$ |
(6,250 |
) |
|
$ |
(1,722,073 |
) |
|
$ |
20,487 |
|
|
$ |
(81,787 |
) |
|
|
$ |
21,480 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(63,615 |
) |
|
|
— |
|
|
|
(63,615 |
) |
|
|
|
— |
|
Change in unrealized gain or loss on investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
360 |
|
|
|
— |
|
|
|
— |
|
|
|
360 |
|
|
|
|
— |
|
Foreign currency translation adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,033 |
) |
|
|
— |
|
|
|
— |
|
|
|
(1,033 |
) |
|
|
|
— |
|
Shares issued from stock plans, net of payroll taxes paid |
|
|
134,880 |
|
|
|
1 |
|
|
|
(84 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(83 |
) |
|
|
|
— |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
9,476 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
9,476 |
|
|
|
|
— |
|
Balance at September 30, 2023 |
|
|
98,339,123 |
|
|
$ |
983 |
|
|
$ |
1,634,459 |
|
|
$ |
(6,923 |
) |
|
$ |
(1,785,688 |
) |
|
$ |
20,487 |
|
|
$ |
(136,682 |
) |
|
|
$ |
21,480 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2022 |
|
|
93,733,034 |
|
|
$ |
937 |
|
|
$ |
1,509,636 |
|
|
$ |
(6,930 |
) |
|
$ |
(1,399,863 |
) |
|
$ |
19,967 |
|
|
$ |
123,747 |
|
|
|
$ |
— |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(91,650 |
) |
|
|
— |
|
|
|
(91,650 |
) |
|
|
|
— |
|
Change in unrealized gain or loss on investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
20 |
|
|
|
— |
|
|
|
— |
|
|
|
20 |
|
|
|
|
— |
|
Foreign currency translation adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(436 |
) |
|
|
— |
|
|
|
— |
|
|
|
(436 |
) |
|
|
|
— |
|
Shares issued from stock plans, net of payroll taxes paid |
|
|
203,306 |
|
|
|
2 |
|
|
|
(995 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(993 |
) |
|
|
|
— |
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
15,585 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
15,585 |
|
|
|
|
— |
|
Balance at September 30, 2022 |
|
|
93,936,340 |
|
|
$ |
939 |
|
|
$ |
1,524,226 |
|
|
$ |
(7,346 |
) |
|
$ |
(1,491,513 |
) |
|
$ |
19,967 |
|
|
$ |
46,273 |
|
|
|
$ |
— |
|
5
Table of Contents
FIBROGEN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT) (CONTINUED)
(In thousands, except share data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For The Nine Month Period |
|
|
|
Common Stock |
|
|
Additional Paid-in |
|
|
Accumulated Other Comprehensive |
|
|
Accumulated |
|
|
Nonredeemable Non-Controlling |
|
|
Total |
|
|
|
Redeemable Non-Controlling |
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Loss |
|
|
Deficit |
|
|
Interests |
|
|
Equity (Deficit) |
|
|
|
Interests |
|
|
|
|