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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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: 001-36740

 

FIBROGEN, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

77-0357827

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification No.)

 

409 Illinois Street

 

 

San Francisco, CA

 

94158

(Address of Principal Executive Offices)

 

(Zip Code)

(415) 978-1200

Registrant’s telephone number, including area code:

 

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

 

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:

 

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 Exchange Act Rule 12b-2). Yes No ☑

The number of shares of common stock outstanding as of July 31, 2022 was 93,741,180.

 

 


 

FIBROGEN, INC.

TABLE OF CONTENTS

 

 

 

Page

PART I—FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Financial Statements

 

2

 

Condensed Consolidated Balance Sheets as of June 30, 2022 and December 31, 2021 (Unaudited)

 

2

 

Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2022 and 2021 (Unaudited)

 

3

 

Condensed Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2022 and 2021 (Unaudited)

 

4

 

Condensed Consolidated Statements of Changes in Equity for the Three and Six Months Ended June 30, 2022 and 2021 (Unaudited)

 

5

 

Condensed Consolidated Statements of Cash Flows for the Six Months Ended March 31, 2022 and 2021 (Unaudited)

 

7

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

8

Item 2.

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

 

23

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

40

Item 4.

Controls and Procedures

 

41

 

 

 

 

PART II—OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

42

Item 1A.

Risk Factors

 

42

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

82

Item 3.

Defaults Upon Senior Securities

 

82

Item 4.

Mine Safety Disclosures

 

82

Item 5.

Other Information

 

83

Item 6.

Exhibits

 

83

 

Signatures

 

84

 

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)

 

 

 

June 30, 2022

 

 

December 31, 2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

167,758

 

 

$

171,223

 

Short-term investments

 

 

270,375

 

 

 

233,967

 

Accounts receivable, net ($26,779 and $10,930 from related parties)

 

 

33,573

 

 

 

17,401

 

Inventories

 

 

40,899

 

 

 

31,015

 

Prepaid expenses and other current assets

 

 

8,038

 

 

 

20,453

 

Total current assets

 

 

520,643

 

 

 

474,059

 

Restricted time deposits

 

 

2,072

 

 

 

2,072

 

Long-term investments

 

 

45,920

 

 

 

167,796

 

Property and equipment, net

 

 

24,505

 

 

 

28,277

 

Equity method investment in unconsolidated variable interest entity

 

 

4,494

 

 

 

3,825

 

Operating lease right-of-use assets

 

 

84,654

 

 

 

91,112

 

Other assets

 

 

4,501

 

 

 

6,680

 

Total assets

 

$

686,789

 

 

$

773,821

 

 

 

 

 

 

 

 

Liabilities, stockholders’ equity and non-controlling interests

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

29,360

 

 

$

26,097

 

Accrued and other current liabilities ($43,286 and $4 to a related party)

 

 

193,099

 

 

 

172,599

 

Deferred revenue ($5,204 and $3,201 to related parties)

 

 

6,897

 

 

 

15,857

 

Operating lease liabilities, current

 

 

10,984

 

 

 

10,944

 

Total current liabilities

 

 

240,340

 

 

 

225,497

 

Product development obligations

 

 

16,439

 

 

 

17,613

 

Deferred revenue, net of current ($49,733 and $25,891 to a related party)

 

 

205,351

 

 

 

186,801

 

Operating lease liabilities, non-current

 

 

83,080

 

 

 

88,776

 

Other long-term liabilities

 

 

17,832

 

 

 

26,021

 

Total liabilities

 

 

563,042

 

 

 

544,708

 

 

 

 

 

 

 

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.01 par value; 125,000 shares authorized; no shares issued
   and outstanding at June 30, 2022 and December 31, 2021

 

 

 

 

 

 

Common stock, $0.01 par value; 225,000 shares authorized at June 30, 2022
   and December 31, 2021;
93,733 and 92,881 shares issued and outstanding at
  June 30, 2022 and December 31, 2021

 

 

937

 

 

 

929

 

Additional paid-in capital

 

 

1,509,636

 

 

 

1,476,414

 

Accumulated other comprehensive loss

 

 

(6,930

)

 

 

(4,163

)

Accumulated deficit

 

 

(1,399,863

)

 

 

(1,264,034

)

Total stockholders’ equity

 

 

103,780

 

 

 

209,146

 

Non-controlling interests

 

 

19,967

 

 

 

19,967

 

Total equity

 

 

123,747

 

 

 

229,113

 

Total liabilities, stockholders’ equity and non-controlling interests

 

$

686,789

 

 

$

773,821

 

 

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)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

License revenue (includes $0, $0 and $22,590
   and $
0 from a related party)

 

$

 

 

$

 

 

$

22,590

 

 

$

 

Development and other revenue (includes $1,825, $2,645,
   $
7,005 and $6,256 from a related party)

 

 

5,457

 

 

 

19,641

 

 

 

17,219

 

 

 

34,228

 

Product revenue, net (includes $19,736, $11,760, $35,959,
   and $
22,167 from a related party)

 

 

23,256

 

 

 

13,371

 

 

 

42,137

 

 

 

28,733

 

Drug product revenue (includes $1,093, $(1,974), $8,687 
   and $
2,056 from a related party)

 

 

1,093

 

 

 

(8,648

)

 

 

8,687

 

 

 

(168

)

Total revenue

 

 

29,806

 

 

 

24,364

 

 

 

90,633

 

 

 

62,793

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

6,809

 

 

 

3,078

 

 

 

11,048

 

 

 

6,479

 

Research and development

 

 

70,963

 

 

 

122,567

 

 

 

159,981

 

 

 

197,243

 

Selling, general and administrative

 

 

30,258

 

 

 

32,554

 

 

 

60,820

 

 

 

63,334

 

Total operating costs and expenses

 

 

108,030

 

 

 

158,199

 

 

 

231,849

 

 

 

267,056

 

Loss from operations

 

 

(78,224

)

 

 

(133,835

)

 

 

(141,216

)

 

 

(204,263

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other, net

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(141

)

 

 

(355

)

 

 

(238

)

 

 

(856

)

Interest income and other income (expenses), net

 

 

5,199

 

 

 

(363

)

 

 

4,876

 

 

 

(817

)

Total interest and other, net

 

 

5,058

 

 

 

(718

)

 

 

4,638

 

 

 

(1,673

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before income taxes

 

 

(73,166

)

 

 

(134,553

)

 

 

(136,578

)

 

 

(205,936

)

Provision for (benefit from) income taxes

 

 

23

 

 

 

(3

)

 

 

136

 

 

 

130

 

Investment income in unconsolidated variable
   interest entity

 

 

565

 

 

 

562

 

 

 

885

 

 

 

323

 

Net loss

 

$

(72,624

)

 

$

(133,988

)

 

$

(135,829

)

 

$

(205,743

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted

 

$

(0.78

)

 

$

(1.45

)

 

$

(1.46

)

 

$

(2.24

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares used to calculate
   net loss per share - basic and diluted

 

 

93,475

 

 

 

92,276

 

 

 

93,260

 

 

 

91,983

 

 

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 June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net loss

 

$

(72,624

)

 

$

(133,988

)

 

$

(135,829

)

 

$

(205,743

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

159

 

 

 

40

 

 

 

408

 

 

 

(30

)

Available-for-sale investments:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on investments, net of tax effect

 

 

(584

)

 

 

17

 

 

 

(3,175

)

 

 

(38

)

Other comprehensive gain (loss), net of taxes

 

 

(425

)

 

 

57

 

 

 

(2,767

)

 

 

(68

)

Comprehensive loss

 

$

(73,049

)

 

$

(133,931

)

 

$

(138,596

)

 

$

(205,811

)

 

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 EQUITY

(In thousands, except share data)

(Unaudited)

 

 

 

For The Three Month Period

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Non
Controlling

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Interests

 

 

Total

 

Balance at March 31,
   2022

 

 

93,288,584

 

 

$

933

 

 

$

1,490,859

 

 

$

(6,505

)

 

$

(1,327,239

)

 

$

19,967

 

 

$

178,015

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(72,624

)

 

 

 

 

 

(72,624

)

Change in unrealized gain
   or loss on investments

 

 

 

 

 

 

 

 

 

 

 

(584

)

 

 

 

 

 

 

 

 

(584

)

Foreign currency
   translation adjustments

 

 

 

 

 

 

 

 

 

 

 

159

 

 

 

 

 

 

 

 

 

159

 

Shares issued from stock
   plans, net of payroll
   taxes paid

 

 

444,450

 

 

 

4

 

 

 

2,119

 

 

 

 

 

 

 

 

 

 

 

 

2,123

 

Stock-based compensation

 

 

 

 

 

 

 

 

16,658

 

 

 

 

 

 

 

 

 

 

 

 

16,658

 

Balance at June 30,
   2022

 

 

93,733,034

 

 

$

937

 

 

$

1,509,636

 

 

$

(6,930

)

 

$

(1,399,863

)

 

$

19,967

 

 

$

123,747

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at March 31,
   2021

 

 

92,080,399

 

 

$

921

 

 

$

1,420,471

 

 

$

(4,624

)

 

$

(1,045,766

)

 

$

19,271

 

 

$

390,273

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(133,988

)

 

 

 

 

 

(133,988

)

Change in unrealized gain
   or loss on investments

 

 

 

 

 

 

 

 

 

 

 

17

 

 

 

 

 

 

 

 

 

17

 

Foreign currency
   translation adjustments

 

 

 

 

 

 

 

 

 

 

 

40

 

 

 

 

 

 

 

 

 

40

 

Shares issued from stock
   plans, net of payroll
   taxes paid

 

 

528,530

 

 

 

5

 

 

 

4,503

 

 

 

 

 

 

 

 

 

 

 

 

4,508

 

Stock-based compensation

 

 

 

 

 

 

 

 

19,001

 

 

 

 

 

 

 

 

 

 

 

 

19,001

 

Balance at June 30,
   2021

 

 

92,608,929

 

 

$

926

 

 

$

1,443,975

 

 

$

(4,567

)

 

$

(1,179,754

)

 

$

19,271

 

 

$

279,851

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5


Table of Contents

FIBROGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (CONTINUED)

(In thousands, except share data)

(Unaudited)

 

 

 

For The Six Month Period

 

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Non
Controlling

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Interests

 

 

Total

 

Balance at December 31,
   2021

 

 

92,880,533

 

 

$

929