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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 September 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 October 31, 2022 was 93,957,688.

 

 

 

FIBROGEN, INC.

TABLE OF CONTENTS

 

 

 

Page

PART I—FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Financial Statements

 

2

 

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

 

2

 

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

 

3

 

Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2022 and 2021 (Unaudited)

 

4

 

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

 

5

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 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

 

24

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

42

Item 4.

Controls and Procedures

 

43

 

 

 

 

PART II—OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

44

Item 1A.

Risk Factors

 

44

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

86

Item 3.

Defaults Upon Senior Securities

 

86

Item 4.

Mine Safety Disclosures

 

86

Item 5.

Other Information

 

87

Item 6.

Exhibits

 

87

 

Signatures

 

88

 

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)

 

 

 

September 30, 2022

 

 

December 31, 2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

155,960

 

 

$

171,223

 

Short-term investments

 

 

252,560

 

 

 

233,967

 

Accounts receivable, net ($14,337 and $10,930 from related parties)

 

 

15,328

 

 

 

17,401

 

Inventories

 

 

39,950

 

 

 

31,015

 

Prepaid expenses and other current assets

 

 

10,426

 

 

 

20,453

 

Total current assets

 

 

474,224

 

 

 

474,059

 

Restricted time deposits

 

 

2,072

 

 

 

2,072

 

Long-term investments

 

 

17,780

 

 

 

167,796

 

Property and equipment, net

 

 

22,287

 

 

 

28,277

 

Equity method investment in unconsolidated variable interest entity

 

 

4,631

 

 

 

3,825

 

Operating lease right-of-use assets

 

 

82,903

 

 

 

91,112

 

Other assets

 

 

4,940

 

 

 

6,680

 

Total assets

 

$

608,837

 

 

$

773,821

 

 

 

 

 

 

 

 

Liabilities, stockholders’ equity and non-controlling interests

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

19,323

 

 

$

26,097

 

Accrued and other current liabilities ($55,305 and $4 to a related party)

 

 

213,806

 

 

 

172,599

 

Deferred revenue ($4,706 and $3,201 to related parties)

 

 

7,361

 

 

 

15,857

 

Operating lease liabilities, current

 

 

11,504

 

 

 

10,944

 

Total current liabilities

 

 

251,994

 

 

 

225,497

 

Product development obligations

 

 

15,422

 

 

 

17,613

 

Deferred revenue, net of current ($42,278 and $25,891 to a related party)

 

 

199,758

 

 

 

186,801

 

Operating lease liabilities, non-current

 

 

81,091

 

 

 

88,776

 

Other long-term liabilities

 

 

14,299

 

 

 

26,021

 

Total liabilities

 

 

562,564

 

 

 

544,708

 

 

 

 

 

 

 

 

Commitments and Contingencies (Note 8)

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

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

 

 

—

 

 

 

—

 

Common stock, $0.01 par value; 225,000 shares authorized at September 30, 2022
   and December 31, 2021; 93,936 and 92,881 shares issued and outstanding at
  September 30, 2022 and December 31, 2021

 

 

939

 

 

 

929

 

Additional paid-in capital

 

 

1,524,226

 

 

 

1,476,414

 

Accumulated other comprehensive loss

 

 

(7,346

)

 

 

(4,163

)

Accumulated deficit

 

 

(1,491,513

)

 

 

(1,264,034

)

Total stockholders’ equity

 

 

26,306

 

 

 

209,146

 

Non-controlling interests

 

 

19,967

 

 

 

19,967

 

Total equity

 

 

46,273

 

 

 

229,113

 

Total liabilities, stockholders’ equity and non-controlling interests

 

$

608,837

 

 

$

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 September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

License revenue (includes $0, $108,434, $22,590
   and $108,434 from a related party)

 

$

—

 

 

$

116,434

 

 

$

22,590

 

 

$

116,434

 

Development and other revenue (includes $1,414, $14,127,
   $8,419 and $20,383 from a related party)

 

 

2,453

 

 

 

26,097

 

 

 

19,672

 

 

 

60,325

 

Product revenue, net (includes $14,914, $10,328, $50,873
   and $32,495 from a related party)

 

 

17,359

 

 

 

13,442

 

 

 

59,495

 

 

 

42,175

 

Drug product revenue (includes $(4,077), $0, $4,610 
   and $2,056 from a related party)

 

 

(4,077

)

 

 

—

 

 

 

4,610

 

 

 

(168

)

Total revenue

 

 

15,735

 

 

 

155,973

 

 

 

106,367

 

 

 

218,766

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

4,308

 

 

 

3,266

 

 

 

15,355

 

 

 

9,746

 

Research and development

 

 

75,182

 

 

 

75,880

 

 

 

235,163

 

 

 

273,123

 

Selling, general and administrative

 

 

29,902

 

 

 

25,853

 

 

 

90,722

 

 

 

89,186

 

Total operating costs and expenses

 

 

109,392

 

 

 

104,999

 

 

 

341,240

 

 

 

372,055

 

Income (loss) from operations

 

 

(93,657

)

 

 

50,974

 

 

 

(234,873

)

 

 

(153,289

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other, net

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(84

)

 

 

(109

)

 

 

(321

)

 

 

(965

)

Interest income and other income (expenses), net

 

 

1,798

 

 

 

(1,303

)

 

 

6,672

 

 

 

(2,120

)

Total interest and other, net

 

 

1,714

 

 

 

(1,412

)

 

 

6,351

 

 

 

(3,085

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 

(91,943

)

 

 

49,562

 

 

 

(228,522

)

 

 

(156,374

)

Provision for income taxes

 

 

114

 

 

 

106

 

 

 

250

 

 

 

235

 

Investment income in unconsolidated variable
   interest entity

 

 

407

 

 

 

342

 

 

 

1,293

 

 

 

664

 

Net income (loss)

 

$

(91,650

)

 

$

49,798

 

 

$

(227,479

)

 

$

(155,945

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share - basic and diluted

 

$

(0.98

)

 

$

0.54

 

 

$

(2.43

)

 

$

(1.69

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares used to
     calculate net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

93,767

 

 

 

92,644

 

 

 

93,431

 

 

 

92,206

 

Diluted

 

 

93,767

 

 

 

92,808

 

 

 

93,431

 

 

 

92,206

 

 

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 INCOME (LOSS)

(In thousands)

(Unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net income (loss)

 

$

(91,650

)

 

$

49,798

 

 

$

(227,479

)

 

$

(155,945

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

(436

)

 

 

396

 

 

 

(28

)

 

 

366

 

Available-for-sale investments:

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

20

 

 

 

13

 

 

 

(3,155

)

 

 

(25

)

Other comprehensive gain (loss), net of taxes

 

 

(416

)

 

 

409

 

 

 

(3,183

)

 

 

341

 

Comprehensive income (loss)

 

$

(92,066

)

 

$

50,207

 

 

$

(230,662

)

 

$

(155,604

)

 

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 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30,
   2021

 

 

92,608,929

 

 

$

926

 

 

$

1,443,975

 

 

$

(4,567

)

 

$

(1,179,754

)

 

$

19,271

 

 

$

279,851

 

Net income

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

49,798

 

 

 

—

 

 

 

49,798

 

Change in unrealized gain or
   loss on investments

 

 

—

 

 

 

—

 

 

 

—

 

 

 

13

 

 

 

—

 

 

 

—

 

 

 

13

 

Foreign currency translation
   adjustments

 

 

—

 

 

 

—

 

 

 

—

 

 

 

396

 

 

 

—

 

 

 

—

 

 

 

396

 

Shares issued from stock
   plans, net of payroll taxes
   paid

 

 

99,023

 

 

 

1

 

 

 

(