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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, 2020

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, 2020 was 90,355,096.

 

 

 

 


 

FIBROGEN, INC.

TABLE OF CONTENTS

 

 

 

Page

PART I—FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Condensed Consolidated Financial Statements (Unaudited)

 

2

 

Condensed Consolidated Balance Sheets as of June 30, 2020 and December 31, 2019 (Unaudited)

 

2

 

Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2020 and 2019 (Unaudited)

 

3

 

Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Six Months Ended June 30, 2020 and 2019 (Unaudited)

 

4

 

Condensed Consolidated Statements of Changes in Equity for the Three and Six Months Ended June 30, 2020 and 2019 (Unaudited)

 

5

 

Condensed Consolidated Statements of Cash Flows for the Six Months Ended March 31, 2020 and 2019 (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

 

25

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

43

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

 

80

Item 3.

Defaults Upon Senior Securities

 

80

Item 4.

Mine Safety Disclosures

 

81

Item 5.

Other Information

 

81

Item 6.

Exhibits

 

81

 

Signatures

 

83

 

1


Table of Contents

 

 

FIBROGEN, INC.

PART I—FINANCIAL INFORMATION

ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except per share amounts)

(Unaudited)

 

 

 

June 30, 2020

 

 

December 31, 2019

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

429,269

 

 

$

126,266

 

Short-term investments

 

 

256,317

 

 

 

407,491

 

Accounts receivable, net ($12,090 and $4,845 from a related party)

 

 

26,519

 

 

 

28,455

 

Inventories

 

 

8,582

 

 

 

6,887

 

Prepaid expenses and other current assets ($0 and $125,210 from

    a related party)

 

 

6,481

 

 

 

133,391

 

Total current assets

 

 

727,168

 

 

 

702,490

 

 

 

 

 

 

 

 

 

 

Restricted time deposits

 

 

2,072

 

 

 

2,072

 

Long-term investments

 

 

229

 

 

 

61,118

 

Property and equipment, net

 

 

36,984

 

 

 

42,743

 

Finance lease right-of-use assets

 

 

34,368

 

 

 

39,602

 

Other assets

 

 

6,862

 

 

 

9,372

 

Total assets

 

$

807,683

 

 

$

857,397

 

 

 

 

 

 

 

 

 

 

Liabilities, stockholders’ equity and non-controlling interests

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

5,015

 

 

$

6,088

 

Accrued and other current liabilities ($216 and $36,883 to a related party)

 

 

50,464

 

 

 

83,816

 

Deferred revenue

 

 

9,813

 

 

 

490

 

Finance lease liabilities, current

 

 

12,279

 

 

 

12,351

 

Total current liabilities

 

 

77,571

 

 

 

102,745

 

 

 

 

 

 

 

 

 

 

Long-term portion of lease obligations

 

 

940

 

 

 

1,141

 

Product development obligations

 

 

16,959

 

 

 

16,780

 

Deferred revenue, net of current

 

 

138,242

 

 

 

99,449

 

Finance lease liabilities, non-current

 

 

31,586

 

 

 

37,610

 

Other long-term liabilities

 

 

127,242

 

 

 

64,266

 

Total liabilities

 

 

392,540

 

 

 

321,991

 

 

 

 

 

 

 

 

 

 

Commitments and Contingencies (Note 9)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.01 par value; 125,000 shares authorized; no shares issued

   and outstanding at June 30, 2020 and December 31, 2019

 

 

 

 

 

 

Common stock, $0.01 par value; 225,000 shares authorized at March 31, 2020

   and December 31, 2019; 90,228 and 87,657 shares issued and outstanding at

  June 30, 2020 and December 31, 2019

 

 

902

 

 

 

877

 

Additional paid-in capital

 

 

1,344,912

 

 

 

1,300,725

 

Accumulated other comprehensive loss

 

 

(1,561

)

 

 

(747

)

Accumulated deficit

 

 

(948,381

)

 

 

(784,720

)

Total stockholders’ equity

 

 

395,872

 

 

 

516,135

 

Non-controlling interests

 

 

19,271

 

 

 

19,271

 

Total equity

 

 

415,143

 

 

 

535,406

 

Total liabilities, stockholders’ equity and non-controlling interests

 

$

807,683

 

 

$

857,397

 

 

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,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License revenue (includes $0, $117,470, $0 and $117,470

   from a related party)

 

$

 

 

$

150,581

 

 

$

 

 

$

150,581

 

Development and other revenue (includes $4,766, $17,223,

   $9,503 and $22,082 from a related party)

 

 

18,957

 

 

 

40,985

 

 

 

38,402

 

 

 

64,848

 

Product revenue, net

 

 

15,693

 

 

 

 

 

 

20,648

 

 

 

 

Drug product revenue (includes $8,238, $0, $8,238

   and $0 from a related party)

 

 

8,238

 

 

 

 

 

 

8,238

 

 

 

 

Total revenue

 

 

42,888

 

 

 

191,566

 

 

 

67,288

 

 

 

215,429

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

3,076

 

 

 

 

 

 

4,047

 

 

 

 

Research and development

 

 

61,414

 

 

 

52,008

 

 

 

116,315

 

 

 

102,505

 

Selling, general and administrative

 

 

63,535

 

 

 

26,739

 

 

 

113,138

 

 

 

48,948

 

Total operating costs and expenses

 

 

128,025

 

 

 

78,747

 

 

 

233,500

 

 

 

151,453

 

Income (loss) from operations

 

 

(85,137

)

 

 

112,819

 

 

 

(166,212

)

 

 

63,976

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(651

)

 

 

(736

)

 

 

(1,284

)

 

 

(1,507

)

Interest income and other, net

 

 

644

 

 

 

4,125

 

 

 

3,810

 

 

 

8,303

 

Total interest and other, net

 

 

(7

)

 

 

3,389

 

 

 

2,526

 

 

 

6,796

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 

(85,144

)

 

 

116,208

 

 

 

(163,686

)

 

 

70,772

 

Provision for (benefit from) income taxes

 

 

169

 

 

 

205

 

 

 

(25

)

 

 

180

 

Net income (loss)

 

$

(85,313

)

 

$

116,003

 

 

$

(163,661

)

 

$

70,592

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.95

)

 

$

1.34

 

 

$

(1.84

)

 

$

0.82

 

Diluted

 

$

(0.95

)

 

$

1.26

 

 

$

(1.84

)

 

$

0.77

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares used to

     calculate net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

89,451

 

 

 

86,445

 

 

 

88,835

 

 

 

86,077

 

Diluted

 

 

89,451

 

 

 

91,728

 

 

 

88,835

 

 

 

92,069

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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 June 30,

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net income (loss)

 

$

(85,313

)

 

$

116,003

 

 

$

(163,661

)

 

$

70,592

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments (Note 1)

 

 

(1,615

)

 

 

(180

)

 

 

(1,334

)

 

 

111

 

Available-for-sale investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on investments, net of tax effect

 

 

(1,129

)

 

 

655

 

 

 

520

 

 

 

1,097

 

Other comprehensive income, net of taxes

 

 

(2,744

)

 

 

475

 

 

 

(814

)

 

 

1,208

 

Comprehensive income (loss)

 

$

(88,057

)

 

$

116,478

 

 

$

(164,475

)

 

$

71,800

 

 

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,

   2020

 

 

88,895,630

 

 

$

889

 

 

$

1,319,354

 

 

$

1,183

 

 

$

(863,068

)

 

$

19,271

 

 

$

477,629

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(85,313

)

 

 

 

 

 

(85,313

)

Change in unrealized gain or

   loss on investments

 

 

 

 

 

 

 

 

 

 

 

(1,129

)

 

 

 

 

 

 

 

 

(1,129

)

Foreign currency translation

   adjustments (Note 1)

 

 

 

 

 

 

 

 

 

 

 

(1,615

)

 

 

 

 

 

 

 

 

(1,615

)

Shares issued from stock

   plans, net of payroll taxes

   paid

 

 

1,332,663

 

 

 

13

 

 

 

7,914

 

 

 

 

 

 

 

 

 

 

 

 

7,927

 

Stock-based compensation

 

 

 

 

 

 

 

 

17,644

 

 

 

 

 

 

 

 

 

 

 

 

17,644

 

Balance at June 30,

   2020

 

 

90,228,293

 

 

$

902

 

 

$

1,344,912

 

 

$

(1,561

)

 

$

(948,381

)

 

$

19,271

 

 

$

415,143

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at March 31,

   2019

 

 

86,129,564

 

 

$

861

 

 

$

1,242,460

 

 

$

(937

)

 

$

(753,161

)

 

$

19,271

 

 

$

508,494

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

116,003

 

 

 

 

 

 

116,003

 

Change in unrealized gain or

   loss on investments

 

 

 

 

 

 

 

 

 

 

 

655

 

 

 

 

 

 

 

 

 

655

 

Foreign currency translation

   adjustments

 

 

 

 

 

 

 

 

 

 

 

(180

)

 

 

 

 

 

 

 

 

(180

)

Shares issued from stock

   plans, net of payroll taxes

   paid

 

 

717,508

 

 

 

7

 

 

 

5,681

 

 

 

 

 

 

 

 

 

 

 

 

5,688

 

Stock-based compensation

 

 

 

 

 

 

 

 

17,642

 

 

 

 

 

 

 

 

 

 

 

 

17,642

 

Balance at June 30,

   2019

 

 

86,847,072

 

 

$

868

 

 

$

1,265,783

 

 

$

(462

)

 

$

(637,158

)

 

$

19,271

 

 

$

648,302

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5


Table of Contents

 

 

FIBROGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Note 1)

 

 

 

 

 

 

 

 

 

Balance at December 31,

   2019

 

 

87,657,489

 

 

$

877

 

 

$

1,300,725

 

 

$

(747

)

 

$

(784,720

)

 

$

19,271

 

 

$

535,406

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(163,661

)

 

 

 

 

 

(163,661

)

Change in unrealized gain or

   loss on investments

 

 

 

 

 

 

 

 

 

 

 

520

 

 

 

 

 

 

 

 

 

520

 

Foreign currency translation

   adjustments (Note 1)

 

 

 

 

 

 

 

 

 

 

 

(1,334

)

 

 

 

 

 

 

 

 

(1,334

)

Shares issued from stock

   plans, net of payroll taxes

   paid

 

 

2,570,804

 

 

 

25

 

 

 

9,627

 

 

 

 

 

 

 

 

 

 

 

 

9,652

 

Stock-based compensation

 

 

 

 

 

 

 

 

34,560

 

 

 

 

 

 

 

 

 

 

 

 

34,560

 

Balance at June 30,

   2020

 

 

90,228,293

 

 

$

902

 

 

$

1,344,912

 

 

$

(1,561

)

 

$

(948,381

)

 

$

19,271

 

 

$

415,143

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31,

   2018

 

 

85,432,102

 

 

$

854

 

 

$

1,226,453

 

 

$

(2,281

)

 

$

(715,827

)

 

$

19,271

 

 

$

528,470

 

Impact of adoption of

   ASC 842

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,688

 

 

 

 

 

 

8,688

 

Impact of change in

   accounting principle upon

   adoption of ASU 2018-02

 

 

 

 

 

 

 

 

 

 

 

611

 

 

 

(611

)

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

70,592

 

 

 

 

 

 

70,592

 

Change in unrealized gain or

   loss on investments

 

 

 

 

 

 

 

 

 

 

 

1,097

 

 

 

 

 

 

 

 

 

1,097

 

Foreign currency translation

   adjustments

 

 

 

 

 

 

 

 

 

 

 

111

 

 

 

 

 

 

 

 

 

111

 

Shares issued from stock

   plans, net of payroll taxes

   paid

 

 

1,414,970

 

 

 

14

 

 

 

5,258

 

 

 

 

 

 

 

 

 

 

 

 

5,272

 

Stock-based compensation

 

 

 

 

 

 

 

 

34,072

 

 

 

 

 

 

 

 

 

 

 

 

34,072

 

Balance at June 30,

   2019

 

 

86,847,072

 

 

$

868

 

 

$

1,265,783

 

 

$

(462

)

 

$

(637,158

)

 

$

19,271

 

 

$

648,302

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements

6


Table of Contents

 

 

FIBROGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

Operating activities

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(163,661

)

 

$

70,592

 

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

 

 

 

 

 

 

 

 

Depreciation

 

 

5,737

 

 

 

5,523

 

Amortization of finance lease right-of-use assets

 

 

5,247

 

 

 

5,140

 

Net accretion of discount on investments

 

 

(22

)

 

 

(2,457

)

Unrealized loss (gain) on equity investments

 

 

15

 

 

 

(59

)

Gain on disposal of property and equipment

 

 

 

 

 

(10

)

Stock-based compensation

 

 

34,560

 

 

 

34,072

 

Tax benefit on unrealized gain on available-for-sale securities

 

 

(138

)

 

 

 

Realized loss on sales of available-for-sale securities

 

 

258

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable, net

 

 

1,903

 

 

 

57,231

 

Inventories

 

 

(2,016

)

 

 

(1,981

)

Prepaid expenses and other current assets

 

 

126,874

 

 

 

(131,803

)

Other assets

 

 

4,025

 

 

 

(200

)

Accounts payable

 

 

(1,060

)

 

 

(5,079

)

Accrued and other liabilities

 

 

(33,501

)

 

 

917

 

Deferred revenue

 

 

48,117

 

 

 

(46,818

)

Accrued interest for finance lease liabilities

 

 

(115

)

 

 

241

 

Other long-term liabilities

 

 

63,956

 

 

 

8,519

 

Net cash provided by (used in) operating activities

 

 

90,179

 

 

 

(6,172

)