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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, 2019

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, 2019 was 87,250,064.

 

 

 

 


 

FIBROGEN, INC.

TABLE OF CONTENTS

 

 

 

Page

PART I—FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Condensed Consolidated Financial Statements (Unaudited)

 

2

 

Condensed Consolidated Balance Sheets as of September 30, 2019 and December 31, 2018 (Unaudited)

 

2

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2019 and 2018 (Unaudited)

 

3

 

Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2019 and 2018 (Unaudited)

 

4

 

Condensed Consolidated Statements of Changes in Stockholders' Equity for the Three and Nine Months Ended September 30, 2019 and 2018 (Unaudited)

 

5

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2019 and 2018 (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

 

46

Item 4.

Controls and Procedures

 

46

 

 

 

 

PART II—OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

47

Item 1A.

Risk Factors

 

47

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

89

Item 3.

Defaults Upon Senior Securities

 

89

Item 4.

Mine Safety Disclosures

 

89

Item 5.

Other Information

 

89

Item 6.

Exhibits

 

90

 

Signatures

 

91

 

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)

 

 

 

September 30, 2019

 

 

December 31, 2018

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

196,592

 

 

$

89,258

 

Short-term investments

 

 

432,040

 

 

 

532,144

 

Accounts receivable ($17,662 and $47,210 from a related party)

 

 

19,225

 

 

 

63,684

 

Inventories

 

 

4,908

 

 

 

 

Prepaid expenses and other current assets ($126,012 and $0 from a related party)

 

 

133,715

 

 

 

4,929

 

Total current assets

 

 

786,480

 

 

 

690,015

 

 

 

 

 

 

 

 

 

 

Restricted time deposits

 

 

4,145

 

 

 

4,145

 

Long-term investments

 

 

10,999

 

 

 

55,820

 

Property and equipment, net

 

 

43,208

 

 

 

127,198

 

Finance lease right-of-use assets

 

 

42,064

 

 

 

 

Other assets

 

 

7,068

 

 

 

3,420

 

Total assets

 

$

893,964

 

 

$

880,598

 

 

 

 

 

 

 

 

 

 

Liabilities, stockholders’ equity and non-controlling interests

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable ($730 and $0 to a related party)

 

$

4,055

 

 

$

9,139

 

Accrued and other current liabilities ($954 and $444 to a related party)

 

 

70,825

 

 

 

66,123

 

Deferred revenue

 

 

257

 

 

 

13,771

 

Finance lease liabilities, current

 

 

12,149

 

 

 

 

Total current liabilities

 

 

87,286

 

 

 

89,033

 

 

 

 

 

 

 

 

 

 

Long-term portion of lease obligations

 

 

1,242

 

 

 

97,157

 

Product development obligations

 

 

16,256

 

 

 

16,798

 

Deferred rent

 

 

 

 

 

3,038

 

Deferred revenue, net of current

 

 

98,708

 

 

 

136,109

 

Finance lease liabilities, non-current

 

 

40,713

 

 

 

 

Other long-term liabilities

 

 

36,041

 

 

 

9,993

 

Total liabilities

 

 

280,246

 

 

 

352,128

 

 

 

 

 

 

 

 

 

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

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

   and outstanding at September 30, 2019 and December 31, 2018

 

 

 

 

 

 

Common stock, $0.01 par value; 225,000 shares authorized at September 30, 2019

   and December 31, 2018; 87,211 and 85,432 shares issued and outstanding at

  September 30, 2019 and December 31, 2018

 

 

872

 

 

 

854

 

Additional paid-in capital

 

 

1,280,396

 

 

 

1,226,453

 

Accumulated other comprehensive loss

 

 

(224

)

 

 

(2,281

)

Accumulated deficit

 

 

(686,597

)

 

 

(715,827

)

Total stockholders’ equity

 

 

594,447

 

 

 

509,199

 

Non-controlling interests

 

 

19,271

 

 

 

19,271

 

Total equity

 

 

613,718

 

 

 

528,470

 

Total liabilities, stockholders’ equity and non-controlling interests

 

$

893,964

 

 

$

880,598

 

 

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,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License revenue (includes $11,935, $0, $129,405

    and $14,323 from a related party)

 

$

11,935

 

 

$

 

 

$

162,517

 

 

$

14,323

 

Development and other revenue (includes $3,533, $5,131,

    $25,615 and $16,448 from a related party)

 

 

20,660

 

 

 

29,027

 

 

 

85,507

 

 

 

90,580

 

Product revenue

 

 

579

 

 

 

 

 

 

579

 

 

 

 

Total revenue

 

 

33,174

 

 

 

29,027

 

 

 

248,603

 

 

 

104,903

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

242

 

 

 

 

 

 

242

 

 

 

 

Research and development

 

 

49,963

 

 

 

56,443

 

 

 

152,467

 

 

 

165,555

 

Selling, general and administrative

 

 

35,823

 

 

 

15,356

 

 

 

84,772

 

 

 

45,961

 

Total operating costs and expenses

 

 

86,028

 

 

 

71,799

 

 

 

237,481

 

 

 

211,516

 

Income (loss) from operations

 

 

(52,854

)

 

 

(42,772

)

 

 

11,122

 

 

 

(106,613

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(702

)

 

 

(2,739

)

 

 

(2,209

)

 

 

(8,257

)

Interest income and other, net

 

 

4,193

 

 

 

3,079

 

 

 

12,496

 

 

 

7,796

 

Total interest and other, net

 

 

3,491

 

 

 

340

 

 

 

10,287

 

 

 

(461

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 

(49,363

)

 

 

(42,432

)

 

 

21,409

 

 

 

(107,074

)

Provision for income taxes

 

 

76

 

 

 

124

 

 

 

256

 

 

 

299

 

Net income (loss)

 

$

(49,439

)

 

$

(42,556

)

 

$

21,153

 

 

$

(107,373

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.57

)

 

$

(0.50

)

 

$

0.24

 

 

$

(1.28

)

Diluted

 

$

(0.57

)

 

$

(0.50

)

 

$

0.23

 

 

$

(1.28

)

Weighted average number of common shares used to

     calculate net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

87,007

 

 

 

84,508

 

 

 

86,390

 

 

 

83,713

 

Diluted

 

 

87,007

 

 

 

84,508

 

 

 

91,995

 

 

 

83,713

 

 

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,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Net income (loss)

 

$

(49,439

)

 

$

(42,556

)

 

$

21,153

 

 

$

(107,373

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

623

 

 

 

72

 

 

 

734

 

 

 

503

 

Available-for-sale investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on investments, net of tax effect

 

 

(385

)

 

 

(31

)

 

 

712

 

 

 

(28

)

Other comprehensive income, net of taxes

 

 

238

 

 

 

41

 

 

 

1,446

 

 

 

475

 

Comprehensive income (loss)

 

$

(49,201

)

 

$

(42,515

)

 

$

22,599

 

 

$

(106,898

)

 

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

(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

 

 

Loss

 

 

Deficit

 

 

Interests

 

 

Total

 

Balance at June 30,

   2019

 

 

86,847,072

 

 

$

868

 

 

$

1,265,783

 

 

$

(462

)

 

$

(637,158

)

 

$

19,271

 

 

$

648,302

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(49,439

)

 

 

 

 

 

(49,439

)

Change in unrealized gain or

   loss on investments

 

 

 

 

 

 

 

 

 

 

 

(385

)

 

 

 

 

 

 

 

 

(385

)

Foreign currency translation

   adjustments

 

 

 

 

 

 

 

 

 

 

 

623

 

 

 

 

 

 

 

 

 

623

 

Shares issued from stock

   plans, net of payroll taxes

   paid

 

 

363,597

 

 

 

4

 

 

 

(180

)

 

 

 

 

 

 

 

 

 

 

 

(176

)

Stock-based compensation

 

 

 

 

 

 

 

 

14,793

 

 

 

 

 

 

 

 

 

 

 

 

14,793

 

Balance at September 30,

   2019

 

 

87,210,669

 

 

$

872

 

 

$

1,280,396

 

 

$

(224

)

 

$

(686,597

)

 

$

19,271

 

 

$

613,718

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at June 30,

   2018

 

 

84,182,844

 

 

$

842

 

 

$

1,191,524

 

 

$

(2,611

)

 

$

(694,224

)

 

$

19,271

 

 

$

514,802

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(42,556

)

 

 

 

 

 

(42,556

)

Change in unrealized gain or

   loss on investments

 

 

 

 

 

 

 

 

 

 

 

(31

)

 

 

 

 

 

 

 

 

(31

)

Foreign currency translation

   adjustments

 

 

 

 

 

 

 

 

 

 

 

72

 

 

 

 

 

 

 

 

 

72

 

Shares issued from stock

   plans, net of payroll taxes

   paid

 

 

663,898

 

 

 

6

 

 

 

3,966

 

 

 

 

 

 

 

 

 

 

 

 

3,972

 

Stock-based compensation

 

 

 

 

 

 

 

 

14,323

 

 

 

 

 

 

 

 

 

 

 

 

14,323

 

Balance at September 30,

   2018

 

 

84,846,742

 

 

$

848

 

 

$

1,209,813

 

 

$

(2,570

)

 

$

(736,780

)

 

$

19,271

 

 

$

490,582

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5


Table of Contents

 

 

FIBROGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (CONTINUED)

(In thousands, except share data)

(Unaudited)

 

 

 

For The Nine 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,

   2018

 

 

85,432,102

 

 

$

854

 

 

$

1,226,453

 

 

$

(2,281

)

 

$

(715,827

)

 

$

19,271

 

 

$

528,470

 

Impact of adoption of

   ASC 842 (Note 1)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,688

 

 

 

 

 

 

8,688

 

Impact of change in

   accounting principle upon

   adoption of ASU 2018-02

   (Note 1)

 

 

 

 

 

 

 

 

 

 

 

611

 

 

 

(611

)

 

 

 

 

 

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

21,153

 

 

 

 

 

 

21,153

 

Change in unrealized gain or

   loss on investments

 

 

 

 

 

 

 

 

 

 

 

712

 

 

 

 

 

 

 

 

 

712

 

Foreign currency translation

   adjustments

 

 

 

 

 

 

 

 

 

 

 

734

 

 

 

 

 

 

 

 

 

734

 

Shares issued from stock

   plans, net of payroll taxes

   paid

 

 

1,778,567

 

 

 

18

 

 

 

5,078

 

 

 

 

 

 

 

 

 

 

 

 

5,096

 

Stock-based compensation

 

 

 

 

 

 

 

 

48,865

 

 

 

 

 

 

 

 

 

 

 

 

48,865

 

Balance at September 30,

   2019

 

 

87,210,669

 

 

$

872

 

 

$

1,280,396

 

 

$

(224

)

 

$

(686,597

)

 

$

19,271

 

 

$

613,718

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31,

   2017

 

 

82,498,128

 

 

$

825

 

 

$

1,160,094

 

 

$

(1,795

)

 

$

(630,657

)

 

$

19,271

 

 

$

547,738

 

Impact of change in

   accounting principle upon

   adoption of ASU 2016-01

 

 

 

 

 

 

 

 

 

 

 

(1,250

)

 

 

1,250

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(107,373

)

 

 

 

 

 

(107,373

)

Change in unrealized gain or

   loss on investments

 

 

 

 

 

 

 

 

 

 

 

(28

)

 

 

 

 

 

 

 

 

(28

)

Foreign currency translation

   adjustments

 

 

 

 

 

 

 

 

 

 

 

503

 

 

 

 

 

 

 

 

 

503

 

Shares issued from stock

   plans, net of payroll taxes

   paid

 

 

2,348,614

 

 

 

23

 

 

 

11,287

 

 

 

 

 

 

 

 

 

 

 

 

11,310

 

Stock-based compensation

 

 

 

 

 

 

 

 

38,432

 

 

 

 

 

 

 

 

 

 

 

 

38,432

 

Balance at September 30,

   2018

 

 

84,846,742

 

 

$

848

 

 

$

1,209,813

 

 

$

(2,570

)

 

$

(736,780

)

 

$

19,271

 

 

$

490,582

 

 

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)

 

 

 

Nine Months Ended September 30,

 

 

 

2019

 

 

2018

 

Operating activities

 

 

 

 

 

 

 

 

Net income (loss)

 

$

21,153

 

 

$

(107,373

)

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

 

 

 

 

 

 

 

 

Depreciation

 

 

8,715

 

 

 

4,693

 

Amortization of finance lease right-of-use assets

 

 

7,720

 

 

 

 

Net amortization of premium and discount on investments

 

 

(3,354

)

 

 

584

 

Unrealized loss (gain) on cash equivalents and short-term equity investments

 

 

(78

)

 

 

1,103

 

Loss (gain) on disposal of property and equipment

 

 

(10

)

 

 

53

 

Stock-based compensation

 

 

48,865

 

 

 

38,432

 

Realized foreign currency gain

 

 

 

 

 

(1,074

)

Realized gain on sales of available-for-sale securities

 

 

 

 

 

(87

)

Changes in operating assets and liabilities: