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fgen:AstellasMember 2019-06-30 0000921299 us-gaap:CollaborativeArrangementMember fgen:AstellasMember 2018-12-31 0000921299 fgen:AstellasCollaborationAgreementMember fgen:APIShipmentMember fgen:AstellasMember 2018-12-31 0000921299 fgen:AstellasMember srt:EuropeMember 2019-06-30 0000921299 srt:EuropeMember 2019-06-30

 

 

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, 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 July 31, 2019 was 86,915,996.

 

 

 

 


 

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, 2019 and December 31, 2018 (Unaudited)

 

2

 

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

 

3

 

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

 

4

 

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

 

5

 

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 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

 

24

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

40

Item 4.

Controls and Procedures

 

40

 

 

 

 

PART II—OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

41

Item 1A.

Risk Factors

 

41

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

83

Item 3.

Defaults Upon Senior Securities

 

83

Item 4.

Mine Safety Disclosures

 

83

Item 5.

Other Information

 

83

Item 6.

Exhibits

 

84

 

Signatures

 

85

 

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, 2019

 

 

December 31, 2018

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

74,587

 

 

$

89,258

 

Short-term investments

 

 

586,174

 

 

 

532,144

 

Accounts receivable ($4,311 and $47,210 from a related party)

 

 

6,453

 

 

 

63,684

 

Inventories

 

 

1,981

 

 

 

 

Prepaid expenses and other current assets ($127,981 and $0 from a related party)

 

 

136,596

 

 

 

4,929

 

Total current assets

 

 

805,791

 

 

 

690,015

 

 

 

 

 

 

 

 

 

 

Restricted time deposits

 

 

4,145

 

 

 

4,145

 

Long-term investments

 

 

10,915

 

 

 

55,820

 

Property and equipment, net

 

 

44,865

 

 

 

127,198

 

Finance lease right-of-use assets

 

 

44,536

 

 

 

 

Other assets

 

 

4,814

 

 

 

3,420

 

Total assets

 

$

915,066

 

 

$

880,598

 

 

 

 

 

 

 

 

 

 

Liabilities, stockholders’ equity and non-controlling interests

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

4,060

 

 

$

9,139

 

Accrued and other current liabilities ($781 and $444 to a related party)

 

 

66,545

 

 

 

66,123

 

Deferred revenue

 

 

136

 

 

 

13,771

 

Finance lease liabilities, current

 

 

12,071

 

 

 

 

Total current liabilities

 

 

82,812

 

 

 

89,033

 

 

 

 

 

 

 

 

 

 

Long-term portion of lease obligations

 

 

1,342

 

 

 

97,157

 

Product development obligations

 

 

16,846

 

 

 

16,798

 

Deferred rent

 

 

 

 

 

3,038

 

Deferred revenue, net of current

 

 

102,926

 

 

 

136,109

 

Finance lease liabilities, non-current

 

 

43,780

 

 

 

 

Other long-term liabilities

 

 

19,058

 

 

 

9,993

 

Total liabilities

 

 

266,764

 

 

 

352,128

 

 

 

 

 

 

 

 

 

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

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

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

 

 

 

 

 

 

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

   and December 31, 2018; 86,847 and 85,432 shares issued and outstanding at

  June 30, 2019 and December 31, 2018

 

 

868

 

 

 

854

 

Additional paid-in capital

 

 

1,265,783

 

 

 

1,226,453

 

Accumulated other comprehensive loss

 

 

(462

)

 

 

(2,281

)

Accumulated deficit

 

 

(637,158

)

 

 

(715,827

)

Total stockholders’ equity

 

 

629,031

 

 

 

509,199

 

Non-controlling interests

 

 

19,271

 

 

 

19,271

 

Total equity

 

 

648,302

 

 

 

528,470

 

Total liabilities, stockholders’ equity and non-controlling interests

 

$

915,066

 

 

$

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 June 30,

 

 

Six Months Ended June 30,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License revenue (includes $117,470, $14,323, $117,470

    and $14,323 from a related party)

 

$

150,581

 

 

$

14,323

 

 

$

150,581

 

 

$

14,323

 

Development and other revenue (includes $17,223, $6,145,

    $22,082 and $11,317 from a related party)

 

 

40,985

 

 

 

29,629

 

 

 

64,848

 

 

 

61,553

 

Total revenue

 

 

191,566

 

 

 

43,952

 

 

 

215,429

 

 

 

75,876

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

52,008

 

 

 

52,138

 

 

 

102,505

 

 

 

109,112

 

Selling, general and administrative

 

 

26,739

 

 

 

15,055

 

 

 

48,948

 

 

 

30,605

 

Total operating expenses

 

 

78,747

 

 

 

67,193

 

 

 

151,453

 

 

 

139,717

 

Income (loss) from operations

 

 

112,819

 

 

 

(23,241

)

 

 

63,976

 

 

 

(63,841

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(736

)

 

 

(2,750

)

 

 

(1,507

)

 

 

(5,519

)

Interest income and other, net

 

 

4,125

 

 

 

2,645

 

 

 

8,303

 

 

 

4,717

 

Total interest and other, net

 

 

3,389

 

 

 

(105

)

 

 

6,796

 

 

 

(802

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 

116,208

 

 

 

(23,346

)

 

 

70,772

 

 

 

(64,643

)

Provision for income taxes

 

 

205

 

 

 

75

 

 

 

180

 

 

 

174

 

Net income (loss)

 

$

116,003

 

 

$

(23,421

)

 

$

70,592

 

 

$

(64,817

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

1.34

 

 

$

(0.28

)

 

$

0.82

 

 

$

(0.78

)

Diluted

 

$

1.26

 

 

$

(0.28

)

 

$

0.77

 

 

$

(0.78

)

Weighted average number of common shares used to

     calculate net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

86,445

 

 

 

83,750

 

 

 

86,077

 

 

 

83,309

 

Diluted

 

 

91,728

 

 

 

83,750

 

 

 

92,069

 

 

 

83,309

 

 

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,

 

 

 

2019

 

 

2018

 

 

2019

 

 

2018

 

Net income (loss)

 

$

116,003

 

 

$

(23,421

)

 

$

70,592

 

 

$

(64,817

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

(180

)

 

 

958

 

 

 

111

 

 

 

431

 

Available-for-sale investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on investments, net of tax effect

 

 

655

 

 

 

53

 

 

 

1,097

 

 

 

3

 

Other comprehensive income, net of taxes

 

 

475

 

 

 

1,011

 

 

 

1,208

 

 

 

434

 

Comprehensive income (loss)

 

$

116,478

 

 

$

(22,410

)

 

$

71,800

 

 

$

(64,383

)

 

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 March 31,

   2019

 

 

86,129,564

 

 

$

861

 

 

$

1,242,460

 

 

$

(937

)

 

$

(753,161

)

 

$

19,271

 

 

$

508,494

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at March 31,

   2018

 

 

83,420,625

 

 

$

834

 

 

$

1,173,109

 

 

$

(3,622

)

 

$

(670,803

)

 

$

19,271

 

 

$

518,789

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(23,421

)

 

 

 

 

 

(23,421

)

Change in unrealized gain or

   loss on investments

 

 

 

 

 

 

 

 

 

 

 

53

 

 

 

 

 

 

 

 

 

53

 

Foreign currency translation

   adjustments

 

 

 

 

 

 

 

 

 

 

 

958

 

 

 

 

 

 

 

 

 

958

 

Shares issued from stock

   plans, net of payroll taxes

   paid

 

 

762,219

 

 

 

8

 

 

 

5,184

 

 

 

 

 

 

 

 

 

 

 

 

5,192

 

Stock-based compensation

 

 

 

 

 

 

 

 

13,231

 

 

 

 

 

 

 

 

 

 

 

 

13,231

 

Balance at June 30,

   2018

 

 

84,182,844

 

 

$

842

 

 

$

1,191,524

 

 

$

(2,611

)

 

$

(694,224

)

 

$

19,271

 

 

$

514,802

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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,

   2018

 

 

85,432,102

 

 

$

854

 

 

$

1,226,453

 

 

$

(2,281

)

 

$

(715,827

)

 

$

19,271