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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-K/A 

(Amendment No. 1)

 

(Mark One)

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2021

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)

 

Registrant’s telephone number, including area code:

(415) 978-1200 

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

 

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

None

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes      No  

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    Yes       No  

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 has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.         

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    Yes      No  

The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant, computed by reference to the closing price as of the last business day of the registrant’s most recently completed second fiscal quarter, June 30, 2021, was approximately $1,446.8 million. Shares of Common Stock held by each executive officer and director and stockholders known by the registrant to own 10% or more of the outstanding stock based on public filings and other information known to the registrant have been excluded since such persons may be deemed affiliates. This determination of affiliate status is not necessarily a conclusive determination for other purposes.

The number of shares of common stock outstanding as of January 31, 2022 was 93,001,968.

DOCUMENTS INCORPORATED BY REFERENCE

Items 10, 11, 12, 13 and 14 of Part III of this Annual Report on Form 10-K for the year ended December 31, 2021 (the “Annual Report”) incorporate information by reference from the definitive proxy statement for the registrant’s 2022 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than after 120 days after the end of the fiscal year covered by this Annual Report

 

 

 

 


 

 

EXPLANATORY NOTE

This Amendment No. 1 to the Annual Report on Form 10-K (this “Amendment”) amends FibroGen, Inc.’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 (the “Form 10-K”), as filed with the Securities and Exchange Commission on February 28, 2022, and is being filed solely to amend the report titled “Report of Independent Registered Public Accounting Firm” contained in Part II, Item 8 “Consolidated Financial Statements and Supplementary Data” of the Form 10-K (the “Audit Report”) to correct typographical formatting errors which occurred upon conversion of the Form 10-K into the appropriate EDGAR-filing format. The Audit Report in the Form 10-K inadvertently contained strikethrough formatting of the words “Internal Control – Integrated Framework” in the first and second paragraph of the Audit Report and the subheading “Change in Accounting Principle” inadvertently set in bold text.

Pursuant to Rule 12b-15 promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), we have included the entire text of Item 8 of the Form 10-K in this Amendment. However, there have been no changes made to the text of such item other than the changes stated in the immediately preceding paragraph. As required by Rule 12b-15 under the Exchange Act, new certifications by our principal executive officer and principal financial officer are being filed as Exhibits 31.1, 31.2 and 32.1 to this Amendment.

Except as expressly set forth above, this Amendment does not, and does not purport to, amend, update, or restate the information in the remainder of the Form 10-K or reflect any events that have occurred after the filing of the Form 10-K. Accordingly, this Amendment should be read in conjunction with the Form 10-K.

 

 

1


 

 

ITEM 8. CONSOLIDATED FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

 

 

 

 Page 

FibroGen, Inc.

 

  

 

 

 

Report of Independent Registered Public Accounting Firm  (PCAOB ID 238)

 

3

 

 

 

Financial Statements:

 

 

 

 

 

Consolidated Balance Sheets

 

6

 

 

 

Consolidated Statements of Operations

 

7

 

 

 

Consolidated Statements of Comprehensive Loss

 

8

 

 

 

Consolidated Statements of Changes in Stockholders' Equity

 

9

 

 

 

Consolidated Statements of Cash Flows

 

10

 

 

 

Notes to Consolidated Financial Statements

 

11

 

 

 

Financial Statement Schedule:

 

 

 

 

 

II Valuation and Qualifying Accounts for each of the three years ended December 31, 2021

 

58

 

 

2


 

 

Report of Independent Registered Public Accounting Firm

To the Board of Directors and Stockholders of FibroGen, Inc.

Opinions on the Financial Statements and Internal Control over Financial Reporting

We have audited the accompanying consolidated balance sheets of FibroGen, Inc. and its subsidiaries (the “Company”) as of December 31, 2021 and 2020, and the related consolidated statements of operations, of comprehensive loss, of changes in stockholders’ equity and of cash flows for each of the three years in the period ended December 31, 2021, including the related notes and financial statement schedule listed in the accompanying index (collectively referred to as the “consolidated financial statements”). We also have audited the Company's internal control over financial reporting as of December 31, 2021, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2021 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2021, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.

Change in Accounting Principle

As discussed in Note 2 to the consolidated financial statements, the Company changed the manner in which it accounts for leases in 2019.

Basis for Opinions

The Company’s management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s Annual Report on Internal Control over Financial Reporting appearing under Item 9A. Our responsibility is to express opinions on the Company’s consolidated financial statements and on the Company's internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.

Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.

3


 

Definition and Limitations of Internal Control over Financial Reporting

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Critical Audit Matters

The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Determining the Transaction Price for Product Revenue Recognition for Sales to Beijing Falikang Pharmaceutical Co., Ltd. (“Falikang”)

As described in Notes 2 and 3 to the consolidated financial statements, with respect to the roxadustat commercial product, revenue is recognized at a point in time when control of the product is transferred to Falikang. Total product revenue, net recognized related to sales to Falikang was $35.6 million for the year ended December 31, 2021. Revenue is recognized based on the estimated transaction price per unit and the actual quantity of product delivered to Falikang during the reporting period. The estimated transaction price per unit is determined based on the overall transaction price over the total estimated sales quantity for the estimated performance period in which management determined it is likely those sales would occur. Management applied significant judgment in determining the transaction price per unit, which involved the use of significant assumptions such as (i) the estimated total gross transaction price and profit share, (ii) the estimated total sales quantity, and (iii) the estimated performance period in which the Company determined it is likely those sales would occur.

The principal considerations for our determination that performing procedures relating to determining the transaction price for product revenue recognition for sales to Falikang is a critical audit matter are the significant judgment by management when determining the transaction price per unit, which in turn led to a high degree of auditor judgment, subjectivity, and effort in performing procedures and in evaluating management’s significant assumptions related to the estimated total gross transaction price, estimated total sales quantity, and estimated performance period over which the Company determined it is likely those sales would occur.

4


 

Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to revenue recognition, including controls over the determination of the transaction price per unit for sales to Falikang. These procedures also included, among others, testing management’s process for determining the transaction price per unit, which included evaluating the appropriateness of the method, testing the completeness and accuracy of the data used in the method, and evaluating the reasonableness of significant assumptions related to the estimated total gross transaction price, estimated total sales quantity, and estimated performance period over which the Company determined it is likely those sales would occur. Evaluating the reasonableness of the significant assumptions used by management involved evaluating whether the assumptions were reasonable considering (i) the current and historical transaction price and quantity, (ii) the consistency with external market, industry and regulatory data, (iii) whether these assumptions were consistent with evidence obtained in other areas of the audit, and (iv) patent expiration and market exclusivity.

/s/ PricewaterhouseCoopers LLP

San Jose, California

February 28, 2022

We have served as the Company’s auditor since 2000.

5


 

FIBROGEN, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except per share amounts)

 

 

 

December 31, 2021

 

 

December 31, 2020

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

171,223

 

 

$

678,393

 

Short-term investments

 

 

233,967

 

 

 

8,144

 

Accounts receivable, net ($10,930 and $4,127 from related parties)

 

 

17,401

 

 

 

41,883

 

Inventories

 

 

31,015

 

 

 

16,530

 

Prepaid expenses and other current assets ($0 and $889 from a related party)

 

 

20,453

 

 

 

10,160

 

Total current assets

 

 

474,059

 

 

 

755,110

 

Restricted time deposits

 

 

2,072

 

 

 

2,072

 

Long-term investments

 

 

167,796

 

 

 

244

 

Property and equipment, net

 

 

28,277

 

 

 

33,647

 

Finance lease right-of-use assets

 

 

761

 

 

 

29,606

 

Equity method investment in unconsolidated variable interest entity

 

 

3,825

 

 

 

2,728

 

Operating lease right-of-use assets

 

 

91,112

 

 

 

2,043

 

Other assets

 

 

5,919

 

 

 

1,390

 

Total assets

 

$

773,821

 

 

$

826,840

 

 

 

 

 

 

 

 

 

 

Liabilities, stockholders’ equity and non-controlling interests

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable ($0 and $1,118 to a related party)

 

$

26,097

 

 

$

24,789

 

Accrued and other current liabilities ($4 and $24 to a related party)

 

 

172,588

 

 

 

118,333

 

Deferred revenue ($3,201 and $2,907 to related parties)

 

 

15,857

 

 

 

6,547

 

Finance lease liabilities, current

 

 

11

 

 

 

12,330

 

Operating lease liabilities, current

 

 

10,944

 

 

 

1,188

 

Total current liabilities

 

 

225,497

 

 

 

163,187

 

Product development obligations

 

 

17,613

 

 

 

18,697

 

Deferred revenue, net of current ($25,891 and $4,636 to a related party)

 

 

186,801

 

 

 

138,474

 

Finance lease liabilities, non-current

 

 

3

 

 

 

25,391

 

Operating lease liabilities, non-current

 

 

88,776

 

 

 

853

 

Other long-term liabilities

 

 

26,018

 

 

 

38,789

 

Total liabilities

 

 

544,708

 

 

 

385,391

 

 

 

 

 

 

 

 

 

 

Commitments and Contingencies (Note 9)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

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

   and outstanding at December 31, 2021 and 2020

 

 

 

 

 

 

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

   2021 and 2020; 92,881 and 91,441 shares issued and outstanding at

   December 31, 2021 and 2020

 

 

929

 

 

 

914

 

Additional paid-in capital

 

 

1,476,414

 

 

 

1,399,774

 

Accumulated other comprehensive loss

 

 

(4,163

)

 

 

(4,499

)

Accumulated deficit

 

 

(1,264,034

)

 

 

(974,011

)

Total stockholders’ equity

 

 

209,146

 

 

 

422,178

 

Non-controlling interests

 

 

19,967

 

 

 

19,271

 

Total equity

 

 

229,113

 

 

 

441,449

 

Total liabilities, stockholders’ equity and non-controlling interests

 

$

773,821

 

 

$

826,840

 

 

The accompanying notes are an integral part of these Consolidated Financial Statements.

6


 

FIBROGEN, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

 

  

 

Years Ended December 31,

 

 

 

2021

 

 

2020

 

 

2019

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

License revenue (includes $108,434, $14,323

   and $129,405 from a related party)

 

$

116,434

 

 

$

14,323

 

 

$

177,086

 

Development and other revenue (includes $21,928, $19,174

   and $29,393 from a related party)

 

 

70,275

 

 

 

80,592

 

 

 

114,115

 

Product revenue, net (includes $35,568, $0 and $0 from

   a related party)

 

 

47,638

 

 

 

72,498

 

 

 

1,700

 

Drug product revenue (includes $3,186, $4,281 and

   $(36,324) from a related party)

 

 

962

 

 

 

8,906

 

 

 

(36,324

)

Total revenue

 

 

235,309

 

 

 

176,319

 

 

 

256,577

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

12,871

 

 

 

8,869

 

 

 

1,147

 

Research and development

 

 

387,043

 

 

 

252,924

 

 

 

209,265

 

Selling, general and administrative

 

 

123,925

 

 

 

106,406

 

 

 

135,479

 

Total operating costs and expenses

 

 

523,839

 

 

 

368,199

 

 

 

345,891

 

Loss from operations

 

 

(288,530

)

 

 

(191,880

)

 

 

(89,314

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other, net

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(1,075

)

 

 

(2,402

)

 

 

(2,876

)

Interest income and other income (expenses), net

 

 

(1,078

)

 

 

5,553

 

 

 

15,548

 

Total interest and other, net

 

 

(2,153

)

 

 

3,151

 

 

 

12,672

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before income taxes

 

 

(290,683

)

 

 

(188,729

)

 

 

(76,642

)

Provision for income taxes

 

 

347

 

 

 

360

 

 

 

328

 

Investment income (loss) in unconsolidated variable

   interest entity

 

 

1,007

 

 

 

(202

)

 

 

 

Net loss

 

$

(290,023

)

 

$

(189,291

)

 

$

(76,970

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted

 

$

(3.14

)

 

$

(2.11

)

 

$

(0.89

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares used to calculate

   net loss per share - basic and diluted

 

 

92,349

 

 

 

89,854

 

 

 

86,633

 

 

The accompanying notes are an integral part of these Consolidated Financial Statements.

 

7


 

 

FIBROGEN, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands)

 

 

 

Years Ended December 31,

 

 

 

2021

 

 

2020

 

 

2019

 

Net loss

 

$

(290,023

)

 

$

(189,291

)

 

$

(76,970

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

1,235

 

 

 

(3,207

)

 

 

331

 

Available-for-sale investments:

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

(899

)

 

 

(545

)

 

 

592

 

Other comprehensive income (loss), net of taxes

 

 

336

 

 

 

(3,752

)

 

 

923

 

Comprehensive loss

 

$

(289,687

)

 

$

(193,043

)

 

$

(76,047

)

 

The accompanying notes are an integral part of these Consolidated Financial Statements.

 

8


 

 

FIBROGEN, INC.

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(In thousands, except share data)

 

  

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

Other

Comprehensive

 

 

Accumulated

 

 

Non

Controlling

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Interests

 

 

Total

 

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 2)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,688

 

 

 

 

 

 

8,688

 

Impact of change in

   accounting principle

   upon adoption of ASU

   2018-02 (Note 2)

 

 

 

 

 

 

 

 

 

 

 

611

 

 

 

(611

)

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(76,970

)

 

 

 

 

 

(76,970

)

Change in unrealized gain

   or loss on investments

 

 

 

 

 

 

 

 

 

 

 

592

 

 

 

 

 

 

 

 

 

592

 

Foreign currency

   translation adjustments

 

 

 

 

 

 

 

 

 

 

 

331

 

 

 

 

 

 

 

 

 

331

 

Shares issued from stock

   plans, net of payroll

   taxes paid

 

 

2,220,957

 

 

 

23

 

 

 

7,939

 

 

 

 

 

 

 

 

 

 

 

 

7,962

 

Stock-based compensation

 

 

 

 

 

 

 

 

66,267

 

 

 

 

 

 

 

 

 

 

 

 

66,267

 

Warrants exercised

 

 

4,430

 

 

 

 

 

 

66

 

 

 

 

 

 

 

 

 

 

 

 

66

 

Balance at December 31,

   2019

 

 

87,657,489