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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
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 |
|
|
|
877 |
|
|
|
1,300,725 |
|
|
|
(747 |
|