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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, 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)

(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, 2021 was 92,709,943.

 

 

 

 


 

 

FIBROGEN, INC.

TABLE OF CONTENTS

 

 

 

Page

PART I—FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Condensed Consolidated Financial Statements (Unaudited)

 

4

 

Condensed Consolidated Balance Sheets as of September 30, 2021 and December 31, 2020 (Unaudited)

 

4

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)

 

5

 

Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)

 

6

 

Condensed Consolidated Statements of Changes in Equity for the Three and Nine Months Ended September 30, 2021 and 2020 (Unaudited)

 

7

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020 (Unaudited)

 

9

 

Notes to the Condensed Consolidated Financial Statements (Unaudited)

 

10

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

31

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

49

Item 4.

Controls and Procedures

 

49

 

 

 

 

PART II—OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

51

Item 1A.

Risk Factors

 

51

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

86

Item 3.

Defaults Upon Senior Securities

 

86

Item 4.

Mine Safety Disclosures

 

86

Item 5.

Other Information

 

87

Item 6.

Exhibits

 

88

 

Signatures

 

89

 


1


 

 

SUMMARY RISK FACTORS

The success of the Company will depend on a number of factors, many of which are beyond our control and involve risks, including but not limited to the following:

Risks Related to the Development and Commercialization of Our Product Candidates

We are substantially dependent on the success of our lead product, roxadustat, and our second compound in development, pamrevlumab.

As a company, we have limited commercialization experience, and the time and resources to develop such experience are significant. If we fail to achieve and sustain commercial success for roxadustat with our collaboration partners, our business would be harmed.

Although regulatory approval has been obtained for roxadustat in the European Union, Great Britain, China, Japan, South Korea, and Chile, we may be unable to obtain regulatory approval for other countries, or such approval may be delayed or limited, due to a number of factors, many of which are beyond our control.

The CRL we received for roxadustat has decreased the likelihood of approval and successful commercialization of roxadustat in the U.S., will decrease and/or delay expected revenue, and may increase the possibility that our Collaboration Agreement with AstraZeneca could be amended or terminated.

Preclinical, Phase 1 and Phase 2 clinical trial results may not be indicative of the results that may be obtained in larger clinical trials.

We do not know whether our ongoing or planned clinical trials of roxadustat or pamrevlumab will need to be redesigned based on interim results or if we will be able to achieve sufficient patient enrollment or complete planned clinical trials on schedule.

Our product candidates may cause or have attributed to them undesirable side effects or have other properties that delay or prevent their regulatory approval or limit their commercial potential.

Clinical trials of our product candidates may not uncover all possible adverse effects that patients may experience.

If our manufacturers or we cannot properly manufacture the appropriate volume of product, we may experience delays in development, regulatory approval, launch or successful commercialization.

Regulatory authorities will do their own benefit risk analysis and may reach a different conclusion than we or our partners have, and these regulatory authorities may base their approval decision on different analyses, data, and statistical methods than ours.

Even if we are able to obtain regulatory approval of our product candidates, the label we obtain may limit the indicated uses for which our product candidates may be marketed.

We face substantial competition in the discovery, development and commercialization of product candidates.

Our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community necessary for commercial success.

No or limited reimbursement or insurance coverage of our approved products, if any, by third-party payors may render our products less attractive to patients and healthcare providers.

Risks Related to COVID-19

Our business could continue to be adversely affected by the ongoing COVID-19 global pandemic.

Risks Related to Our Reliance on Third Parties

If our collaborations were terminated or if Astellas or AstraZeneca were to prioritize other initiatives over their collaborations with us, our ability to successfully develop and commercialize our product candidates would suffer.

If our preclinical and clinical trial contractors do not properly perform their agreed upon obligations, we may not be able to obtain or may be delayed in receiving regulatory approvals for our product candidates.

We currently rely, and expect to continue to rely, on third parties to conduct many aspects of our product manufacturing and distribution, and these third parties may terminate these agreements or not perform satisfactorily.

Certain components of our products are acquired from single-source suppliers or without long-term supply agreements. The loss of these suppliers, or their failure to supply, would materially and adversely affect our business.

Risks Related to Our Intellectual Property

If our efforts to protect our proprietary technologies are not adequate, we may not be able to compete effectively in our market.

Intellectual property disputes may be costly, time consuming, and may negatively affect our competitive position.

Our reliance on third parties and agreements with collaboration partners requires us to share our trade secrets, which increases the possibility that a competitor may discover them or that our trade secrets will be misappropriated or disclosed.

The cost of maintaining our patent protection is high and requires continuous review and diligence. We may not be able to effectively maintain our intellectual property position throughout the major markets of the world.

The laws of some foreign countries do not protect proprietary rights to the same extent as do the laws of the U.S., and we may encounter significant problems in securing and defending our intellectual property rights outside the U.S.

2


 

Intellectual property rights do not address all potential threats to any competitive advantage we may have.

The existence of counterfeit pharmaceutical products in pharmaceutical markets may compromise our brand and reputation and have a material adverse effect on our business, operations and prospects.

Risks Related to Government Regulation

The regulatory approval process is highly uncertain and we may not obtain regulatory approval for our product candidates.

Our product candidates could fail to receive regulatory approval from the FDA or other regulatory authorities for many reasons.

Our current and future relationships with customers, physicians, and third-party payors are subject to healthcare fraud and abuse laws, false claims laws, transparency laws, privacy and security laws, and other regulations. If we are unable to comply with such laws, we could face substantial penalties.

We are subject to laws and regulations governing corruption, which will require us to maintain costly compliance programs.

We have identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these, or if we otherwise fail to maintain an effective system of internal control, it may result in material misstatements in our financial statements.

The impact of U.S. healthcare reform may adversely affect our business model.

Roxadustat is considered a Class 2 substance on the 2019 World Anti-Doping Agency Prohibited List that could limit sales and increase security and distribution costs for our partners and us.

Our employees may engage in misconduct or improper activities, which could result in significant liability or harm our reputation.

If we fail to comply with environmental, health or safety laws and regulations, we could incur fines, penalties or other costs.

Risks Related to Our International Operations

We have established operations in China and are seeking approval to commercialize our product candidates outside of the U.S., and a number of risks associated with international operations could materially and adversely affect our business.

The pharmaceutical industry in China is highly regulated and such regulations are subject to change.

We have limited experience distributing drugs in China.

We use our own manufacturing facilities in China to produce roxadustat API and drug product for the market in China. There are risks inherent to operating commercial manufacturing facilities, and with these being our single source suppliers, we may not be able to continually meet market demand.

As a company, we have limited experience in pharmacovigilance, medical affairs, and management of the third-party distribution logistics, and cannot assure you we will be able to meet regulatory requirements or operate in these capacities successfully.

Our collaboration partner in China, AstraZeneca, and we may experience difficulties in successfully growing and sustaining sales of roxadustat in China.

The retail prices of any product candidates that we develop may be subject to pricing control in China and elsewhere.

FibroGen Beijing would be subject to restrictions on paying dividends or making other payments to us, which may restrict our ability to satisfy our liquidity requirements.

Any capital contributions from us to FibroGen Beijing must be approved by the Ministry of Commerce in China, and failure to obtain such approval may materially and adversely affect the liquidity position of FibroGen Beijing.

We may be subject to currency exchange rate fluctuations and currency exchange restrictions with respect to our operations in China, which could adversely affect our financial performance.

Because FibroGen Beijing’s funds are held in banks that do not provide insurance, the failure of any bank in which FibroGen Beijing deposits its funds could adversely affect our business.

We may be subject to tax inefficiencies associated with our offshore corporate structure.

Our foreign operations, particularly those in China, are subject to significant risks involving the protection of intellectual property.

Uncertainties with respect to the China legal system and regulations could have a material adverse effect on us.

Changes in China’s economic, governmental, or social conditions could have a material adverse effect on our business.

Our operations in China subject us to various Chinese labor and social insurance laws, and our failure to comply with such laws may materially and adversely affect our business, financial condition and results of operations.

Risks Related to the Operation of Our Business

Please see Part II – Other Information, Item 1A. Risk Factors for additional risk factors related to the operation of our Business.  

There are also a variety of Risks Related to Our Common Stock

Please see Part II – Other Information, Item 1A. Risk Factors for additional risk factors related to our Common Stock.

 

 

3


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, 2021

 

 

December 31, 2020

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

274,527

 

 

$

678,393

 

Short-term investments

 

 

211,875

 

 

 

8,144

 

Accounts receivable, net ($23,126 and $4,127 from related parties)

 

 

35,994

 

 

 

41,883

 

Inventories

 

 

29,315

 

 

 

16,530

 

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

 

 

21,688

 

 

 

10,160

 

Total current assets

 

 

573,399

 

 

 

755,110

 

Restricted time deposits

 

 

2,072

 

 

 

2,072

 

Long-term investments

 

 

142,636

 

 

 

244

 

Property and equipment, net

 

 

29,052

 

 

 

33,647

 

Finance lease right-of-use assets

 

 

771

 

 

 

29,606

 

Equity method investment in unconsolidated variable interest entity

 

 

3,421

 

 

 

2,728

 

Operating lease right-of-use assets

 

 

94,055

 

 

 

2,043

 

Other assets

 

 

5,107

 

 

 

1,390

 

Total assets

 

$

850,513

 

 

$

826,840

 

 

 

 

 

 

 

 

 

 

Liabilities, stockholders’ equity and non-controlling interests

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

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

 

$

23,868

 

 

$

24,789

 

Accrued and other current liabilities ($18 and $24 to a related party)

 

 

151,346

 

 

 

118,333

 

Deferred revenue ($9,113 and $2,907 to a related party)

 

 

23,256

 

 

 

6,547

 

Finance lease liabilities, current

 

 

15

 

 

 

12,330

 

Operating lease liabilities, current

 

 

10,831

 

 

 

1,188

 

Total current liabilities

 

 

209,316

 

 

 

163,187

 

Product development obligations

 

 

17,914

 

 

 

18,697

 

Deferred revenue, net of current ($10,604 and $4,636 to a related party)

 

 

162,415

 

 

 

138,474

 

Finance lease liabilities, non-current

 

 

5

 

 

 

25,391

 

Operating lease liabilities, non-current

 

 

91,478

 

 

 

853

 

Other long-term liabilities

 

 

24,322

 

 

 

38,789

 

Total liabilities

 

 

505,450

 

 

 

385,391

 

 

 

 

 

 

 

 

 

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

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

   and outstanding at September 30, 2021, and December 31, 2020

 

 

 

 

 

 

Common stock, $0.01 par value; 225,000 shares authorized at September 30, 2021, and December 31, 2020; 92,708 and 91,441 shares issued and outstanding at

   September 30, 2021, and December 31, 2020

 

 

927

 

 

 

914

 

Additional paid-in capital

 

 

1,458,979

 

 

 

1,399,774

 

Accumulated other comprehensive loss

 

 

(4,158

)

 

 

(4,499

)

Accumulated deficit

 

 

(1,129,956

)

 

 

(974,011

)

Total stockholders’ equity

 

 

325,792

 

 

 

422,178

 

Non-controlling interests

 

 

19,271

 

 

 

19,271

 

Total equity

 

 

345,063

 

 

 

441,449

 

Total liabilities, stockholders’ equity and non-controlling interests

 

$

850,513

 

 

$

826,840

 

 

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

4


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,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License revenue(includes $108,434, $0, $108,434

   and $0 from a related party)

 

$

116,434

 

 

$

 

 

$

116,434

 

 

$

 

Development and other revenue (includes $14,127, $4,736,

   $20,383 and $14,239 from a related party)

 

 

26,097

 

 

 

20,663

 

 

 

60,325

 

 

 

59,065

 

Product revenue, net (includes $10,328, $0, $32,495 and

   $0 from a related party)

 

 

13,442

 

 

 

22,683

 

 

 

42,175

 

 

 

43,331

 

Drug product revenue (includes $0, $(3,957), $2,056

   and $4,281 from a related party)

 

 

 

 

 

686

 

 

 

(168

)

 

 

8,924

 

Total revenue

 

 

155,973

 

 

 

44,032

 

 

 

218,766

 

 

 

111,320

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

 

3,266

 

 

 

2,207

 

 

 

9,746

 

 

 

6,253

 

Research and development

 

 

75,880

 

 

 

58,476

 

 

 

273,123

 

 

 

174,792

 

Selling, general and administrative

 

 

25,853

 

 

 

(48,981

)

 

 

89,186

 

 

 

64,157

 

Total operating costs and expenses

 

 

104,999

 

 

 

11,702

 

 

 

372,055

 

 

 

245,202

 

Income (loss) from operations

 

 

50,974

 

 

 

32,330

 

 

 

(153,289

)

 

 

(133,882

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(109

)

 

 

(580

)

 

 

(965

)

 

 

(1,864

)

Interest income and other income (expenses), net

 

 

(1,303

)

 

 

1,482

 

 

 

(2,120

)

 

 

5,292

 

Total interest and other, net

 

 

(1,412

)

 

 

902

 

 

 

(3,085

)

 

 

3,428

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income (loss) before income taxes

 

 

49,562

 

 

 

33,232

 

 

 

(156,374

)

 

 

(130,454

)

Provision for income taxes

 

 

106

 

 

 

215

 

 

 

235

 

 

 

190

 

Investment income (loss) in unconsolidated variable

   interest entity

 

 

342

 

 

 

(13

)

 

 

664

 

 

 

(13

)

Net income (loss)

 

$

49,798

 

 

$

33,004

 

 

$

(155,945

)

 

$

(130,657

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

0.54

 

 

$

0.36

 

 

$

(1.69

)

 

$

(1.46

)

Diluted

 

$

0.54

 

 

$

0.35

 

 

$

(1.69

)

 

$

(1.46

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares used to

     calculate net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

92,644

 

 

 

90,558

 

 

 

92,206

 

 

 

89,414

 

Diluted

 

 

92,808

 

 

 

93,678

 

 

 

92,206

 

 

 

89,414

 

 

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

5


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,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net income (loss)

 

$

49,798

 

 

$

33,004

 

 

$

(155,945

)

 

$

(130,657

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

396

 

 

 

(2,038

)

 

 

366

 

 

 

(3,372

)

Available-for-sale investments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

13

 

 

 

(657

)

 

 

(25

)

 

 

(137

)

Other comprehensive income (loss), net of taxes

 

 

409

 

 

 

(2,695

)

 

 

341

 

 

 

(3,509

)

Comprehensive income (loss)

 

$

50,207

 

 

$

30,309

 

 

$

(155,604

)

 

$

(134,166

)

 

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

 

6


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 June 30,

   2021

 

 

92,608,929

 

 

$

926

 

 

$

1,443,975

 

 

$

(4,567

)

 

$

(1,179,754

)

 

$

19,271

 

 

$

279,851

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

49,798

 

 

 

 

 

 

49,798

 

Change in unrealized gain or

   loss on investments

 

 

 

 

 

 

 

 

 

 

 

13

 

 

 

 

 

 

 

 

 

13

 

Foreign currency translation

   adjustments

 

 

 

 

 

 

 

 

 

 

 

396

 

 

 

 

 

 

 

 

 

396

 

Shares issued from stock

   plans, net of payroll taxes

   paid

 

 

99,023

 

 

 

1

 

 

 

(700

)

 

 

 

 

 

 

 

 

 

 

 

(699

)

Stock-based compensation

 

 

 

 

 

 

 

 

15,704

 

 

 

 

 

 

 

 

 

 

 

 

15,704

 

Balance at September 30,

   2021

 

 

92,707,952

 

 

$

927

 

 

$

1,458,979

 

 

$

(4,158

)

 

$

(1,129,956

)

 

$

19,271

 

 

$

345,063