fgen-10q_20160331.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

Form 10-Q

 

(Mark One)

þ

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

For the quarterly period ended March 31, 2016

OR

o

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:

 

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  þ    No  o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  þ    No  o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act:

 

Large accelerated filer

þ

Accelerated filer

o

 

 

 

 

Non-accelerated filer

o  (Do not check if a smaller reporting company)

Smaller reporting company

¨

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

The number of shares of common stock outstanding as of April 30, 2016 was 62,450,875.

 

 

 

 


 

FIBROGEN, INC.

TABLE OF CONTENTS

 

 

 

Page

PART I—FINANCIAL INFORMATION

 

 

 

 

 

 

Item 1.

Condensed Consolidated Financial Statements

 

3

 

Condensed Consolidated Balance Sheets as of March 31, 2016 and December 31, 2015

 

3

 

Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2016 and 2015

 

4

 

Condensed Consolidated Statements of Comprehensive Loss for the Three Months Ended March 31, 2016 and 2015

 

5

 

Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2016 and 2015

 

6

 

Notes to the Condensed Consolidated Financial Statements

 

7

Item 2.

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

 

15

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

27

Item 4.

Controls and Procedures

 

27

 

 

 

 

PART II—OTHER INFORMATION

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

28

Item 1A.

Risk Factors

 

28

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

67

Item 3.

Defaults Upon Senior Securities

 

67

Item 4.

Mine Safety Disclosures

 

67

Item 5.

Other Information

 

67

Item 6.

Exhibits

 

67

 

Signatures

 

68

 

Exhibit Index

 

69

 

2


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)

 

 

 

March 31, 2016

 

 

December 31, 2015

 

 

 

 

 

 

 

(Note 1)

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

140,959

 

 

$

153,324

 

Short-term investments

 

 

32,454

 

 

 

27,847

 

Accounts receivable ($3,662 and $4,455 from a related party)

 

 

5,937

 

 

 

15,405

 

Prepaid expenses and other current assets

 

 

4,651

 

 

 

3,988

 

Total current assets

 

 

184,001

 

 

 

200,564

 

 

 

 

 

 

 

 

 

 

Restricted cash

 

 

7,254

 

 

 

7,254

 

Long-term investments

 

 

122,009

 

 

 

131,720

 

Property and equipment, net

 

 

127,613

 

 

 

129,020

 

Other assets

 

 

1,658

 

 

 

2,016

 

Total assets

 

$

442,535

 

 

$

470,574

 

 

 

 

 

 

 

 

 

 

Liabilities, stockholders’ equity and non-controlling interests

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,543

 

 

$

6,521

 

Accrued liabilities ($1,639 and $2,045 to related parties)

 

 

44,038

 

 

 

47,932

 

Deferred revenue

 

 

12,722

 

 

 

12,728

 

Total current liabilities

 

 

58,303

 

 

 

67,181

 

 

 

 

 

 

 

 

 

 

Long-term portion of lease financing obligations

 

 

97,077

 

 

 

97,042

 

Product development obligations

 

 

15,786

 

 

 

15,085

 

Deferred rent

 

 

4,581

 

 

 

4,702

 

Deferred revenue, net of current

 

 

85,328

 

 

 

85,132

 

Other long-term liabilities

 

 

5,237

 

 

 

4,607

 

Total liabilities

 

 

266,312

 

 

 

273,749

 

 

 

 

 

 

 

 

 

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.01 par value; 125,000 shares authorized at March 31, 2016 and

   December 31, 2015; no shares issued and outstanding at March 31, 2016

   and December 31, 2015

 

 

 

 

 

 

Common stock, $0.01 par value; 225,000 shares authorized at March 31, 2016 and

   December 31, 2015; 62,425 and 61,985 shares issued and outstanding at

   March 31, 2016 and December 31, 2015

 

 

624

 

 

 

620

 

Additional paid-in capital

 

 

593,935

 

 

 

586,647

 

Accumulated other comprehensive loss

 

 

(1,704

)

 

 

(1,651

)

Accumulated deficit

 

 

(435,903

)

 

 

(408,062

)

Total stockholders’ equity

 

 

156,952

 

 

 

177,554

 

Non-controlling interests

 

 

19,271

 

 

 

19,271

 

Total equity

 

 

176,223

 

 

 

196,825

 

Total liabilities, stockholders’ equity and non-controlling interests

 

$

442,535

 

 

$

470,574

 

 

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

3


Table of Contents

FIBROGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2016

 

 

2015

 

Revenue:

 

 

 

 

 

 

 

 

      License and milestone revenue (includes $3,313 and $4,692 from a related party)

 

$

19,738

 

 

$

11,506

 

      Collaboration services and other revenue (includes $352 and $634 from a related party)

 

 

8,544

 

 

 

4,792

 

Total revenue

 

 

28,282

 

 

 

16,298

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

Research and development

 

 

43,650

 

 

 

50,539

 

General and administrative

 

 

11,417

 

 

 

10,482

 

Total operating expenses

 

 

55,067

 

 

 

61,021

 

Loss from operations

 

 

(26,785

)

 

 

(44,723

)

 

 

 

 

 

 

 

 

 

Interest and other, net

 

 

 

 

 

 

 

 

Interest expense

 

 

(2,777

)

 

 

(2,758

)

Interest income and other, net

 

 

1,416

 

 

 

843

 

Total interest and other, net

 

 

(1,361

)

 

 

(1,915

)

 

 

 

 

 

 

 

 

 

Loss before income taxes

 

 

(28,146

)

 

 

(46,638

)

Benefit from income taxes

 

 

(305

)

 

 

(271

)

Net loss

 

$

(27,841

)

 

$

(46,367

)

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted

 

$

(0.45

)

 

$

(0.78

)

Weighted average number of common shares used to calculate net loss per share - basic and diluted

 

 

62,184

 

 

 

59,197

 

 

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

4


Table of Contents

FIBROGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2016

 

 

2015

 

Net loss

 

$

(27,841

)

 

$

(46,367

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

Foreign currency translation adjustments

 

 

(642

)

 

 

1,705

 

Available-for-sale investments:

 

 

 

 

 

 

 

 

Unrealized gain on investments, net of tax effect

 

 

589

 

 

 

711

 

Reclassification from accumulated other comprehensive loss

 

 

 

 

 

(5

)

Net change in unrealized loss on available-for-sale

   investments

 

 

589

 

 

 

706

 

Other comprehensive income, net of taxes

 

 

(53

)

 

 

2,411

 

Comprehensive loss

 

$

(27,894

)

 

$

(43,956

)

 

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

 

5


Table of Contents

FIBROGEN, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

 

 

Three Months Ended March 31,

 

 

 

2016

 

 

2015

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(27,841

)

 

$

(46,367

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Depreciation

 

 

1,502

 

 

 

1,388

 

Amortization of premium on investments

 

 

695

 

 

 

768

 

Unrealized foreign exchange gain on short-term investments

 

 

(620

)

 

 

-

 

Stock-based compensation

 

 

7,340

 

 

 

6,446

 

Tax benefit on unrealized gain on available-for-sale securities

 

 

(339

)

 

 

(271

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

9,468

 

 

 

6,490

 

Prepaid expenses and other current assets

 

 

(663

)

 

 

(780

)

Other assets

 

 

358

 

 

 

(112

)

Accounts payable

 

 

(4,978

)

 

 

(2,118

)

Accrued liabilities

 

 

(3,214

)

 

 

(7,048

)

Deferred revenue

 

 

190

 

 

 

(822

)

Lease financing liability

 

 

136

 

 

 

156

 

Other long-term liabilities

 

 

708

 

 

 

80

 

Net cash used in operating activities

 

 

(17,258

)

 

 

(42,190

)

 

 

 

 

 

 

 

 

 

Investing activities

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(898

)

 

 

(448

)

Purchases of available-for-sale securities

 

 

(19

)

 

 

 

Proceeds from maturities of available-for-sale securities

 

 

5,976

 

 

 

5,000

 

Net cash provided by investing activities

 

 

5,059

 

 

 

4,552

 

 

 

 

 

 

 

 

 

 

Financing activities

 

 

 

 

 

 

 

 

Repayments of lease liability

 

 

(101

)

 

 

(101

)

Cash paid for payroll taxes on restricted stock unit releases

 

 

(1,261

)

 

 

 

Proceeds from issuance of common stock

 

 

1,213

 

 

 

721

 

Net cash provided by (used in) financing activities

 

 

(149

)

 

 

620

 

Effect of exchange rate change on cash and cash equivalents

 

 

(17

)

 

 

(68

)

Net decrease in cash and cash equivalents

 

 

(12,365

)

 

 

(37,086

)

Cash and cash equivalents at beginning of period

 

 

153,324

 

 

 

165,455

 

Cash and cash equivalents at end of period

 

$

140,959

 

 

$

128,369

 

 

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

 

 

6


Table of Contents

FIBROGEN, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

1.

Significant Accounting Policies

Description of Operations

FibroGen, Inc. (“FibroGen” or the “Company”) was incorporated in 1993 in Delaware and is a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics agents to treat serious unmet medical needs. The Company’s focus in the areas of fibrosis and hypoxia-inducible factor (“HIF”) biology has generated multiple programs targeting various therapeutic areas. The Company’s most advanced product candidate, roxadustat, or FG-4592, is an oral small molecule inhibitor of HIF prolyl hydroxylases in Phase 3 clinical development for the treatment of anemia in chronic kidney disease. FG-3019 is the Company’s monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis, pancreatic cancer, Duchenne muscular dystrophy and liver fibrosis. We have taken a global approach with respect to the development and future commercialization of our product candidates, and this includes development and commercialization in the People’s Republic of China (“China”).

Basis of Presentation and Principles of Consolidation

The condensed consolidated financial statements include the accounts of FibroGen, its wholly owned subsidiaries and its majority-owned subsidiaries, FibroGen Europe Oy and FibroGen China Anemia Holdings, Ltd. (“FibroGen China”). All inter-company transactions and balances have been eliminated in consolidation. The Company operates in one segment — the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs.

The unaudited condensed consolidated financial statements and related disclosures have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) applicable to interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) and, therefore, do not include all information and footnote disclosures normally included in the annual consolidated financial statements. The December 31, 2015 condensed consolidated balance sheet data contained within this Form 10-Q was derived from audited consolidated financial statements included in the Company’s Annual Report on Form 10-K filed with the SEC for the year ended December 31, 2015 (the “2015 Form 10-K”), but does not include all disclosures required by U.S. GAAP.

The financial information included herein should be read in conjunction with the consolidated financial statements and related notes in the 2015 Form 10-K. The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 2 to the consolidated financial statements included in the 2015 Form 10-K.

Use of Estimates

The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. In our opinion, the accompanying unaudited condensed consolidated financial statements include all normal recurring adjustments necessary for a fair presentation of our financial position, results of operations and cash flows for the interim periods presented.

Recently Issued Accounting Guidance Not Yet Adopted

In March 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-09, Compensation - Stock Compensation (Topic 718). This guidance identifies areas for simplification involving several aspects of accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, an option to recognize gross stock compensation expense with actual forfeitures recognized as they occur, as well as certain classifications on the statement of cash flows. This guidance is effective for the annual reporting period beginning after December 15, 2016, including interim periods within that reporting period, with early adoption permitted. The Company is currently evaluating the impact on its consolidated financial statements upon the adoption of this guidance.

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Table of Contents

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). Under this guidance, an entity is required to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. This guidance offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. This guidance is effective for the annual reporting period beginning after December 15, 2018, including interim periods within that reporting period, and requires a modified retrospective adoption, with early adoption permitted. The Company is currently evaluating the impact on its consolidated financial statements upon the adoption of this guidance.

In January 2016, the FASB issued ASU 2016-01, Financial Instruments-Overall (Subtopic 825-10), which requires equity investments that are not accounted for under the equity method of accounting to be measured at fair value with changes recognized in net income, simplifies the impairment assessment of certain equity investments, and updates certain presentation and disclosure requirements. This guidance is effective for the annual reporting period beginning after December 15, 2017 and interim periods within those annual periods. The Company is currently evaluating the impact on its consolidated financial statements upon the adoption of this guidance.

In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements - Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. This guidance requires management to evaluate, at each interim and annual reporting period, whether there are conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date the financial statements are issued, and provide related disclosures. This guidance will be effective for annual period ending after December 15, 2016, and for annual and interim periods thereafter. Early adoption is permitted. The Company does not expect a material impact on its consolidated financial statements upon the adoption of this guidance.

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which supersedes the revenue recognition requirements in Accounting Standards Codification (“ASC”) 605, Revenue Recognition. ASU 2014-09 is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2014-09 also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 can be adopted either retrospectively to each prior reporting period presented, or retrospectively with a cumulative-effect adjustment recognized as of the date of adoption. In April 2016, the FASB issued ASU 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing (“ASU 2016-10”), which clarifies the implementation guidance on identifying performance obligations in a contract and determining whether an entity’s promise to grant a license provides a customer with either a right to use the entity’s intellectual property (which is satisfied at a point in time) or a right to access the entity’s intellectual property (which is satisfied over time). The effective date and transition requirements for ASU 2016-10 are the same as those for ASU 2014-09. The original effective date of ASU 2014-09 for public entities was for the annual reporting period beginning after December 15, 2016. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers (Topic 606), to defer the effective date of ASU 2014-09 by one year, to the annual reporting period beginning after December 15, 2017, including interim periods within that reporting period. A reporting entity may choose to early adopt the guidance as of the original effective date. The Company does not anticipate an early adoption, and is currently evaluating the impact on its consolidated financial statements upon the adoption of ASU 2014-09 and ASU 2016-10.

2.

Collaboration Agreements

Astellas Agreements

Japan Agreement

In June 2005, the Company entered into a collaboration agreement with Astellas Pharma Inc. (“Astellas”) for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in Japan (“Japan Agreement”). Under this agreement, Astellas paid license fees and other consideration totaling $40.1 million (such amounts were fully received as of February 2009). The Japan Agreement also provides for additional development and regulatory approval milestone payments up to $117.5 million, a commercial sales related milestone of $15.0 million and additional consideration based on net sales (as defined) in the low 20% range after commercial launch. A clinical milestone payment of $12.5 million was received in 2013. The Company evaluated the criteria under ASC 605-28 and concluded that the aforementioned milestone was substantive.

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Table of Contents

Europe Agreement

In April 2006, the Company entered into a separate collaboration agreement with Astellas for the development and commercialization of roxadustat for the treatment of anemia in Europe, the Middle East, the Commonwealth of Independent States and South Africa (“Europe Agreement”). Under the terms of the Europe Agreement, Astellas paid license fees and other upfront consideration totaling $320.0 million (such amounts were fully received as of February 2009). The Europe Agreement also provides for additional development and regulatory approval milestone payments up to $425.0 million. Clinical milestone payments of $40.0 million and $50.0 million were received in 2010 and 2012, respectively. The Company evaluated the criteria under ASC 605-28 and concluded that each of those milestones was substantive. Under the Europe Agreement, Astellas committed to fund 50% of joint development costs for Europe and North America, and all territory-specific costs. The Europe Agreement also provides for tiered payments based on net sales of product (as defined) in the low 20% range.

AstraZeneca Agreements

U.S./Rest of World Agreement

Effective July 30, 2013, the Company entered into a collaboration agreement with AstraZeneca AB (“AstraZeneca”) for the development and commercialization of roxadustat for the treatment of anemia in the U.S. and all other countries in the world, other than China, not previously licensed under the Astellas Europe and Astellas Japan Agreements (“U.S./RoW Agreement”). It also excludes China, which is covered by a separate agreement with AstraZeneca described below. Under the terms of the U.S./RoW Agreement, AstraZeneca has agreed to pay upfront, non-contingent and time-based payments totaling $374.0 million, which the Company expects to receive in various amounts through June 2016, of which $312.0 million was received as of March 31, 2016. The remaining payment of $62.0 million is contingent upon the occurrence of a specified event and accordingly is also not considered fixed or determinable. In addition, the U.S./RoW Agreement also provides for development and regulatory approval based milestone payments of up to $550.0 million, which include potential future indications which the companies choose to pursue, and commercial related milestone payments of up to $325.0 million. During the second quarter of 2015, the Company received a $15.0 million development milestone payment as a result of the finalization of its two audited pre-clinical carcinogenicity study reports. The Company evaluated the criteria under ASC 605-28 and concluded that the aforementioned milestone was substantive.

Under the U.S./RoW Agreement, the Company and AstraZeneca will share equally in the development costs of roxadustat not already paid for by Astellas, up to a total of $233.0 million (i.e. the Company’s share of development costs is $116.5 million). Any additional development costs incurred by FibroGen during the development period in excess of the $233.0 million (aggregated spend) will be fully reimbursed by AstraZeneca. AstraZeneca will pay the Company tiered royalty payments on AstraZeneca’s future net sales (as defined in the agreement) of roxadustat in the low 20% range. In addition, the Company will receive a transfer price for delivery of commercial product based on a percentage of AstraZeneca’s net sales (as defined in the agreement) in the low- to mid-single digit range.

China Agreement

Effective July 30, 2013, the Company (through its subsidiaries affiliated with China) entered into a collaboration agreement with AstraZeneca for the development and commercialization (but not manufacture) of roxadustat for the treatment of anemia in China (“China Agreement”). Under the terms of the China Agreement, AstraZeneca agreed to pay upfront consideration totaling $28.2 million (such amounts were fully received as of March 31, 2014). In addition, the China Agreement provides for AstraZeneca to pay regulatory approval and other approval related milestones of up to $161.0 million. The China Agreement also provides for sales related milestone payments of up to $167.5 million and contingent payments of $20.0 million related to possible future compounds. The China Agreement is structured as a 50/50 profit or loss share (as defined) and provides for joint development costs (including capital and equipment costs for construction of the manufacturing plant in China), to be shared equally during the development.

Summary of Revenue Recognized Under the Collaboration Agreements

The table below summarizes the accounting treatment for the various deliverables pursuant to each of the Astellas and AstraZeneca agreements. License amounts identified below are included in the “License and milestone revenue” line item in the condensed consolidated statements of operations. All other elements identified below are included in the “Collaboration services and other revenue” line item in the condensed consolidated statements of operations.

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Amounts recognized as revenue under the Japan Agreement were as follows (in thousands): 

 

 

 

 

 

Three Months Ended March 31,

 

Agreement

 

Deliverable

 

2016

 

 

2015

 

Japan

 

    License

 

$

75

 

 

$

437

 

 

 

    Milestones

 

 

 

 

 

 

 

 

Total license and milestone revenue

 

$

75

 

 

$

437

 

 

 

Collaboration services revenue*

 

$

4

 

 

$

58

 

 

*

When and if available compounds, manufacturing — clinical supplies and committee services have each been identified as separate units of accounting with standalone value and amounts allocable to these elements have been recognized and classified within the Collaboration services revenue line item within the condensed consolidated statements of operations.

The total arrangement consideration has been allocated to each of the following deliverables under the Japan Agreement, along with any associated deferred revenue as follows (in thousands):

 

 

 

Cumulative

Revenue

Through

March 31, 2016

 

 

Deferred

Revenue at

March 31, 2016

 

 

Total

Consideration

Through

March 31, 2016

 

License

 

$

42,320

 

 

$

 

 

$

42,320

 

When and if available compounds

 

 

15

 

 

 

27

 

 

 

42

 

Manufacturing--clinical supplies

 

 

1,969

 

 

 

 

 

 

1,969

 

Committee services

 

 

17

 

 

 

 

 

 

17

 

Total license and collaboration services revenue

 

$

44,321

 

 

$

27

 

 

$

44,348

 

Amounts recognized as revenue under the Europe Agreement were as follows (in thousands):

 

 

 

 

 

Three Months Ended March 31,

 

Agreement

 

Deliverable

 

2016

 

 

2015

 

Europe

 

    License

 

$

3,238

 

 

$

4,255

 

 

 

    Milestones

 

 

 

 

 

 

 

 

Total license and milestone revenue

 

 

3,238

 

 

 

4,255

 

 

 

Collaboration services revenue*

 

$

348

 

 

$

576

 

 

 

*

When and if available compounds, manufacturing — clinical supplies, development services — in progress at the time of signing of the agreement, and committee services have each been identified as a separate unit of accounting with standalone value and amounts allocable to these units have been recognized in revenue as services are performed and classified within the Collaboration services revenue line item within the condensed consolidated statements of operations.

The total arrangement consideration has been allocated to each of the following deliverables under the Europe Agreement, along with any associated deferred revenue as follows (in thousands):

 

 

 

Cumulative

Revenue

Through

March 31, 2016

 

 

Deferred

Revenue at

March 31, 2016

 

 

Total

Consideration

Through

March 31, 2016

 

License

 

$

404,554

 

 

$

 

 

$

404,554

 

When and if available compounds

 

 

343

 

 

 

427

 

 

 

770

 

Manufacturing--clinical supplies

 

 

9,690

 

 

 

 

 

 

9,690

 

Development services--in progress

 

 

32,413

 

 

 

 

 

 

32,413

 

Committee services

 

 

278

 

 

 

2

 

 

 

280

 

Total license and collaboration services revenue

 

$

447,278

 

 

$

429

 

 

$

447,707

 

 

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Amounts recognized as revenue under the U.S./RoW Agreement were as follows (in thousands):

 

 

 

 

 

Three Months Ended March 31,

 

Agreement

 

Deliverable

 

2016

 

 

2015

 

U.S. / RoW

and China

 

    License

 

$

16,425

 

 

$

6,814

 

 

 

    Milestones

 

 

 

 

 

 

 

 

Total license and milestone revenue

 

 

16,425

 

 

 

6,814

 

 

 

Collaboration services revenue*

 

 

8,184

 

 

 

4,138

 

 

 

China single unit of accounting**

 

$

 

 

$

 

 

*

Co-development, information sharing, and committee services have been combined into a single unit of accounting because the requirements to share information and serve on committees are useful only in combination with the development services, and because all three items are delivered over the same period while manufacturing — clinical supplies has been identified as a separate unit of accounting with standalone value and amounts allocable to this unit of accounting have been recognized and classified within the Collaboration services revenue line item within the condensed consolidated statements of operations.

**

All revenues attributable to the China unit of accounting are deferred until all deliverables are met. The China license and collaboration services elements have been combined into a single unit of accounting and consideration allocable to this unit is being deferred due to FibroGen’s retention of manufacturing rights and lack of standalone value.

The total arrangement consideration has been allocated to each of the following deliverables under the U.S./RoW Agreement, along with any associated deferred revenue as follows (in thousands):

 

 

 

Cumulative

Revenue

Through

March 31, 2016

 

 

Deferred

Revenue at

March 31, 2016

 

 

Total

Consideration

Through

March 31, 2016

 

License

 

$

306,191

 

 

$

 

 

$

306,191

 

Co-development, information sharing & committee

   services

 

 

58,317

 

 

 

34,775

 

 

 

93,092

 

Manufacturing--clinical supplies

 

 

261

 

 

 

57

 

 

 

318

 

China-single unit of accounting

 

 

 

 

 

62,761

 

 

 

62,761

 

Total license and collaboration services revenue

 

$

364,769

 

 

$

97,593

 

 

$

462,362

 

 

Other Revenues

Other revenues consist of royalty payments received, which are recorded on a monthly basis as they are reported to the Company, and collagen feasibility sales. Other revenues were immaterial for all periods presented.

Deferred Revenue

Deferred revenue represents amounts billed to the Company’s collaboration partners for which the related revenues have not been recognized because one or more of the revenue recognition criteria have not been met. The current portion of deferred revenue represents the amount to be recognized within one year from the balance sheet date based on the estimated performance period of the underlying deliverables. The long term portion of deferred revenue represents amounts to be recognized after one year through the end of the non-contingent performance period of the underlying deliverables. The long term portion of deferred revenue also includes amounts allocated to the China unit of accounting under the AstraZeneca arrangement as revenue recognition associated with this unit of accounting is tied to the commercial launch of the products within China, which is not expected to occur within the next year.

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3.

Fair Value Measurements

The fair values of our financial assets that are measured on a recurring basis are as follows (in thousands):

 

 

 

March 31, 2016

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Corporate bonds

 

$

 

 

$

126,279

 

 

$

 

 

$

126,279

 

Bond and mutual funds

 

 

25,712

 

 

 

 

 

 

 

 

 

25,712

 

Equity investments

 

 

231

 

 

 

 

 

 

 

 

 

231

 

Money market funds

 

 

44,761

 

 

 

 

 

 

 

 

 

44,761

 

Certificate of deposits

 

 

 

 

 

2,241

 

 

 

 

 

 

2,241

 

Total

 

$

70,704

 

 

$

128,520

 

 

$

 

 

$

199,224

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2015

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Corporate bonds

 

$

 

 

$

126,103

 

 

$

 

 

$

126,103

 

Bond and mutual funds

 

 

25,052

 

 

 

 

 

 

 

 

 

25,052

 

Equity investments

 

 

197

 

 

 

 

 

 

 

 

 

197

 

Money market funds

 

 

77,639

 

 

 

 

 

 

 

 

 

77,639

 

Certificate of deposits

 

 

 

 

 

8,215

 

 

 

 

 

 

8,215

 

Total

 

$

102,888

 

 

$

134,318

 

 

$

 

 

$

237,206

 

 

Our Level 2 investments are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar investments, issuer credit spreads, benchmark investments, prepayment/default projections based on historical data and other observable inputs.

The fair values of our financial liabilities that are carried at historical cost are as follows (in thousands): 

 

 

 

March 31, 2016

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Lease financing obligations

 

$

 

 

$

 

 

$

97,480

 

 

$

97,480

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2015

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Lease financing obligations

 

$

 

 

$

 

 

$

97,445

 

 

$

97,445

 

 

The fair values of our financial liabilities were derived by using an income approach, which required Level 3 inputs such as discounted estimated future cash flows.

There were no transfers of assets or liabilities between levels for any of the periods presented.

 

4.

Balance Sheet Components

Cash and Cash Equivalents

Cash and cash equivalents consisted of the following (in thousands):

 

 

 

March 31, 2016

 

 

December 31, 2015

 

Cash

 

$

96,198

 

 

$

75,685

 

Money market funds

 

 

44,761

 

 

 

77,639

 

Total cash and cash equivalents

 

$

140,959

 

 

$

153,324

 

At March 31, 2016, a total of $26.0 million of our cash and cash equivalents were held outside of the U.S. in our foreign subsidiaries to be used primarily for our China operations.

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Investments

All investments are classified as available-for-sale. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s available-for-sale investments by major investments type are summarized in the tables below (in thousands):

 

 

 

March 31, 2016

 

 

 

Amortized Cost

 

 

Gross Unrealized

Holding Gains

 

 

Gross Unrealized

Holding Losses

 

 

Fair Value

 

Corporate bonds

 

$

125,825

 

 

$

529

 

 

$

(75

)

 

$

126,279

 

Certificate of deposits

 

 

2,241

 

 

 

 

 

 

 

 

 

2,241

 

Bond and mutual funds

 

 

25,712

 

 

 

 

 

 

 

 

 

25,712

 

Equity investments

 

 

126

 

 

 

105

 

 

 

 

 

 

231

 

Total investments

 

$

153,904

 

 

$

634

 

 

$

(75

)

 

$

154,463

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2015

 

 

 

Amortized Cost

 

 

Gross Unrealized

Holding Gains

 

 

Gross Unrealized

Holding Losses

 

 

Fair Value

 

Corporate bonds

 

$

126,522

 

 

$

54

 

 

$

(473

)

 

$

126,103

 

Certificate of deposits

 

 

8,217

 

 

 

 

 

 

(2

)

 

 

8,215

 

Bond and mutual funds

 

 

25,052

 

 

 

 

 

 

 

 

 

25,052

 

Equity investments

 

 

126

 

 

 

71

 

 

 

 

 

 

197

 

Total investments

 

$

159,917

 

 

$

125

 

 

$

(475

)

 

$

159,567

 

At March 31, 2016, all of the available-for-sale investments had contractual maturities within three years. The Company periodically reviews its available-for-sale investments for other-than-temporary impairment. The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and our intent to sell. For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. During the three months ended March 31, 2016 and 2015, the Company did not recognize any other-than-temporary impairment loss.

Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):

 

 

 

March 31, 2016

 

 

December 31, 2015

 

Preclinical and clinical trial accruals

 

$

29,023

 

 

$

27,973

 

Payroll and related accruals

 

 

9,511

 

 

 

13,535

 

Professional services

 

 

1,338

 

 

 

1,662

 

Other

 

 

4,166

 

 

 

4,762

 

Total accrued liabilities

 

$

44,038

 

 

$

47,932

 

 

5.

Stock-Based Compensation

Stock-based compensation expense was allocated to research and development and general and administrative expense as follows (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2016

 

 

2015

 

Research and development

 

$

4,496

 

 

$

4,222

 

General and administrative

 

 

2,844

 

 

 

2,224

 

Total stock-based compensation expense

 

$

7,340

 

 

$

6,446

 

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The assumptions used to estimate the fair value of stock options granted and ESPPs using the Black-Scholes option valuation model were as follows:

 

 

 

Three Months Ended March 31,

 

 

 

2016

 

 

2015

 

Stock Options

 

 

 

 

 

 

 

 

Expected term (in years)

 

 

5.3

 

 

 

5.2

 

Expected volatility

 

 

69

%

 

 

70

%

Risk-free interest rate

 

 

1.4

 

 

 

1.4

 

Expected dividend yield

 

 

 

 

 

 

Weighted average estimated fair value

 

$

11.46

 

 

$

17.49

 

 

 

 

 

 

 

 

 

 

ESPPs

 

 

 

 

 

 

 

 

Expected term (in years)

 

0.4 - 2.0

 

 

0.4 - 2.0

 

Expected volatility

 

58.5 - 70.3%

 

 

58.5 - 68.3%

 

Risk-free interest rate

 

0.1 - 0.9%

 

 

0.1 - 0.4%

 

Expected dividend yield

 

 

 

 

 

 

Weighted average estimated fair value

 

$

12.80

 

 

$

13.27

 

 

6.

Income Taxes

The benefit from income taxes for the three months ended March 31, 2016 was primarily due to the discrete tax effect arising from other comprehensive income related to available-for-sale securities. The benefit for income taxes for the three months ended March 31, 2015 was due to the discrete tax effect arising from other comprehensive income related to available-for-sale securities.  

Based upon the weight of available evidence, which includes our historical operating performance, reported cumulative net losses since inception and expected continuing net loss, we have established and continue to maintain a full valuation allowance against our deferred tax assets as we do not currently believe that realization of those assets is more likely than not.

 

7.

Related Party Transactions

Astellas is an equity investor in the Company and considered a related party. During the quarter ended March 31, 2016 and 2015, the Company recorded revenue related to collaboration agreements with Astellas of $3.7 million and $5.3 million, respectively. During the quarter ended March 31, 2016 and 2015, the Company recorded expense related to collaboration agreements with Astellas of $1.6 million and $3.0 million, respectively.

As of March 31, 2016 and December 31, 2015, accounts receivable from Astellas were $3.7 million and $4.5 million, respectively, and amounts due to Astellas were $1.6 million and $2.0 million, respectively.

Julian N. Stern, a director of the Company since November 1996, is of counsel to the law firm of Goodwin Procter LLP, which he joined in 2008. He has received, and continues to receive, no compensation from Goodwin Procter LLP since joining it as of counsel. The Company retains Goodwin Procter LLP as legal counsel for various matters, primarily consisting of intellectual property matters. During the three months ended March 31, 2016 and 2015, the Company made payments to Goodwin Procter LLP of less than $0.1 million, respectively. As of March 31, 2016 and December 31, 2015, the balance of accrued liability for Goodwin Proctor LLP was immaterial.

 

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Table of Contents

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with the condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q, and in our Securities and Exchange Commission (“SEC”) filings, including our Annual Report on Form 10-K for the year ended December 31, 2015 filed with the SEC on February 29, 2016.

FORWARD-LOOKING STATEMENTS

The following discussion and information contained elsewhere in this Quarterly Report on Form 10-Q contain “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “should,” “estimate,” or “continue,” and similar expressions or variations. Such forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section titled “Risk Factors,” set forth in Part II, Item 1A of this Quarterly Report on Form 10-Q. The forward-looking statements in this Quarterly Report on Form 10-Q represent our views as of the date of this Quarterly Report on Form 10-Q. We anticipate that subsequent events and developments will cause our views to change. New risks emerge from time to time, and it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties, and assumptions, the forward-looking events and circumstances discussed in this Quarterly Report on Form 10-Q may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. While we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Quarterly Report on Form 10-Q and are cautioned not to place undue reliance on such forward-looking statements.

BUSINESS OVERVIEW

We were incorporated in 1993 in Delaware and are a research-based, biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. We have capitalized on our extensive experience in fibrosis and hypoxia-inducible factor (“HIF”) biology to generate multiple programs targeting various therapeutic areas. Roxadustat, or FG-4592, is an oral small molecule inhibitor of HIF prolyl hydroxylases (“HIF-PHs”) in Phase 3 clinical development for the treatment of anemia in chronic kidney disease (“CKD”). FG-3019 is our monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (“IPF”), pancreatic cancer, Duchenne muscular dystrophy (“DMD”) and liver fibrosis. We have taken a global approach with respect to our product candidates, and this includes development and commercialization of product candidates in the People’s Republic of China (“China”).

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Table of Contents

Financial Highlights

 

 

Three Months Ended March 31,

 

 

2016

 

 

2015

 

 

(in thousands, except for per share data)

 

Result of Operations

 

 

 

 

 

 

 

Revenue

$

28,282

 

 

$

16,298

 

Operating expenses

$

55,067

 

 

$

61,021

 

Net loss

$

(27,841

)