Delaware

001-36740

77-0357827

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

¨

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02

Results of Operations and Financial Condition.

Item 9.01

Financial Statements and Exhibits.

(d)

Exhibits

Exhibit No.

Description

99.1

Press Release titled “FibroGen Reports Financial Results for the First Quarter of 2016,” dated May 9, 2016

FIBROGEN, INC.

Dated: May 9, 2016

By:

/s/ Pat Cotroneo

Pat Cotroneo

Vice President, Finance and Chief Financial Officer

Exhibit No.

Description

99.1

Press Release titled “FibroGen Reports Financial Results for the First Quarter of 2016,” dated May 9, 2016

·

Timelines for roxadustat remain on track. The company expects to initiate new drug application submissions for roxadustat in 2016 for China and in 2018 for the U.S.

·

FibroGen and partners AstraZeneca and Astellas are conducting a total of seven Phase 3 trials for registration in the U.S., Europe, and other territories. FibroGen has completed target enrollment for two out of the three FibroGen-sponsored studies, and we have achieved over 80% of target enrollment in the third study.

·

The independent data safety monitoring board overseeing roxadustat U.S. and Europe Phase 3 studies met in April 2016 to review the roxadustat safety data, and confirmed that the trials should proceed with current Phase 3 protocols without modification.

·

In China, we are conducting two pivotal Phase 3 trials with roxadustat. We are over 80% enrolled in our 300 patient dialysis study, for which the primary efficacy endpoint is 26 weeks, and expect to complete enrollment this month. We are approximately one-third enrolled in our 150 patient non-dialysis study, for which the primary efficacy endpoint is eight weeks, and expect to complete enrollment in the third quarter of 2016. We expect to be able to report data in both studies by year-end.

·

In idiopathic pulmonary fibrosis (IPF), promising data from our open-label, single-arm dose-finding trial in subjects with moderate to severe IPF were presented in a manuscript published in the European Respiratory Journal (on-line publication in March, and in-print publication in May of this year). Results of the study showed that after 48 weeks of treatment 35% of the subjects receiving FG-3019 had stable or improved lung fibrosis, 24% had improved fibrosis, both as measured by quantitative high resolution computed tomography. For subjects in the high dose group with baseline forced vital capacity (FVC)≥55% predicted, 37% showed improvement in pulmonary function (as measured by FVC) at the end of the initial 48 week treatment portion of the study. An accompanying editorial noted that, to the best of current knowledge, neither of the two currently approved IPF treatments are targeting connective tissue growth factor (CTGF), posing a promising basis for a future placebo-controlled trial combining our anti-CTGF antibody FG-3019 with pirfenidone or nintedanib.

·

We continue to see promising preliminary data from our ongoing open-label Phase 2 study in patients with inoperable Stage 3 pancreatic cancer. Subjects entering the trial must have failed resection scoring, i.e., been found to have unresectable tumors, and thus not eligible for surgery. At present, of nine patients randomized to receive FG-3019 plus chemotherapy (standard-of-care) three patients continue on treatment, one discontinued treatment early due to a chemotherapy-related serious adverse event and five patients completed six months of treatment. All five who completed treatment were reassessed as eligible for resection based on standard scoring criteria set forth in the protocol. Seven patients have been randomized to the comparator arm with only standard of care chemotherapy. Of the seven patients, three experienced disease progression prior to completing treatment and four completed the treatment regimen, of which only one was reassessed as eligible for tumor removal.  

·

We continue to enroll subjects and add sites in our open-label Phase 2 study of FG-3019 in non-ambulatory Duchenne muscular dystrophy (DMD) patients.

·

Net loss per basic and diluted share, for the quarter ended March 31, 2016, was $0.45 per share, an improvement of $0.33 per share as compared to the same period last year.

·

At March 31, 2016, FibroGen had $309.9 million of cash, cash equivalents, investments, receivables and restricted cash.

·

For the quarter ended March 31, 2016, revenue increased 74% and research and development expenses decreased 14% as compared to the same period last year, largely due to the fact that we had reached the 50/50 spending cap with AstraZeneca during the fourth quarter of 2015 on our initial funding obligations for roxadustat. Under an agreement between FibroGen and AstraZeneca, FibroGen’s total funding obligations for roxadustat development in CKD outside China are limited to $116.5 million. As of the end of the fourth quarter of 2015, the $116.5 million cap on our share of development costs for roxadustat has been reached. Therefore starting in the first quarter of 2016, we no longer share 50% of the development costs compared to the prior periods, as, Astellas and AstraZeneca are now responsible for funding future development and commercialization costs for roxadustat in CKD through launch for all territories, excluding China, where AstraZeneca pays 50% of development costs.

March 31, 2016

December 31, 2015

(Unaudited)

(1)

Assets

Current assets:

Cash and cash equivalents

$

140,959

$

153,324

Short-term investments

32,454

27,847

Accounts receivable

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

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

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

(1)

The condensed consolidated balance sheet amounts at December 31, 2015 are derived from audited financial statements.

Three Months Ended March 31,

2016

2015

(Unaudited)

Revenue:

License and milestone revenue

$

19,738

$

11,506

Collaboration services and other revenue

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