fgen-8k_20180227.htm

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 27, 2018

 

FibroGen, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

001-36740

 

77-0357827

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

FibroGen, Inc.

409 Illinois Street

San Francisco, CA 94158

(Address of principal executive offices, including zip code)

(415) 978-1200

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

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))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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.  

 


 

 

 

 

Item 2.02

Results of Operations and Financial Condition.

On February 27, 2018, FibroGen, Inc. (“FibroGen”) issued a press release announcing financial results for the quarter and full year ended December 31, 2017. A copy of such press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

The information in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in Exhibit 99.1 shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by FibroGen, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01

Financial Statements and Exhibits.

 

(d)

Exhibits

 

 

 

Exhibit No.

  

Description

 

 

99.1

  

Press Release titled “FibroGen Reports Fourth Quarter and Full Year 2017 Financial Results,” dated February 27, 2018



 

 

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

 

 

 

 

 

 

 

 

FIBROGEN, INC.

 

 

 

Dated: February 27, 2018

 

 

 

 

 

 

 

 

 

 

 

 

By:

 

/s/ Pat Cotroneo

 

 

 

 

 

 

Pat Cotroneo

 

 

 

 

 

 

Vice President, Finance and Chief Financial Officer

 

fgen-ex991_6.htm

Exhibit 99.1

FibroGen Reports Fourth QUARTER and FULL YEAR 2017 Financial Results

 

Roxadustat U.S. Phase 3 Program in CKD Anemia Enrollment Completion and Data Readout in 2018

Pamrevlumab Phase 2 IPF Study Achieves Statistically Significant Attenuation of Lung Fibrosis as Measured by Quantitative HRCT

 

Conference Call and Webcast to be Held Today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time

 

SAN FRANCISCO, February 27, 2018 -- FibroGen, Inc. (NASDAQ: FGEN), a science-based biopharmaceutical company, today reported financial results for the fourth quarter and full year 2017 and provided an update on the company’s recent developments.

 

“In 2017, we continued to make significant progress on key clinical and regulatory milestones. Our first NDA submission for roxadustat was accepted for review by the China Food and Drug Administration. With our partners, we are advancing the roxadustat Phase 3 CKD anemia programs to completion with plans to file for market approvals in the U.S., Europe, and Japan. In our fibrosis program, pamrevlumab has demonstrated tremendous potential in multiple indications. In a randomized double-blind, placebo-controlled Phase 2b study in IPF, pamrevlumab was well-tolerated and achieved statistical significance in the primary endpoint of FVC % predicted, in FVC, and in the secondary endpoints of quantitative changes of lung fibrosis, disease progression, and patient-reported outcomes,” said Thomas B. Neff, FibroGen’s Chief Executive Officer. “We are intensely focused on the execution of critical activities for our CKD anemia, idiopathic pulmonary fibrosis, and pancreatic cancer programs as these approach important new milestones in 2018.”

 

Recent Developments and Highlights

Roxadustat for CKD Anemia in U.S./ROW

With our partner AstraZeneca, we have agreed to a timeline for Phase 3 enrollment completion in the second quarter of 2018 and data readout in the fourth quarter of 2018 to support U.S. regulatory submission in the first half of 2019

DSMB recommended Phase 3 clinical studies to continue under current protocols with no changes

 

Roxadustat for CKD Anemia in China

Positive efficacy and safety results reported from two Phase 3 trials

New Drug Application accepted for filing by the CFDA  


Roxadustat for CKD Anemia in Japan

Our partner Astellas has completed three of six Phase 3 trials  

Topline positive Phase 3 results reported in peritoneal dialysis study

 

Roxadustat for MDS Anemia

Enrollment commenced in our first U.S./Europe Phase 3 study for the treatment of anemia in myelodysplastic syndromes (MDS)

 

Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Statistically significant high-resolution computed tomography (HRCT) results achieved in our randomized double-blind, placebo-controlled Phase 2b study  

Positive Phase 2b study results presented at European Respiratory Society (ERS) International Congress 2017

 

Pamrevlumab for Pancreatic Cancer

Reported positive interim Phase 2 open-label results at 2017 ASCO-GI conference showing a majority of pamrevlumab-treated patients converted from unresectable to resectable cancer; all resection evaluations complete and results continue to be favorable for pamrevlumab

 


Corporate and Financial

Net loss for the fourth quarter of 2017 was $22.1 million, or $0.27 per share, compared to $34.0 million, or $0.54 per share one year ago

Net loss for the year ended December 31, 2017 was $126.2 million, or $1.73 per share, compared to $61.7 million, or $0.98 per share one year ago

At December 31, 2017, FibroGen had $762.2 million in cash, restricted time deposits, cash equivalents, investments, and receivables  

 

o

Received a $15.0 million milestone payment from AstraZeneca in the fourth quarter of 2017 upon roxadustat NDA submission to CFDA  

 

o

Completed financings in April 2017 and in August 2017 with net proceeds of $115.1 million and $356.2 million, respectively

 

2018 Outlook

U.S. Phase 3 CKD anemia enrollment completion in the second quarter of 2018

U.S. Phase 3 CKD anemia data readout in the fourth quarter of 2018 to support U.S. regulatory submission in the first half of 2019

NDA approval decision expected in China for CKD anemia by the end of 2018

Expect to confirm plans with our partner Astellas for regulatory submissions in Europe and Japan

Anticipate data readout from two Japan Phase 3 hemodialysis studies, a long-term conversion study and a correction (ESA-naïve) study, in the first quarter of 2018

Anticipate initiation of roxadustat Phase 2/3 clinical study in China for anemia associated with MDS in first half of 2018

Expect to present HRCT and health-related quality-of-life results from the IPF Phase 2b trial at an upcoming scientific conference

Design pivotal trials for IPF and locally advanced pancreatic cancer

 

Conference Call and Webcast Details  

FibroGen will host a conference call and webcast today, February 27, 2018, at 5:00 p.m. Eastern (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen fourth quarter and full year 2017 Financial Results conference call, and use passcode 46307822#. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 46307822#.

 

About Roxadustat

Roxadustat is a first-in-class oral therapeutic in global Phase 3 clinical development as a treatment for anemia associated with chronic kidney disease (CKD) with the potential to offer a safer and more effective, convenient, and accessible treatment than current therapies. Roxadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), promotes erythropoiesis, or the production of red bloods, by increasing endogenous erythropoietin, improving iron regulation, and reducing hepcidin, including in the presence of inflammation and without need for supplemental intravenous iron.

 

The roxadustat Phase 3 program is the largest Phase 3 clinical program in anemia to date, and is supported by extensive Phase 2 results demonstrating correction and maintenance of hemoglobin levels in anemia in multiple subpopulations of CKD dialysis and non-dialysis patients. A New Drug Application (NDA) has been accepted for review by the China Food and Drug Administration (CFDA), and enrollment completion and data readout for the Phase 3 program are expected in 2018. Roxadustat is also in Phase 3 clinical development in the U.S. and Europe, and expected to shortly enter Phase 2/3 development in China, for anemia associated with myelodysplastic syndromes (MDS). For information about roxadustat studies currently recruiting patients, please visit www.clinicaltrials.gov.

 

About Pamrevlumab

Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). Pamrevlumab has been well tolerated in a number of Phase 2 clinical studies to date, with a good safety and tolerability profile. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

 


About FibroGen

FibroGen, Inc., headquartered in San Francisco, CA with subsidiary offices in Beijing and Shanghai, PRC, is a leading science-based biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology and clinical development to advance innovative medicines for the treatment of anemia, fibrotic disease, and cancer. Roxadustat, the company’s most advanced product candidate, is an oral small molecule inhibitor of HIF prolyl hydroxylase activity in worldwide Phase 3 clinical development for the treatment of anemia in chronic kidney disease (CKD) with the exception of China, where a New Drug Application is currently under review by the CFDA for regulatory approval. Roxadustat is in Phase 3 clinical development in the U.S. and Europe, and expected to shortly enter Phase 2/3 development in China, for anemia associated with myelodysplastic syndromes (MDS). Pamrevlumab, a fully-human monoclonal anti-CTGF antibody, is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD).  FibroGen is also developing a biosynthetic cornea in China. For more information, please visit www.fibrogen.com.

 

Forward-Looking Statements

This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development of the company's product candidates pamrevlumab and roxadustat, the potential safety and efficacy profile of our product candidates, and our clinical, regulatory, and commercial plans, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as “may,” “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.      

 

 

# # #



 

Condensed Consolidated Balance Sheets

(In thousands)

 

December 31, 2017

 

 

December 31, 2016

 

 

(Unaudited)

 

 

(1)

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

673,658

 

 

$

173,782

 

Short-term investments

 

62,060

 

 

 

79,397

 

Accounts receivable

 

8,452

 

 

 

10,448

 

Prepaid expenses and other current assets

 

4,800

 

 

 

2,889

 

Total current assets

 

748,970

 

 

 

266,516

 

 

 

 

 

 

 

 

 

Restricted time deposits

 

5,181

 

 

 

6,217

 

Long-term investments

 

10,506

 

 

 

71,010

 

Property and equipment, net

 

129,476

 

 

 

123,657

 

Other assets

 

4,517

 

 

 

2,152

 

Total assets

$

898,650

 

 

$

469,552

 

 

 

 

 

 

 

 

 

Liabilities, stockholders' equity and non-controlling interests

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

5,509

 

 

$

6,223

 

Accrued liabilities

 

63,781

 

 

 

50,914

 

Deferred revenue

 

7,968

 

 

 

7,988

 

Total current liabilities

 

77,258

 

 

 

65,125

 

 

 

 

 

 

 

 

 

Long-term portion of lease financing obligations

 

97,763

 

 

 

97,352

 

Product development obligations

 

17,244

 

 

 

14,854

 

Deferred rent

 

3,657

 

 

 

4,212

 

Deferred revenue, net of current

 

112,231

 

 

 

106,709

 

Other long-term liabilities

 

8,047

 

 

 

6,191

 

Total liabilities

 

316,200

 

 

 

294,443

 

 

 

 

 

 

 

 

 

Total stockholders’ equity

 

563,179

 

 

 

155,838

 

Non-controlling interests

 

19,271

 

 

 

19,271

 

Total equity

 

582,450

 

 

 

175,109

 

Total liabilities, stockholders' equity and non-controlling interests

$

898,650

 

 

$

469,552

 

(1)

The condensed consolidated balance sheet amounts at December 31, 2016 are derived from audited financial statements.

 



Condensed Consolidated Statements of Operations

(In thousands, except per share data)

 

Three Months Ended December 31,

 

 

Years Ended December 31,

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

 

(Unaudited)

 

 

 

(Unaudited)

 

 

 

(1)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License and milestone revenue

$

 

35,126

 

 

$

 

23,551

 

 

$

 

96,056

 

 

$

 

137,352

 

Collaboration services and other revenue

 

 

7,383

 

 

 

 

8,362

 

 

 

 

29,612

 

 

 

 

42,225

 

Total revenue

 

 

42,509

 

 

 

 

31,913

 

 

 

 

125,668

 

 

 

 

179,577

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

52,469

 

 

 

 

50,607

 

 

 

 

196,517

 

 

 

 

187,206

 

General and administrative

 

 

13,851

 

 

 

 

12,585

 

 

 

 

51,760

 

 

 

 

46,025

 

Total operating expenses

 

 

66,320

 

 

 

 

63,192

 

 

 

 

248,277

 

 

 

 

233,231

 

Loss from operations

 

 

(23,811

)

 

 

 

(31,279

)

 

 

 

(122,609

)

 

 

 

(53,654

)

Interest and other, net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

(1,806

)

 

 

 

(2,750

)

 

 

 

(9,706

)

 

 

 

(10,725

)

Interest income and other, net

 

 

3,651

 

 

 

 

217

 

 

 

 

6,433

 

 

 

 

2,628

 

Total interest and other, net

 

 

1,845

 

 

 

 

(2,533

)

 

 

 

(3,273

)

 

 

 

(8,097

)

Loss before income taxes

 

 

(21,966

)

 

 

 

(33,812

)

 

 

 

(125,882

)

 

 

 

(61,751

)

Provision for (benefit from) income taxes

 

 

156

 

 

 

 

189

 

 

 

 

321

 

 

 

 

(71

)

Net loss

$

 

(22,122

)

 

$

 

(34,001

)

 

$

 

(126,203

)

 

$

 

(61,680

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted

 

$

(0.27

)

 

 

$

(0.54

)

 

 

$

(1.73

)

 

 

$

(0.98

)

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

 

 

82,151

 

 

 

 

63,345

 

 

 

 

72,987

 

 

 

 

62,744

 

(1)

The condensed consolidated statements of operations amounts for the year ended December 31, 2016 are derived from audited financial statements.

Contact

FibroGen, Inc.

Karen L. Bergman

Vice President, Investor Relations and Corporate Communications

1 (415) 978-1433

kbergman@fibrogen.com