false 0000921299 0000921299 2020-05-07 2020-05-07

 

 

 

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): May 7, 2020

 

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))

 

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 is an emerging growth company 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.☐

 

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Item 2.02	Results of Operations and Financial Condition.

On May 7, 2020, FibroGen, Inc. (“FibroGen”) issued a press release announcing financial results for the quarter ended March 31, 2020. 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, 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 First Quarter 2020 Financial Results,” dated May 7, 2020
104			Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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: May 7, 2020
				By:		/s/ Pat Cotroneo
						Pat Cotroneo
						Senior Vice President, Finance and Chief Financial Officer

 

Exhibit 99.1

FibroGen Reports First Quarter 2020 Financial Results

 

- Roxadustat U.S. NDA review and E.U. MAA filing on track -

Conference Call Today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time

 

SAN FRANCISCO, May 07, 2020 -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the first quarter of 2020 and provided an update on the company’s recent developments.

 

“During this difficult time, we continue to be inspired by our unique opportunity to leverage world-class science to benefit patients,” said Enrique Conterno, Chief Executive Officer, FibroGen. “The COVID-19 pandemic has presented a number of unprecedented challenges, including in the conduct and enrollment of our clinical trials. Nevertheless, I want to reassure patients, healthcare providers, and stakeholders of our continued commitment to bring to patients our potential first-in-class medicines for the treatment of chronic and life-threatening conditions. Our strong financial position gives us sufficient runway to navigate this storm.”  

 

“We remain focused on ensuring the regulatory and commercial success of roxadustat, a potentially transformational oral medicine in anemia therapy, first demonstrated in patients with chronic kidney disease. With pamrevlumab, our monoclonal antibody targeting connective tissue growth factor (CTGF), we are implementing a comprehensive plan to accelerate development across the three indications of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD) once the situation with COVID-19 improves. Finally, we continue to advance the innovation of our hypoxia-inducible factor (HIF) and CTGF platforms.”

 

Key Events in Recent Months and Other Developments

 

Roxadustat

Pamrevlumab

 

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Upcoming Events

 

Corporate and Financial

 

Conference Call and Webcast Details  

FibroGen will host a conference call and webcast today, Thursday, May 7, 2020, at 5:00 p.m. Eastern Time (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 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen first quarter 2020 financial results conference call, and use passcode 9946439. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and use passcode 9946439.

 

About Roxadustat

Roxadustat is a first-in-class, orally administered small molecule HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, and improved iron absorption, transport and mobilization. Roxadustat is approved in China for the treatment of anemia in CKD patients on dialysis and patients not on dialysis, and is approved in Japan for the treatment of anemia in CKD patients on dialysis, and a supplemental NDA for the treatment of anemia in CKD patients not on dialysis is under regulatory review. The roxadustat NDA for the treatment of anemia in CKD is under review by the U.S. FDA with a Prescription Drug User Fee Act date of December 20, 2020. Our partner Astellas expects the Marketing Authorization Application filing for roxadustat for the treatment of anemia in CKD in the second quarter of 2020. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia.

 

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan and Europe. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets.

 

About Pamrevlumab

Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

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About FibroGen

FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing 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 to advance innovative medicines to treat unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer, and Duchenne muscular dystrophy (DMD). 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 and commercialization of the company’s product candidates, our financial results, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, 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,” “will”, “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, 2019 and our Quarterly Report on Form 10-Q for quarter ended March 31, 2020 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.

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Condensed Consolidated Balance Sheets

(In thousands)

 

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Condensed Consolidated Statements of Operations

(In thousands, except per share data)

 

 

Contact: FibroGen, Inc.

 

Media Inquiries:

Sara Iacovino

1.703.474.4452

sara.iacovino@gcihealth.com

 

Investors:

Michael Tung, M.D.

Corporate Strategy / Investor Relations

1.415.978.1434

mtung@fibrogen.com