0000921299falseFIBROGEN INC00009212992022-05-092022-05-09

 

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 09, 2022

 

 

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.)
409 Illinois Street
San Francisco, California				94158
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (415) 978-1200

 

(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(s)		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 9, 2022, FibroGen, Inc. (“FibroGen”) issued a press release announcing financial results for the quarter ended March 31, 2022. 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 2022 Financial Results,” dated May 9, 2022
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 thereunto duly authorized.

			FIBROGEN, INC.
Date:	May 9, 2022	By:	/s/ Juan Graham
			Juan Graham Senior Vice President and Chief Financial Officer

 

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Exhibit 99.1

FibroGen Reports First Quarter 2022 Financial Results

 

• Completed enrollment in ZEPHYRUS-1 Phase 3 study of pamrevlumab in idiopathic pulmonary fibrosis

• 1Q 2022 revenue of $60.8M, growth of 58% vs. 1Q 2021

• Significant roxadustat volume growth in China in first quarter 2022 offsetting NRDL price reduction

 

 

SAN FRANCISCO, May 9, 2022 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the first quarter 2022 and provided an update on the company’s recent developments.

 

“We continue our progress in advancing pamrevlumab in three high value indications and are delighted to have completed enrollment of the ZEPHYRUS-1 Phase 3 study in idiopathic pulmonary fibrosis,” said Enrique Conterno, Chief Executive Officer, FibroGen. “In addition, roxadustat is off to a strong start in 2022 in China with significant year over year volume growth.”

 

Recent Developments:

 

China Performance:

 

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[1] Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.

 

 

 

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Upcoming Milestones:

 

Financial:

 

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Monday, May 9, 2022, 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 2022 financial results conference call, and use confirmation number 2487763. A replay of the webcast will be available shortly after the call for a period of 7 days. To access the replay, please dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international) and use passcode 2487763.

 

About Pamrevlumab

Pamrevlumab is a potential first-in-class antibody being developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD). Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

 

About Roxadustat

Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for anemia of chronic kidney disease (CKD) and anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA).

Roxadustat is approved in European Union (EU) member states, including the European Economic Area (EEA) countries, as well as in Japan, China, Chile, South Korea, Russia, and the UK for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca to regulatory authorities across the globe, and are currently under review.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets not licensed to Astellas.

 

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About FibroGen

FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of potential first-in-class therapeutics. The Company applies its pioneering expertise in connective tissue growth factor (CTGF) biology and hypoxia-inducible factor (HIF) to advance innovative medicines for the treatment of unmet needs. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD). 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), anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA). FibroGen recently expanded its research and development portfolio to include product candidates in the immuno-oncology and autoimmune space. 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, 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, 2021 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)

 

	March 31, 2022				December 31, 2021
	(Unaudited)				(1)
Assets
Current assets:
Cash and cash equivalents	$	185,896			$	171,223
Short-term investments		242,179				233,967
Accounts receivable, net		43,883				17,401
Inventory		43,067				31,015
Prepaid expenses and other current assets		9,390				20,453
Total current assets		524,415				474,059
Restricted time deposits		2,072				2,072
Long-term investments		93,488				167,796
Property and equipment, net		26,881				28,277
Equity method investment in unconsolidated variable interest entity		4,155				3,825
Operating lease right-of-use assets		87,990				91,112
Other assets		6,933				6,680
Total assets	$	745,934			$	773,821
Liabilities, stockholders’ equity and non-controlling interests
Current liabilities:
Accounts payable	$	36,353			$	26,097
Accrued and other liabilities		203,299				172,599
Deferred revenue		4,744				15,857
Operating lease liabilities, current		10,978				10,944
Total current liabilities		255,374				225,497
Product development obligations		17,374				17,613
Deferred revenue, net of current		184,893				186,801
Operating lease liabilities, non-current		85,948				88,776
Other long-term liabilities		24,330				26,021
Total liabilities		567,919				544,708
Total stockholders’ equity		158,048				209,146
Non-controlling interests		19,967				19,967
Total equity		178,015				229,113
Total liabilities, stockholders’ equity and non-controlling interests	$	745,934			$	773,821

 

 

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Condensed Consolidated Statements of Operations

(In thousands, except per share data)

	Three Months Ended March 31,
	2022				2021
	(Unaudited)
Revenue:
License revenue	$	22,590			$	—
Development and other revenue		11,762				14,587
Product revenue, net		18,881				15,362
Drug product revenue		7,594				8,480
Total revenue		60,827				38,429
Operating costs and expenses:
Cost of goods sold		4,238				3,401
Research and development		89,018				74,676
Selling, general and administrative		30,564				30,779
Total operating costs and expenses		123,820				108,856
Loss from operations		(62,993	)			(70,427	)
Interest and other, net:
Interest expense		(97	)			(501	)
Interest income and other income (expenses), net		(322	)			(453	)
Total interest and other, net		(419	)			(954	)
Loss before income taxes		(63,412	)			(71,381	)
Provision for income taxes		113				134
Investment income (loss) in unconsolidated    variable interest entity		320				(240	)
Net loss	$	(63,205	)		$	(71,755	)
Net loss per share - basic and diluted	$	(0.68	)		$	(0.78	)
Weighted average number of common shares used to     calculate net loss per share - basic and diluted		93,043				91,688

 

 

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Contacts:

FibroGen, Inc.

 

Investors:

Michael Tung, M.D.

Corporate Strategy / Investor Relations

415.978.1434

mtung@fibrogen.com

 

Media:

Meichiel Keenan

Investor Relations and Corporate Communications

mkeenan@fibrogen.com

 

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